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Advances and future research prospects in regulatory policies for clinical trials of artificial intelligence medical devices LIANG Hao, WANG Shun, CUI Cheng, SONG Ling, SUN Ailin, LI Man, QIAO Jie, SONG Chunli, LI Haiyan, ZHAO Yangguang, LI Haiyan, ZHANG Chenguang, LIU Dongyang Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 427-431.   DOI: 10.12092/j.issn.1009-2501.2025.03.017 Abstract （359）      PDF （581KB）（2600）       Knowledge map    Save Artificial intelligence (AI) has emerged as a cutting-edge technology leading the future and is a key engine for China's development. In the innovation and research of medical devices, AI has provided critical support in the areas of intelligent diagnostic assistance, intelligent therapeutic assistance, intelligent monitoring, life support, et al. Machine learning-enabled device software functions (ML-DSFs) have become an essential component of many medical devices. Recently, the United States Food and Drug Administration (FDA) released a draft guidance titled " Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (Draft). " that aimed to provide a forward-looking approach to foster the development of ML medical devices. By supporting iterative updates through modifications, this approach ensures the continuous safety and effectiveness of the devices. This guidance represents the latest in regulatory direction and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI products. Therefore, we plan to provide a detailed introduction and interpretation of the guidance, with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence. Related Articles | Metrics

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Research progress on the clinical application and mechanism of commonly used traditional Chinese medicine in the treatment of breast cancer LI Shanshan, WEI Dandan, KANG Hanyu, LIU Xiaopeng, YAN Shuxun, JIANG Shiqing Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (7): 977-983.   DOI: 10.12092/j.issn.1009-2501.2025.07.013 Abstract （299）      PDF （988KB）（2316）       Knowledge map    Save Breast cancer is a common clinical gynecological tumor. According to the 2022 global cancer data statistics, breast cancer ranks second in terms of incidence among newly diagnosed cancer cases worldwide. Modern medicine often adopts surgical operation, chemotherapy, and other methods, which have certain efficacy but also many problems such as high drug resistance rates and significant adverse reactions. Chinese patent medicines exhibit extensive anticancer effects. The study found that Shenyi Capsule, Pingxiao Capsule, and Zhenqi Fuzheng Granules were widely used in the treatment of breast cancer, exerting therapeutic effects on breast cancer by inhibiting cell proliferation, invasion, and metastasis, suppressing angiogenesis, reversing cellular drug resistance, and inhibiting precancerous lesions. Meanwhile, the oral administration of Chinese patent medicines in combination with other traditional Chinese medicine (TCM) compounds, TCM decoctions, or modern medical treatments can improve patients' quality of life and reduce adverse reactions. Currently, there are numerous studies on the treatment of breast cancer with Chinese patent medicines, but a systematic summary is lacking. Therefore, this study conducted a systematic review of the mechanisms of action and clinical applications of Chinese patent medicines as adjuvant therapy for breast cancer, aiming to provide guidance for clinical medication. Related Articles | Metrics

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Research progress of traditional Chinese medicine intervention in chemotherapy renal injury LIU Yeyuan, QI Yafeng, ZHANG Maofu, LI Xinyu, SHEN Yanyun, LIU Yu, ZHANG Shangzu, LI Yangyang, ZHANG Liying, ZHANG Zhiming Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 556-569.   DOI: 10.12092/j.issn.1009-2501.2025.04.015 Abstract （299）      PDF （843KB）（2312）       Knowledge map    Save Renal injury is one of the common adverse reactions in the clinical application of chemotherapy drugs, which is the main reason why the chemotherapy can not be carried out in the whole cycle. The pathological mechanism of chemotherapy-induced renal injury is very complicated, mainly involving oxidative stress, inflammatory response, apoptosis, mitochondrial dysfunction, and regulation of transporters, causing pathological damage to renal tubules or glomeruli. At present, there is no specific pharmacological intervention for the treatment of chemotherapy-induced renal injury. As a treasure of traditional Chinese medicine, traditional Chinese medicine has the advantages of overall regulation, multi-targeting, small adverse reactions and no obvious drug dependence in the prevention and treatment of chemotherapy-induced renal injury. In recent years, there have been more and more studies on the intervention of chemotherapy-induced renal injury by multi-component and multi-directional intervention of active components, extracts and compounds of traditional Chinese medicine, and some progress has been made. A large number of studies have shown that the potential mechanisms of traditional Chinese medicine in preventing and treating renal injury induced by chemotherapy include inhibiting oxidative stress, reducing inflammatory response and inhibiting apoptosis. Although there are many studies on the mechanism of action of traditional Chinese medicine in the treatment of chemotherapy-induced renal injury, there is still a lack of systematic review. Based on this, this paper summarizes the mechanism of renal injury induced by chemotherapy and the intervention of traditional Chinese medicine, so as to provide theoretical support for its clinical treatment and new drug innovation. Related Articles | Metrics

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Mechanism of action and research progress of vaccine adjuvants ZHANG Li, LU Chang, AN Minghui, WANG Mengmeng, ZONG Xiaoyu, YU Lin, RAN Zhuo-ling, SONG Jing, LI Huijie, GONG Jian Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (7): 785-791.   DOI: 10.12092/j.issn.1009-2501.2024.07.008 Abstract （887）      PDF （831KB）（2152）       Knowledge map    Save Vaccines are among the most effective measures for preventing infectious diseases and play a crucial role in controlling the spread of these diseases. Adjuvants, serving as auxiliary components in vaccines, are indispensable in the vaccine development process. Ideal adjuvants not only enhance the immune response, enabling the body to achieve optimal protective immunity but also play important roles in reducing the dosage of immunogens and lowering vaccine production costs. To meet the demands of novel vaccines, many new types of adjuvants have been developed. However, there is still a lack of adjuvants that are safe, effective, easy to prepare, highly pure, and suitable for a variety of vaccines in clinical settings. This article categorizes adjuvants and summarizes their mechanisms of action and characteristics, focusing on traditional aluminum salt adjuvants and more modern lipid-based and nucleic acid-based adjuvants. The summary is based on a computer search of databases including PubMed, Embase, The Cochrane Library, CNKI (China National Knowledge Infrastructure), VIP Database, and Wanfang Database, using English search keywords such as Adjuvants, Vaccine, Vaccine Adjuvant, aluminum salts, MF59, AS03, Toll-like receptor agonist, etc., and corresponding Chinese search terms. The aim is to provide references for the development and application of adjuvants. Related Articles | Metrics

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Progress on anti-tumor mechanisms of Ganoderma lucidum active ingredients LV Yujiao, ZHOU Shuting, WANG Lina, SHEN Mingmei, LIU Yongchao Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (8): 947-954.   DOI: 10.12092/j.issn.1009-2501.2024.08.012 Abstract （805）      PDF （712KB）（2105）       Knowledge map    Save Malignant tumors are one of the main causes of death from chronic diseases in China, and their incidence and mortality rates show an increasing trend year by year. Advanced non-surgical treatment of malignant tumors is an important means of improving patients' prognosis and enhancing their quality of life. The traditional Chinese medicine Ganoderma lucidum has anti-tumor effects and plays a role in the treatment of many malignant tumors. In this paper, a systematic review of the effects of Ganoderma lucidum active ingredients on tumors has been conducted at home and abroad in the past five years to explore the anti-tumor mechanism of Ganoderma lucidum active ingredients and to lay a theoretical foundation for the application of Ganoderma lucidum active ingredients in clinical practice. Related Articles | Metrics

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Research progress on the inhibition of cardiac remodeling by vericiguat DING Ding, WU Shengnan, WANG Ancai, WANG Deguo Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (6): 858-863.   DOI: 10.12092/j.issn.1009-2501.2025.06.016 Abstract （160）      PDF （699KB）（2050）       Knowledge map    Save Heart failure (HF) has become a major global medical burden. Despite the existence of several drugs for the treatment of HF, the prognosis is still not optimistic, which motivates us to seek new treatments for this disease. Vericiguat, a novel soluble guanylate cyclase (sGC) stimulator, has been approved for use in patients with heart failure. Cardiac remodeling is the important pathophysiological basis of cardiovascular disease occurrence and development, and closely related to the prognosis of patients. Accumulating evidence suggests that vericiguat inhibits cardiac remodeling, but the molecular mechanism remains unclear. Therefore, an in-depth understanding of the molecular mechanism of action of vericiguat will be important for future studies of this drug as a potential therapy for slowing the severity of heart failure. This article reviews the mechanism and research status of the inhibitory effect of Vericiguat on cardiac remodeling. Related Articles | Metrics

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Research progress of Pinellia ternata and its active ingredients in cardiovascular diseases SONG Min, DIAO Tingting, WANG Yichao, LIU Luyi, QI Qiqi, BI Jingjing, ZHU Nailiang, QIAO Xinrong Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 251-264.   DOI: 10.12092/j.issn.1009-2501.2025.02.013 Abstract （330）      PDF （1237KB）（1899）       Knowledge map    Save Cardiovascular diseases (CVD) are chronic disease with high morbidity and mortality in the world. Pinellia ternata is a traditional Chinese medicinal herb and has the effects on drying dampness, resolving phlegm, lowering symptoms, stopping vomiting and relieving swelling. In recent years, researches showed that Pinellia ternata and its active ingredients (β- sitosterol, baicalin, baicalein, quercetin) had significant effects in the treatment of cardiovascular diseases. This review summarized and analyzed the role and mechanism of Pinellia ternata and its active ingredients in cardiovascular diseases, which provided a theoretical basis for its clinical application. Related Articles | Metrics

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Engineered bacteria modulate tumor-associated macrophages to enhance immunotherapy WANG Long, WANG Yuchen, GUO Yilin, WU Jinhui Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 297-312.   DOI: 10.12092/j.issn.1009-2501.2025.03.002 Abstract （343）      PDF （1338KB）（1803）       Knowledge map    Save The immunosuppressive tumor microenvironment significantly limits the efficacy of immunotherapy. Tumor-associated macrophages (TAMs), the most abundant immune cells in the tumor microenvironment, often exhibit an immunosuppressive M2 phenotype, contributing to this immunosuppressive landscape. Modulating TAMs to adopt anti-tumor phenotypes can enhance immunotherapy outcomes and inhibit tumor progression.In recent years, tumor immunotherapy leveraging engineered bacteria has garnered considerable attention. Bacteria possess the ability to target tumors, preferentially colonizing tumor regions, and contain abundant pathogen-associated molecular patterns that effectively activate TAMs within the immunosuppressive tumor environment. This activation enhances the tumoricidal and clearance capabilities of TAMs. With the rapid advancements in synthetic biology, engineered bacteria have emerged as a potent therapeutic modality for immunotherapy, leading to increased focus on the regulation of TAMs by engineered bacteria.This paper first outlines clinical studies on targeted TAMs therapy and engineered bacteria-based tumor therapy. It then reviews recent advancements in bacterial regulation of TAMs, detailing how engineered bacteria enhance TAM recruitment, improve TAM phagocytosis, and remodel TAM phenotypes. Modulating TAMs with engineered bacteria presents a promising therapeutic strategy and introduces a novel approach in tumor immunotherapy. Related Articles | Metrics

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Advancements and frontiers in targeted therapy for pancreatic cancer DU Nan, WEI Miaoyan, XU Jin Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 183-192.   DOI: 10.12092/j.issn.1009-2501.2025.02.004 Abstract （948）      PDF （762KB）（1792）       Knowledge map    Save The incidence of pancreatic cancer has been increasing each year, and the 5-year survival rate is still around 10%. Diagnosis and treatment strategies are major concerns in the industry. Gene sequencing and multi-omics research have revealed more signal pathways and actionable targets, offering the potential for new targeted therapeutic drugs. However, current drug treatment for pancreatic cancer still relies mainly on chemotherapy, and targeted therapy strategies are not yet fully developed and require further discussion. As basic and translational research in pancreatic cancer advances and precision medicine develops, it is expected that targeted treatment for pancreatic cancer will become more precise and individualized in the future. This article discusses the current progress and frontiers of targeted treatment for pancreatic cancer. Related Articles | Metrics

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Research progress on the role of macrophage polarization in cardiovascular diseases CUI Hanyu, HU Changping Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 548-555.   DOI: 10.12092/j.issn.1009-2501.2025.04.014 Abstract （310）      PDF （699KB）（1687）       Knowledge map    Save As phagocytic innate immune cells, macrophages interact with various tissue types and play an important role in immune defense, inflammatory response and tissue remodeling. Macrophages participate in the occurrence and development of disease by polarizing into classically activated M1 type and substitutively activated M2 type, or more complex phenotypes, when the tissue microenvironment changes. This paper focused on the application of macrophage polarization in cardiovascular diseases, and introduces macrophage origin and activation to propose the relationship between macrophage polarization and cardiovascular diseases. Then, the strategies for targeted macrophage therapy were proposed to provide an important theoretical basis for improving the inflammatory state of cardiovascular diseases. Related Articles | Metrics

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Research and progress in the treatment of cardiovascular diseases with metabolic drugs SUN Min, WANG Hongya, HE Hongbo, ZHU Zhiming, GAO Peng Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (7): 984-997.   DOI: 10.12092/j.issn.1009-2501.2025.07.014 Abstract （249）      PDF （798KB）（1660）       Knowledge map    Save Cardiovascular disease (CVD), as one of the diseases with the highest morbidity and mortality rates globally, has always been a focus of medical research. In recent years, with a deeper understanding of the pathogenesis of CVD, novel metabolic drugs have demonstrated great potential in its treatment. These novel drugs regulate multiple aspects of cardiovascular metabolism, including reducing blood glucose and lipid levels, inhibiting inflammatory responses, and protecting vascular endothelial cells, thereby providing new strategies for the prevention and treatment of CVD. In terms of lowering blood glucose levels, SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, and Metformin, as clinically commonly used drugs, have been proven to be beneficial for the prevention and treatment of CVD, regardless of the presence or absence of diabetes. For lipid regulation, PCSK9 inhibitors and Ezetimibe, as newly developed lipid-lowering drugs, not only reduce serum low-density lipoprotein cholesterol levels but also directly protect the cardiovascular system from damage. The development and application of these drugs have not only improved the treatment outcomes of CVD but also provided patients with more therapeutic options. Related Articles | Metrics

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The NO-sGC-cGMP pathway and heart failure LI Dilu, PEI Yuanyuan, WANG Wuchao, CAO Lingjie, YANG Fengtao, SHI Shuangkui, ZHOU Guyue, YANG Kunyu, ZHU Jihong Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (5): 702-708.   DOI: 10.12092/j.issn.1009-2501.2025.05.015 Abstract （279）      PDF （621KB）（1612）       Knowledge map    Save Heart failure, as a global public health challenge, is experiencing an increasingly severe disease burden. Given the close relationship between the Nitric Oxide-Soluble Guanylate Cyclase-Cyclic Guanosine Monophosphate (NO-sGC-cGMP) signaling pathway and heart failure, this study, through a comprehensive search and review of recent literature on the NO-sGC-cGMP pathway and heart failure, aims to outline the mechanism of action of this signaling pathway and its connection with heart failure, in order to explore new avenues for the treatment of heart failure. Related Articles | Metrics

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Research progress on pharmacokinetic interactions of sodium-glucose co-transporter 2 inhibitors DENG Yanru, CAO Gexi, LI Ying, LI Yajing, DONG Zhanjun Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 570-576.   DOI: 10.12092/j.issn.1009-2501.2025.04.016 Abstract （275）      PDF （651KB）（1553）       Knowledge map    Save Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a new class of oral hypoglycemic drugs with definite hypoglycemic effects, low risk of hypoglycemia, cardiovascular protection, and kidney benefits. In recent years, SGLT2 inhibitors have been widely used in clinical practice, and their interactions with other drugs have gradually attracted attention. The SGLT2 inhibitors commonly used in China's clinic include canagliflozin, dapagliflozin, empagliflozin, ertugliflozin and henagliflozin currently, they are mainly metabolized by the phase Ⅱ metabolic enzyme uridine diphosphate glucuronosyltransferase (UGT), and various transporters are involved in the disposal of SGLT2 inhibitors in vivo. This article reviews the pharmacokinetic characteristics of different SGLT2 inhibitors mentioned above, as well as their pharmacokinetic interaction studies with various drugs such as statins, antineoplastic drugs, antimicrobials, nonsteroidal anti-inflammatory drugs and traditional Chinese medicine, in order to promote the safe and rational use of SGLT2 inhibitors in clinical practice. Related Articles | Metrics

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Research progress in the treatment of early Alzheimer's disease with lecanemab JIN Panpan, LIU Yang, QIU Bo, WU Huizhen Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (2): 207-214.   DOI: 10.12092/j.issn.1009-2501.2024.02.011 Abstract （947）      PDF （672KB）（1487）       Knowledge map    Save Lecanemab is a new drug used to treat early Alzheimer's disease (AD) with mild cognitive impairment or mild dementia. It is a human anti-Aβ fibril monoclonal IgG1 antibody, which is injected intravenously into the patient, through the blood-brain barrier into the brain, clearing amyloid plaque, thereby slowing the rate of cognitive decline in patients and delaying disease progression. This article reviews the pharmacological studies, clinical studies, safety and limitations of lecanemab, in order to help clinical understand the current research status and existing achievements of this drug. Related Articles | Metrics

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Advances in precision diagnosis and treatment of cholangiocarcinoma CHEN Zhenmei, CHEN Jinhong Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 159-170.   DOI: 10.12092/j.issn.1009-2501.2025.02.002 Abstract （724）      PDF （909KB）（1484）       Knowledge map    Save Cholangiocarcinoma (CCA) is a highly aggressive and heterogeneous biliary malignancy characterized by challenges in early diagnosis, limited efficacy of traditional chemotherapy, and poor prognosis. Due to its significant heterogeneity at the genomic, epigenetic, and molecular levels, molecular testing and targeted therapy have become increasingly important in CCA management, forming an integral part of the era of precision oncology. The development of next-generation sequencing (NGS) has advanced research into the molecular subtypes and therapeutic targets of CCA, including FGFR2 fusions/rearrangements, IDH1 mutations, and BRAF mutations. Recently, two phase III clinical trials, TOPAZ-1 and KEYNOTE-966, have established the pivotal role of immunotherapy combined with chemotherapy in advanced CCA. While precision diagnosis and treatment in CCA have shown promising progress, this field remains in its exploratory phase and faces numerous challenges. This review summarizes recent advancements in the diagnosis, molecular targeted therapy, immunotherapy, resistance mechanisms, and the development of novel strategies for CCA.  Related Articles | Metrics

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Expert consensus on the diagnosis and treatment of insomnia in specified populations CHEN Guihai, DENG Liying, DU Yijie, HUANG Zhili, JIANG Fan, JIN Furui, LI Yanpeng, LIU Chunfeng, PAN Jiyang, PENG Yanhui, SU Changjun, TANG Jiyou, WANG Tao, WANG Zan, WU Huijuan, XUE Rong, YANG Yuechang, YU Fengchun, YU Huan, ZHAN Shuqin, ZHANG Hongju, ZHANG Lin, ZHAO Zhengqing, ZHAO Zhongxin Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (8): 841-852.   DOI: 10.12092/j.issn.1009-2501.2024.08.001 Abstract （937）      PDF （795KB）（1402）       Knowledge map    Save Clinicians need to focus on various points in the diagnosis and treatment of insomnia. This article prescribed the treatment protocol based on the unique features, such as insomnia in the elderly, women experiencing specific physiological periods, children insomnia, insomnia in sleep-breathing disorder patients, insomnia in patients with chronic liver and kidney dysfunction. It provides some reference for clinicians while they make decision on diagnosis, differentiation and treatment methods. Related Articles | Metrics

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Progress in the clinical application of the biased μ-opioid agonist oliceridine ZHU Changmao, XIE Li, WU Zifeng, WANG Sen, ZHANG Qi, XU Xiangqing, YANG Chun Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (9): 1057-1061.   DOI: 10.12092/j.issn.1009-2501.2024.09.012 Abstract （943）      PDF （596KB）（1397）       Knowledge map    Save Opioid receptors μOR, δOR, κOR and NOPR are all G protein-coupled receptors (GPCRs), which mainly function through G protein and β-arrestin. Recent studies have found that G protein mediates analgesia, while β-arrestin reduces analgesia and is related to the side effects of opioids. Oliceridine is the first biased μOR agonist approved for commerce. It mainly exerts analgesic effect by activating G protein. It has rapid onset of action and reliable analgesic effect. Due to its low activity on β-arrestin, the incidence of side effects is low, comparing to the classic opioid morphine. Oliceridine can be safely used in patients with liver or kidney insufficiency and its metabolite is inactive. This article summarizes the current progress of pharmacological research and clinical application of oliceridine, aiming to provide reference for the clinical practice of oliceridine. Related Articles | Metrics

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Research progress of empagliflozin in the treatment of type 2 diabetes mellitus and cardiovascular and renal benefits LIU Zihan, DU Wenyu, GUO Caihui, WANG Zhi, LI Ying, DONG Zhanjun Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 412-418.   DOI: 10.12092/j.issn.1009-2501.2025.03.015 Abstract （349）      PDF （952KB）（1332）       Knowledge map    Save Type 2 diabetes mellitus (T2DM) is an insulin resistance disease. Improving insulin resistance and controlling blood glucose are the main means of clinical treatment for T2DM. Empagliflozin is a highly selective sodium-dependent glucose transporters (SGLT)2 inhibitor, which is independent of insulin. It can effectively control blood glucose levels, reduce blood pressure and body weight, protect heart and kidney function, reduce the rehospitalization rate and the risk of death in patients with heart failure (HF), and does not increase the risk of hypoglycemia. Empagliflozin can be used alone or in combination with other hypoglycemic drugs to control blood glucose. This article reviews the mechanism of action, clinical benefits, and combination with other drugs of empagliflozin, aiming to provide reference for the clinical use of empagliflozin. Related Articles | Metrics

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SPP1 expression in SMARCA4-deficient non-small cell lung cancer and its relationship with PD-L1 WU Juan, HUANG Xi, LI Jiajia, WEI Yuqing, ZHANG Liqing, YU Yongmei, LU Zhiwei, ZHANG He Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 477-486.   DOI: 10.12092/j.issn.1009-2501.2025.04.005 Abstract （304）      PDF （1297KB）（1320）       Knowledge map    Save AIM: To analyze the expression of secreted phosphoprotein 1 (SPP1) and programmed cell death-ligand 1 (PD-L1) in SMARCA4-deficient non-small cell lung cancer, and to provide a scientific basis for the study of the follow-up treatment of this rare pathological type of lung cancer. METHODS: The clinical and pathological characteristics of 12 patients with this disease were analyzed retrospectively, and the patients were divided into two groups of adenocarcinomas and poorly differentiated carcinomas according to their morphological characteristics, and the relationship between the expression of SPP1 and PD-L1 was analyzed in the two groups. RESULTS: SPP1 expression was detected in all patients and Its expression level was significantly higher in the poorly differentiated carcinoma group compared with the adenocarcinoma group (P=0.015); PD-L1 expression was found in 6/7 patients (5 cases were not measured), compared with the adenocarcinoma group,PD-L1 was also highly expressed in the poorly differentiated carcinoma group (P=0.048) and the PD-L1 difference between the two groups suggested that the results were similar to those of SPP1. CONCLUSION: SMARCA4-deficient non-small cell lung cancer has high positive expression of SPP1 and PD-L1. It was more pronounced in patients with poorly differentiated carcinoma. There may be a positive correlation between SPP1 and PD-L1 expression in SMARCA4-deficient non-small cell lung cancer and the mechanism of the correlation needs to be further verified in subsequent studies. Related Articles | Metrics

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Expert consensus on the model informed precision dosing of tacrolimus in patients receiving anti-rejection therapy CHEN Bing, ZUO Xiaocong, LI Xingang, SHANG Dewei, ZHOU Peijun, DING Junjie, XIANG Xiaoqiang, QIU Xiaoyan, WANG Zhuo, LI Xiaoyu, ZHANG Yi, ZHAO Wei, WANG Yuzhu, GAO Jianjun, JIAO Zheng Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 433-445.   DOI: 10.12092/j.issn.1009-2501.2025.04.001 Abstract （330）      PDF （844KB）（1257）       Knowledge map    Save There is significant inter-individual variation of pharmacokinetics and pharmacodynamics in patients receiving tacrolimus (TAC) for anti-rejection therapy, which cause the rejection or toxic action. Based on results of therapeutic drug monitoring and pathophysiological index of transplant patients, the individualized dosing regimen can be designed and adjusted by using model informed precision dosing (MIPD). The patients' clinical outcome can be improved. In the consensus, the different methods of MIPD used for patients received TAC for anti-rejection therapy were introduced, which can be used for the designing and adjusting doing regimen, predicting adverse drug reaction, improving medication adherence and economics during therapy. Related Articles | Metrics

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Mechanism of Fuyangjing gel in the treatment of chronic eczema via JAK1/STAT5 signaling pathway LI Yanmei, MA Chaochao, NIU Fanqi, YANG Pengfei, WANG Ning, WANG Sinong, LI Tingbao Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (9): 1011-1018.   DOI: 10.12092/j.issn.1009-2501.2024.09.006 Abstract （258）      PDF （1234KB）（1249）       Knowledge map    Save AIM: To explore the molecular mechanism of Fuyangjing gel in the treatment of chronic eczema rats model based on janus protein kinase 1 (JAK1)/signal transducer and activator of transcription 5 (STAT5) signaling pathway. METHODS: Thirty-six SPF Wistar rats were randomly divided into normal group, model group, Qingpeng ointment group, Fuyangjing gel low, medium and high dose groups. Except the normal group, the other groups of rats were treated with 2,4-dinitrochlorophenone solution to induce chronic eczema-like lesions on the back. After 3 weeks of modeling, Qingpeng ointment group and Fuyangjing gel low, medium and high dose groups were respectively treated with corresponding drugs. The model group was smeared with blank gel matrix once a day for 2 weeks, while the normal group was not treated. The severity and pathological changes of back lesions in chronic eczema rats were observed. The expression of phosphorylated protein tyrosine kinase 1 (p-JAK1) and phosphorylated signal transduction and transcriptional activator 5 (p-STAT5) in rat dorsal skin was detected by Western blot. Detection of thymic stromallymphopietin (TSLP), JAK1, STAT5, interleukin-10 (IL-10) and IL-17 mRNA expression levels in rat back skin by qRT-PCR; The levels of IL-4, IL-6, IL-10, IL-13 and IL-17 in serum of rats were determined by enzyme-linked immunosorbent assay (ELISA). RESULTS: Compared with normal group, the serum levels of IL-4, IL-6, IL-13 and IL-17 in model group were significantly increased, while IL-10 levels were significantly decreased (P<0.05). The expression levels of p-JAK1, p-STAT5 protein and TSLP, JAK1, STAT5 and IL-17 mRNA in back lesions were significantly increased, while IL-10 mRNA levels were significantly decreased (P<0.05). Compared with model group, serum levels of IL-4, IL-6, IL-13 and IL-17 in Qingpeng ointment group and Fuyangjing gel low, medium and high dose groups were significantly decreased, while IL-10 levels were significantly increased (P<0.05). The expression levels of p-JAK1, p-STAT5 protein and TSLP, JAK1, STAT5 and IL-17 mRNA in back lesions were significantly decreased, while the mRNA levels of IL-10 were significantly increased (P<0.05). The serum levels of IL-4, IL-6, IL-13 and IL-17 in Qingpeng ointment group were decreased, while IL-10 levels were increased (P<0.05). The expression levels of p-JAK1, p-STAT5 protein and TSLP, JAK1, STAT5 and IL-17 mRNA in back lesions were decreased, while the mRNA levels of IL-10 were increased (P<0.05). Compared with Qingpeng ointment group, there were no significant differences in serum levels of IL-4, IL-6, IL-10, IL-13 and IL-17 in Fuyangjing gel high-dose group (P>0.05). There were no significant differences in the expression levels of p-JAK1, p-STAT5 protein and TSLP, JAK1, STAT5, IL-10 and IL-17 mRNA in back lesions (P>0.05). CONCLUSION: Fuyangjing gel may play a role in the treatment of chronic eczema by regulating the expression of JAK1/STAT5 signaling pathway related inflammatory factors, proteins and genes. Related Articles | Metrics

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Research progress in clinical trials of new drugs and candidate drugs for type 2 diabetes mellitus ZHOU Xin, WANG Zhi, DU Wenyu, LIU Zihan, LI Ying, DONG Zhanjun Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (10): 1185-1193.   DOI: 10.12092/j.issn.1009-2501.2024.10.012 Abstract （581）      PDF （641KB）（1170）       Knowledge map    Save A number of drugs for the treatment of type 2 diabetes mellitus (T2DM) are currently under clinical investigation, including the sodium-dependent glucose transporters 2 (SGLT2) inhibitor rongliflozin, the SGLT1/2 inhibitor LIK066, the dipeptidyl peptidase-4 (DPP-4) inhibitor DBPR108, the glucagon-likepeptide-1 receptor (GLP-1R) agonist CJC-1134-PC, the G-protein-coupled receptor 40 (GRP40) agonist SCO-267 and the Glucokinase (GK) agonist PB201. This article briefly reviews the clinical research progress of drugs targeting the above targets in the field of T2DM treatment, in order to provide reference for the treatment of T2DM patients. Related Articles | Metrics

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Study on the mechanism of action of Siheifang on zebrafish melanin based on metabolomics and network pharmacology SU Qihui, WANG Jing, LUO Rongrong, HUANG Yurong, LI Xin, WANG Yingli, JIA Ying Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (9): 988-1001.   DOI: 10.12092/j.issn.1009-2501.2024.09.004 Abstract （358）      PDF （4001KB）（1144）       Knowledge map    Save AIM: To study the mechanism of Siheifang (SHF) in improving pigment deficiency disease (PD) by combining network pharmacology and metabolomics. METHODS: Using zebrafish embryos with pigment deficiency disease induced by 1-phenyl-2-thiourea (PTU) as an animal model, the effects of SHF extract (0.01, 0.02, 0.04 mg/mL) on the morphology, melanin area, tyrosinase activity, and melanin content of zebrafish embryos were analyzed. Ultra high performance liquid chromatography-mass spectrometry (UHPLC-MS) was used to screen differential metabolites and obtain relevant metabolic pathways in the SHF treatment of melanin deficient zebrafish embryos model. Network pharmacology was used to obtain key targets for SHF treatment of PD and conduct KEGG pathway enrichment analysis. Import The identified differential metabolites and SHF PD intersection targets were imported into the Metscape plugin, to establish a "metabolite reaction enzyme gene" network, and search for key metabolites, targets, and metabolic pathways. RESULTS: SHF treatment could increase the formation of zebrafish melanin, activate tyrosinase activity, and increase melanin content. Metabolomics analysis obtained 54 differential metabolites, and metabolic pathway analysis was conducted on these metabolites, involving the biosynthesis of phenylalanine, tyrosine, and tryptophan, glycerol phospholipid metabolism, tyrosine metabolism, linoleic acid metabolism, and aminoacyl tRNA biosynthesis pathways. Network pharmacology had obtained 55 cross targets of components and diseases. KEGG involved pancreatic cancer, TNF, cancer and other signal pathways. The joint analysis of metabolomics and network pharmacology identified four key targets: COMT, CYP1B1, TYR, and ALDH2; three key metabolites: L-tyrosine, homovanllate, L-lysine; three important metabolic pathways: tyrosine metabolism, valine/leucine/isoleucine degradation, and lysine metabolism. CONCLUSION: SHF has a good improvement effect on PD, and combined with metabolomics and network pharmacology, SHF may enhance its influence on the tyrosine metabolism pathway by regulating the metabolite L-tyrosine, thereby promoting the formation of melanin. Related Articles | Metrics

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Research on the application of machine learning algorithms in anticancer drug response prediction TAN Yanchen, WANG Wenwen, XIA Jielai, LI Chen Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 200-208.   DOI: 10.12092/j.issn.1009-2501.2025.02.006 Abstract （483）      PDF （958KB）（1136）       Knowledge map    Save With the continuous development of genomics and precision medicine, targeted therapy and immunotherapy targeting biomarkers have ushered in a new era of anti-tumor therapy. However, due to the heterogeneity of tumor cells and the variability of tumor microenvironment, there are still significant differences in response to the same drug even in patient populations with the same biomarker enrichment. By combining omics data with drug sensitivity algorithms, the response of anti-tumor drugs can be predicted and transformed into personalized diagnosis and treatment strategies required for precision medicine, which is expected to improve the effectiveness of anti-tumor drugs in clinical treatment. Currently, machine learning is one of the commonly used modeling algorithms for predicting the response of anti-tumor drugs. However, due to differences in input data and algorithm construction methods, there is currently a lack of comprehensive literature review in this field. Therefore, this article provides a review of machine learning algorithms for predicting anti-tumor drug responses, summarizing publicly available cell genome characterization datasets, machine learning algorithms, and evaluation indicators in drug response prediction, as well as the current situation and challenges faced in clinical applications, in order to provide methodological references for the main research problems and potential solutions of machine learning algorithms in the field of drug response prediction. Related Articles | Metrics

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Application of single-cell multi-omics sequencing technology in the study of ischemic stroke MENG Qian, WANG Yiwen, CUI Na, BAI Min, YANG Le, DING Yi Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (6): 690-699.   DOI: 10.12092/j.issn.1009-2501.2024.06.011 Abstract （618）      PDF （810KB）（1101）       Knowledge map    Save Ischemic stroke is an acute cerebrovascular disease with high disability and mortality, is the most common cause of death in China. Despite years of research, there are still no biomarkers for stroke, and the molecular mechanisms remain largely unknown. In the past decade, single-cell sequencing technology, as a rapidly developing emerging technology, can conduct high-throughput sequencing of multiple omics including genome, transcriptome, epigenome and proteome at the level of a single cell, providing a new way to discover biomarkers and analyze pathological mechanisms. In this paper, the progress of single-cell multi-omics sequencing technology and its application in the discovery of biomarkers, pathological mechanisms and drug development of ischemic stroke are introduced in detail, in order to provide valuable reference for precision medicine of ischemic stroke. Related Articles | Metrics

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Effects of liposomal bupivacaine for interscalene brachial plexus block on postoperative analgesia and diaphragmatic function in patients with arthroscopic rotator cuff repair surgery LUO Jingyu, WU Hong, CHEN Gang, XU Mengting, ZHANG Yantong, LI Jun Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (5): 665-672.   DOI: 10.12092/j.issn.1009-2501.2025.05.010 Abstract （275）      PDF （830KB）（1066）       Knowledge map    Save AIM: To evaluate the effects of liposomal bupivacaine for interscalene brachial plexus block on postoperative analgesia and diaphragmatic function in patients undergoing arthroscopic rotator cuff repair surgery based on a  randomized controlled trial. METHODS: Forty patients who scheduled to undergo arthroscopic rotator cuff repair surgery, regardless of gender, aged 18 to 65 years, ASA grade I or II were selected from October 2023 to February 2024. The patients were randomly divided into bupivacaine liposome group (group LB) and the levobupivacaine group (group BV), with 20 cases in each group. Patients in both groups received an ultrasound-guided interscalene brachial plexus block, 15 mL mixed liquids (bupivacaine liposome 10 mL+0.5% levobupivacaine 10 mL) were injected into the level of C5-C6 nerve roots and 5 mL onto the surface of prevertebral fascia in the LB group, and same volume of 0.375% levobupivacaine were injected at the same sites in the BV group respectively. Standardized general anesthesia and standardized postoperative analgesia were followed. The primary outcome measures included 48 h rest/motor numerical rating scale (NRS) scores after surgery and the incidence of hemidiaphragmatic paralysis (HDP) after block. The secondary outcome measures included rest/motor NRS scores at other time points after surgery, pulse oxygen saturation (SpO2) 30 min after block, duration of sensory and motor block, number of analgesic pump presses, time of first postoperative used of opioid drugs and opioid consumption, use of additional analgesics in the wards, satisfaction with analgesia, and the occurrence of perioperative adverse effects and neurological complications. RESULTS: Compared with group BV, patients in LB group showed lower rest NRS scores at 48 h postoperation (P<0.05) and higher incidence of HDP at 24 h after block (45% vs. 5.3%, P<0.05). However, there was no significant difference in motor NRS scores at 48 h, HDP incidence at 30 min and 6 h after block between the two groups (P>0.05). Both groups showed a decrease in SpO2 after block compared to before block (P<0.05). Compared with BV group, patients in LB group had a significantly longer duration of sensory and motor block (P<0.01), fewer effective presses with the analgesic pump (P<0.01), delay in first opioid use and less opioid consumption (P<0.05), higher level of satisfaction with analgesia (P<0.01), and a lower rate of use of additional analgesics in the ward (P<0.05). There was no statistically significant difference in the total intraoperative remifentanil consumption, incidence of perioperative adverse reactions and neurological complication between the two groups (P>0.05). CONCLUSION: Compared with using levobupivacaine alone, the addition of liposomal bupivacaine for interscalene brachial plexus block in arthroscopic rotator cuff repair can reduce postoperative NRS scores, decrease postoperative opioid dosage and significantly prolong blockduration, but can easily lead to longer duration of HDP in patients. Related Articles | Metrics

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Study on the neuroprotective effect and mechanism of Tianma Gouteng Decoction on combining rat model of Hyperactivity of Liver Yang and MCAO based on autophagic flux and CXCL12/CXCR4 axis WANG Xiaoli, SHAO Jing, ZHANG Wei, TIAN Ping, ZHANG Xuexia, LIU Changhe, LI Kaiyan, YANG Dan, GUO Xiaoyan Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (8): 1037-1048.   DOI: 10.12092/j.issn.1009-2501.2025.08.004 Abstract （154）      PDF （5317KB）（1059）       Knowledge map    Save AIM: To investigate autophagic status in ischemic stroke with Liver Yang Hyperactivity and the mechanism of Tianma Gouteng Decoction (TMGTD). METHODS: SD rats were divided into sham, model, TMGTD high/medium/low-dose (20.52/10.26/5.13 g·kg-1·d-1), and Nimodipine (30 mg·kg-1·d-1) groups. A Liver Yang Hyperactivity and cerebral ischemia-reperfusion model was established using Fuzi Decoction (2 g·kg-1·d-1) and thread-occlusion. After 21 days of Fuzi decoction pretreatment, rats received daily drug administration for 12 days. Syndrome indicators (irritability, 24-hour water intake, 24-hour urine volume, facial temperature) were recorded, plasma NE, E, cAMP, and cGMP were measured by ELISA, neurological function was assessed using Zea Longa and mNSS methods, brain histopathology was evaluated by HE staining, protein expression of soluble/insoluble p62 and LC3B was detected by Western blot, autophagy-related genes were analyzed by PCR array, additionally, mRNA and protein levels of CXCR4 and CXCL12 were measured by qRT-PCR and Western blot. RESULTS: Compared to the sham group, the model group showed increased irritability, 24-hours water intake, 24-hours urine volume, facial temperature, and level of NE, E, cGMP (P<0.01), neurological scores (P<0.01), LC3B-II, insoluble p62, CXCR4, CXCL12 expression (P<0.01), but decreased soluble p62 (P<0.01). TMGTD groups exhibited reduced irritability, water intake, urine volume, facial temperature, NE, E, cGMP (P<0.05, P<0.01), neurological scores (P<0.05, P<0.01), p62 expression (P<0.01), alongside increased LC3B-II (P<0.01) and improved cortical pathology. TMGD also reversed dysregulated autophagy-apoptosis genes (CXCR4, Lamp1, Tgfb1, APP, Rab24) and reduced CXCR4, CXCL12 expression (P<0.01). CONCLUSION:In the Liver Yang Hyperactivity and cerebral ischemia-reperfusion model, autophagy genes were activated but flux was impaired, and Tianma Gouteng Decoction may protect by restoring autophagic flux and inhibiting the CXCL12/CXCR4 axis. Reference | Related Articles | Metrics

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Effect and mechanism of Tamarix chinensis Lour. on streptozotocin-induced diabetic rats based on network pharmacology, molecular docking and experimental validation LI Qian, WANG Zhenxiang, LIANG Yanting, MA Weiwei, ZHANG Zhen, WANG Xia, AN Qiong Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (7): 907-920.   DOI: 10.12092/j.issn.1009-2501.2025.07.005 Abstract （175）      PDF （2020KB）（1033）       Knowledge map    Save AIM: To investigate the mechanism of action of Tamarix chinensis Lour. on streptozotocin-induced type 2 diabetes mellitus (T2DM) through network pharmacology, molecular docking and experimental validation. METHODS: Using the TCSMP database and Swiss Target Prediction tools screen the active components and predict potential targets in Tamarix chinensis Lour.. Retrieving potential disease targets associated with T2DM from databases such as GeneCards, OMIM, and DisGeNET. The intersection targets of Tamarix chinensis Lour. and T2DM disease was obtained through Venny platform. The STRING database was used to constructed PPI network, and Cytoscape 3.8.0 software was use to visualized. GO function enrichment and KEGG pathway enrichment analysis were performed through the Metascape database. Docking of important target proteins and compounds was carried out by AutoDock software. SPF grade male rats were randomly divided into normal group, model group, MET group (88.5 mg/kg), TE high-dose (800 mg/kg) group, TE medium-dose (400 mg/kg) group and TE low-dose (200 mg/kg) group (n=10). High-fat and high sugar feed combined with low dose STZ (45 mg/kg) was used to induce T2DM rat model, and the rats were administered orally for 5 weeks. Fasting blood glucose( FBG),insulin（FINS）level and HOMA-IR index, biochemical indicators ［superoxide dismutase (SOD), malondialdehyde (MDA), glycosylated hemoglobin A1c (HbA1c) and inflammatory factor ［interleukin-1β (IL-1β), tumor necrosis factor α (TNF-α), vascular cell adhesion molecular (VCAM-1) levels of the rats were also observed; morphological changes of renal tissue was observe by HE staining. RESULTS: Based on the screening conditions of oral bioavailability (OB) ≥ 30% and drug like properties (DL) ≥ 0.18, a total of 19 main active ingredients with potential therapeutic effects on T2DM were screened from Tamarix chinensis Lour., including ergosta-5,24(28)-dien-3,7,16-triol, quercetin-3,3'-dimethyl ether, kaempferol, quercetin, and others. By analyzing the potential targets of Tamarix chinensis Lour. for treating T2DM, a total of 185 potential target genes were screened, including SRC, EGFR, HSP90AA1, AKT1, ESR1, H1F1A, TNF, PIK3R1, etc, involving cancer signaling pathways, insulin resistance, MAPK signaling pathways, PI3K Akt signaling pathways, etc. Molecular docking results showed that the binding energies were all less than -5.0 kcal/mol, indicating that a strong binding ability between the active ingredients screened by Tamarix chinensis Lour. and the potential targets for the treatment of T2DM. The animal experiment results showed that compared with the model group, the weight loss of rats in the MET and TE groups was slowed down, and the levels of FBG, FINS, MDA, HbA1c, IL-1β, TNF-α, VCAM-1, HOMA-IR index were reduced，the SOD level was increased，and the differences were statistically significant (P<0.05，P<0.01),Renal tissue cellular morphology also showed notable improvement. Most importantly, all these results demonstrating dose-dependent effects. CONCLUSION: Tamarix chinensis Lour. displays a significant therapeutic effect on T2DM through multi-component, multi-target, and multi-pathway synergistic actions to improve blood glucose levels. The findings of this study provide a theoretical basis for the clinical application of Tamarix chinensis Lour. in the treatment of T2DM. Related Articles | Metrics

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Research progress on non-coding RNA mediated apoptosis in lung cancer LIU Dewei, WU Dong, HUANG Dan, ZHAO Xuanna, WU Bin Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (7): 968-976.   DOI: 10.12092/j.issn.1009-2501.2025.07.012 Abstract （184）      PDF （1276KB）（1028）       Knowledge map    Save Lung cancer is the most common malignant tumors in clinical practice, posing a significant threat to human health. In recent years, with the advancement of high-throughput sequencing technologies, a large number of non-coding RNAs (ncRNAs) have been found to play crucial roles in the regulation of apoptosis in lung cancer cells. This article reviews the research progress of ncRNA (miRNA, lncRNA, circRNA, piRNA) mediated apoptosis in lung cancer, aiming to provide new theoretical basis for ncRNA therapy of lung cancer. Related Articles | Metrics

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Mechanism of Yi-xin-yin oral liquid according to homotherapy for heteropathy theory based on UHPLC-Q-TOF/MS combined with network pharmacology and molecular docking techniques WANG Yejian, JIAO Guangyang, PANG Tao, WENG Nan, GAO Jie, LI Juan, CHEN Wansheng, CHEN Weidong, ZHANG Feng Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (1): 11-25.   DOI: 10.12092/j.issn.1009-2501.2024.01.002 Abstract （572）      PDF （4865KB）（1024）       Knowledge map    Save AIM: To predict the core targets and related signaling pathways of Yi-xin-yin oral liquid for the treatment of arrhythmia, heart failure and myocarditis based on UHPLC-Q-TOF/MS, network pharmacology, molecular docking methods, cell experiments, according to the “homotherapy for heteropathy” theory in traditional Chinese medicine. METHODS: UHPLC-Q-TOF/MS was used to analyze and identify the chemical composition of Yi-xin-yin oral liquid Extract and the blood-absorbing components of rats oral administrated with Yi-xin-yin oral liquid extract, which compounds were applied in the databases searching for the potential targets (TCMSP, SwissTargetPrediction) and disease targets (OMIM, Genecard). Venn diagram was used for target intersection, and the subsequent protein-protein interaction network obtained core targets by STRING11.5 database, and then construct a "disease-component-target" network by cytoscape3.9.0. Finally, DAVID database was used to analysis GO function and KEGG enrichment analysis of core targets, and molecular docking validation was performed using Autodock vina software.And, validated with H9c2 cells for potential active ingredients and targets. RESULTS: A total of 156 compounds were identified from Yi-xin-yin Oral Liquid extract; 34 compounds were identified from rat serum, including 6-gingerol, isoliquiritigenin, glycyrrhizic acid and other compounds, and 139 intersecting targets were obtained. The KEGG pathway enrichment analysis mainly involved the TNF signaling pathway, IL-17 signaling pathway, MAPK signaling pathway, PI3K-Akt signaling pathway and so on. The TNF and IL-6 targets were selected for molecular docking with the main compounds, and the docking results were good (less than -5 kcal/mol). In vitro cellular experiments have shown that Yi-xin-yin oral liquid can exert therapeutic effects by regulating TNF and IL-6. CONCLUSION: The main potential active ingredients of Yi-xin-yin oral liquid may be isoliquiritigenin, glycyrrhetinic acid, calycosin-7-glucoside, salvianolic acid B, and 6-gingerol, which mainly act on TNF, IL-6 and other targets to regulate specific signaling pathways and exert therapeutic effects. Related Articles | Metrics

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Progress and prospect of inhaled biological agents in asthma LI Guanghui, HUANG Jing, ZHU Min, ZHAO Rui, WAN Yakun, CHEN Zhihong Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (4): 406-414.   DOI: 10.12092/j.issn.1009-2501.2024.04.007 Abstract （888）      PDF （904KB）（998）       Knowledge map    Save More than 300 million people worldwide suffer from asthma, and the incidence is increasing year by year. As one of the most common chronic diseases, asthma is an immune-mediated inflammatory disease with complex triggering mechanisms and strong heterogeneity. With the in-depth study of physiological and pathological mechanisms, therapeutic small molecule and hormone drugs have been introduced to control and treat most patients, but about 5%-10% of patients still suffer from various subtypes of difficult to control and treat asthma, that is, severe asthma. In the past decade, with the rapid development of biopharmaceutical research, protein and antibody have become the key drugs for the treatment of severe asthma with high efficacy, high specificity and high safety. However, biological drugs are usually administered by injection, they cannot be noninvasive and directly delivered into the lung to quickly absorb and take effect. Therefore, there is an urgent need for the introduction of inhaled biologics with quick effectiveness, convenience, economy and safety in clinical. The review summarizes the existing small molecule, hormone and biological therapy drugs, and summarizes the development of inhalable biological agents of asthma, and analyzes the future prospects of the inhalable biological drugs, which is designed to deepen the perception of the direction of the inhalable biological drugs research, and update the information of the field, in order to provide reference for the development of more inhalable biologics. Related Articles | Metrics

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Study on the efficacy and mechanism of Qingre xiaoyanning against influenza A H3N2 virus ZHOU Shasha, CHENG Xueqing, PENG Dongdong, WANG Xiaoqing, FU Lijun, XIAO Wenxi, ZHANG Guomin Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 347-354.   DOI: 10.12092/j.issn.1009-2501.2025.03.007 Abstract （281）      PDF （1860KB）（995）       Knowledge map    Save AIM: To investigate the antiviral efficacy and mechanism of Qingre Xiaoyanning (QRXYN) in vivo, and provide experimental basis for their prevention and treatment of influenza A virus. METHODS: We constructed a mouse model infected with influenza A H3N2 virus. To evaluate the therapeutic effect of QRXYN on influenza A virus, we measured the body weight changes, pathological changes in lung tissue, hemagglutination titer, and viral load in mouse. To evaluate the possible mechanism of QRXYN's anti influenza A virus infection, we used the ELISA to measure the levels of TNF-α, IL-1β, IL-4, IFN-γ, and vascular cell adhesion molecule-1 (VCAM-1) in mouse bronchoalveolar lavage fluid; used flow cytometry to assess the proportions of macrophages (F4/80), helper T lymphocytes (CD4+ T lymphocytes), and natural killer (NK) cells in lung tissue; and used Western blotting to detect the expression of Toll-like receptor 4 (TLR4), myeloid differentiation factor 88 (MYD88), inhibitor of kappa B kinase-β (IKK-β), NF-kappa-B inhibitor alpha (IκBα), and phospho-IKB alpha (p-IκBα) in lung tissue. RESULTS: Compared to the model group, both Oseltamivir and QRXYN can alleviate the severity of lung tissue lesions in mice, decrease the blood coagulation titer and viral load of mouse lung tissue (P<0.01), lower the levels of TNF-α, IL-4, and VCAM-1 in bronchoalveolar lavage fluid (P<0.05, P<0.01), reduce the proportion of macrophages (P<0.05, P<0.01), and increase the proportion of CD4+T lymphocytes and NK cells (P<0.05, P<0.01). Additionally, oseltamivir can reduce the expression of MYD88 protein in mouse lungs (P<0.05), while QRXYN can decrease the expression of IKK-β and P-IκBα proteins in mouse lungs (P<0.05). CONCLUSION: QRXYN have good in vivo antiviral effects against the influenza A virus, and their mechanism may be related to the regulation of the immunologic function and NF-κB signal pathway. Related Articles | Metrics

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Research progress on targeted therapy combined with immune-activating strategies in CLDN18.2-positive gastric cancer NIE Yang, WANG Yue, WEI Jia Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 146-158.   DOI: 10.12092/j.issn.1009-2501.2025.02.001 Abstract （982）      PDF （1213KB）（984）       Knowledge map    Save Claudin 18 isoform 2 (Claudin18.2, CLDN18.2) is a crucial structural protein involved in cell-cell tight junctions. While its expression is limited in normal tissues, it is specifically overexpressed in malignant tumors such as gastric cancer, pancreatic cancer, and esophageal cancer, making it a promising therapeutic target for cancer treatment. Recent advances in CLDN18.2-targeted therapies have been encouraging, and studies suggest that CLDN18.2-positive gastric cancer may possess a unique immune microenvironment. This raises the potential for combining targeted therapies with immune activation to achieve synergistic effects, potentially improving treatment outcomes for patients with advanced gastric cancer. This review will focus on the immune microenvironment characteristics of CLDN18.2-positive gastric cancer and summarize the current research and clinical trial progress in targeted therapies combined with immune activation for this specific cancer type. Related Articles | Metrics

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Research progress of epigenetics in the pathogenesis of depression ZHANG Yao, ZOU Manshu, HAN Yuanshan, WANG Yuhong Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 517-525.   DOI: 10.12092/j.issn.1009-2501.2025.04.010 Abstract （474）      PDF （924KB）（940）       Knowledge map    Save Depression is a mental disease with increasing prevalence worldwide, which seriously endangers human health with high disability rate and high suicide rate. Epigenetics is an emerging genetic theory in the 21st century. Its main research content is to regulate the process of gene transcription or translation and affect its function and characteristics without changing the DNA sequence. These include DNA methylation, histone modification, chromatin remodeling and non-coding RNA regulation. The nervous system is susceptible to changes in the activity of epigenetic modifiers, and an increasing number of studies have shown that genetics and environment play an important role in the development of depression. This review will focus on the epigenetic mechanisms of depression. Related Articles | Metrics

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Research progress of JAK/STAT signaling pathway in the intervention of diabetic microvascular complications LI Tao, YANG Lixia, GAO Bo, LI Qin, SONG Shuang Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (12): 1415-1421.   DOI: 10.12092/j.issn.1009-2501.2023.12.012 Abstract （387）      PDF （685KB）（925）       Knowledge map    Save Diabetic microvascular complications are the main reason for the high mortality of diabetic patients. There is still a great shortage of existing therapeutic drugs, so there is an urgent need for more effective new drugs. Janus kinase/signal transducer and activator of transcription (JAK/STAT) is involved in the progression of diabetic microvascular complications, which can be improved by regulating this pathway. Therefore, this article reviews the progress of JAK/STAT in diabetic microvascular complications (diabetic kidney disease, diabetic retinopathy, diabetic peripheral neuropathy), and summarizes the potential drugs that intervene JAK/stat to improve diabetic microvascular complications in recent years from three aspects of therapeutic drugs, preclinical drugs, and traditional Chinese medicine, in order to provide ideas for drug development and treatment of diabetic microvascular complications. Related Articles | Metrics

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Analysis and verification of the effect of Yi Qi Yang Yin decoction on rheumatoid arthritis GUAN Rui, YAO Jiashu, ZHAO Yeyu, ZHENG Jiannan, QI Qing, YU Jing, GAO Mingli Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (1): 26-36.   DOI: 10.12092/j.issn.1009-2501.2024.01.003 Abstract （283）      PDF （5757KB）（921）       Knowledge map    Save AIM: Yi Qi Yang Yin Decoction (YQYY) has been used to treat patients with rheumatoid arthritis (RA) and achieved good results in clinical applications, but the mechanism still needs to be explored. The purpose was to investigate the mechanism of YQYY in rats with collagen-induced arthritis. METHODS: The possible treatment target and signaling pathway were predicted by bioinformatics and network pharmacology analysis. Elisa,quantitative real-time polymerase chain reaction, and Western Blot were used to verify the mechanism of YQYY in treating RA. RESULTS: FABP4, MMP9 and PTGS2 were the most common predicational therapeutic targets. The results of pathology and CT showed that YQYY could improve ankle swelling, synovitis and bone erosion in CIA rats. Compared with the model group, YQYY or YQYY+MTX can significantly reduce the secretion of CRP, TNF-α, IL-1β and FABP4 in serum of CIA rats (P<0.05 or P<0.01), meanwhile, reduce the mRNA of FABP4, IKKα and p65 in synovial tissue (P<0.01), PPARγ was increased (P<0.01). YQYY could significantly reduce the expression of FABP4, IKKα and pp65 proteins in synovium, and suppress the activate of NF-κB signaling pathway. CONCLUSION: FABP4, MMP9 and PTGS2 may be the targets of YQYY decoction for RA treatment. YQYY can relieve joint symptoms in CIA rats, and regulate inflammation by inhibiting FABP4/PPARγ/NF-κB signaling pathway, playing a role in the treatment of RA. The effect of YQYY combined with MTX was more prominent. This provided experimental evidence for the efficacy of YQYY decoction in clinical practice. Related Articles | Metrics

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Research progress of uterine endometrial epithelial cell organoids in the field of reproduction CAO Zhiwen, YAN Guijun Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (5): 576-582.   DOI: 10.12092/j.issn.1009-2501.2024.05.013 Abstract （713）      PDF （829KB）（918）       Knowledge map    Save In recent years, significant progress has been made in the study of endometrial epithelial organoids in the field of reproduction. Traditional two-dimensional cell culture models and animal experiments fail to accurately replicate the three-dimensional structure and physiological functions of the endometrium, limiting the in-depth exploration of its normal physiological mechanisms and related disease mechanisms. Emerging organoid technologies have provided new avenues for research. These organoids, formed by self-organization of stem cells or progenitor cells in a three-dimensional culture system, faithfully recapitulate the characteristics of endometrial glands in situ. Not only can these organoid models mimic the changes in the endometrium at different stages of the menstrual cycle, but they can also simulate the interaction between the fertilized embryo and the endometrium. Moreover, organoid systems have become essential tools for fundamental research in the field of reproduction and for disease research, including studies related to reproductive biology, drug screening and development, disease mechanism exploration, drug action mechanisms, drug combination therapies, and targeted therapies. These studies have provided novel insights and methods for a deeper understanding of the biological properties of the endometrium, its disease mechanisms, and the development of therapeutic strategies for related disorders. Related Articles | Metrics

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The mechanism and application prospects of mitochondrial quality control in osteoarthritis WANG Liang, DENG Yinshuan, QU Tao, DA Chaoming, HE Yunfei, LIU Rui, NIU Weimin, YAN Weishun, CHEN Zhen, LI Shuo, YANG Zhiyun, GUO Binbin, LAI Xueqian Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 282-288.   DOI: 10.12092/j.issn.1009-2501.2025.02.016 Abstract （583）      PDF （615KB）（910）       Knowledge map    Save Osteoarthritis (OA) is a common joint disease in clinical practice, and cartilage damage is a typical pathological change. The pathogenesis of OA is complex, and various adverse factors can lead to the occurrence of OA. Mitochondria are important organelles within cells and play important roles in cellular physiological and pathological activities. Mitochondrial quality control is an important regulatory mechanism in the body to maintain normal mitochondrial structure and function, mainly including mitochondrial biogenesis, mitochondrial dynamics, mitochondrial autophagy, mitochondrial oxidative stress, and other forms. The imbalance of mitochondrial quality control in chondrocytes is closely related to the occurrence and development of osteoarthritis, and regulating the balance of mitochondrial quality control is a potential therapeutic point for osteoarthritis. The author reviewed relevant research literature in recent years to provide a review of the relationship between mitochondrial quality control and the occurrence and development of osteoarthritis, in order to provide new ideas and directions for the research and diagnosis and treatment strategies of osteoarthritis. Related Articles | Metrics

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Dexmedetomidine alleviates ferroptosis in rat cerebral ischemia/reperfusion injury by inhibiting the Nrf2 pathway YANG Huanran, WU Shengnan, GAO Qin Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (7): 921-928.   DOI: 10.12092/j.issn.1009-2501.2025.07.006 Abstract （130）      PDF （1468KB）（886）       Knowledge map    Save AIM: To observe the effect of dexmedetomidine (DEX) on cerebral ischemia and reperfusion (I/R) injury and investigate the possible mechanism of nuclear factor erythroid derived 2-like 2 (Nrf2) mediated ferroptosis on hippocampal neurons. METHODS: The oxygen glucose deprivation/reoxygenation (OGD/R) model in rat primary cultured hippocampal neurons was simulated, DEX (50 μmol/L) and Nrf inhibitor BRU (100 nmol/L) were used to observe the changes of ROS levels by DHE fluorescence probe. The middle cerebral artery occlusion model in male SD rats were established, the degree of neurological impairment was detected by Longa score, and cerebral infarct size was detected by TTC staining. The Fe2+ concentration and levels of oxidative stress related factors were detected, oxidative stress and ferroptosis related protein expressions were detected by Western blot. RESULTS: The fluorescence intensity of DHE in OGD/R+Dex Group was lower than that in CON group, and the fluorescence intensity of DHE in OGD/R+DEX + BRU group was higher than that in OGD/R+Dex group. Compared with Sham group, the Longa score and cerebral infarct size in I/R group were significantly increased (P<0.01), the levels of SOD, CAT, GSH and GSH-PX were significantly decreased. MDA and Fe2+ concentrations were increased, the protein expressions of Nrf2, HO-1, GPX4, FTH1 and FPN1 were decreased, and TFR1 protein expression was increased. Compared with I/R group, in DEX+I/R group, the Longa score and cerebral infarct size were decreased (P<0.01), the levels of SOD, CAT, GSH and GSH-PX were increased. MDA and Fe2+ concentrations were decreased, the protein expressions of Nrf2, HO-1, GPX4, FTH1 and FPN1 were increased, and TFR1 protein expression was decreased. The Nrf2 inhibitor Bru reversed the role of DEX. CONCLUSION: DEX protects against cerebral I/R injury through activating Nrf2 signaling pathway and inhibiting ferroptosis in hippocampal neurons. Related Articles | Metrics

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Research progress on CXC chemokines and their receptors and pulmonary fibrosis CHEN Feng, LI Long, WANG Jie, LIU Shengfei Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (5): 583-589.   DOI: 10.12092/j.issn.1009-2501.2024.05.014 Abstract （339）      PDF （665KB）（878）       Knowledge map    Save Pulmonary fibrosis (PF) is a common, persistent, irreversible, fatal chronic lung disease with a median survival of 2-4 years after diagnosis. It is characterized by excessive extracellular matrix deposition and scarring in the lungs, leading to functional failure, severe respiratory problems and even death. Numerous studies have shown that CXC chemokines and their receptors play important roles in PF and other desmoplastic disorders. Several studies have shown that chemokines may become new targets for the treatment of many diseases. Here, we review the role of key CXC chemokines and their receptors in PF to provide a reference for the treatment of PF. Related Articles | Metrics