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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 （718）      PDF （581KB）（13901）       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 Recently, the United States Food and Drug Administration (FDA) released a draft guidance titled " Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device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 of lemborexant in the treatment of insomnia disorder GUO Lijia, DONG Zixuan, WU Huizhen Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (10): 1429-1435.   DOI: 10.12092/j.issn.1009-2501.2025.10.015 Abstract （587）      PDF （685KB）（7775）       Knowledge map    Save Lemborexant is a new drug for the treatment of insomnia. It is a dual orexin receptor antagonist that competitively binds to two orexin receptors, OX1R and OX2R, inhibits orexin neurotransmission, and regulates the sleep-wake rhythm. This article comprehensively reviews the discovery of the drug target, basic information, clinical studies, safety assessment, and limitation analysis of lemborexant, aiming to provide a comprehensive understanding of the current research status and achievements of this drug in clinical practice. 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 （611）      PDF （988KB）（5416）       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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The world's first PD-1/VEGF bispecific antibody:ivonescimab SUN Caihong, HU Taotao, XIAO Xingxing, YUAN Mengnan, JIANG Simin, CHEN Yinqi, RUAN Guodong Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (9): 1290-1296.   DOI: 10.12092/j.issn.1009-2501.2025.09.016 Abstract （789）      PDF （1036KB）（4720）       Knowledge map    Save Ivonescimab is a humanized bispecific antibody targeting human vascular endothelial growth factor-A (VEGF-A) and programmed death protein-1 (PD-1). It was approved by National Medical Products Administration on May 24th, 2024, and can be used in combination with pemetrexed and carboplatin for locally advanced or positive EGFR gene mutation after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. This paper mainly introduces the research progress of the world's first PD-1/VEGF bispecific antibody ivonescimab, and summarizes the mechanism of action, pharmacokinetics, phase I-III clinical trials and drug safety. 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 （679）      PDF （1237KB）（4666）       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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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 （1206）      PDF （712KB）（4458）       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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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 （1272）      PDF （831KB）（4303）       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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Targeting the cGAS-STING pathway for the treatment of ischemic stroke  QIAN Qingfang, LI Wenjing, LI Qiang Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (5): 690-694.   DOI: 10.12092/j.issn.1009-2501.2025.05.013 Abstract （985）      PDF （770KB）（4012）       Knowledge map    Save Ischemic stroke is a devastating neurological disease worldwide, with high global burden. The microglial activation-driven neuroinflammation plays a critical role in pathophysiology of ischemic stroke. After the ictus of brain ischemic attack, cytosolic double-stranded DNA (dsDNA) released by necrotic neuronal cells is a potential damage-associated molecular pattern (DAMP) to activate cyclic GMP-AMP synthase (cGAS)-stimulator of interferon genes (STING) signaling pathway. cGAS-STING signaling pathway has emerged as a key player in microglial activation, sterile neuroinflammation, and cell death following ischemic stroke. Targeting this pathway holds promise for developing novel therapeutics that effectively mitigate neuroinflammation, prevent cell death, and enhance patient outcomes. In this review, we first outline the principal elements of the cGAS-STING signaling cascade, then discusses the pivotal role of the cGAS-STING pathway in ischemic stroke. Then, we outline selective small-molecules modulators that function as cGAS-STING inhibitors and summarize their mechanisms to treat Ischemic stroke. Finally, we discuss key limitations of the current therapeutic paradigm and generate possible strategies to overcome them.  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 （519）      PDF （843KB）（3886）       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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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 （358）      PDF （699KB）（3848）       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 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 （504）      PDF （651KB）（3356）       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 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 （1368）      PDF （1213KB）（3342）       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 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 （480）      PDF （798KB）（3293）       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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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 （481）      PDF （699KB）（3198）       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 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 （961）      PDF （641KB）（3048）       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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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 （642）      PDF （1338KB）（3029）       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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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 （524）      PDF （4001KB）（2939）       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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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 （561）      PDF （621KB）（2839）       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 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 （598）      PDF （952KB）（2694）       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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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 （377）      PDF （1234KB）（2554）       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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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 （647）      PDF （844KB）（2551）       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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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 （1024）      PDF （909KB）（2462）       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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Drug therapy and new technology progress of type 2 diabetes mellitus LIU Xing, CHEN Ying Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (9): 1215-1223.   DOI: 10.12092/j.issn.1009-2501.2025.09.008 Abstract （692）      PDF （665KB）（2416）       Knowledge map    Save As the incidence of diabetes in China continues to rise, its complications pose a serious threat to the life health of patients. New hypoglycemic agents are constantly emerging, with particular attention being paid to glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose cotransporter 2 inhibitor (SGLT2i), which can not only effectively control blood glucose levels, but also significantly improve the cardiac and renal outcomes of diabetic patients. New technologies for diabetes management based on artificial intelligence (AI) are also developing rapidly, playing a crucial role in the diagnosis of diabetic retinopathy (DR) and insulin dose-assisted decision-making. Continuous glucose monitoring (CGM) and automated insulin delivery system (AID) have already been used clinically. This article reviews the progress in drug therapy and new technologies for type 2 diabetes mellitus T2DM, aiming to provide guidance for the treatment of T2DM patients. 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 （550）      PDF （1297KB）（2404）       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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Research progress on the pharmacological effects and mechanisms of oxazepam Yiqun WANG, Zhilin WANG, Qingyang LI, Wenjie CEN, Qiaoyuan ZHENG, Zhili HUANG Chinese Journal of Clinical Pharmacology and Therapeutics    2026, 31 (3): 352-361.   DOI: 10.12092/j.issn.1009-2501.2026.03.007 Abstract （296）   HTML （0）    PDF （717KB）（2345）       Knowledge map    Save Oxazepam belongs to the class of medium-to-short-acting benzodiazepine sedative-hypnotic drugs. Its mechanism of action mainly involves regulating the γ-aminobutyric acid A receptor through positive allosteric effects, thereby enhancing the inhibitory neural transmission of γ-aminobutyric acid. Studies have shown that oxazepam has significant efficacy in regulating biological rhythms, improving sleep, and alleviating anxiety. Recent researches have found that this drug can also promote the generation of neurosteroids by binding to mitochondrial translocation proteins, thereby potentially playing a role in the treatment of drug addiction and alcohol dependence. In terms of safety, compared with some long-acting benzodiazepine drugs, oxazepam has a relatively smaller impact on cognitive function, especially in elderly patients, as its metabolic pathway does not rely on cytochrome P450, and there are fewer cases of excessive sedation and drug accumulation, making it safer. When using this drug clinically, it is necessary to fully consider the patient's symptom characteristics and individual condition, comprehensively weigh the pros and cons, and use it in a standardized and reasonable manner. Table and Figures | Reference | Related Articles | Metrics

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Lraglutide improves postoperative cognitive function of aged mice via inhibiting the β-arrestin2/STING/TBK1 pathway SUN Hong, HAN Chao, LEI Daoyun, LIU Jinming Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (12): 1419-1426.   DOI: 10.12092/j.issn.1009-2501.2024.12.012 Abstract （428）      PDF （3605KB）（2317）       Knowledge map    Save AIM: To investigate the effects and possible mechanisms of liraglutide on postoperative cognitive function in aged mice. METHODS: C57BL/6J male-aged mice were randomly divided into 4 groups: control group (N group), liraglutide group (L group), model group (M group), and model+liraglutide group (ML group). There were 12 mice in each group. The model was constructed by using sevoflurane anesthesia combined with dissecting the abdominal cavity in M and ML groups. In L and M groups, liraglutide was injected into the peritoneal cavity at 300 μg/kg, once per day, for 14 days. Postoperatively, the cognitive function of mice was detected by using the open field test, the Y maze experiment, and the conditioned fear experiment. Western blotting and ELISA were used to detect the expression of hippocampal glucagon-like peptide-1 receptor (GLP1R), β-arrestin2 (β-arrestin2), stimulator of interferon genes (STING), TANK-binding kinase 1 (TBK1), IL-1β, and IL-6; immunofluorescence was used to observe the Iba1-positive microglial cell quantity. RESULTS: Compared with N group, M group showed a decrease in the postoperative spontaneous alternation rate, percentage of freezing time, and GLP1R expression in hippocampal tissue (P<0.05) and an increase in the expression of β-arrestin2, STING, P-TBK1, IL-6, IL-1β, and the number of Iba1-positive cells (P<0.05). Compared with M group, postoperative spontaneous alternation rate, percentage of freezing time, and GLP1R expression were increased in ML group (P<0.05), and the number of β-arrestin2, P-TBK1, IL-6, IL-1β, and Iba1-positive cells was significantly decreased in ML group (P<0.05). CONCLUSION: Liraglutide may ameliorate postoperative cognitive impairment in aged mice by inhibiting the β-arrestin2/STING/TBK1 pathway. Related Articles | Metrics

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Research progress on the mechanism of quercetin in preventing and treating acute lung injury LIN Yiyan, WU Yueying, YAN Rui, WU Dong Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (9): 1272-1280.   DOI: 10.12092/j.issn.1009-2501.2025.09.014 Abstract （451）      PDF （723KB）（2290）       Knowledge map    Save Acute lung injury is an acute and critical respiratory disease with complex pathogenesis, which has a high incidence rate and high mortality. At present, acute lung injury is mainly treated by mechanical ventilation, glucocorticoid anti-inflammatory and extracorporeal membrane oxygenation. Traditional Chinese medicine also shows great potential in improving the clinical manifestations and prognosis of patients. Quercetin is a flavonol compound, which can prevent and treat acute lung injury by anti-inflammatory, anti-oxidative stress, regulating programmed cell death, antibacterial and antiviral. This article summarizes the mechanism of action and research progress of quercetin in the treatment of acute lung injury, aiming to provide reference for subsequent research and clinical applications. Related Articles | Metrics

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Low-dose rituximab improves progression in early-stage medium-to-high-risk membranous nephropathy: an exploratory study XU Qiuyu, AI Sanxi, WANG Gangan, JIA Chunyu, WANG Jiahui, ZHENG Ke, QIN Yan, CHEN Gang, LI Xuemei Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (7): 744-751.   DOI: 10.12092/j.issn.1009-2501.2024.07.003 Abstract （857）      PDF （1117KB）（2189）       Knowledge map    Save Membranous nephropathy (MN) is the predominant cause of primary nephrotic syndrome (NS) among adults. The identification of PLA2R as target antigen has brought about a profound transformation in the management of MN, offering a basis for the utilization of B-cell depleting agents such as rituximab (RTX). The question of whether early intervention targeting antibodies can effectively impede the progression of MN, contributing to enhanced disease control and long-term renal outcomes for patients, remains further exploration. We analyzed demographic data, laboratory parameters, and renal involvement in 13 patients with PLA2R antibody-related MN who received at least one RTX treatment at our center from October 2019 to March 2023. Early-stage medium-to-high-risk MN was defined as baseline or admission anti-PLA2R antibody levels exceeding 50 RU/mL, excluding patients who already presented with nephrotic syndrome at baseline. The median duration of MN at the initiation of the first RTX treatment was 4.1 months (IQR 1-7.7), and the median follow-up time after RTX therapy was 27 months (IQR 23-45). All patients had commenced renin-angiotensin system inhibitors before receiving RTX. Following RTX therapy, none of the 13 patients progressed to NS during the follow-up period, and 12 patients achieved complete or partial remission at the 2-year follow-up or the last visit. No deaths, severe infections, or other serious adverse reactions occurred during the follow-up period. In conclusion, RTX demonstrates favorable efficacy and safety in early-stage, medium-to-high-risk MN patients. Initiating antibody clearance therapy in these patients may be beneficial for long-term disease control and distant renal outcomes. Related Articles | Metrics

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Progress in basic and clinical research of pitolisant in treating narcolepsy ZHANG Huimin, ZHAN Shuqin Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (8): 1127-1132.   DOI: 10.12092/j.issn.1009-2501.2025.08.015 Abstract （451）      PDF （1545KB）（2158）       Knowledge map    Save Pitolisant, a selective histamine H3 receptor inverse agonist, promotes wakefulness by blocking H3 autoreceptor-mediated feedback inhibition to elevate central histamine levels. It is clinically indicated for wake promotion in narcolepsy. The development journey of pitolisant spans over two decades, encompassing extensive preclinical and clinical research. These studies have demonstrated both sustained efficacy in managing narcolepsy and a favorable long-term safety profile. Notably, pitolisant received formal marketing authorization from China's National Medical Products Administration (NMPA) for treating excessive daytime sleepiness or cataplexy in adult narcolepsy patients. This approval addresses an unmet medical need in China's therapeutic landscape, providing patients with a safe, effective, and well-tolerated novel therapeutic option. This article will summarize the basic and clinical research progress of pitolisant from the aspects of development history, preclinical studies and pharmacological effects, clinical research and indications, medication guidelines, and safety, aiming to provide a scientific basis for the clinical treatment of narcolepsy. Reference | 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 （518）      PDF （830KB）（2141）       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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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 （717）      PDF （958KB）（2137）       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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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 （742）      PDF （924KB）（2071）       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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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 （324）      PDF （5317KB）（2057）       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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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 （1485）      PDF （762KB）（2025）       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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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 （1352）      PDF （795KB）（1959）       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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Effects of branched-chain and aromatic amino acids on type 2 diabetes mellitus and the progress ZHANG Mengli, WU Fangfang, TAN Zhien, OU Min, LIU Lingjie, LU Na, QIAO Liya, YANG Xiaonan Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 526-532.   DOI: 10.12092/j.issn.1009-2501.2025.04.011 Abstract （496）      PDF （1193KB）（1937）       Knowledge map    Save Type 2 diabetes mellitus is a metabolic disease characterized by high blood sugar levels. Traditionally, amino acids are primarily viewed as the basic building blocks for proteins and peptide synthesis. However, in recent years, amino acids have gained increased attention as signaling molecules that play crucial roles in the maintenance and regulation of metabolic homeostasis. It has been found that there is a close correlation between the metabolism of branched-chain and/or aromatic amino acids and the occurrence or development of type 2 diabetes mellitus. Furthermore, there have been successive reports on the regulation mechanism involved. This article will focus on the metabolic processes, mechanisms and clinical value of branched-chain and aromatic amino acids in type 2 diabetes mellitus. It will also summarize and provide an outlook on the current state of amino acid metabolism in the treatment of diabetes mellitus, with the aim of offering new ideas for the treatment of type 2 diabetes mellitus. 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 （422）      PDF （1860KB）（1846）       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 mechanism of action of Chaenomeles speciosa Nakai in the treatment of rheumatoid arthritis bone restruction CAO Jun, ZHOU Yanlin, AI Zhengwen, LI Shigang Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 404-411.   DOI: 10.12092/j.issn.1009-2501.2025.03.014 Abstract （526）      PDF （800KB）（1825）       Knowledge map    Save Rheumatoid arthritis is an autoimmune disease characterized by progressive bone destruction, with joint swelling caused by synovial inflammation in the early stage, and joint deformity caused by cartilage and bone destruction occurring in the middle and late stages as inflammation develops, resulting in a 75% disability and deformity rate within three years, and the prevention and treatment of RA bone and joint destruction is of urgency, and it is therefore of great significance to search for effective drugs to treat RA bone destruction. Studies have shown that wrinkled skin papaya can treat RA bone destruction, but the composition and mechanism of action are unknown, so this review aims to provide an overview of the mechanism of action of the effective active ingredients in wrinkled skin papaya for the treatment of rheumatoid arthritis bone destruction, and to provide a basis and direction for the development of novel formulations of traditional Chinese medicines for anti-RA bone destruction. 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 （1467）      PDF （596KB）（1806）       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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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 （306）      PDF （2020KB）（1797）       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