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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
    Abstract502)      PDF (581KB)(3793)       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 Recently, the United States Food and Drug Administration (FDA) released a draft guidance titled " Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device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.
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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
    Abstract427)      PDF (988KB)(3503)       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.
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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
    Abstract379)      PDF (843KB)(2954)       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.
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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
    Abstract499)      PDF (1237KB)(2832)       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.
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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
    Abstract216)      PDF (699KB)(2717)       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.
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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
    Abstract329)      PDF (798KB)(2562)       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.
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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
    Abstract419)      PDF (1338KB)(2446)       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.
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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
    Abstract358)      PDF (699KB)(2344)       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.
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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
    Abstract400)      PDF (621KB)(2150)       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.
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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
    Abstract330)      PDF (651KB)(2063)       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.
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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
    Abstract372)      PDF (1297KB)(1977)       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.
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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
    Abstract229)      PDF (685KB)(1969)       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.
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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
    Abstract1158)      PDF (762KB)(1868)       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.
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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
    Abstract828)      PDF (909KB)(1833)       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. 
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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
    Abstract427)      PDF (952KB)(1691)       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.
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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
    Abstract1068)      PDF (1213KB)(1680)       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.
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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
    Abstract425)      PDF (844KB)(1650)       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.
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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
    Abstract223)      PDF (5317KB)(1594)       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.
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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
    Abstract727)      PDF (770KB)(1512)       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. 
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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
    Abstract568)      PDF (958KB)(1491)       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.
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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
    Abstract217)      PDF (723KB)(1484)       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.
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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
    Abstract343)      PDF (1860KB)(1476)       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.
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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
    Abstract249)      PDF (1276KB)(1382)       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.
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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
    Abstract351)      PDF (830KB)(1356)       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.
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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
    Abstract213)      PDF (2020KB)(1339)       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.
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    Role and mechanism of dexmedetomidine alleviating sepsis-induced lung injury
    CHANG Hong, LIU Junchao, CHEN Sijie, ZHAO Jianqing, ZHAO Zigang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (5): 695-701.   DOI: 10.12092/j.issn.1009-2501.2025.05.014
    Abstract226)      PDF (706KB)(1332)       Save
    The sepsis and sepsis-induce lung injury threats seriously human health. Dexmedetomidine (DEX), a sedative drug, plays an active role in preventing sepsis-induced lung injury during the basic and clinical practice. The current article reviews the role and mechanism of DEX dexmedetomidine alleviating sepsis-induced lung injury from the aspects of inflammation, oxidative stress, apoptosis, mitochondrial dynamics, autophagy, vascular permeability, neuro-regulation, targeting miR-128-3p/MAPK14 and DNA methylation, etc. This review looks forward to deepen the understanding the application of DEX in the field of critical care medicine, expand the pharmacological effect of DEX and provide a new idea for the prevention and treatment of sepsis from the sedation approach. 
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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
    Abstract584)      PDF (924KB)(1261)       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.
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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
    Abstract643)      PDF (615KB)(1229)       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.
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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
    Abstract177)      PDF (1468KB)(1197)       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.
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    New progress in the treatment of polycythemia vera 
    LI Yueming, ZHANG Yongchao, CHEN Fang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (7): 961-967.   DOI: 10.12092/j.issn.1009-2501.2025.07.011
    Abstract542)      PDF (738KB)(1129)       Save
    Polycythemia vera (PV) is a type of BCR::ABL1 negative myeloproliferative neoplasms (MPN), which is a chronic myeloid tumor caused by gene mutations in hematopoietic stem cells. PV has a certain risk of progressing to myelofibrosis or acute myeloid leukemia. At present, the goal of PV treatment is still to prevent thrombosis. With the deepening of PV research, it is possible to transform the lifelong treatment to prevent the progression of the disease from alleviating the symptoms of patients. This article reviews the mechanism of traditional cytoreductive therapy drugs and the latest clinical trial results, as well as the early clinical trial data and their mechanism of action of new PV drugs and combination of drugs, in order to provide help for researchers who pay attention to PV treatment.
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    Characteristics and applications in bioequivalence of physiologically based on pharmacokinetic model
    WANG Jianxiong, HU Xiao, MIAO Beibei, ZHANG Lan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 244-250.   DOI: 10.12092/j.issn.1009-2501.2025.02.012
    Abstract727)      PDF (623KB)(1108)       Save
    Physiologically based pharmacokinetics (PBPK) model is a tool to simulate the process of drug absorption, distribution, metabolism and excretion in vivo. It is widely used in drug research and regulation. In the bioequivalence evaluation of generic drug consistency evaluation and drug production process change,the PBPK model can provide a certain reference and theoretical support for the drug bioequivalence, thereby promoting safer and more economic drug clinical trials. In this paper, the application progress of PBPK model in bioequivalence study will be reviewed in order to provide support for clinical research on drugs in China.
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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
    Abstract360)      PDF (665KB)(1086)       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.
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    Short-chain fatty acids modulate the role of NLRP3 inflammatory vesicle pathway in CKD and the progress of traditional Chinese medicine intervention
    GAO Zitian, CHEN Yu, HE Haidong, TANG Yuyan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (6): 812-819.   DOI: 10.12092/j.issn.1009-2501.2025.06.011
    Abstract215)      PDF (1231KB)(1075)       Save
    The regulation of gut flora metabolites-short-chain fatty acids (SCFAs), NLRP3 inflammatory vesicles, and interactions has been shown to play a key role in many diseases. While chronic kidney disease (CKD) is a common progressive disease whose pathogenesis is related to the reduction of SCFAs, a metabolite of intestinal flora, and the over-activation of NLRP3 inflammatory vesicles. In this paper, we summarize the role of SCFAs and NLRP3 inflammatory pathway in the pathogenesis of CKD, and sort out the research on the intervention of traditional Chinese medicine (TCM) in this inflammatory pathway in the treatment of CKD in recent years, so as to provide the direction and ideas for the exact mechanism of TCM in the treatment of CKD.
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    The role of platelets in tumor development and the treatments based on them
    LU Qi, DU Lili, SUN Jin
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 290-296.   DOI: 10.12092/j.issn.1009-2501.2025.03.001
    Abstract352)      PDF (821KB)(989)       Save
    The platelets play the important role in tumor angiogenesis, growth, and metastasis, in addition to coagulation. The interaction between tumors and platelets can produce "tumor-induced platelets", which leads various changes of platelet characteristics. In addition, activated platelets can also inhibit the effects of both chemotherapy and immunotherapy, therefore, both inhibiting platelet activation and depleting platelets can effectively improve tumor prognosis. In this review, we introduced the key role of platelets in the development of tumors, summarized their application in tumor diagnosis, monitoring, and treatment, and provided our view on how to develop precise delivery strategies based on platelets for achieve efficient and safe tumor treatment.
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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
    Abstract250)      PDF (1545KB)(967)       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.
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    Research progress on the resistance mechanism of anti-angiogenesis targeted drugs in the treatment of colorectal cancer 
    JIANG Haitao, XU Yangxian
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 193-199.   DOI: 10.12092/j.issn.1009-2501.2025.02.005
    Abstract577)      PDF (589KB)(957)       Save
    Colorectal cancer (CRC) is one of the most common malignancies worldwide, although anti-angiogenic targeted agents such as bevacizumab have shown significant efficacy in the treatment of metastatic CRC, however, the emergence of drug resistance is still a key obstacle affecting the success rate of treatment and survival of patients. This article reviews the progress of anti-angiogenesis targeted drugs in the treatment of CRC, the mechanism of drug resistance and how to solve the problem of drug resistance. 
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    Research progress on antitumor effects of Hedysari radix and active components
    WEI Xiaocheng, LI Xinrong, HE Jungang, LI Xu, QIANG Zhengze, WANG Yan, WANG Mingwei, LI Chengyi
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (8): 1112-1121.   DOI: 10.12092/j.issn.1009-2501.2025.08.013
    Abstract192)      PDF (1743KB)(910)       Save
    Hedysari radix is the characteristic chinese medicine of Gansu Province, with "MiCang Hedysari radix" as the best. Modern pharmacological research has shown that it has polysaccharides and flavonoids, which have good anti-tumor effects and can inhibit the occurrence and development of various cancers, such as lung cancer, liver cancer, and breast cancer. Cancer is ranked as the second leading cause of death in the world, and the morbidity and mortality rates are increasing year by year, seriously affecting the quality of life. At present, with the modernization of Traditional Chinese Medicine (TCM), there has been a significant breakthrough in the treatment of malignant tumors with TCM. Based on this, by collating the relevant literature at home and abroad in recent years, the anti-tumor effects and mechanisms of Hedysari radix and its active ingredients are summarized to provide a scientific basis for the study of elucidating the material basis of the anti-tumor effects of Hedysari radix and to promote the development of the Hedysari radix industry.
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    Advances in the anti-fibrosis effect of oxidative stress-related regulatory protein Cygb
    YANG Dongli, LI Jing, DUAN Lifang, ZHANG Wenjiang, LI Na, ZHANG Hong
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (5): 683-689.   DOI: 10.12092/j.issn.1009-2501.2025.05.012
    Abstract302)      PDF (1243KB)(898)       Save
    Cytoglobin (Cygb) is a recently discovered astrocyte specific globin that is widely distributed in mammalian visceral organs such as the lung, heart, spleen, liver, pancreas, stomach, small intestine, kidney, neuron, and bone tissue. It plays an important role in clearing reactive oxygen species, nitric oxide and nitrite signal transduction, alleviating oxidative stress, anti-fibrosis, regulation of cell apoptosis and treatment of cancer, etc. It is worth noting that the anti-fibrosis role of Cygb has attracted increasing attention in recent years. The existing research has involved various fibrotic diseases such as the liver, pancreas, kidney, spleen, etc., especially in the study of liver fibrosis, which has made great progress. This article system reviews the role of Cygb in various fibrotic diseases, with a focus on its mechanism of alleviating oxidative stress. Although the application of Cygb in fibrotic diseases is still in its infancy and the underlying mechanisms still require extensive research and exploration, there is no doubt that Cygb can serve as a promising therapeutic target, with the potential to be widely used in the prevention and treatment of fibrotic diseases.
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    Huangqi sanqi mixture inhibits lncRNA Gm51500/Adam12 axis to improve renal fibrosis in CKD
    LIN Jingyi, HAN Rangyue, XU Linghui, TAN Ruizhi, SU Hongwei, WANG Li
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (6): 750-762.   DOI: 10.12092/j.issn.1009-2501.2025.06.004
    Abstract167)      PDF (5753KB)(889)       Save
    AIM: To explore the potential of Huangqi sanqi mixture (AP) in improving renal fibrosis by performing transcriptome sequencing of the kidneys of the unilateral ureteral ligation mouse group and the Huangqi sanqi mixture intervention group, and using bioinformatics to verify the signitficantly different IncRNAs mechanism. METHODS: Twenty-four C57 mice were divided into sham operation group, renal fibrosis group, Huangqi sanqi mixture intervention group (3.944 g/kg) and irbesartan positive control intervention group, with 6 mice in each group. A mouse model of renal fibrosis was established by unilateral ureteral ligation (UUO). The animals were given intragastric administration after operation, and the animals were sacrificed and the specimens were collected after seven consecutive days of administration. The changes of Huangqi sanqi mixture on renal fibrosis pathological damage were analyzed by HE and Masson staining, and the protein levels of Fn and α-SMA in renal tissue of each group were detected by Western blot and immunohistochemistry to evaluate the alleviating effect of Huangqi sanqi mixture on renal fibrosis. Subsequently, lncRNA expression information was obtained by transcriptome sequencing, and Quantitative Real-time PCR (qPCR) was performed after data quality, GO enrichment and differential lncRNA were analyzed. According to the differential lncRNA and target analysis results obtained by sequencing, lncRNA Gm51500/Adam12 was overexpressed in vitro, and its mechanism in the protection of renal fibrosis by Huangqi sanqi mixture was studied by immunohistochemistry, immunofluorescence staining and qPCR verification. RESULTS: Compared with the model group, the renal fibrosis of the mice in the Huangqi sanqi mixture intervention group was significantly reduced, and the protein levels of α-SMA and Fn and the expression of IncRNA in the renal tissue were significantly down-regulated (P<0.000 1). Three lncRNAs were screened and verified to increase in the model group and significantly decrease after AP intervention, namely lncRNA Gm29994, Gm51500 and Gm35391. Target analysis showed that lncRNA Gm51500 had the most significant relationship with Adam12. The results of animal experiments showed that Adam12 was highly expressed in the kidney of UUO mice and was significantly inhibited after AP intervention. Subsequent cell experiments confirmed that overexpression of lncRNA Gm51500 could up-regulate TGF-β-induced renal tubular cell fibrosis and Adam12 expression. Cell recovery experiments confirmed that Adam12 overexpression reversed the inhibitory effect of AP on renal tubular cell injury and fibrosis. CONCLUSION: Huangqi sanqi mixture can improve renal fibrosis. Based on transcriptomic sequencing, lncRNA Gm51500/Adam12 axis may be a potential target for Huangqi sanqi mixture to improve renal fibrosis. 
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    Real-world study of the efficacy and safety of infliximab in the treatment of Crohn's disease with perianal fistula
    WU Jian, FANG Xiaoli, LI Ming, CHEN Hao, GAO Jiarong
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (5): 640-647.   DOI: 10.12092/j.issn.1009-2501.2025.04.007
    Abstract163)      PDF (1151KB)(881)       Save
    AIM: To evaluate the efficacy of infliximab in the maintenance of Perianal fstulizing Crohn's disease. METHODS: The clinical data of 24 patients with perianal fistula Crohn's disease (PFCD) treated with infliximab (IFX) in the Department of Anorectal Surgery of our hospital from November 2020 to October 2023 were retrospectively collected. The clinical efficacy and safety were evaluated by observing the clinical characteristics for 54 weeks. The fistula remission rate, clinical remission rate, and endoscopic remission rate of patients were calculated. The changes of laboratory indexes before and after treatment were recorded. Logistic regression was used to analyze the related factors of fistula remission. All adverse reactions occurred during IFX treatment were recorded. RESULTS: After 54 weeks of IFX treatment, the fistula remission rate, clinical remission rate, and endoscopic remission rate were 37.5%, 45.83%, and 33.33%, respectively. Fistula response at 14 weeks of treatment (OR=19.419, 95%Cl: 1.267-297.559, P=0.033) was predictive factors for fistula remission at 54 weeks of treatment. The inflammatory indexes and nutritional indexes were significantly improved compared with those before treatment (P<0.01). The scores of PDAI, CDAI and SES-CD were significantly different from those before treatment (P<0.01). Five patients (20.83%) had adverse reactions, and the symptoms disappeared or improved after symptomatic treatment, and no patient had serious adverse reactions. CONCLUSION: IFX can effectively promote the closure of PFCD fistula, improve the chronic inflammatory reaction of intestinal mucosa, alleviate clinical symptoms, and improve the quality of life of patients. IFX is effective and safe for PFCD maintenance treatment.
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