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Research progress of traditional Chinese medicine intervention in chemotherapy renal injury LIU Yeyuan, QI Yafeng, ZHANG Maofu, LI Xinyu, SHEN Yanyun, LIU Yu, ZHANG Shangzu, LI Yangyang, ZHANG Liying, ZHANG Zhiming Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 556-569.   DOI: 10.12092/j.issn.1009-2501.2025.04.015 Abstract （299）      PDF （843KB）（2314）       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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Advances and future research prospects in regulatory policies for clinical trials of artificial intelligence medical devices LIANG Hao, WANG Shun, CUI Cheng, SONG Ling, SUN Ailin, LI Man, QIAO Jie, SONG Chunli, LI Haiyan, ZHAO Yangguang, LI Haiyan, ZHANG Chenguang, LIU Dongyang Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 427-431.   DOI: 10.12092/j.issn.1009-2501.2025.03.017 Abstract （359）      PDF （581KB）（2607）       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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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 （155）      PDF （5317KB）（1070）       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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Effects of hawthorn flavonoids on atherosclerotic and hyperlipidemia LI Junmin, NIU Hengli, XIE Mingquan, SU Jinlong Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (3): 276-282.   DOI: 10.12092/j.issn.1009-2501.2023.03.005 Abstract （795）      PDF （2953KB）（1452）       Knowledge map    Save AIM: To investigate the preventive and therapeutic effects of Hawthorn flavone on hy-perlipidemia and atherosclerosis rats. METHODS: The atherosclerosis model was established by high fat diet plus vitamin D2. The blood lipid levels, heart index, atherosclerosis index (AI1, AI2) and cor-onary heart index were measured in each group. The histopathological changes of aorta were ob-served by oil red O staining, HE staining and Mas-son staining. ELISA experiments were used to de-tect IL-6, ICAM-1, MCP-1 and VCAM-1 protein level. RESULTS: Compared with normal group, total cho-lesterol (TC), triglyceride (TG), low density lipopro-tein (LDL-C), heart index, atherosclerosis index (AI1, AI2) and coronary index in atherosclerosis model group were significantly increased (P<0.01), while high density lipoprotein cholesterol (HDL-C) was significantly decreased (P<0.01). The pathological score of aorta and the degree of fibrosis were sig-nificantly increased (P<0.01). Compared with model group, TC, TG, LDL-C, heart index, atherosclerosis index (AI1, AI2) and coronary heart index were significantly decreased (P<0.01), and high-density lipo-protein cholesterol (HDL-C) was significantly in-creased (P<0.01) in medium, high dose hawthorn flavonoids and atorvastatin groups. The pathological score of aorta significantly decreased and the degree of fibrosis significantly improved (P<0.01). The variation trend of blood lipid levels in hyperlip-idemia rats is basically consistent with atheroscle-rotic rats. Meanwhile, compared with model group, the medium, high dose hawthorn flavonoids and atorvastatin groups could significantly inhibit the expression levels of IL-6, MCP-1, ICAM-1 and VCAM-1 adhesion molecules (P<0.01). CONCLUSION: The hawthorn flavone can inhibit the forma-tion of aortic endothelial atherosclerotic plaque, re-duce the degree of fibrosis and inflammation of atherosclerotic plaque in rats, and achieve the pur-pose of anti-atherosclerosis. Meanwhile, the haw-thorn flavone has the effect of regulating blood lip-id. 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 （147）      PDF （723KB）（851）       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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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 （345）      PDF （1338KB）（1811）       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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Research progress on the clinical application and mechanism of commonly used traditional Chinese medicine in the treatment of breast cancer LI Shanshan, WEI Dandan, KANG Hanyu, LIU Xiaopeng, YAN Shuxun, JIANG Shiqing Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (7): 977-983.   DOI: 10.12092/j.issn.1009-2501.2025.07.013 Abstract （299）      PDF （988KB）（2324）       Knowledge map    Save Breast cancer is a common clinical gynecological tumor. According to the 2022 global cancer data statistics, breast cancer ranks second in terms of incidence among newly diagnosed cancer cases worldwide. Modern medicine often adopts surgical operation, chemotherapy, and other methods, which have certain efficacy but also many problems such as high drug resistance rates and significant adverse reactions. Chinese patent medicines exhibit extensive anticancer effects. The study found that Shenyi Capsule, Pingxiao Capsule, and Zhenqi Fuzheng Granules were widely used in the treatment of breast cancer, exerting therapeutic effects on breast cancer by inhibiting cell proliferation, invasion, and metastasis, suppressing angiogenesis, reversing cellular drug resistance, and inhibiting precancerous lesions. Meanwhile, the oral administration of Chinese patent medicines in combination with other traditional Chinese medicine (TCM) compounds, TCM decoctions, or modern medical treatments can improve patients' quality of life and reduce adverse reactions. Currently, there are numerous studies on the treatment of breast cancer with Chinese patent medicines, but a systematic summary is lacking. Therefore, this study conducted a systematic review of the mechanisms of action and clinical applications of Chinese patent medicines as adjuvant therapy for breast cancer, aiming to provide guidance for clinical medication. Related Articles | Metrics

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Research progress of 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 （331）      PDF （1237KB）（1905）       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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Research progress on the inhibition of cardiac remodeling by vericiguat DING Ding, WU Shengnan, WANG Ancai, WANG Deguo Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (6): 858-863.   DOI: 10.12092/j.issn.1009-2501.2025.06.016 Abstract （160）      PDF （699KB）（2056）       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 and progress in the treatment of cardiovascular diseases with metabolic drugs SUN Min, WANG Hongya, HE Hongbo, ZHU Zhiming, GAO Peng Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (7): 984-997.   DOI: 10.12092/j.issn.1009-2501.2025.07.014 Abstract （249）      PDF （798KB）（1663）       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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Effects and safety of Xinmaining for cerebral infarction treatment:a systematic review LI Lin, HUANG Ji-han, ZHANG Guang-min, LIU Chuan-gui, ZHANG Ping, XIE Xue-feng, HUANG Xiao-hui Chinese Journal of Clinical Pharmacology and Therapeutics    2014, 19 (9): 1025-1032.   Abstract （458）      PDF （1416KB）（1964）       Knowledge map    Save AIM: To conduct a meta-analysis to evaluate the efficacy and safety of Xinmaining for cerebral infarction. METHODS: CBM, CNKI,WanFang Data, Cochrane Library, MEDLINE, EMbase were electronically searched for randomized controlled trials (RCTs) involving Xinmaining in the treatment for cerebral infarction. Meanwhile, all relevant Chinese and English literatures were retrieved by hand search. Stata 11.0 was used for Meta analysis.RESULTS: A total of twenty three randomized controlled trails involving 2737 patients were included . Clinical assessment measures were total response rates, neurological deficit scores, changes of hemorheology and blood lipids. The result of meta-analysis (twenty two trials) showed that there was significant difference on total response rates[RR=1.14,95%CI(1.11,1.18)]; Xinmaining group was superior to the control group in lowering WBLSV,WBHSV,plasma viscosity, HCT ,fibrinogen and WBRV; Xinmaining group showed better results in decreasing TC and TG and increasing HDL-C; Mild adverse effects were reported in only three patients of one trial.CONCLUSION: Current evidences showed that xinmaining could increase the total response rates, reduce the neurological deficit scores, decrease the hemodynamic indexes and improve the blood lipid parameters with a low incidence of adverse effects,which provides a good application prospect in clinical practice. However,the quality of current clinical trials was not high, more high-quality RCTs were needed to provide clear evidences for the efficacy and safety of Xinmaining for cerebral infarction. Reference | Related Articles | Metrics

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Research progress of finerenone in the treatment of type 2 diabetes mellitus complicated with chronic kidney disease ZHAI Weiwei, YU Qiaoling, LIU Ping, QIU Bo, WU Huizhen Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (9): 1067-1074.   DOI: 10.12092/j.issn.1009-2501.2022.09.015 Abstract （422）      PDF （446KB）（2179）       Knowledge map    Save Finerenone is a new non-steroidal mineralocorticoid receptor antagonists, which can prevent and treat type 2 diabetes mellitus complicated with chronic kidney disease through antioxidant, anti-inflammatory and anti-fibrosis effects, and has a significant cardiovascular protection effect. Compared with traditional mineralocorticoid receptor antagonists, finerenone has a higher selectivity. In this review, the basic introduction, basic research, clinical research and limitations of finerenone were reviewed in order to provide more ideas and options for the treatment of type 2 diabetes mellitus complicated with chronic kidney disease. Related Articles | Metrics

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Research progress on pharmacokinetic interactions of sodium-glucose co-transporter 2 inhibitors DENG Yanru, CAO Gexi, LI Ying, LI Yajing, DONG Zhanjun Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 570-576.   DOI: 10.12092/j.issn.1009-2501.2025.04.016 Abstract （275）      PDF （651KB）（1556）       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 the role of macrophage polarization in cardiovascular diseases CUI Hanyu, HU Changping Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 548-555.   DOI: 10.12092/j.issn.1009-2501.2025.04.014 Abstract （310）      PDF （699KB）（1695）       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 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 （111）      PDF （685KB）（458）       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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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 （281）      PDF （621KB）（1614）       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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Study on the efficacy and mechanism of Qingre xiaoyanning against influenza A H3N2 virus ZHOU Shasha, CHENG Xueqing, PENG Dongdong, WANG Xiaoqing, FU Lijun, XIAO Wenxi, ZHANG Guomin Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 347-354.   DOI: 10.12092/j.issn.1009-2501.2025.03.007 Abstract （281）      PDF （1860KB）（997）       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 on the pharmacokinetics of prodrugs ZHU Yin-ci, SUN Jian-guo, PENG Ying, WANG Guang-ji Chinese Journal of Clinical Pharmacology and Therapeutics    2012, 17 (12): 1433-1440.   Abstract （603）      PDF （587KB）（2994）       Knowledge map    Save Prodrugs are chemicals with little or no pharmacological activity, which can be changed to therapeutically active metabolite after undergoing biotransformation in vivo. The design of prodrugs has become an important way to overcome the shortcomings of drugs such as poor solubility, low bioavailability, short elimination half-life, devoid of ideal targets and so on. However, there still lacks criteria to evaluate pharmacokinetic properties of prodrugs. This paper reviews the pharmacokinetic profiles of various types of prodrugs in recent years, and proposes full evaluation from absorption, distribution, metabolism and excretion perspectives. Reference | Related Articles | Metrics

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Protective effects and mechanism of low dose aspirin on focal cerebral ischemia-reperfusion rats QIU Li-ying, YU Juan, ZHOU Yu, CHEN Chong-hong Chinese Journal of Clinical Pharmacology and Therapeutics    2006, 11 (6): 659-664.   Abstract （122）      PDF （461KB）（922）       Knowledge map    Save AIM: To investigate the protective effects and the mechanism of low dose aspirin on focal cerebral ischemia-reperfusion rats.Methods: Right middle cerebral artery was occluded by inserting a thread through internal carotid artery for 2 h, and then reperfused for 24 h.6 mg·kg-1 dose of aspirin was intragastric administered at reperfusion 0 and 6 h.The brain injuried area, the neuronal density, the numbers of apoptotic cells and the ratio of Bcl-2 protein and Bax protein from occluded brain were estimated.The ratio of prostacyclin (PGI2) and thromboxane (TXA2) in plasma, the contents of malondialdehyde (MDA), adenosion 5'-triphosphate (ATP) and myeloperoxidase(MPO) in brain tissue from the occluded side were assayed.Apoptosis was measured in paraffin sections with TUNEL method.Bcl-2 and Bax were detected by immunohistochemical staining method.Adjacent sections were stained with hematoxylin and eosin, and neuronal density subfield was counted.The contents of PGI2 and TXA2 in plasma were measured by 125I radioimmunoassay method.The content of MDA and MPO in brain tissue was determined by biochemical method.The content of ATP in brain tissue was separated by capillary electrophoresis.Results: The injuried area of brain occluded side was dramatically reduced after 6 mg·kg-1 dose of aspirin was intragastric administrated.Most of neurons in the injuried regions survived ischemia-reperfusion result when 6 mg·kg-1 dose of aspirin was given, where as most of vehicle group neurons were lost without aspirin treatment.The numbers of apoptotic cells were dramatically reduced by 6 mg·kg-1 dose of aspirin.The ratio of Bcl-2 and Bax was increased by aspirin.The ratio of PGI2/TXA2 in plasma was increased by aspirin.In brain tissue of occluded side, no significant change between 6 mg·kg-1 and vehicle groups in MDA content, ATP level, and MPO content were discovered.Conclusion: The neuroprotective effects of low dose of aspirin on focal cerebral ischemia-reperfusion rats might be attributed to its effects by increasing the ratio of PGI2/TXA2, inhibiting apoptosis and improving the ratio of Bcl-2 Bax. Reference | Related Articles | Metrics

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Chinese Journal of Clinical Pharmacology and Therapeutics    2000, 5 (2): 162-163.   Abstract （155）      PDF （74KB）（4251）       Knowledge map    Save Reference | Related Articles | Metrics

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SPP1 expression in SMARCA4-deficient non-small cell lung cancer and its relationship with PD-L1 WU Juan, HUANG Xi, LI Jiajia, WEI Yuqing, ZHANG Liqing, YU Yongmei, LU Zhiwei, ZHANG He Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 477-486.   DOI: 10.12092/j.issn.1009-2501.2025.04.005 Abstract （304）      PDF （1297KB）（1326）       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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Effects of polymorphisms in follicle stimulating hormone receptor genes on female reproductive function YAN Yuan-liang, GONG Zhi-cheng Chinese Journal of Clinical Pharmacology and Therapeutics    2013, 18 (8): 944-949.   Abstract （256）      PDF （1143KB）（1514）       Knowledge map    Save Follicle stimulating hormone (FSH) is a glycoprotein hormone played an essential role in reproduction and widely used in the treatment of infertility. However, in the assisted reproductive technology programs, the response of ovulating women to exogenous FSH is quite variable in individuals. FSH action is mediated by the FSH receptor (FSHR). More than 900 polymorphisms of FSHR gene are known, it has been previously reported that SNPs of FSHR may be related to the response of the patients to FSH stimulation and should, therefore, be considered in assessment of efficacy in controlled ovarian hyperstimulation during assisted reproduction techniques in women. The aim of these studies would be the prediction of the genetic causes of diseases to enable an individual clinical setting according to the patient's genetic background undergoing FSH stimulation. In this review we discuss the latest information about the effects of polymorphisms of the FSHR genes on reproductive functions of female, and discuss their clinical implications. Reference | Related Articles | Metrics

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Research progress on non-coding RNA mediated apoptosis in lung cancer LIU Dewei, WU Dong, HUANG Dan, ZHAO Xuanna, WU Bin Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (7): 968-976.   DOI: 10.12092/j.issn.1009-2501.2025.07.012 Abstract （184）      PDF （1276KB）（1032）       Knowledge map    Save Lung cancer is the most common malignant tumors in clinical practice, posing a significant threat to human health. In recent years, with the advancement of high-throughput sequencing technologies, a large number of non-coding RNAs (ncRNAs) have been found to play crucial roles in the regulation of apoptosis in lung cancer cells. This article reviews the research progress of ncRNA (miRNA, lncRNA, circRNA, piRNA) mediated apoptosis in lung cancer, aiming to provide new theoretical basis for ncRNA therapy of lung cancer. Related Articles | Metrics

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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 （202）      PDF （665KB）（538）       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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Exploring the intervention mechanism of Ginkgo biloba for steroid-induced necrosis of the femoral head based on network pharmacology CAO Fang, QIN Kairong, ZHENG Guoshuang, ZHAO Dewei Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (3): 266-275.   DOI: 10.12092/j.issn.1009-2501.2023.03.004 Abstract （423）      PDF （4588KB）（1197）       Knowledge map    Save AIM: To explore the mechanism of Ginkgo biloba in the treatment of steroid-induced osteonecrosis of the femoral head based on net-work pharmacology. METHODS: The active ingredients and targets of Ginkgo biloba were predicted by the TCMSP, ADME, and PharmMapper databases. The disease targets related to steroid-induced osteonecrosis of the femoral head were searched by the GeneCards and OMIM databases. Cytoscape 3.6.1 was used to construct a protein-protein inter-action network. The core target analysis, modular analysis, GO enrichment analysis, and KEGG pathway analysis of the targets of Ginkgo biloba in the intervention of steroid-induced osteonecrosis of the femoral head were performed by the STRING database. RESULTS: In this study, a total of 16 active ingredients of Ginkgo biloba and 547 targets were screened, of which 133 targets were related to steroid-induced femoral head necrosis. By PPI network topology analysis, TP53, AKT1, IL6, VEGFA, MAPK1, JUN, MAPK8, EGFR, EGF, and MYC were identified as the core targets. GO modularization analysis showed that these core targets were mainly related to apoptosis and angiogenesis. GO enrichment analysis was used to analyze the biological processes, cellular localization, and molecular functions of the core targets. KEGG enrichment analysis showed that the targets were mainly involved in molecular signaling pathways, among which the PI3K/AKT signaling pathway was the most relevant. CONCLUSION: Ginkgo biloba can inhibit steroid-induced os-teonecrosis of the femoral head through multiple components, targets, and pathways, which pro-vides the theoretical basis and reference for subse-quent cell and animal experiments. Related Articles | Metrics

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Preclinical pharmacology research of oxiracetam JIN Lei, LI Bo, YE Lei, CAI Yun-Hong, RONG Zu-Yuan Chinese Journal of Clinical Pharmacology and Therapeutics    2011, 16 (3): 354-360.   Abstract （728）      PDF （267KB）（3078）       Knowledge map    Save It has been more than 20 years since the birth of nootropic drug oxiracetam, extensive and deep research has been focused on its pharmacological features in china and abroad. As a general pharmacologically inactive and non-toxic cognition enhancer, it possesses good pharmacokinetics characteristics. The pharmacological effects of oxiracetam include the improvement of learning and memory and neuroprotective function. The mechanism of its action may involve: the effect on central acetylcholine system and the interaction between other neurotransmitter systems associated with cognition (such as glutamate system, monoamine neurotransmitter system) and the cholinergic system, induction and maintenance of LTP, activation of protein kinase C, promotion of brain metabolism, the impact of peripheral steroid hormones, etc. Reference | Related Articles | Metrics

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Advances in animal models of diabetic erectile dysfunction based on therapeutic approaches JING Jiawen, MENG Qingbo, BI Zheng, WANG Fanjing, LI Yufan, FANG Zhaohui Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (9): 1224-1232.   DOI: 10.12092/j.issn.1009-2501.2025.09.009 Abstract （112）      PDF （713KB）（452）       Knowledge map    Save Diabetic erectile dysfunction is a common complication of diabetes that severely affects the quality of life of men and their sexual partners. Active participation in scientific research on diabetic erectile dysfunction is particularly important, and animal models are an important basis for exploring the pathogenesis of the disease, evaluating the efficacy of drug treatments, and developing new drugs. The pathogenesis of diabetic erectile dysfunction is complex, and current treatments mainly focus on regulating blood sugar, anti-oxidative stress, PDE5 inhibitors, stem cell therapy, inhibiting neurovascular injury, anti-fibrosis, traditional Chinese medicine, and other aspects. In particular, correcting hyperglycemia is crucial for preventing or stopping the progression of the disease. This article summarizes and updates existing treatment methods by reviewing the latest literature, and reviews the animal models used in different treatment methods, in order to provide a reference for animal experiments and clinical treatment. Related Articles | Metrics

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Latest development of Melia toosendan SHI Deng, LIU Yan-ru, YANG Jian-yun, XIAO Bing-kun, HUANG Rong-qing Chinese Journal of Clinical Pharmacology and Therapeutics    2012, 17 (3): 357-360.   Abstract （634）      PDF （218KB）（2361）       Knowledge map    Save In this paper, the progresses about the identification,processing,chemical constituents,pharmacological action and toxicity of Melia toosendan are summarized , which could provide some useful information for further study and application of Melia toosendan. Reference | 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 （145）      PDF （1545KB）（524）       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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Correlation of levofloxacin pharmacokinetic/pharmacodynamic parameters with selection of staphylococcus aureus resistance CUI Jun-chang, LIU You-ning, WANG Rui, TONG Wei-hang, LIANG Bei-bei Chinese Journal of Clinical Pharmacology and Therapeutics    2007, 12 (9): 989-992.   Abstract （383）      PDF （172KB）（1229）       Knowledge map    Save AIM: To study the correlation of levofloxacin pharmacokinetic/pharmacodynamic parameters with selection of staphylococcus aureus resistance.METHODS: Tissue cage infection model with staphylococcus aureus was established in rabbits, and the infected animals were given levofloxacin intragastrically at various doses.Changes in levofloxacin concentration, levofloxacin susceptibility of bacteria were monitored at the site of infection.RESULTS: AUC24/MIC, AUC24/MPC, Cmax/MIC, Cmax/MPC, time above MPC and Tmsw showed a statistically significant correlation with selection of staphylococcus aureus resistance, and time above MIC did not (MIC :minimal inhibitory concentration, MPC :mutant prevention concentration, MSW :mutant selection window). Loss of bacterial susceptibility occurred easily when AUC24/MIC was between 20 h and 150 h, and keeping AUC24/MPC above 25 h could restrict selection of resistance.The upper boundary of the selection window in vivo was estimated as an AUC24/MPC value of 25 h, and the lower boundary was estimated as an AUC24/MIC value of 20 h.CONCLUSION: AUC24/MPC, Cmax/MPC and time above MPC may be the parameters for predicting resistance. Reference | 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 （332）      PDF （844KB）（1261）       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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Phase Ⅰ clinical tolerability trial of (S)-ornidazole tablets XIE An-yun, CHENG Ze-neng, OU-YANG Dong-sheng, GUO Xin, HUANG Zhi-jun, ZHANG Gui-xiang, LIU Chang,TAN Hong-yi,YANG Li, YANG Guo-ping Chinese Journal of Clinical Pharmacology and Therapeutics    2011, 16 (4): 412-416.   Abstract （432）      PDF （186KB）（1643）       Knowledge map    Save AIM: To evaluate the tolerability of (S)-ornidazole in healthy volunteers. METHODS: It is a randomized, blinded, placebo-controlled single-center clinical study. Fowrty-eight healthy volunteers enrolled the study. Thirty-eight healthy volunteers were randomly divided into four groups to attend single-dose tolerability trial (250, 500, 1000, 1500 mg, respectively). Ten healthy volunteers entered multi-dose tolerability trial for 7 days [1000 mg (S)-ornidazole, Qd]. Two healthy volunteers of each group were given placebo.Vital signs, electrocardiogram and serum biochemical indicators were observed before and after (S)-ornidazole administration and adverse effects were recorded. RESULTS: In the study, there were no abnormal findings in vital signs, electrocardiogram and serum biochemical indicators.20 healthy volunteers experienced mild adverse effects of dizziness, fatigue, drowsiness nausea and so on. CONCLUSION: (S)-ornidazole tablet is safe for healthy volunteers at daily dose of 250 to 1000 mg Reference | 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 （350）      PDF （952KB）（1340）       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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Research progress on the interaction between epithelial cells and macrophages in lung diseases LI Mengyu, JIANG Wei, ZHANG Yafei, PAN Xin, WANG Yuanyuan Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (9): 1253-1259.   DOI: 10.12092/j.issn.1009-2501.2025.09.012 Abstract （103）      PDF （863KB）（394）       Knowledge map    Save The interaction between epithelial cells and macrophages plays a crucial role in the progression of lung diseases, including immune defense, inflammation regulation, tissue repair, and regeneration. However, an imbalance in this interaction can contribute to the development of various lung diseases. In idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, and lung cancer, macrophages can promote disease progression by secreting cytokines that act on epithelial cells. Simultaneously, activated epithelial cells release cytokines to recruit and activate more macrophages in a positive feedback loop. Thus, comprehensive studies of the interactions between epithelial cells and macrophages in various lung diseases have the potential to identify new therapeutic targets and develop innovative strategies for disease management. This review aims to summarize the current knowledge regarding the interaction between epithelial cells and macrophages in idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, and lung cancer, with the goal of inspiring new research directions for the treatment of lung diseases. Related Articles | Metrics

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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 Abstract （191）      PDF （706KB）（831）       Knowledge map    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.  Related Articles | Metrics

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Bioequivalence study of clindamycin palmitate hydrochloride chewable tablets in healthy volunteers SHI Xiao-peng, WANG Zhi-rui, YANG Zhi-fu, WU Yin, CHEN Su-ning, JIN Xin, WEN Ai-dong Chinese Journal of Clinical Pharmacology and Therapeutics    2008, 13 (5): 552-556.   Abstract （268）      PDF （204KB）（1163）       Knowledge map    Save AIM:To compare the pharmacokinetics and relative bioequivalence of chewable tablet of clindamycin palmitate hydrochloride with that of dispersible tablet. METHODS:An open randomized and two-period crossover study with a one week washout interval was performed in 20 healthy volunteers. Concentrations of clindamycin in plasma were assayed by High Performance Liquid Chromatography method after a single oral dose of 600 mg of the tested or the reference tablets. RESULTS:Limit of quantification was accepted as 0.125 μg/mL (r =0. 999). The main pharmacokinetic parameters of the test and the reference formulations were as follows: Cmax were (4. 5 ±1. 4) and (4. 6 ±1. 4) μg/mL;tmax were (0. 83 ±0. 33) and (0. 90 ±0. 29) h; t1/2 were (2. 3 ±0. 7) and (2. 3 ±0. 7) h; AUC0→t were (16 ±6) and (17 ±6) μg·mL-1·h; AUC0→∞ were (17 ±6) and (18 ±6) μg·mL-1·h. There was no significant difference between the parameters of two tablets. CONCLUSION: The relative bioavailability of the test tablet to reference tablet was 96. 3% .The results of the statistical analysis show that the two formulations are bioequivalent. Reference | Related Articles | Metrics

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Progress in clinical application of topical anesthesia TAO Yijia, YANG Chun, LIU Cunming Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (5): 594-600.   DOI: 10.12092/j.issn.1009-2501.2023.05.015 Abstract （542）      PDF （614KB）（5963）       Knowledge map    Save Topical anesthesia are being widely used in clinical diagnostic or therapeutic fields such as ophthalmology, ENT, dermatology, urology. It is defined as superficial loss of sensation in mucous membranes or skin, produced by direct application of penetrating local anesthetics. Topical anesthesia has the advantages of simple performance, high safety, quick recovery, which can effectively improve patient's satisfaction. In recent years, more and more attention has been paid to the concept of comfortable diagnosis and treatment. The new drugs and application methods of topical anesthesia are emerging constantly, special attention must be paid to their pharmacological characteristics and possible adverse reactions when using them. This article reviews the research progress of topical anesthesia in clinical application in order to provide reference for clinical practice. Related Articles | Metrics

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Sequelae of hypergastrinemia due to long-term administration of proton pumPinhibitors and its management SHEN Jian, WU Jian-xin, LI Ding-guo Chinese Journal of Clinical Pharmacology and Therapeutics    2006, 11 (12): 1321-1325.   Abstract （174）      PDF （192KB）（1540）       Knowledge map    Save Proton pumPinhibitor (PPI) is considered as the standard treatment for acid-related disorders.However,its long-term use, especially in patients with gastroesophageal reflux disease, would cause potential risks,such as hypergastrinemia along with reduced gastric acidity,hyperplasia of enterochromaffin cells (ECL), gastric neoplasms, rebound gastric acid hypersecretion when PPI treatment is stopped, increased oxyntic gastritis in patients with H.pylori infection, and the possible stimulation of growth of non-gastric tumours due to hypergastrinaemia.Each of these trends has led to numerous studies and evaluations on the potential risk-benefit ratio of the long-term use of PPIs, and countermeasures are being proposed for these problems. Reference | Related Articles | Metrics

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Effects and model evaluation of Jianpi Huatan formula on regulatory T cells and Th17 cells in polycystic ovary syndrome patients with spleen deficiency phlegm dampness syndrome DAI Yue, HE Bing, YANG Sijie, YU Ximing, YANG Zhengwang, LI Lan Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (9): 1153-1164.   DOI: 10.12092/j.issn.1009-2501.2025.09.001 Abstract （172）      PDF （2203KB）（421）       Knowledge map    Save AIM: To explore the effects of Jianpi Huatan formula on regulating T cells and helper T cells 17 (Th17) cells in patients with polycystic ovary syndrome (PCOS) due to spleen deficiency and phlegm dampness syndrome, and conduct a model evaluation. METHODS: Ninety-two patients with spleen deficiency phlegm dampness syndrome (PCOS) admitted to our hospital from January 2023 to October 2024 were selected as the research subjects. Propensity score matching (PSM) method was used to match them in a 1:1 ratio, with 46 patients in each group. The control group received conventional treatment, while the observation group received treatment with Jianpi Huatan formula on the basis of the control group. Compared and analyze the differences in clinical data and laboratory indicators between two groups; Compared the changes of sex hormone, glucose metabolism and TCM syndrome score before and after treatment in the two groups, and focused on the changes of regulatory T cells (Treg) and Th17 cells in the two groups before and after treatment; And used the Generalized Estimation Equation (GEE) model to analyze its improvement. Multiple linear regression analysis was used to examine its correlation with the score of traditional Chinese medicine syndrome. A time effect model of Jianpi Huatan formula for treating PCOS with spleen deficiency and phlegm dampness syndrome was established using a nonlinear mixed effects model. The fitting effect of the final model was evaluated through the goodness of fit. Bootstrap was used to test and evaluate the stability of model parameters. Visual prediction testing was used to evaluate the predictive performance of the model. Typical time effect curves of traditional Chinese medicine symptom scores was simulated based on the final model for each baseline. RESULTS: After treatment, the total effective rate of the observation group was significantly higher than that of the control group (χ2=4.842, P=0.028); Compared with before treatment, after 1months and 3 months of treatment, TC, TG, LDL-C, T, LH, FSH, AMH, FPG, FINS, HOMA-IR, the score of traditional Chinese medicine syndrome were significantly reduced, while E2 and HDL-C were significantly increased, and the improvement in the observation group was significantly greater than that in the control group (P<0.05);The results of repeated measures ANOVA showed significant differencesin the time effects, inter group effects, and interaction effects of Treg, Th17, and Treg/Th17 between the two groups of patients (P<0.05) . The GEE analysis results showed that the improvement of Treg, Th17, and Treg/Th17 in the observation group were better than that in the control group (P<0.05);The results of multiple linear regression analysis showed that the levels of TC,TG, LDL-C,T, LH, FSH, AMH, FPG, FINS, HOMA-IR, Th17 were significantly positively correlated with TCM syndrome score, while the levels of E2, HDL-C, Treg, and Treg/Th17 were significantly negatively correlated with TCM syndrome score (P<0.05); The decrease in traditional Chinese medicine symptom score compared to baseline gradually increases over time, eventually reaching the pharmacological platform, which was consistent with the classic Emax model. After gradually screening covariates, it was found that the baseline value of traditional Chinese medicine symptom score had a significant impact on the efficacy parameter Emax. The final model was Emax, i=15.42+1.21×(Baselinei-24.41). The goodness of fit results showed that the final model had a good fitting effect on the measured data. The model parameters obtained from Bootstrap testing were very consistent with the original model, indicated that the model parameter estimation was robust. The visual prediction test results showed that the model had good predictive performance. The typical efficacy time curve showed that the higher the baseline value of TCM symptom score, the greater the decrease in score. At 3 months of treatment, the TCM symptom score at each baseline basically decreased to below 10 points. CONCLUSION: The formula for strengthening the spleen and resolving phlegm can effectively improve the levels of Treg and Th17 in PCOS patients with spleen deficiency and phlegm dampness syndrome, and has good therapeutic effects, which is worthy of clinical application. Related Articles | Metrics

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Research progress on the role of the Nrf2 signaling pathway in the complications associated with obstructive sleep apnea ZHU Haobin, YUE Hongmei, WU Xingdong, LIU Miaomiao, LI Yating, XU Jinhui Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (11): 1283-1291.   DOI: 10.12092/j.issn.1009-2501.2023.11.011 Abstract （346）      PDF （892KB）（713）       Knowledge map    Save Mammalian cell defense mechanisms are constantly evolving in response to increasing endogenous and exogenous oxidative stress factors. In recent years, as research has deepened, nuclear factor E2-related factor 2 (Nrf2) has been hailed as a "star" molecule in antioxidant damage defense. Billions of dollars have been spent internationally on developing targeted activators or inhibitors. Obstructive sleep apnea (OSA) is the most common form of sleep breathing disorder in clinical practice. Oxidative stress is one of its main pathological mechanisms and is closely related to target organ damage in the heart, brain, lungs, kidneys, and other systems. Recent research has revealed the mechanistic relationship of the Nrf2 pathway in OSA complications, and some natural Nrf2 activators have demonstrated emerging therapeutic effects in animal experiments. However, the activation mode and effect pathway of Nrf2 in different target organs of OSA have not been clarified. Therefore, this article reviews the research progress of the Nrf2 pathway in OSA and its complications, to deepen understanding of the mechanism of OSA complications and provide a potential treatment strategy. Related Articles | Metrics