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    Pharmacological effects and clinical evaluation of toludesvenlafaxine in the treatment of depression
    LI Yumeng, DU Xiaoyu, QIU bo, WU Huizhen
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 419-426.   DOI: 10.12092/j.issn.1009-2501.2025.03.016
    Abstract1295)      PDF (954KB)(780)       Save
    Depression is a common mental disease. At present, there are poor efficacy and drug-related safety problems in antidepressant treatment. Toludesvenlafaxine, as a new triple reuptake inhibitor (TRIs/SNDRIs), increases the inhibitory effect of dopamine (DA) reuptake on the basis of serotonin (5-HT) and norepinephrine (NE), achieves multi-target synergistic therapy and reduces 5-HT/NE-related adverse drug reactions. This article reviews the basic introduction, preclinical research, clinical efficacy and safety of toludesvenlafaxine, in order to provide more ideas and options for the treatment of depression.
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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
    Abstract1163)      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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    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
    Abstract1069)      PDF (1213KB)(1756)       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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    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
    Abstract831)      PDF (909KB)(1835)       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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    Current status and progress of targeted therapy for hepatocellular carcinoma
    CHEN Zhiwen, WANG Longrong, WANG Lu
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 171-182.   DOI: 10.12092/j.issn.1009-2501.2025.02.003
    Abstract779)      PDF (763KB)(758)       Save
    Hepatocellular carcinoma, as a common malignant tumor, remains a serious global health problem. Traditional methods such as surgical resection and chemotherapy have limited effects in improving the prognosis of advanced hepatocellular carcinoma. With the deepening of research into molecular mechanisms, targeted therapy has become an important direction for the treatment of hepatocellular carcinoma. In this review, we summarize the main targeted drugs and associated therapeutic strategies for hepatocellular carcinoma, aiming to provide references and evidence for future related research.
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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
    Abstract737)      PDF (623KB)(1116)       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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    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
    Abstract729)      PDF (770KB)(1556)       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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    Clinical efficacy of Tirellizumab combined with lenvatinib in the treatment of advanced liver cancer
    WU Yuanyuan, LI Chenlu, CHEN Yan, CAO Mengda, SHAO Hua
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 392-397.   DOI: 10.12092/j.issn.1009-2501.2025.03.012
    Abstract704)      PDF (642KB)(418)       Save
    AIM: To investigate the efficacy and safety of checkpoint inhibitor lenvatinib combined with Tirelizumab in the treatment of advanced hepatocellular carcinoma (HCC). METHODS: A retrospective analysis was performed on 52 patients with advanced HCC treated with Renvatinib, tirellizumab or their combination from January 2021 to December 2022 in Zhongda Hospital Affiliated to Southeast University, with disease progression, death and intolerance as endpoints. Efficacy was assessed according to RECIST 1.1 criteria and follow-up was conducted up to June 2023. The main endpoints of the study were objective response rate (ORR), disease control rate (DCR), progression-free survival, PFS) and security. RESULTS: The combination therapy significantly improved ORR and mPFS in patients compared with tirelizumab or lenvatinib monotherapy. Compared with single tirellizumab or lenvastinib, there was no significant difference in the adverse reactions associated with the combination treatment, suggesting that the combination of the two was generally well tolerated and the side effects are controllable. CONCLUSION: Lonvastinib combined with tirelizumab is more effective in the treatment of HCC, can significantly prolong PFS, and is generally well tolerated, which may be a potential treatment for advanced HCC.
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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
    Abstract648)      PDF (615KB)(1234)       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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    Research progress on the addictivity and neurotoxicity of ketamine
    ZI Zhian, ZHAO Tingyi, WANG Gongwu, CAO Jun
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (9): 1233-1242.   DOI: 10.12092/j.issn.1009-2501.2025.09.010
    Abstract639)      PDF (676KB)(569)       Save
    As a new type of rapid antidepressant, ketamine has provided a new approach for the treatment and research on the pathological mechanism of major depressive disorder. However, the addictive potential and neurotoxicity of ketamine have become issues that cannot be ignored in clinical medication. This article briefly introduces the relevant research progress on ketamine addiction and neurotoxicity mechanisms at home and abroad, hoping to provide a reference for the rational development and utilization of ketamine.
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    SAS macro tool for pharmacokinetic parameter estimation based on non-compartmental models
    ZHANG Li, LOU Donghua
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (5): 608-621.   DOI: 10.12092/j.issn.1009-2501.2025.05.004
    Abstract628)      PDF (706KB)(687)       Save
    AIM: To develop a SAS macro tool for calculating pharmacokinetic (PK) parameters using non-compartmental analysis (NCA) that is applicable to various routes and frequencies of drug administration. METHODS: By incorporating the principles of NCA PK parameter calculations, the structure of the SAS macro program is designed and programmed. The usage of the macro program is demonstrated through simulated examples. RESULTS: Based on NCA, this study programmed a SAS macro using SAS macro language to calculate both single-dose and steady-state complete PK parameters. It supports three modes of drug administration: extravascular, intravenous infusion, and intravenous bolus injection, as well as four algorithms for calculating area under the curve (AUC). By comparing with authoritative calculation software, the results were found to be highly consistent across various calculation scenarios, with more accurate calculations for the time of first measurable concentration (Tlag). CONCLUSION: The %M_CREATE_PK_PARAMETERS macro is a SAS macro that supports comprehensive PK parameter calculations in NCA, providing an accurate, efficient, and flexible solution for PK parameter estimation with broad application prospects.
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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
    Abstract585)      PDF (924KB)(1270)       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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    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
    Abstract581)      PDF (589KB)(962)       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 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
    Abstract572)      PDF (958KB)(1493)       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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    Clinical research progress of efgartigimod in the treatment of generalized myasthenia gravis
    LIU Shu, SUN Chunhui, TAN Zhirong, XING Man
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (5): 714-720.   DOI: 10.12092/j.issn.1009-2501.2025.05.017
    Abstract570)      PDF (742KB)(814)       Save
    Myasthenia gravis (MG) is a chronic autoimmune disease that causes partial or systemic skeletal muscle weakness and fatigue. Efgartigimod is an antibody fragment targeting the Fc receptor in newborns, which clears pathogenic immunoglobulin G antibodies through a unique mechanism. Efgartigimod is used to treat systemic myasthenia gravis safely and efficiently, which can significantly improve muscle strength and quality of life for patients. This article reviews pharmacological, clinical research, and safety of efgartigimod, in order to providing reference for its clinical treatment in systemic myasthenia gravis (gGM).
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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
    Abstract543)      PDF (738KB)(1132)       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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    Research progress on targeted drug delivery strategies in inflammatory lung diseases
    LI Xiaonan, LI Yang, XU Zhangxi, KANG Shuzhen, KONG Li, ZHANG Zhiping
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 313-324.   DOI: 10.12092/j.issn.1009-2501.2025.03.003
    Abstract543)      PDF (946KB)(847)       Save
    Inflammatory lung diseases are currently a major challenge threatening human health and life. Imbalanced inflammation and excessive inflammation can lead to tissue damage and trigger the occurrence and development of systemic diseases. Anti-inflammatory treatment is of vital importance for improving patient survival and quality of life. In recent years, significant progress has been made in the exploration and research of drug targeting strategies, effectively addressing issues such as slow onset, low bioavailability, and rapid in vivo clearance rates during drug delivery. Drug targeting can increase local drug concentrations, reduce dosing frequency, and mitigate side effects. This review primarily elaborates on the classification and characteristics of inflammatory lung diseases. It comprehensively reviews targeted drug delivery strategies for inflammatory lung diseases from three perspectives: local targeting, passive targeting, and active targeting. Furthermore, it discusses the prospects and challenges of drug targeted therapy for lung diseases, potentially providing new research and application ideas for the targeted treatment of inflammatory lung diseases.
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    Radix angelica sinensis and astragalus mongholicus extract mediating the Jagged1/Notch1 pathway to inhibit fibroblast transdifferentiation and resist radiation induced myocardial fibrosis
    LI Wen, JIANG Hugang, WANG Xinqiang, LI Yingdong, LIU Kai, ZHAO Xinke
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 209-215.   DOI: 10.12092/j.issn.1009-2501.2025.02.007
    Abstract537)      PDF (2873KB)(372)       Save
    AIM: To study the mechanism of action of radix angelica sinensis and astragalus mongholicus extract (RAS-AM) in inhibiting fibroblast transdifferentiation (CMT) and preventing radiation-induced myocardial fibrosis (RIMF) via the Jagged1/Notch1 pathway. METHODS: Sixty male Wistar rats were randomly divided into blank group, model group, benazepril hydrochloride group, low dose RAS-AM group, medium dose RAS-AM group, and high dose RAS-AM group, with 10 rats in each group. Except for the blank group, all other groups were induced with high-energy radiation at a dose of 38 Gy to establish RIMF models. The blank group and the model group received sterile distilled water by gavage, and the other groups received medication for 4 weeks of intervention: benazepril hydrochloride group (1.0 mg·kg-1·d-1), low dose RAS-AM group (150 mg·kg-1·d-1), medium dose RAS-AM group (300 mg·kg-1·d-1), and high dose RAS-AM group (600 mg·kg-1·d-1). The general condition of rats, the ultrastructure of myocardial tissue were observed using electron microscopy, changes in myocardial tissue fibers using Masson staining, and  CMT related protein Vimentin and α-SMA expression using immunohistochemical staining techniques. ELISA was used to detect serum inflammatory factors IL-6 and TNF-α in rats. The levels of cTnI and ST2, and the expression of Jagged1 and Notch1 were detected by Western blot. RESULTS: Compared with the blank group, the model group rats exhibited symptoms such as mental fatiguem anorexiam and loose stools; The arrangement of some myofibrils in the myocardium is disordered, with dissolution and breakage of myofibrilsm abnormal Z-line structure in some partsm disordered mitochondrial arrangement, rupture of mitochondrial membranem, and rupture or disappearance of mitochondrial ridge structure in some parts. A large amount of collagen fibers proliferate and deposit in the myocardium, and the fibrotic area significantly increases (P<0.01); The expression of myocardial tissue Vimentin α-SMA protein increased (P<0.05), while the expression of Jagged1 and Notch1 proteins decreased (P<0.05); serum IL-6 and TNF-α, the expression of inflammatory factors such as cTnI and ST2 increased (P<0.05). compared with the model group, the RAS-AM and benazepril hydrochloride groups showed varying degrees of improvement in general conditions; the pathological changes of myocardial ultrastructure have been improved, and myocardial fibrosis has been alleviated; The area of collagen fibers significantly decreased (P<0.01); Myocardial tissue Vimentin α-SMA protein expression decreased (P<0.05), while Jagged1 and Notch1 expression increased (P<0.05); Serum IL-6 and TNF-α, The expression of inflammatory factors such as cTnI and ST2 decreased (P<0.05). CONCLUSION: RAS-AM may alleviate RIMF by intervening in the Jagged1/Notch1 pathway to inhibit CMT. The specific mechanism still needs further investigation. 
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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
    Abstract504)      PDF (581KB)(3830)       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 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
    Abstract502)      PDF (1237KB)(2873)       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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    Optimizing the dosing regimen of aripiprazole microspheres by population pharmacokinetic modeling and simulation
    MENG Qingheng, HAN Zhihui, LEI Qi, CHEN Bin, YIN Xia, HU Haitang, LIU Hongxia, ZHENG Qingshan, XU Ling, HUANG Qin
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 493-500.   DOI: 10.12092/j.issn.1009-2501.2025.04.007
    Abstract490)      PDF (2366KB)(361)       Save
    AIM: To optimize the clinical dosage and administration regimen of a novel long-acting injectable aripiprazole microsphere (LZMT05) using plasma concentration data from two clinical trials. METHODS: Plasma concentrations were collected from 196 schizophrenia patients administered LZMT05, and a population pharmacokinetic (PopPK) model was developed. The therapeutic window was defined as the steady-state trough-to-peak concentration range (94.0-534 ng/mL) of oral aripiprazole. Multiple clinical scenarios were simulated to identify the optimal regimen. RESULTS: A one-compartment model with dual first-order absorption and first-order elimination characterized LZMT05 pharmacokinetics. Covariates like sex and CYP2D6 genotype were integrated into the final model. Simulations demonstrated that switching from 10 mg oral aripiprazole to 350 mg LZMT05 every 4 weeks sustained concentrations within the therapeutic window with minimal peak-to-trough fluctuations. CONCLUSION: The PopPK-guided optimized LZMT05 regimen maintained drug exposure within the therapeutic window, suggesting favorable efficacy and safety.
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    Network pharmacological analysis of berberine inhibiting breast cancer cell proliferation and in vitro cell validation#br#
    ZHANG Huihui, JIN Le, LIU Su, CHEN Hongxiao, CHEN Zhaolin, TANG Liqin
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 332-338.   DOI: 10.12092/j.issn.1009-2501.2025.03.005
    Abstract440)      PDF (1702KB)(192)       Save
    AIM: To explore the mechanism of berberine on breast cancer cells based on network pharmacology and in vitro cell experiments. METHODS: Firstly, berberine and breast cancer were taken as the research objects, the intersection targets of the two were screened by VEEN diagram, GO function and KEGG enrichment analysis were performed by R language, and molecular docking and visualization were carried out by Autodock Vina and Pymol software. Then, berberine treated breast cancer MCF-7 cells for 24 h, and then in vitro cell experiments were performed. CCK-8 was used to detect cell viability, Edu and plate cloning were used to detect cell proliferation and cloning, and apoptosis was detected by An-nexin V-FITC/PI double staining and Western blot. Laser confocal and CETSA were used to verify the binding effect of berberine and AKT1 protein. RESULTS: The results of network pharmacology showed that berberine had a good binding to the core targets AKT1, AKT2 and MAPK3. Berberine (20, 40, 80 μmol/L) significantly inhibited the proliferation and cloning ability of MCF-7 cells in a concentration-dependent manner (P<0.05, P<0.01). The results of laser confocal and CETSA experiments showed that berberine and AKT1 had a binding effect, and the stability of the two was enhanced after the combination. CONCLUSION: Berberine inhibits MCF-7 cell proliferation and induces apoptosis in human breast cancer cells by targeting binding to AKT1 protein.
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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
    Abstract431)      PDF (988KB)(3544)       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 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
    Abstract429)      PDF (952KB)(1761)       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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    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
    Abstract426)      PDF (844KB)(1651)       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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    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
    Abstract424)      PDF (1338KB)(2453)       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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    Recent research progress of Menin inhibitors in NPM1-mutated acute myeloid leukemia
    YU Xiaoda, LI Jiajing, WANG Anan, GUO Jiangang, LIU Bei
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 533-540.   DOI: 10.12092/j.issn.1009-2501.2025.04.012
    Abstract421)      PDF (999KB)(344)       Save
    The nucleophosmin 1 (NPM1) mutation is one of the most frequent subtypes in acute myeloid leukemia (AML). Under the conditions of FLT3-internal tandem duplications (FLT3-ITD) and/or DNMT3A co-mutations or adverse cytogenetics, the originally favorable prognosis will deteriorate. In recent years, studies have found that multiple endocrine neoplasia protein (Menin) inhibitors targeting Menin-KMT2A complex can downregulate the overexpression of leukemia causing genes HOX (homeotic gene) and MEIS1 (myeloid ecotropic viral integration site 1) in NPM1-mutated AML, demonstrating remarkable anti-leukemia activity. This article aims to review the mechanism and clinical research of Menin inhibitors, novel small molecule targeted drugs in NPM1-mutated AML, as well as the resistance mechanism of Menin inhibitors, hoping to provide promising approaches for the subsequent treatment of NPM1-mutated AML patients. 
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    Progress in the pharmacological effects of naringin on cardiovascular diseases
    LIU Dan, MIAO Jiawei, TAN Zihao, HE Chunyao, ZHAO Mingzhu, HE Xiuzhen
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 272-281.   DOI: 10.12092/j.issn.1009-2501.2025.02.015
    Abstract419)      PDF (832KB)(677)       Save
    Naringin is a flavonoid compound with a wide range of biological and pharmacological activities, which can be used in treating tumor, diabetes, neurodegenerative diseases, cardiovascular diseases, metabolic syndrome, etc. Among them, the application of naringin in cardiovascular diseases has attracted the attention of many researchers. This article mainly reviews the role of naringin in cardiovascular disease (regulating blood lipids, anti atherosclerosis, lowering blood pressure, inhibiting myocardial hypertrophy, anti myocardial infarction, protecting myocardial ischemia/reperfusion injury, reducing myocardial ischemia/reperfusion injury and improving pulmonary arterial hypertension), the protective effect on cardiotoxicity, and the signal pathways in cardiovascular disease (PI3K-Akt-mTOR, p-eNOS/p-Akt/p-ERK, miR-126/GSK-3 β/β-Catenin), clinical trials, etc. This paper is expected to review the current research status of naringin in cells and animal models so as to reveal its clinical application prospects and provide reference for further research in related fields.
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    Research progress on advanced therapeutic approaches and emerging technologies in the drug treatment of refractory thyroid cancer
    CHEN Hongdan, HUANG Yinde, LI Chong
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 325-331.   DOI: 10.12092/j.issn.1009-2501.2025.03.004
    Abstract407)      PDF (845KB)(462)       Save
    Poorly differentiated and advanced thyroid cancers are characterized by high malignancy, progress rapidly, and resistance to radiotherapy and chemotherapy. These characteristics pose significant challenges, severely limiting effective treatment options. Various kinase inhibitors have been used in the treatment of refractory thyroid cancer were used accompanying by the carcinogenic mechanisms' studies investigating in thyroid cancer, such as Dabrafenib (BRAF inhibitor), Trametinib (MEK inhibitor), Vandetanib (RET inhibitor), Lenvatinib (VEGF inhibitor), and multi-target kinase inhibitors. However, drug resistance remains an inevitable issue, significantly limiting the efficacy and application of kinase inhibitors. Therapeutic approaches such as immunotherapy, redifferentiation strategies for thyroid cancer, radiopharmaceutical conjugates, and the application of nanotechnology are currently in the clinical research stage, requiring further clarification of their efficacy. Comprehensive understanding of therapeutic strategies and available treatment combinations for refractory thyroid cancer is of paramount importance in the diagnosis and treatment of thyroid cancer. Therefore, this article reviews technologies and methods for treating refractory thyroid cancer, focusing on chemotherapy, molecular targeted therapy, immunotherapy, and radiopharmaceutical therapy, aiming to provide a reference for selecting treatment strategies for refractory thyroid cancer.
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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
    Abstract404)      PDF (621KB)(2165)       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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    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (11): 1440-.  
    Abstract404)      PDF (3523KB)(66)       Save
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    Research progress on mechanism of action of Chaenomeles speciosa Nakai in the treatment of rheumatoid arthritis bone restruction
    CAO Jun, ZHOU Yanlin, AI Zhengwen, LI Shigang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (3): 404-411.   DOI: 10.12092/j.issn.1009-2501.2025.03.014
    Abstract396)      PDF (800KB)(778)       Save
    Rheumatoid arthritis is an autoimmune disease characterized by progressive bone destruction, with joint swelling caused by synovial inflammation in the early stage, and joint deformity caused by cartilage and bone destruction occurring in the middle and late stages as inflammation develops, resulting in a 75% disability and deformity rate within three years, and the prevention and treatment of RA bone and joint destruction is of urgency, and it is therefore of great significance to search for effective drugs to treat RA bone destruction. Studies have shown that wrinkled skin papaya can treat RA bone destruction, but the composition and mechanism of action are unknown, so this review aims to provide an overview of the mechanism of action of the effective active ingredients in wrinkled skin papaya for the treatment of rheumatoid arthritis bone destruction, and to provide a basis and direction for the development of novel formulations of traditional Chinese medicines for anti-RA bone destruction.
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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
    Abstract380)      PDF (843KB)(2963)       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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    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
    Abstract375)      PDF (1297KB)(1982)       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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    Effects of branched-chain and aromatic amino acids on type 2 diabetes mellitus and the progress
    ZHANG Mengli, WU Fangfang, TAN Zhien, OU Min, LIU Lingjie, LU Na, QIAO Liya, YANG Xiaonan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (4): 526-532.   DOI: 10.12092/j.issn.1009-2501.2025.04.011
    Abstract370)      PDF (1193KB)(600)       Save
    Type 2 diabetes mellitus is a metabolic disease characterized by high blood sugar levels. Traditionally, amino acids are primarily viewed as the basic building blocks for proteins and peptide synthesis. However, in recent years, amino acids have gained increased attention as signaling molecules that play crucial roles in the maintenance and regulation of metabolic homeostasis. It has been found that there is a close correlation between the metabolism of branched-chain and/or aromatic amino acids and the occurrence or development of type 2 diabetes mellitus. Furthermore, there have been successive reports on the regulation mechanism involved. This article will focus on the metabolic processes, mechanisms and clinical value of branched-chain and aromatic amino acids in type 2 diabetes mellitus. It will also summarize and provide an outlook on the current state of amino acid metabolism in the treatment of diabetes mellitus, with the aim of offering new ideas for the treatment of type 2 diabetes mellitus.
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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
    Abstract361)      PDF (699KB)(2353)       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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    Advances in pharmacokinetics of isavuconazole in special population
    XIE Jingxian, DU Jianjun, CHEN Lu, ZHANG Lijuan, YANG Yong
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (5): 709-713.   DOI: 10.12092/j.issn.1009-2501.2025.05.016
    Abstract361)      PDF (612KB)(385)       Save
    Isavuconazole represents a novel generation of triazole antifungal agents for the treatment of invasive trichothecenes in adults. The pharmacokinetic profile of isavuconazole differs in special populations, including children, patients with extracorporeal membrane oxygenation, those with hepatic or renal injury, patients undergoing blood purification, and critically ill individuals and solid organ transplant recipients. These differences impact the safety and efficacy of patient treatment. This article presents the latest progress in the pharmacokinetic study of isavuconazole in these special populations.
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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)(1094)       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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    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
    Abstract353)      PDF (821KB)(994)       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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    Effects of different frequencies 0.01% atropine eye drops on the ocular surface in adolescent myopia control
    XU Qibin, LI Qiushi, WEI Jiamin, DAI Hongmei
    Chinese Journal of Clinical Pharmacology and Therapeutics    2025, 30 (2): 238-243.   DOI: 10.12092/j.issn.1009-2501.2025.02.011
    Abstract353)      PDF (694KB)(668)       Save
    AIM: To evaluate the effect of different frequencies 0.01% atropine eye drops on the ocular surface in adolescent myopia control. METHODS: A total of 84 adolescent patients with myopia were recruited for this study. They were randomly assigned to receive 0.01% atropine eye drops at different frequencies (morning group, evening group, morning and evening group). During the treatment period, ocular and systemic adverse reactions were observed, spherical equivalent refraction (SER) and axial length (AX) were examined. Additionally, ocular surface disease index (OSDI) questionnaire was obtained, tear meniscus height (TMH) ,non-invasive first tear film break-up time (NifBUT), non-invasive average tear film break-up time (NiaBUT), and meibomian gland atrophy score (MaS) were measured by Keratograph 5M. RESULTS: During the 6-month treatment with 0.01% atropine eye drops, all adverse reaction  symptoms were relatively mild and infrequent. Only one case of systemic reaction was reported, with temporary xerostomia. Six patients reported discomfort such as ocular itching and dryness. The ocular reactions of photophobia and blurred near vision were slightly more common in the morning and combined morning-evening groups compared to the evening group, but there were no significant differences among the three groups (P>0.05). Compared to baseline, there were significant differences in SER and AX among the three groups after six months of treatment (P<0.05). Compared to baseline, no significant differences were observed in the Morning group after six months of treatment in terms of OSDI score (P=0.656), TMH value (P=0.362), NifBUT (P=0.510), NiaBUT (P=0.700), and MaS (P=0.846). Similarly, no significant changes were found in the Evening group regarding OSDI score (P=0.429), TMH value (P=0.462), NifBUT (P=0.462), NiaBUT (P=0.598), and MaS (P=0.351). Additionally, in the Morning and evening group, no significant changes were detected in OSDI score (P=0.457), TMH value (P=0.748), NifBUT (P=0.197), NiaBUT (P=0.070), and MaS (P=0.802) after six months of treatment. CONCLUSION: After six months of using 0.01% atropine eye drops with different frequencies in adolescent myopia control, there was no significant impact on the ocular surface.
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