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    Ferroptosis regulatory signaling pathway and its research progress in related diseases
    ZHANG Liang, LIAO Yongqun, XIA Qinchuan, ZHOU Shitong, LI Xiaoli
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (2): 227-234.   DOI: 10.12092/j.issn.1009-2501.2022.02.015
    Abstract1063)      PDF (440KB)(832)       Save
    Ferroptosis is an iron-dependent novel type of programmed cell death. The main features of ferroptosis include lipid reactive oxygen accumulation, iron accumulation and lipid peroxidation. The main mechanisms and signal pathways of ferroptosis are complex and closely related to cystine/glutamate antiporter system, glutathione peroxidase 4, ferroptosis suppressor protein 1, and dihydroorotate dehydrogenase. This review summarizes the current regulatory mechanisms of ferroptosis and discusses the research progress of ferroptosis in tumors, non-alcoholic fatty liver disease, Parkinson's disease, and congestive heart failure.
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    Regulatory mechanism of LDLR and research progress of its related diseases and drugs
    LI Miao, YU Qinwei, JIANG Zhenzhou, ZHANG Luyong,
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (8): 946-954.   DOI: 10.12092/j.issn.1009-2501.2022.08.014
    Abstract913)      PDF (519KB)(585)       Save
    Cholesterol is an important lipid component in the body, which not only participates in the formation of cell membranes, but also is the raw material for the synthesis of bile acids and steroid hormones. Low density lipoprotein receptor (LDLR) is involved in cholesterol metabolism and plays an important role in maintaining the cholesterol homeostasis of organism cells. The expression of LDLR is precisely regulated by transcription, post-transcription and post-translation, and the imbalance of ldlr expression will lead to the occurrence and development of many diseases. In this paper, the molecular regulation mechanism of LDLR, the damage of target organs caused by the imbalance of LDLR expression and the research and development progress of drugs targeting LDLR are reviewed, which provides theoretical basis for further understanding of the progress of diseases related to lipid metabolism disorder and new insights for developing drugs targeting LDLR with more effective and less side effects.
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    Research progress in pharmacological and non-pharmacological treatments of hypertension
    XU Jianfei, LIN Li
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (4): 433-441.   DOI: 10.12092/j.issn.1009-2501.2022.04.013
    Abstract906)      PDF (473KB)(504)       Save
    Hypertension is the most common chronic non-communicable disease in the world and the most important risk factor for cardiovascular and cerebrovascular diseases. At present, the control rate of hypertension treatment standard is less than 50%, and it is still not effectively managed to a large extent. Despite numerous clinical studies and trials over the past four decades, the progress of new antihypertensive drugs has not been satisfactory. This review discusses recent advances in pharmacological and non-pharmacological treatments for patients with hypertension, and may provide new options for clinical hypertension treatment in the future.
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    Pharmacology and clinical evaluation of vericiguat in the treatment of heart failure
    LIU Ping, QIU Bo, WU Huizhen
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (2): 212-218.   DOI: 10.12092/j.issn.1009-2501.2022.02.013
    Abstract902)      PDF (1896KB)(606)       Save
    Vericiguat is a soluble guanylate cyclase stimulator, acting on nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate pathway. Vericiguat can improve the sensitivity soluble guanylate cyclase sensitivity to nitric oxide, stimulate soluble guanylate cyclase without relying on nitric oxide, leading to increased formation of cyclic guanosine monophosphate , which results in multi-dimensional protection effects for the heart. It provides a new therapeutic approach for patients with heart failure. This review provides an overview of mechanism, preclinical studies, pharmacokinetics, clinical efficacy, drug-drug interactions and limitations of vericiguat.
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    Human body networks mechanisms of melatonin and its clinical applications
    SHAO Mingkun, LIU Rong, SUN Pin, GUAN Shui, LIAO Bingcan, LI Sha, CONG Tao, LIANG Kai, MA Hui, SUN Changkai
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (9): 1031-1040.   DOI: 10.12092/j.issn.1009-2501.2022.09.010
    Abstract838)      PDF (2524KB)(540)       Save
    Melatonin is mainly an endogenous indoleamine hormone with many physiological functions. Melatonin not only plays an important role in the treatment of sleep disorders, but also plays an important role in the treatment of nervous system diseases, cancer, cardiovascular diseases, and bone diseases. In this paper, the human body networks mechanisms and the clinical applications of melatonin were summarized to provide reference for exploring the focus and direction of further clinical application research.
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    Role of the m7G methyltransferase METTL1 in tumours
    HONG Ziqiang, GOU Wenxi, CUI Baiqiang, BAI Xiangdou, JIN Dacheng, GOU Yunjiu
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (1): 93-100.   DOI: 10.12092/j.issn.1009-2501.2023.01.012
    Abstract812)      PDF (1346KB)(362)       Save
    N7-methylguanosine (m7G) is a common post-transcriptional modification of RNA that plays an important role in RNA processing, metabolism and function and is mainly regulated by the methyltransferase 1 (METTL1) and WD repeat domain 4 (WDR4) complexes. Several studies have shown that the METTL1/WDR4 complex promotes or inhibits the progression of many tumours, including head and neck tumours, lung, liver, colon, bladder and esophageal squamous cancers, which are dependent on m7G methylation modification of tRNA or miRNA. Therefore, METTL1 and m7G modification can be used as biomarkers or potential intervention targets, providing a new direction for early diagnosis and treatment of tumors. This article will mainly discuss the mechanism and corresponding research progress of METTL1 in tumorigenesis through m7G.
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    Research progress on immunotherapy for triple-negative breast cancer
    HE Lihua, ZHU Xiuzhi, JIANG Yizhou
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (8): 842-853.   DOI: 10.12092/j.issn.1009-2501.2023.08.001
    Abstract777)      PDF (754KB)(647)       Save
    Triple-negative breast cancer (TNBC) is a subtype of breast cancer characterized by the absence of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). It is highly aggressive, easy to relapse, and chemotherapy remains its mainstay treatment due to the lack of therapeutic targets. In recent years, many advances have been made in the development of immunotherapy for TNBC. This review summarizes the primary modalities of immunotherapy for TNBC, including immune checkpoint inhibitors, adoptive immune cell therapy, tumor vaccines and oncolytic virus. We present the latest research progress on each treatment from the perspective of clinical study and fundamental research, while introducing the potential predictive biomarkers and resistance mechanisms of immunotherapy for TNBC.
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    Progress of hypertension pharmacological treatment
    LIU Guijian, CHENG Kuan, ZHU Wenqing, GE Junbo
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (4): 446-449.   DOI: 10.12092/j.issn.1009-2501.2022.04.015
    Abstract740)      PDF (295KB)(512)       Save
    Hypertension is a common cardiovascular disease. Chinese guidelines for the management of hypertension, the global practice guidelines for hypertension of the International Hypertension Society (ISH) and the guidelines for the treatment of adult hypertension drugs of the World Health Organization have been issued successively, which play an important role in guiding the clinical medication of hypertension. Calcium channel blockers (CCB), angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARBs), angiotensin receptor neprilysin inhibitor (ARNI), thiazide diuretics and β-receptor blockers are commonly used in clinical antihypertensive drugs. The goal of hypertension drug control, the application timing of hypertension drugs, the selection of combined medication scheme, the drug selection of hypertension complicated with other diseases, and the medication of gestational hypertension are all problems that clinicians need to master.
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    Model informed precision dosing of warfarin: China expert consensus report (2022 version)
    ZHANG Jinhua, LIU Maobai, CAI Mingzhi, ZHENG Yingli, LAO Haiyan, XIANG Qian, DU Liping, ZHU Zhu, DONG Jing, ZUO Xiaocong, LI Xingang, SHANG Dewei, CHEN Bing, YE Yanrong, WANG Yuzhu, GAO Jianjun, ZHANG Jian, CHEN Wansheng, XIE Haitang, JIAO Zheng
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (11): 1201-1212.   DOI: 10.12092/j.issn.1009-2501.2022.11.001
    Abstract715)      PDF (780KB)(699)       Save
    Model informed precision dosing for warfarin is to provide individualized dosing by integrating information related to patient characteristics, disease status and pharmacokinetics /pharmacodynamics of warfarin, through mathematical modeling and simulation techniques based on the quantitative pharmacology. Compared with empirical dosing, it can improve the safety, effectiveness, economy, and adherence of pharmacotherapy of warfarin. This consensus report describes the commonly used modeling and simulation techniques for warfarin, their application in developing and adjusting dosing regimens, medication adherence and economy. Moreover, this consensus also elaborates the detailed procedures for the implementation in the warfarin pharmacy service pathway to facilitate the development and application of model informed precision dosing for warfarin.
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    Advances in targeted therapy for HER2-positive breast cancer
    LUO Shiping, ZHANG Jie, YU Yushuai, SONG Chuangui
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (8): 876-886.   DOI: 10.12092/j.issn.1009-2501.2023.08.004
    Abstract708)      PDF (761KB)(492)       Save
    Since the beginning of the 21st century, with the continuous development of anti-HER2-targeted drugs, more treatment options have been provided for patients with HER2-positive breast cancer and the survival prognosis has been significantly improved. At present, anti-HER2 targeted drugs mainly include monoclonal antibody drugs such as trastuzumab and pertuzumab, small molecule tyrosine kinase inhibitors such as lapatinib and neratinib, and antibody-drug conjugates such as T-DM1 and T-DXd, which play an extremely important role in different disease processes. The treatment of HER2-positive breast cancer is based on targeted therapy with trastuzumab. Early-stage patients with high risk factors can be treated with intensive targeted therapy to further improve the prognosis, while advanced patients need a reasonable arrangement of targeted therapy to overcome drug resistance and prolong survival. This article will review the current status, the latest research progress and the future prospects of anti-HER2 targeted therapy in different stages of the disease.
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    Research progress of β2 microglobulin
    ZHANG Xiaoyi, KUAI Zheng, ZOU Yunzeng
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (4): 390-396.   DOI: 10.12092/j.issn.1009-2501.2022.04.006
    Abstract691)      PDF (411KB)(327)       Save
    β2 microglobulin (β2-MG) is a key component I molecule of the major histocompatibility complex class that assists in the cytotoxic T lymphocyte (CTL) immune response. Serum β2-MG content is dynamically correlated with many diseases. Most studies on β2-MG mainly focus on the pathogenesis of kidney disease, tumor and amyloid fibrils. In recent years, some studies have found that β2-MG is also involved in the adverse prognosis of cardiovascular system, cognitive impairment of aging and antibacterial effects. This paper summarized the domestic and foreign studies on β2-MG in recent years, and proposed the possible role of β2-MG in multi-system human body and its potential application prospect of drug molecular targeting.
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    Progress of medical treatment of coronary heart disease
    CHANG Shufu
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (4): 405-408.   DOI: 10.12092/j.issn.1009-2501.2022.04.008
    Abstract663)      PDF (298KB)(632)       Save
    Coronary heart disease (CHD) treatment methods are changing rapidly, and new drugs are constantly entering the clinic. Antiplatelet drugs are the basis for the treatment of CHD, but there are currently no new drugs that can challenge the status of aspirin and P2Y12 receptor inhibitors. Inflammation is the mechanism of the occurrence and development of CHD, and anti-inflammatory treatment is just beginning, and further exploration is still needed. This paper aims to summarize the progress of drug treatment for CHD and provide a new perspective for clinical practice.
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    New development of lipid-lowering therapy of coronary heart disease: Bempedoic acid
    WANG Qi, ZOU Yunzeng
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (4): 369-372.   DOI: 10.12092/j.issn.1009-2501.2022.04.003
    Abstract659)      PDF (273KB)(311)       Save
    Inability to tolerate statins because of muscle symptoms contributes to uncontrolled cholesterol levels and insufficient cardiovascular risk reduction. Bempedoic acid, an enzyme with high expression in the liver but that is undetectable in the skeletal muscle. Lack of the activating enzyme in skeletal muscle may prevent the muscular adverse effects associated with statins. In this review, we summarize the latest advances in bempedoic acid, and review the phase 2 and phase 3 clinical trials results, adverse events, and the clinical trials results in progress of Bempedoic acid. Finally, we discuss the current status of bempedoic acid in the clinical works. 
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    New progress in research and application of fenneridone
    CHENG Kuan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (4): 450-456.   DOI: 10.12092/j.issn.1009-2501.2022.04.016
    Abstract598)      PDF (410KB)(513)       Save
    Aldosterone is a mineralocorticoid hormone produced by the adrenal cortex, which acts on receptors in the distal and collecting tubules of the nephron, causing reabsorption of sodium and secretion of potassium. Aldosterone can promote inflammatory response and lead to myocardial remodeling and fibrosis. Aldosterone acts through mineralocorticoid receptor (MR), which is mainly expressed in heart, kidney and blood vessels. Excessive activation of MR can cause endothelial dysfunction, fibrinolysis disorder, oxidative stress, cardiovascular and renal fibrosis, and eventually lead to organ injury, dysfunction and even organ failure. Mineralocorticoid receptor antagonist (MRA) can achieve cardiorenal protection by inhibiting inflammation and fibrosis caused by MR activation. The novel nonsteroidal MRA fenneridone can effectively block MR with its high selectivity and bring definite cardiac and renal protective effects.
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    Application of β-blockers for hypertension
    CUI Sumei, CUI Zhaoqiang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (4): 423-427.   DOI: 10.12092/j.issn.1009-2501.2022.04.011
    Abstract545)      PDF (325KB)(335)       Save
    β-blockers are widely administered to patients with various cardiovascular diseases including hypertension. However, in recent years, studies have questioned or even denied the antihypertensive effect of β-blockers, which has caused confusion to cardiovascular clinicians. Based on the systematic analysis of a number of studies, the author believes that β-blockers still remain the status as the first-line antihypertensives.
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    PDE4 inhibitors serve as therapeutic targets for pulmonary fibrosis 
    LIU Nanyu, YUE Hongmei, SONG Peipei, WEI Jifang, WEI Yaqian, XIE Yingying, WANG Jiaqi
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (3): 355-360.   DOI: 10.12092/j.issn.1009-2501.2023.03.015
    Abstract545)      PDF (665KB)(677)       Save
    Idiopathic pulmonary fibrosis (IPF) is a progressive and ultimately fatal chronic interstitial lung disease characterized by a progressive decline in lung function, and current treatment options are limited. cAMP is one of the most important second messengers and plays a key role in relaxing airway smooth muscle cells and reducing inflammation. Phosphodiesterase (PDE) is a superfamily of enzymes, and PDE4 enzymes dominate 11 PDE super-family enzymes, available in four isoforms-PDE4A, PDE4B, PDE4C and PDE4D, which selectively decompose cAMP, while PDE4 inhibitors increase cAMP levels by preventing cAMP from breaking down, thereby exerting anti-inflammatory, anti-remodeling effects and providing an attractive drug target for the treatment of IPF. This review summarizes knowledge about the association of pulmonary fibrosis with PKE4, as well as emerging preclin-ical studies and clinical trials regarding PDE4 inhibitors.
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    Integrins targeting αv are used as drug targets for pulmonary fibrosis
    LIU Nanyu, YUE Hongmei, SONG Peipei, WEI Jifang, WEI Yaqian, XIE Yingying, WANG Jiaqi
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (6): 709-714.   DOI: 10.12092/j.issn.1009-2501.2022.06.015
    Abstract542)      PDF (369KB)(333)       Save
    IPF is a chronic progressive interstitial lung disease of unknown etiology and poor prognosis, and despite receive treatment, most patients consideration are likely to progress or worsen. Integrins are heterodimer cell surface proteins that are promising therapeutic targets for intervention in pulmonary fibrosis. Alphav integrins are central to the development of fibrosis because they activate latent TGF-β, a known pro-fibrosis cytokine. The alphav subunit may form heterodimers with the β1, β3, β5, β6, or β8 subunits, one or more of which are essential for the development of pulmonary fibrosis, but their relative importance is unclear. This review summarizes the knowledge of the association of pulmonary fibrosis with alpha-val-integrins, as well as emerging preclinical studies and clinical trials of alpha-fibrosis inhibitors.
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    Bioequivalence study of cinacalcet hydrochloride tablets in healthy Chinese volunteers
    YAN Qiangyong, XIANG Daxiong, ZHU Ronghua, YANG Lingfeng, YANG Xiding, LI Jingjing, FAN Xiao, LIU Sai, XIONG Shoujun, FANG Pingfei
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (2): 171-177.   DOI: 10.12092/j.issn.1009-2501.2023.02.007
    Abstract538)      PDF (1053KB)(228)       Save
    AIM: To evaluate the bioequivalence of cinacalcet hydrochloride tablets in healthy Chinese volunteers. METHODS: A randomized, open, double-period and crossover trial was conducted, 48 healthy volunteers were administered a single dose of cinacalcet test tablets or reference tablets orally under each fasting and fed condition. The concentration of cinacalcet was determined by validated LC-MS/MS method. Pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.0 to study its bioequivalence. RESULTS: The main pharmacokinetic parameters of test tablets and reference tablets under fasting condition were as follows: Cmax (5.96±4.15) and (6.11±4.08) ng/mL, AUC0-72h (45.82±30.20) and (46.11±29.50) ng·h·mL-1, AUC0-∞  (49.65±33.64) and (49.63±32.01) ng·h·mL-1, Tmax (4.5[1.0, 6.0]) and (4.5[1.0, 6.0]) h, t1/2 (23.15±9.23) and (22.43±8.81) h, respectively. Under fed condition, the main pharmacokinetic parameters of test tablets and reference tablets were as follows: Cmax (11.14±5.24) and  (10.24±5.39) ng/mL, AUC0-72h (76.70±39.34) and (75.18±34.36) ng·h·mL-1, AUC0-∞ (83.28±43.00) and (81.38±38.03) ng·h·mL-1, Tmax (3.0[1.5,5.0]) and (4.3[1.5,7.0]) h, t1/2 (28.07±6.37) and (27.46±5.44) h, respectively. The 90%confidence intervals of the geometric average ratios of Cmax, AUC0-72h and AUC0-∞ were all within the equivalent interval of 80.00%-125.00%. CONCLUSION: Two formulations of cinacalcet tablets are bioequivalent and safe.
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    Research progress of lactate dehydrogenase A in digestive system tumors and related drugs
    WANG Siyu, LI Jiawei, LI Chenghao, LI Ling, GUO Qingyang, QIU Lu, ZHOU Shiqin, LIU Yongqi
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (4): 445-454.   DOI: 10.12092/j.issn.1009-2501.2023.04.012
    Abstract537)      PDF (1441KB)(765)       Save
    Malignant tumors of digestive system are highly prevalent malignant tumors that seriously threaten human health around the world. At present, the curative efficacy and prognosis of traditional treatment methods cannot reach the expectation, so it is urgent to find new targets for cancer treatment and realize targeted therapy for tumors. Abnormal energy metabolism in tumor  cells is regarded as a hallmark of cancer, and malignant tumor cells absorb glucose through aerobic glycolysis pathway, and obtain a small amount of energy and produce lactate under the catalysis of a series of enzymes. Lactate dehydrogenase A (Lactate dehydrogenase A, LDHA), as a key enzyme in the aerobic glycolysis pathway of tumor cells, plays an important role in the metabolic changes of tumor cells. Studies have demonstrated that LDHA has high expression characteristics in a variety of tumor cells,and its high expression in clinic is often related to the poor prognosis and high metastasis rate of tumors, which is expected to be a new target for cancer therapy. This article reviews the role of LDHA in the development of digestive system tu- mors and the research progress of related drugs.
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    Progress of pharmacotherapy for heart failure
    PENG Juan, FAN Linlin, LI Ranyi, LI Xiaoyu, LV Qianzhou, ZOU Yunzeng
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (4): 373-381.   DOI: 10.12092/j.issn.1009-2501.2022.04.004
    Abstract515)      PDF (521KB)(577)       Save
    Heart failure is the terminal stage of all kinds of heart diseases. Despite the use of a variety of traditional drug standard treatment, the prognosis is still not ideal, and there is an urgent need for the update and improvement of new drugs and treatment methods. In recent years, angiotensin receptor-enkephalase inhibitors (Sacubitril/Valsartan), sodium-glucose cotransporter 2 inhibitors (SGLT-2i), soluble guanoside cyclase agonists (Vericiguat) and myocardial myosin activators omecamtiv mecarbil have been developed successively. SGLT2 inhibitors can improve ventricular load, reduce fibrosis and affect myocardial metabolism. sGC agonists play an anti-heart failure role by enhancing l-ARg-No-SGC-CGMP signaling pathway, improving myocardial and vascular function, reversing ventricular hypertrophy and fibrosis, slowing ventricular remodeling, and reducing ventricular afterload through systemic and pulmonary vasodilation. In addition, fineridone, a novel salt corticosteroid receptor antagonist, has also been reported in clinical studies in the field of heart failure. Therefore, it is the direction and hope for the development of heart failure in the future to select appropriate drugs for different types of patients with heart failure and carry out individualized treatment according to the optimized process of heart failure.
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    Research progress in population pharmacokinetics of rituximab
    LI Mengxue, HE Jie, YU Xiaxia, HU Linlin, SHAO Hua
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (4): 468-474.   DOI: 10.12092/j.issn.1009-2501.2023.04.015
    Abstract513)      PDF (638KB)(613)       Save
    Rituximab, a chimeric human-mouse monoclonal antibody, has been used as a first-line treatment for CD20+ B-cell non-Hodgkin lymphoma in combination with chemotherapy. It is also used for autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus and immunemediated nephropathy. The clinical therapeutic effect of rituximab is significant. However, individual pharmacokinetics vary greatly, which bring some uncertainties to the efficacy and safety of clinical application, individualized treatment is needed to improve the rationality of its medication. Currently, studies on the optimization of rituximab administration regimen using population pharmacokinetics have been reported. Our paper reviewed the research progress in population pharmacokinetics of rituximab, aiming to provide reference to formulate an individualized dosing scheme of rituximab and realize precise administration for domestic patients.
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    Research progress in the treatment of early Alzheimer's disease with lecanemab
    JIN Panpan, LIU Yang, QIU Bo, WU Huizhen
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (2): 207-214.   DOI: 10.12092/j.issn.1009-2501.2024.02.011
    Abstract512)      PDF (672KB)(1139)       Save
    Lecanemab is a new drug used to treat early Alzheimer's disease (AD) with mild cognitive impairment or mild dementia. It is a human anti-Aβ fibril monoclonal IgG1 antibody, which is injected intravenously into the patient, through the blood-brain barrier into the brain, clearing amyloid plaque, thereby slowing the rate of cognitive decline in patients and delaying disease progression. This article reviews the pharmacological studies, clinical studies, safety and limitations of lecanemab, in order to help clinical understand the current research status and existing achievements of this drug.
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    A comparative investigation of the impact of oral midazolam solution and dexmedetomidine nasal spray on preoperative anxiety in pediatric patients
    WU Xiongzhi, WANG Xuan, XU Siqi, JU Xia, WANG Shengbin, CHEN Yongquan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (6): 666-670.   DOI: 10.12092/j.issn.1009-2501.2023.06.009
    Abstract506)      PDF (630KB)(186)       Save
    AIM: To investigate the impact of oral midazolam solution and dexmedetomidine nasal spray on preoperative anxiety in pediatric patients.  METHODS: A total of 90 children who planned to receive elective surgery in our hospital from June to December 2022 were selected and divided into midazolam oral solution group, dexmedetomidine nasal spray group and normal saline nasal drops group by random number table method. Thirty minutes before anesthesia, midazolam oral solution 0.5 mg/kg was administered to midazolam oral solution group. Dexmedetomidine nasal spray group received 2 μg/kg dexmedetomidine nasal spray and normal saline nasal drops group received 2 mL normal saline nasal drip. Drug acceptance was recorded in the three groups. modified Yale preoperative anxiety scale-short form (m-YPAS-SF) score of the three groups of children were analyzed before administration (T1), while separated from their parents (T2), while during anesthesia induction (T3), while 24 hours after surgery (T4). The scores of induction Cooperation Scale (ICC) in induction of anesthesia were recorded in the three groups. The recovery time and PACU residence time of the three groups were recorded. RESULTS: Compared with dexmedetomidine nasal spray group and normal saline nasal drops group, midazolam oral solution group exhibited a lower drug acceptance score (P<0.05), as well as lower m-YPAS-SF scores at T2, T3, and T4 (P<0.05). Additionally, midazolam oral solution group had a lower ICC score (P<0.05) and longer recovery time (P<0.05), but no significant difference in the length of PACU stay was observed (P>0.05). CONCLUSION: Oral midazolam solution is more readily accepted by pediatric patients compared to dexmedetomidine nasal spray, and it exhibits superior efficacy in alleviating preoperative anxiety, however, its recovery time is prolonged. 
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    Recent progress of mitophagy in hepatic insulin resistance
    QUAN Haiyan, JIANG Xing, HE Lu
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (2): 198-204.   DOI: 10.12092/j.issn.1009-2501.2022.02.011
    Abstract501)      PDF (392KB)(320)       Save
    Metabolic syndrome, characterized by centralobesity, hypertension, bycentralobesity, hypertension, and hyperlipidemia, increases the incidence and mortality of cardiovascular disease, type 2 diabetes, nonalcoholic fatty liver disease, and other metabolic diseases. It is well known that insulin resistance, especially hepatic insulin resistance, is a risk factor for metabolic syndrome. Current research has shown that the accumulation of hepatic fatty acid can cause hepatic insulin resistance through increased gluconeogenesis, lipogenesis, chronic inflammation, oxidative stress and endoplasmic reticulum stress, and impaired insulin signal pathway. Mitochondria are the major sites of fatty acid β-oxidation, which is the major degradation mechanism of fatty acids. Mitochondrial dysfunction has been shown to be involved in the development of hepatic fatty acid-induced hepatic insulin resistance. Mitochondrial autophagy (mitophagy), a catabolic process, selectively degrades damaged mitochondria to reverse mitochondrial dysfunction and preserve mitochondrial dynamics and function. Therefore, mitophagy can promote mitochondrial fatty acid oxidation to inhibit hepatic fatty acid accumulation and improve hepatic insulin resistance. Here, we review advances in our understanding of the relationship between mitophagy and hepatic insulin resistance. Additionally, we also highlight the potential value of mitophagy in the treatment of hepatic insulin resistance and metabolic syndrome.
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    Effects of sakubatril valsartan combined with dagliflozin in the treatment of patients with HFrEF and the effect on serum cTnⅠ and BNP levels
    YANG Sheng, WANG Deguo
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (9): 1010-1015.   DOI: 10.12092/j.issn.1009-2501.2022.09.008
    Abstract501)      PDF (424KB)(214)       Save
    AIM: To investigate the effect of sakubatril valsartan combined with dagliflozin in the treatment of patients with HFrEF and the effect on serum cardiac troponin I (CTnI) and B-type brain natriuretic peptide (BNP) levels.  METHODS: Seventy patients with HFrEF admitted to our hospital from January 2020 to October 2021 were selected and divided, using random number table method, into control group (35 cases, conventional treatment + sakubatril valsartan) and observation group (35 cases, conventional treatment + sakubatril valsartan + dagliflozin). The treatment effect, myocardial markers (serum cTnI, BNP), exercise capacity ( 6 min walking experiment), myocardial remodeling-related indexes [(left ventricular end-diastolic diameter (LVEDd), left ventricular end-systolic internal diameter (LVESD), left ventricular ejection fraction (LVEF)] and adverse effects were compared between the two groups. RESULTS: The total effective rate of treatment in the observation group was lower than that in the control group (P<0.05), and the difference was not statistically significant (P>0.05); the changing trends of serum BNP and cTnI expressions were the same in the two groups at 3 months and 6 months of treatment, and the serum BNP and cTnI expressions of patients in the observation group were lower than those in the control group (P<0.05); at the end of treatment, the 6 min walk test results of patients in the observation group were better than those in the control group (P<0.05); At the end of treatment, the LVEDd and LVESD values in the observation group were lower than those in the control group, and the LVEF values were higher than those in the control group (P<0.05); the differences were not statistically significant when comparing the total incidence of adverse reactions between the two groups (P>0.05). CONCLUSION: The combination of sakubatril valsartan and dagliflozin is effective for patients with HFrEF, and can effectively regulate serum cTnI and BNP levels with low adverse reactions.
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    New narcotic analgesics: esketamine
    JIA Tao, TENG Jinliang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (7): 834-840.   DOI: 10.12092/j.issn.1009-2501.2022.07.015
    Abstract490)      PDF (468KB)(426)       Save
    Esketamine is an excellent anesthetic with higher potency than ketamine, fast onset of action, rapid elimination from the body, mild respiratory depression, and little impact on the circulatory system. It has unique advantages in the field of clinical anesthesia and analgesia. Its sub-anesthetic dose regimen is the most widely used in various surgeries and short examinations. Compared with traditional ketamine, the dose required for anesthesia effect and mental side effects are lower, and the analgesic effect is stronger. It has great clinical application prospects.
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    Bioequivalence trial of fasting oral sorafenib tosylate tablets in healthy Chinese subjects
    WU Juan, WANG Zhiqiang, ZHOU Renpeng, YANG Jingjing, QIN Huiling, ZHANG Qian, LU Chao, HU Wei
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (3): 281-286.   DOI: 10.12092/j.issn.1009-2501.2022.03.006
    Abstract489)      PDF (1247KB)(379)       Save
    AIM: To compare the pharmacokinetic behavior of a single oral sorafenib tosylate tablets in Chinese healthy subjects under fasting conditions and evaluate the bioequivalence of the test reagent (T) and the reference reagent (R).  METHODS: A single-center, randomized, open-labeled, two-agent, three-period, three-sequence (TRR, RTR, RRT), and partially repeated crossover trial design was adopted. The trial was administered once per cycle (0.2 g) under fasting conditions. 36 healthy subjects were randomly divided into 3 groups, each with 12 cases. RESULTS: Thirty-six healthy subjects (9 females, average age 31 years) were enrolled in the trial. The upper limits of the one-sided 95% confidence interval of the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the test reagent and the reference reagent after natural logarithmic transformation were -0.0908, -0.0577, -0.0541. The one-sided 95% upper limit of the confidence interval was less than 0; the ratios of the geometric mean values of the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of sorafenib of the test preparation and the reference preparation were 101.65%, 100.12%, and 99.24%, respectively. In the range of 80.00%-125.00%, the bioequivalence of Cmax, AUC0-t and AUC0-∞ of the test reagent and the reference reagent sorafenib was established under the fasting state. CONCLUSION: The safety and tolerability of a single oral 0.2 g sorafenib tosylate tablet by subjects under fasting conditions were good. The test reagent and the reference reagent are bioequivalent under fasting administration.
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    Advances in new fast-acting antidepressants
    YU Zefang, FAN Liju, YIN Xiaoyu, GAO Lili, DONG Zhanjun
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (5): 595-600.   DOI: 10.12092/j.issn.1009-2501.2022.05.013
    Abstract484)      PDF (384KB)(372)       Save
    Antidepressants are mainly used to treat mental illnesses. Traditional antidepressants mainly target monoamine neurotransmitters, but these drugs are slow to be effective and cannot meet clinical needs. Recently, therapeutics have been developed that depart from the traditional monoamine hypothesis and focus on the glutamatergic, GABAergic, opioidergic, and inflammatory systems. In recent years, great progress has been made in the development of new antidepressants, some of which have been applied in clinical practice. This article mainly summarizes the research mechanisms and treatment programs of new antidepressants, and briefly reviews common rapid-acting antidepressants.
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    Design of case report form for oncology clinical trials based on CDASH
    CHEN Jianfang, LOU Donghua
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (7): 762-767.   DOI: 10.12092/j.issn.1009-2501.2022.07.006
    Abstract476)      PDF (1278KB)(384)       Save
    AIM: To investigate the design significance, method and content of the oncology clinical trial case report form (CRF) based on the clinical data acquisition standards harmonization (CDASH).  METHODS: Compared with CDASH v2.2, the characteristics of oncology clinical trial data were analyzed, and a standardized CRF was designed to meet the actual needs of oncology clinical trials. RESULTS: The CDASH was applied to the design of the CRF of the oncology clinical trial, and the data collection of the oncology clinical trial was standardized, so that the CRF design of the oncology clinical trial was relatively standardized and the data quality was improved. CONCLUSION: The implementation of oncology CRF design based on CDASH can promote the exchange and sharing of oncology clinical research data, which is conducive to improving the reliability of oncology clinical research results. 
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    Research progress of pharmacologic therapy in obstructive sleep apnea
    WU Xingdong, YUE Hongmei, ZHU Haobin, LIU Miaomiao, LI Yating, XU Jinhui
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (2): 215-229.   DOI: 10.12092/j.issn.1009-2501.2024.02.012
    Abstract474)      PDF (1349KB)(312)       Save
    Obstructive sleep apnea (OSA) is a common sleep disordered breathing disorder. As a major global public health problem, untreated OSA can lead to a variety of adverse health outcomes, including various cardiovascular and cerebrovascular diseases, metabolic disorders, and psychiatric disorders such as anxiety and depression. Traditional OSA therapies such as positive airway pressure (PAP), weight loss, oral?appliance, upper airway surgery, and postural therapy focus on the anatomical factors of OSA. However, the pathogenesis of OSA is heterogeneous, and non-anatomical factors also play an important role in most patients. Although there is no drug with exact efficacy for the treatment of OSA, with the deepening understanding of the pathophysiological mechanism of OSA, more and more clinical studies are devoted to the study of drug treatment of OSA and its complications, and a series of results have been achieved. The following is a review of the relevant studies on drug treatment of OSA in recent years, hoping to provide literature support and theoretical basis for future research on drug treatment of OSA.
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    Ethical analysis and countermeasures of artificial intelligence application in clinical trials
    LIU Xing, LU Xiaoran, WU Ying, YU Haitao, WANG Xiaomin
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (3): 322-327.   DOI: 10.12092/j.issn.1009-2501.2022.03.012
    Abstract472)      PDF (980KB)(465)       Save
    The development of artificial intelligence is becoming more and more mature, and has penetrated into every field of clinical trials. Artificial intelligence has brought new development opportunities for clinical trials. However, the application of artificial intelligence in clinical trials is still in the exploratory stage, facing many ethical issues, including trial risk caused by data quality, privacy protection caused by data regulation, and contradiction between data authorization and informed consent. We should precisely position the realizable application of artificial intelligence in clinical trials, understand its practical ethical issues, and formulate corresponding coping strategies to ensure the maximum improvement of the whole process performance of clinical trials, including strengthening data quality management and reducing clinical trial risks; optimizing data monitoring mechanisms to ensure data security and privacy; building a data authorization platform and improving judicial protection of informed consent, etc.
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    State of clinical application of meloxicam
    LI Xinyu, HUANG Xin
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (2): 189-197.   DOI: 10.12092/j.issn.1009-2501.2023.02.010
    Abstract456)      PDF (603KB)(476)       Save
    Meloxicam is a long-acting non-steroidal anti-inflammatory drug, which is mainly used in the treatment of chronic osteoarthritis and postoperative analgesia. Recent studies have found that the drug has great therapeutic potential in anti-tumor, improving cognitive impairment in Alzheimer's disease, mobilizing hematopoietic stem cells and so on. This paper reviewed the pharmacological mechanism of meloxicam, the adverse reactions in gastrointestinal tract, kidney, liver and cardiovascular aspects, summarized various forms of clinical application from the perspective of preparation, and summarized the current clinical treatment strategy of combining with Western medicine and Chinese medicine respectively.
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    Angiotensin receptor neprilysin inhibitor in elderly with hypertension
    KUAI Zheng, ZHANG Xiaoyi, ZOU Yunzeng
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (4): 442-445.   DOI: 10.12092/j.issn.1009-2501.2022.04.014
    Abstract444)      PDF (286KB)(217)       Save
    Angiotensin receptor/neprilysin inhibitor (ARNI) is a novel combination drug that is a dual inhibitor of angiotensin receptor and neprilysin. In June 2021, the National Medical Products Administration approved ARNI for hypertension indications. This review provides an update of current literature on ARNI in elderly hypertension.
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    Comparison of calculation results of five population pharmacokinetic analysis tools
    HUANG Zhiwei, LI Yi, XU Xiaoyong, ZHANG Lei, SHEN Yifeng, LI Huafang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (5): 525-535.   DOI: 10.12092/j.issn.1009-2501.2023.05.006
    Abstract441)      PDF (22940KB)(237)       Save
    AIM: To compare the results calculated by population pharmacokinetic analysis tools Phoenix NLME, Monolix, R nlmixr package and CPhaMAS cloud platform with the gold standard sofeware NONMEM. METHODS: Fifty sparse sampling data sets based on a one-compartment model and fifty dense sampling data sets based on a two-compartment model were simulated, and the above five analysis tools were used to calculate the population typical value, individual variability and individual pharmacokinetic parameters. RESULTS: The population typical value and individual variability calculated by CPhaMAS and Phoenix NLME had the highest matching degree with NONMEM, followed by nlmixr. Monolix had the lowest matching degree, but Monolix and nlmixr might be more robust. The correspondence between clearance and distribution volume was better than the absorption rate constant. Except the absorption rate constant calculated by Monolix and intercompartmental clearance calculated by nlmixr, the correlation coefficients of individual pharmacokinetic parameters calculated by all analytical tools were greater than 0.99. CONCLUSION: The results calculated by the above four population pharmacokinetic analysis tools are highly correlated with that of NONMEM.
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    Helicobacter pylori infection influences the efficacy of immunotherapies for gastric cancer#br#
    WANG Dan, YAN Xiaoli, ZHANG Yuan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (2): 228-234.   DOI: 10.12092/j.issn.1009-2501.2023.02.015
    Abstract440)      PDF (396KB)(226)       Save
    Gastric cancer is a common malignant tumor of digestive tract, and its incidence rate and mortality are very high in China. In recent years, immunotherapy represented by immunocheckpoint inhibitors has brought new therapeutic hope for patients with inoperable advanced gastric cancer. Helicobacter pylori infection is closely related to the occurrence and development of gastric cancer. In this review, we summarized the current status of immunotherapy for gastric cancer, the latest research progress on the impact of Helicobacter pylori infection on gastric mucosal immunity and tumor immunotherapy, and summarized the current challenges and future research directions, with a view to providing new ideas for clinical therapy and scientific research.
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    Design and evaluation of clinical trials of COVID-19 vaccine and monoclonal neutralizing antibody
    LI Shanshan, GU Jingwen, ZHANG Jing, YANG Haijing, LIU Wei, YU Yiqi, ZHANG Wenhong
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (2): 190-197.   DOI: 10.12092/j.issn.1009-2501.2022.02.010
    Abstract437)      PDF (436KB)(382)       Save
    COVID-19 pandemic has put a huge burden on public health and global economy. Vaccines play an important role in controlling virus transmission and reducing mortality. While monoclonal virus neutralizing antibodies can reduce the viral load, improve symptoms, and prevent the aggravation of the disease from hospitalization. Now hundreds of clinical trials of COVID-19 vaccine and monoclonal neutralizing antibody are in progress. The vaccine focuses on disease prevention, while the neutralizing antibody focuses on disease treatment. There are quite many differences between the two kinds of clinical trials by following different technical guidelines, research purpose, trial design, implementation and outcome assessment. Therefore, it is necessary to summarize the similarities and differences between the clinical trials for the reference of new drug research and development as well as clinical researchers.
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    Research progress on interaction between tumor microenvironment and breast cancer cells leading to tumor metastasis
    SHI Jingbin, XIONG Yang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (5): 562-574.   DOI: 10.12092/j.issn.1009-2501.2022.05.010
    Abstract436)      PDF (2368KB)(336)       Save
    Breast cancer is a malignant tumor with strong invasiveness, strong metastasis and high recurrence rate. Breast cancer cells can be transferred to different tissues in a variety of ways. Breast cancer cells can spread because of the tumor microenvironment created by tumor interaction with surrounding cells. This review examines the role and mechanisms of the tumor microenvironment in breast cancer cell metastasis in recent years, including adipocytes, fibroblasts, neuroendocrine cells, immune and inflammatory cells, blood and lymphatic network, and extracellular matrix, as well as how to treat breast cancer metastasis. 
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    Modulating gut miocrobiota: a new strategy in the treatment of gout  
    CHEN Yu, GU Bing, LI Huanan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2022, 27 (11): 1307-1314.   DOI: 10.12092/j.issn.1009-2501.2022.11.014
    Abstract433)      PDF (3701KB)(298)       Save
    Gout is a persistent increase in blood uric acid caused by purine and uric acid metabolism disorders, resulting in monosodium urate crystal deposition induced by recurrent inflammatory diseases, mainly manifested as elevated uric acid and inflammatory attacks. Studies have shown that gout and changes in the gut miocrobiota are mutually causal, and the gut miocrobiota can not only affect purine and uric acid metabolism but also regulate inflammatory response. Therefore, regulating the gut miocrobiota is expected to become a new strategy for the treatment of gout. This article starts from the regulation of purine and uric acid metabolism and inflammatory response by gut miocrobiota, so as to clarify the specific application of gut miocrobiota regulation as a new strategy for gout treatment.
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    General considerations for clinical pharmacology of antitumor antibody-conjugated drugs: Implications from FDA review cases
    GAO Lili, WANG Yuzhu, WANG Yan, LI Jian, WANG Jun
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (1): 75-85.   DOI: 10.12092/j.issn.1009-2501.2023.01.010
    Abstract432)      PDF (639KB)(472)       Save
    Antibody-drug conjugates (ADCs) are conjugated by a linker between an antibody drug targeting a specific antigen and a payload, such as a small cytotoxic drug. ADCs combine the potent killing effect of traditional small cytotoxic drugs with the tumor targeting property of antibody drugs. As of February 2022, the U.S. Food and Drug Administration (FDA) had approved 12 ADC anti-tumor agents. Based on the analysis of clinical pharmacology review reports of approved ADC drugs combined with relevant guidelines, it is found that in the development of ADC, in addition to the general research in clinical pharmacology, there are special considerations in dose selection and dose modification for special population due to the special anti-tumor mechanism of ADC. It is hoped that this paper will be enlightening to domestic researchers when developing ADC.
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    Research progress in vaccine for breast cancer 
    LI Mengxi, ZHANG Kejing, XIA Fan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (8): 918-925.   DOI: 10.12092/j.issn.1009-2501.2023.08.008
    Abstract431)      PDF (704KB)(200)       Save
    Breast cancer was the most commonly diagnosed cancer, with an estimated 2.3 million new cases (11.7%), followed by lung (11.4%) in 2020. Breast cancer ranks first among malignant tumors in the world, seriously threatening women's health. Due to continuously enrichment of treatment methods for breast cancer, patients' prognosis have been greatly improved. The emergence of vaccines is an important treatment method to promote the development of human health. For cancer therapy, preventive vaccines have been popularized for kinds of tumor with specific incentives, such as cervical cancer caused by HPV infection. At present, the causative factors of breast cancer are still unclear, and it is still difficult to develop preventive vaccines against breast cancer. In recent years, a variety of therapeutic vaccines have emerged in the field of breast cancer treatment. When patient completed comprehensive treatment, vaccine is used to stimulate body immune system to recognize tumor cell-specific antigens, thereby reducing the recurrence rate as much as possible. Most of these vaccines are currently aimed at more malignant triple-negative breast cancer and HER2-positive breast cancer. This article will focus on the research progress of several therappeutic vaccines.
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