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    Treatment of sleep disorder in patients with acute cerebrovascular disease
    HUANG Yaqin, XUE Rong
    Chinese Journal of Clinical Pharmacology and Therapeutics    2021, 26 (5): 516-521.   DOI: 10.12092/j.issn.1009-2501.2021.05.007
    Abstract444)      PDF (351KB)(11234)       Save
    The high incidence of cerebrovascular disease and the high rate of disability cause a huge burden on the patient, family and society. The incidence of sleep disorder in acute cerebrovascular disease is high, which has an important effect on the prognosis of patients with cerebrovascular disease. This paper reviews the treatment of sleep disorder in patients with acute cerebrovascular disease, mainly acute ischemic cerebrovascular disease. 
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    Progress in clinical application of topical anesthesia
    TAO Yijia, YANG Chun, LIU Cunming
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (5): 594-600.   DOI: 10.12092/j.issn.1009-2501.2023.05.015
    Abstract348)      PDF (614KB)(2834)       Save
    Topical anesthesia are being widely used in clinical diagnostic or therapeutic fields such as ophthalmology, ENT, dermatology, urology. It is defined as superficial loss of sensation in mucous membranes or skin, produced by direct application of penetrating local anesthetics. Topical anesthesia has the advantages of simple performance, high safety, quick recovery, which can effectively improve patient's satisfaction. In recent years, more and more attention has been paid to the concept of comfortable diagnosis and treatment. The new drugs and application methods of topical anesthesia are emerging constantly, special attention must be paid to their pharmacological characteristics and possible adverse reactions when using them. This article reviews the research progress of topical anesthesia in clinical application in order to provide reference for clinical practice.
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    Evaluation and calculation of the accumulation index in clinical pharmacokinetics
    LI Xian-xing, LI Lu-jin, XU Ling, ZHENG Qing-shan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2013, 18 (1): 34-38.  
    Abstract1579)      PDF (608KB)(3615)       Save
    AIM: To analyze and evaluate the accumulation index (Rac) in clinical pharmacokinetics of multiple dosing administrations in order to obtain one reasonable method. METHODS: The plasma concentration-time data of arteether was simulated for 1000 subjects in multiple doses administration. The 20-40 subjects were sampled for 1000 time by the Boostrap method and values of Rac were calculated by the AUC, Cmax, Ctrough and model. The values of Rac were evaluated by their distributions. RESULTS: The AUC and Cmax method were more stable than the Ctrough and model method. If the efficacy or toxicity was related with the concentration, it was appropriate to use the Cmax method, and if the efficacy or toxicity was related with the time, it was appropriate to use the AUC method. CONCLUSION: The drug accumulation is related with effectiveness and safety, and the reasonable choice of Rac calculation method should be based on drug and data characteristics.
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    Dose conversion among different animals and healthy volunteers in pharmacological study
    HUANG Ji-Han,HUANG Xiao-Hui, CHEN Zhi-Yang, ZHENG Qing-Shan, SUN Rui-Yuan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2004, 9 (9): 1069-1072.  
    Abstract1097)      PDF (152KB)(3774)       Save
    In order to obtain equivalent dose, a dose conversion was important among different animals and healthy volunteers in preclinical pharmacology and I phase clinical trials. Body coefficient and standard weight were introduced into the formula to estimate the equivalent dose in this paper.
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    Research advancement of heartleaf houttuynia herb on antibacterial action
    LI Juan, SHAO Hui, ZHONG Zheng-ling, CHU Ji-ru, XIE Hai-tang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2012, 17 (12): 1427-1432.  
    Abstract477)      PDF (249KB)(2771)       Save
    Heartleaf houttuynia herb has many pharmacologic actions especially antibacterial action. This review describes the research advancement of heartleaf houttuynia herb on antibacterial action from three aspects including the whole antibacterial action evaluation, special antibacterial action, and the trouble in clinic and the study direction. This paper provides a review for the next research.
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    Research development between JNK pathway and apoptosis
    WEI Na, HE Hai-bo, ZHANG Chang-cheng, YUAN Ding, WANG Ting
    Chinese Journal of Clinical Pharmacology and Therapeutics    2013, 18 (7): 807-812.  
    Abstract708)      PDF (261KB)(2334)       Save
    JNK pathway is closely associated with cell differentiation, apoptosis, stress response and many hunman diseases in the past 20 years, whose biochemical function, regulation under cell physiology and pathology are constantly noticed by domestic and foreign scholars. Recently, more research suggests that it plays an important role in regulating apoptosis, and it will be an important potential target for treatment of apoptosis-associated disease by regulating JNK signal pathway. In summary, the physiological and pathophysiological functions of JNK pathway and relation with apoptosis have been reviewed.
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    Analysis of metabolomic data: principal component analysis
    Jiye Aa
    Chinese Journal of Clinical Pharmacology and Therapeutics    2010, 15 (5): 481-489.  
    Abstract1012)      PDF (913KB)(3082)       Save
    Metabolomics has been widely applied to life science and showing a promising perspective. Conventional statistic analysis is not applicable to the large, multivariate dataset generated by high-throughput metabolomic tool, while it's of crucial importance to analyze and interpret the dataset. This article reviews the basic methods of principal components analysis(PCA) that is popular in metabolomics study, aiming at strengthening the fundamental knowledge of PCA and standardizing the methods and procedures for data analysis.
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    Research progress in the treatment of depression with monome of Chinese herb, drug pairs, compound prescriptions and Chinese patent drugs
    CHEN Ying, YUAN Yonggui
    Chinese Journal of Clinical Pharmacology and Therapeutics    2021, 26 (5): 586-593.   DOI: 10.12092/j.issn.1009-2501.2021.05.016
    Abstract1360)      PDF (536KB)(2096)       Save
    Depression is a relatively common psychosomatic disease in clinical practice. It is mainly characterized by significant and lasting depression. It generally manifests as depression, loss of interest, impaired cognitive function, etc. Some patients are accompanied by somatization symptoms such as insomnia or lethargy, Loss of appetite, fatigue, loss of libido, etc. In severe cases, self-injury or even suicide may occur. According to research, depression has become the third leading cause of disability and death. At present, the pathogenesis of depression has not been definitively concluded, but a large number of studies have shown that it is related to biochemical, neuroendocrine, and neuroimmunological factors. At present, selective 5-HT reuptake inhibitors are routinely used in clinical treatment, such as sertraline, citalopram, Prozac, etc., but they often have slow onset and obvious side effects, making it difficult to achieve satisfactory therapeutic effects. Traditional Chinese medicine has gradually begun to be accepted by doctors and patients in the treatment of refractory diseases due to its multi-component and multi-target characteristics. This article mainly discusses the research progress of Chinese herbal extracts, Chinese herbal medicine pairs, Chinese herbal compound prescriptions, and Chinese patent medicines in the treatment of depression, and provides references for the clinical application of Chinese medicines in the treatment of depression.
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    Progress in research and evaluation on drug-plasma protein binding in pharmacology
    GUO Bin, LI Chuan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2005, 10 (3): 241-253.  
    Abstract500)      PDF (406KB)(3064)       Save
    Drug-protein binding changes involved in numerous factors in vivo may cause changes of pharmacokinetic parameters.The tendency gained from large numbers of articles overemphasized the clinical importance of these changes.However, theoretic analysis and review of available literature data indicated that changes in plasma protein binding are usually of no principle pharmacodynamic implication.And they have little effect on the clinical exposure of a patient to a drug in a practical sense. The progress is reviewed in research and current opinions on drug-plasma protein binding in pharmacological basis for pharmacokinetic consequence and clinical relevance in this article.
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    Study on pharmacokinetics of rosuvastatin and its drug interactions with other drugs
    WEN Jin-hua, XIONG Yu-qing
    Chinese Journal of Clinical Pharmacology and Therapeutics    2011, 16 (11): 1309-1314.  
    Abstract572)      PDF (261KB)(2086)       Save
    Rosuvastatin, a new generation of statins , has better liver selectivity, less metabolism and long elimination half-life.It has more lipid-lowering effect and a wide range prospects of clinical applications. Moreover, rosuvastatin has good tolerability and the incidence of adverse reactions was similar to other kind of statins. In this paper, rosuvastatin pharmacokinetics and pharmacokinetic interactions with other drugs are reviewed. In order to lay down a solid theory foundation for the guidance in clinical usage of Rosuvastatin, ensure the safety and effectiveness of clinical usage, achieving individualized therapy in its true sense.
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    Sample size estimation in randomized controlled drug clinical trials
    LI Chan-juan, JIANG Zhi-wei, WANG Rui, XIA Jie-lai
    Chinese Journal of Clinical Pharmacology and Therapeutics    2011, 16 (10): 1132-1136.  
    Abstract756)      PDF (223KB)(2394)       Save
    Sample size estimation is a key research aspect in randomized controlled drug clinical trial. Sample size estimation factors, parameters and basic rules are discussed in our research. In addition, sample size estimation procedures are introduced based on two examples. A reference is provided for estimating sample size in randomized controlled clinical trials.
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    Progress in research of phase Ⅱ metabolisms and their enzymes
    SHI Shu-ya, WANG Lian-sheng
    Chinese Journal of Clinical Pharmacology and Therapeutics    2014, 19 (1): 82-89.  
    Abstract589)      PDF (326KB)(2154)       Save
    Phase Ⅱ drug-metabolizing reaction, characterized by the conjugation reaction, is an important way of body drug disposition. Glucuronidation, acetylation, methylation, glutathione conjugation reaction, and sulphation represent different conjugation reactions and are catalyzed by some similar genes or gene superfamily respectively. All these phase Ⅱ metabolic reactions have their own different characteristics and functional significance. Drug induced significant change of phase Ⅱ drug metabolizing enzyme activity may lead to clinical drug interactions. The genetic polymorphisms of phase Ⅱdrug metabolizing enzymes will affect the metabolism of endogenous substances, which may lead to the increased incidence of certain diseases, and these polymorphisms also affect the metabolism of exogenous substances, causing toxicity or changes in drug efficacy.
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    Determination of evodiamine by high performance liquid chromatographytandem mass spectrometry and pharmacokinetic studies in rats
    XU Ji-hua, LIU Wen-ying, ZHENG Feng, SUN Di, YANG Qian, RAO Jin-hua
    Chinese Journal of Clinical Pharmacology and Therapeutics    2007, 12 (4): 427-433.  
    Abstract83)      PDF (258KB)(175)       Save
    AIM: To establish an LC-MS MS method for determination of evodiamine concentration in rat plasma and to study its pharmacokinetic profile in rats. METHODS: Six rats were administrated (i.g.)evodiamine at the dose of 100 mg/kg.Blood samples were collected from eye socket.Evodiamine concentration in rat plasma was determined by LC-MS MS method.The pharmacokinetic parameters were calculated using DAS program. RESULTS: A good linear relationship was obtained in the concentration range (0.2-50.0 ng mL) studied (r2 =0.9997).Average recoveries ranged from 96.12 % to 99.46 %.Intra-and inter-day relative standard deviations were 4.61 %-13.51 % and 5.65 %-11.49 %, respectively.The main pharmacokinetic parameters of evodiamine were as follows:Cmax(5.3±1.5) ng mL;tmax(22±8)min;t 1 2(451±176)min. CONCLUSION: A selective and sensitive liquid chromatography-tandem mass spectrometric (LC-MS MS)method for the quantification of evodiamine in rat plasma is developed and validated.This method is successfully applied for the pharmacokinetic studies of evodiamine in rats.
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    Research advances in models of hepatic and intestinal first-pass drug metabolism
    ZHU Jing, GUO Jian-jun, LIN Jun-hui, BU Hai-zhi, CHEN Xi-jing
    Chinese Journal of Clinical Pharmacology and Therapeutics    2012, 17 (8): 944-949.  
    Abstract552)      PDF (269KB)(2293)       Save
    Low oral bioavailability of a drug could be attributed to poor absorption and/or extensive first-pass metabolism.The liver and small intestine are the two most important organs for first-pass metabolism. In this review, the important drug-metabolizing enzymes located in the human liver and small intestine are introduced and the effects of different physiological structures of the two organs on overall first-pass metabolism are presented. Moreover, the research advances of the methods used to estimate hepatic and intestinal first-pass metabolism, such as in vitro, in situ, in vivo, in vitro-in vivo combined, knockout and transgenic models, are also summarized.
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    Progress on the pathological mechanism and treatment of frostbite 
    ZHANG Li, LIN Xingyao, SHANG Yun, WANG Qiang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (3): 347-354.   DOI: 10.12092/j.issn.1009-2501.2023.03.014
    Abstract400)      PDF (808KB)(1436)       Save
    Frostbite is a tissue injury that occurs when the body is exposed to extreme cold. Its path-ological mechanism is complex and has not been ful-ly elucidated. In high cold and high altitude areas, outdoor sports people have a high risk of injury, and severe frostbite has high disability and mortality. Ex-ploring the pathological mechanism of frostbite is helpful to determine the treatment methods and timing. At present, the clinical treatment of frostbite is mainly symptomatic treatment, such as drug treatment and surgical treatment, but the curative effect can not meet the clinical needs. Therefore, it is of great significance to seek more efficient drugs or treatment methods. This article reviews the rele-vant research progress in pathophysiological mecha-nism, clinical treatment, cellular and molecular path-ways of frostbite in recent years, in order to provide new ideas for future research and clinical treatment. 
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    Progress in studies of reproductive toxicity of solanine
    ZHOU Guo-liang, SONG Yi-sheng, XIN Yan-fei, XUAN Yao-xian
    Chinese Journal of Clinical Pharmacology and Therapeutics    2013, 18 (11): 1291-1296.  
    Abstract311)      PDF (268KB)(1687)       Save
    Solanine is widely distributed in potatoes, tomatoes and eggplant and other solanaceous plants. It causes widespread concern for anti-tumor and potential toxic effects. This paper reviewed the research progress in the reproductive toxicity studies of solanine.
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    Discussions in pharmacological action and the development in clinical application of puer arin
    YAO Dan, DING Xuan-sheng
    Chinese Journal of Clinical Pharmacology and Therapeutics    2008, 13 (4): 468-474.  
    Abstract325)      PDF (237KB)(1587)       Save
    As a saft and effective traditional Chinese medicine’s parenteral in jection, puerarin, whose molecular formula is 4,7-dihydroxy- 8β-D glucose isoflavone, has comprehensive and extensive phammaco logical action, and is generally used for treatment of cardiovascu lar and cerebrov ascular system diseases such as arhythmia, myocardial ischemia and hypertension.It has an extensive deve lopment perspective. The recent research in the mechanism of phamacological action and clinical application W ere review ed.
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    Two non-parametric methods and its comparation for calculating median difference and its confidence interval
    LI Yun-fei, WANG Kun, HUANG Ji-han, SHENG Yu-cheng, HE Ying-chun, ZHENG Qing-shan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2012, 17 (7): 761-767.  
    Abstract1132)      PDF (548KB)(1813)       Save
    AIM: To introduce two nonparametric methods (Bootstrap and Hodges-Lehmann) for calculating median difference and its confidence interval; the results of these two methods were compared under three pairs of data from three different distributions, and the reason of the difference was discussed. METHODS: Two groups of data were generated from each normal, lognormal and bimodal distribution by computer simulation. The median difference and its confidence interval of each pair were calculated by the two nonparametric methods. This process was repeated for 500 times. RESULTS: The results of the two methods were nearly when data follow normal distribution and it's also agree with the results of parametric method by using mean instead median. For lognormal distribution, the estimated value of median difference and its confidences interval calculated by Bootstrap was larger than the results of Hodges-Lehmann. The results of the two methods was nearly when data distribution was symmetric while the confidence interval was slightly different. CONCLUSION: The two methods are coincident in symmetric distribution. However, Bootstrap emphasizes the position of median while Hodges-Lehmann cares the variance in the case of asymmetric distribution.
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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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    Recent advancement in pharmacological effects of artemisinin and its derivatives
    GUO Yan, WANG Jun, CHEN Zheng-tang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2006, 11 (6): 615-620.  
    Abstract178)      PDF (207KB)(2052)       Save
    Artemisinin, an active compound extracted from Artemisia annua, L.together with its derivatives are widely used as anti-malarial drugs.In recent years, artemisinin and many of its analogs were reported to possess some other effects such as anti-inflammatory, immuno-modulation and antitumor activities besides antiparasitic actions against Plasmodium falciparum and Schistosoma.Based on an introduction of the conventional actions and mechanisms of these drugs, we reviewed the recent progress of their new biological actions in this article.
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    Chinese Journal of Clinical Pharmacology and Therapeutics    1999, 4 (2): 168-170.  
    Abstract81)      PDF (113KB)(1231)       Save
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    Progresses in studies on pharmacologic effects of ginsenosides
    WANG Hai-nan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2006, 11 (11): 1201-1206.  
    Abstract702)      PDF (214KB)(1673)       Save
    Ginsenosides are major active ingredients of ginseng.The Pharmacologic effects of ginsenosides are various.The pharmacologic effects of individual ginsenoside have been studied deeply now, especially focusing on regulation of metabolism.In this article, we reviewed progresses in studies on pharmacologic effects of ginsenosides in recent years in the world, referring to nervous system, small intestinal transit, endocrine system, immune system, signal transduction, anti-aging, hemolysis,burn wound healing, synergy of anti-tumor, human sperm motility, drug metabolism enzyme and lowering plasma glucose.Furthermore, protopanaxadiol-type ginsenosides were compared with protopanaxatriol-type ginsenosides on the pharmacologic effects briefly.
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    Advances of the clinical pharmacology of hydroxychloroquine sulfate
    CUI Cheng, YAO Xueting, TU Siqi, XIE Jieen, LI Haiyan, LIU Dongyang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2020, 25 (2): 221-226.   DOI: 10.12092/j.issn.1009-2501.2020.02.016
    Abstract808)      PDF (350KB)(2097)       Save
    As the number of novel coronavirus disease (COVID-19) continues to increase, the medical situation is still critical, and potential therapeutic drugs, vaccines and stem cell replacement approaches are emerging. Chloroquine has shown better clinical antiviral efficacy than lopinavir/litonavir (clazidine) in clinical trials of small sample size. Since pharmacological action mechanism of hydroxychloroquine is similar with chloroquine and hydroxychloroquine is safer than chloroquine in the treatment of malaria and immunological diseases, the clinical pharmacology characteristics of hydroxychloroquine was reviewed, hoping to provide theoretical support for clinical effect verification of hydroxychloroquine from the perspective of clinical pharmacology and quantitative pharmacology.
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    Mouse models of type 2 diabetes mellitus
    LIU Qian, LI Xia-hui, ZHANG Xue-mei
    Chinese Journal of Clinical Pharmacology and Therapeutics    2013, 18 (10): 1196-1200.  
    Abstract620)      PDF (825KB)(1782)       Save
    Type 2 diabetes was a disease influenced by genetic factors and environmental factors. Animal models of diatetes were essential tools for the understand of the pathogenesis、prevention and treatment of diabetes and its complications. Diabetes mouse models were normally classified into three classes which were spontaneously induced diabetes mouse, experimentally induced diabetes mouse and transgenic diabetes mouse. Each diabetes mouse only imitated clinical diabetes in some aspects and he characteristics of each model about mechanisms and physiology were described in this article. Researchers should choose the suitable diabetes mouse according to their research purpose.
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    Research advance on the characteristics and application of CYP450 metabolic enzymes
    LI Xiao-yu, LIU Gao-lin
    Chinese Journal of Clinical Pharmacology and Therapeutics    2008, 13 (8): 942-946.  
    Abstract320)      PDF (177KB)(1770)       Save
    Cytochrome P450 is an important kind of enzymes for the metabolism of drug and other endoor xeno-biotics.Classification of metabolic enzymes, molecular biological characteristic of CYP3A4, CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP1A2 and CYP2A6were described in this review.Influence of traditional Chinese medicine (TCM)on metabolic enzyme and its application in clinical drug therapeutics and drug development were also reviewed in this article.
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    Research on the pharmacokinetics of prodrugs
    ZHU Yin-ci, SUN Jian-guo, PENG Ying, WANG Guang-ji
    Chinese Journal of Clinical Pharmacology and Therapeutics    2012, 17 (12): 1433-1440.  
    Abstract442)      PDF (587KB)(1413)       Save
    Prodrugs are chemicals with little or no pharmacological activity, which can be changed to therapeutically active metabolite after undergoing biotransformation in vivo. The design of prodrugs has become an important way to overcome the shortcomings of drugs such as poor solubility, low bioavailability, short elimination half-life, devoid of ideal targets and so on. However, there still lacks criteria to evaluate pharmacokinetic properties of prodrugs. This paper reviews the pharmacokinetic profiles of various types of prodrugs in recent years, and proposes full evaluation from absorption, distribution, metabolism and excretion perspectives.
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    Study on the mechanism of cytochrome P450 3A4
    HUANG Wei, HU Xiao
    Chinese Journal of Clinical Pharmacology and Therapeutics    2015, 20 (2): 223-229.  
    Abstract588)      PDF (324KB)(1564)       Save
    The cytochrome P450 (CYP) enzymes, involved in the metabolism of therapeutic drugs, are the major determinants of drug half-life. Among 57 human P450s, CYP3A4 is the most abundant and the most important because it metabolizes the majority of administered drugs. In this review we provide an overview on recent progress in the CYP3A4 research, such as basic structure, active site, mechanism of action, genetic phenotypes, probe substrate, drug metabolism and so on.
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    Advances in study of estrogen and its receptors signal transduction pathway
    FAN Guan-wei, HE Jun, WANG Hong, GAO Xiu-mei
    Chinese Journal of Clinical Pharmacology and Therapeutics    2007, 12 (3): 266-269.  
    Abstract242)      PDF (155KB)(1750)       Save
    Estrogen gradually becomes the research hot spot because it has extensive biological effect, which exerts its function by binding to estrogen receptors (ERs).ERs have the widespread organization distribution, including the reproductive system, the skeleton and the cardiovascular system, and these provided the guarantee for the estrogen to display biology effect.This article reviews the advance of estrogen and its receptors signal transduction pathway in abroad and domestic.
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    Chinese Journal of Clinical Pharmacology and Therapeutics    2000, 5 (2): 162-163.  
    Abstract102)      PDF (74KB)(2168)       Save
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    Current status of clinical drug-drug interactions research of innovative small molecule drugs in China
    LIU Lu, CHEN Xiaoyan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2021, 26 (8): 863-875.   DOI: 10.12092/j.issn.1009-2501.2021.08.003
    Abstract498)      PDF (629KB)(1256)       Save
    In order to improve the efficacy or reduce the side effects, the combination of two or more drugs is often used in clinical practice, which often brings new medication problems that change the process or efficacy of a drug in vivo due to combination. This article reviews the clinical drug-drug interaction (DDI) researches of 44 novel molecular entities which were approved to be launched in China from January 2000 to March 2021. Among them, clinical DDI trials based on test drugs as substrates of the metabolic enzymes (11/44) especially as the substrates of CYP3A4 (7/11) are dominant. The results show that most of test drugs were CYP3A4 substrates with a moderate or lower sensitivity, and no highly sensitive substrates were found. The second is the clinical DDI trials based on synergy or reducing side effects, which mainly focus on the fields of tumors, diabetes, and viral infections, and these studies have not shown pharmacokinetic interactions with clinical significance. The DDI trials of test drugs as metabolic enzyme modulators account for 7/44. And transporter-based DDI trials are relatively rare and most of them are in vitro studies. With the in-depth study of drug metabolism/transport mechanisms in vivo and in vitro, especially the development of clinical trials of radioisotope-labeled drugs and computer simulations, the overall level of DDI research in China is gradually improving, which will provide a solid scientific foundation to ensure drug safety.
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    Research progress on extraction methods and pharmacological activities of polysaccharide from traditional Chinese herb compound
    JING Yongshuai, ZHANG Yuwei, WU Lanfang, ZHANG Ruijuan, MA Yunfeng, ZHANG Danshen
    Chinese Journal of Clinical Pharmacology and Therapeutics    2021, 26 (4): 462-468.   DOI: 10.12092/j.issn.1009-2501.2021.04.015
    Abstract486)      PDF (458KB)(1135)       Save
    Traditional Chinese herb compound is a prescription formulated according to the theory of Chinese medicine, and it is a commonly used method of Chinese medicine. As one of the main active ingredients, the extraction methods of polysaccharides from traditional Chinese herb compound include solvent extraction, ultrasonic assisted extraction, microwave assisted extraction and microbial fermentation extraction. The traditional Chinese herb compound polysaccharide has antitumor, immunoregulatory, intestinal mucosa repair, hypoglycemic, antiviral, antioxidant and other pharmacological activities. In this paper, the extraction methods of polysaccharides from traditional Chinese herb compound and its pharmacological activities were summarized, so as to provide scientific evidence for a better development and utilization of traditional Chinese herb compound polysaccharide. 
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    Overview and progress on the study of the pharmacokinetics of naringin
    ZHU Hong-ping, XIONG Yu-qing
    Chinese Journal of Clinical Pharmacology and Therapeutics    2013, 18 (11): 1297-1303.  
    Abstract352)      PDF (306KB)(1479)       Save
    Naringin is a dihydroflavone compound with the function of promoting gastrointestinal motility, which was found in some Chinese medicine such as Fructus Aurantii, Fructus Aurantii Immaturus, Rhizoma Drynariae, Pummelo Peel and so on. Naringin's oral absorb was bad, extensive distributed in the body, and produced metabolin like p-hydroxybenzoic acid and p-hydroxycinnamic acid by the way of opening loop, dehydrogenation, splitting, then eliminated from the body. Naringin also could interact with other drugs with the inhibiton of some transporters and metabolic enzymes, then influenced the pharmacokinetics of other drugs. This text reviews the pharmacokinetics of naringin and it's influence on other drugs, then points out that the mechanism of interaction through the metabolic process and the influence of genetic polymorphism on its pharmacokinetics still need to be studied.
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    Membrane proteins and membrane proteomics
    LIANG Yan, KAN Hong-wei, YANG Shi-you
    Chinese Journal of Clinical Pharmacology and Therapeutics    2009, 14 (11): 1313-1320.  
    Abstract168)      PDF (259KB)(1096)       Save
    A membrane protein is a protein molecule that is attached to, or integrated into the membrane of a cell or an organelle.As the membrane protein is a good target for drugs, more than 80 % of the drugs on the present market take the effect on the membrane protein.Therefore, it is significant to study the membrane proteins.However, the traditional study on membrane proteomics is obstructed by the difficulties in solubilizing, separating, and identifying membrane proteins.This review summarizes the structure of membrane proteins, the significant role of the membrane proteins on the cell physiology and the human diseases, the potential of the membrane proteins to be the target for drugs and the techniques of the research on the membrane proteomics.
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    Clinical application advancement of pulmonary surfactant
    XU Guo-cheng, LI Zhi-qi
    Chinese Journal of Clinical Pharmacology and Therapeutics    2010, 15 (7): 832-835.  
    Abstract294)      PDF (162KB)(1087)       Save
    Pulmonary surfactant is a type of a phospholipid - protein complexes synthesized by II alveolar epithelial cells. It has many functions as decreasing alveolar surface tension to maintain alveolar stability, reducing alveolar fluid extravasation in the prevention of pulmonary edema, promoting the clearance of inlet ability, inhibiting bronchoconstriction and increasing the pulmonary immune function, reducing the inflammation and improving the lung anti-infection. The natural and synthetic surfactant preparations have some therapeutic effects on the clinical treatment of primary pulmonary surfactant deficiency disease and various secondary pulmonary surfactant-related diseases through tracheal injection or inhalation.
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    Application of chitosan nanoparticle served as drug delivery system for cancer therapy#br#
    SUN Rensong, ZHANG Jianbin, FANG Jiani, LYU Xia, TANG Zeyao, TIAN Yan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2021, 26 (1): 65-75.   DOI: 10.12092/j.issn.1009-2501.2021.01.009
    Abstract832)      PDF (801KB)(1261)       Save
    Cancer is one of the malignant diseases threatening human. In recent years, nanotechnology is becoming the hope the cancer treatment, as it can take the drugs targeting to tumor sites, with enhanced efficacy and reduced toxicity. Chitosan is the only alkaline polysaccharide in nature with good biocompatibility and biodegradability. Moreover, chitosan has many reaction sites to make derivatives with different properties. Chitosan and its derivatives are widely used for drug delivery systems and tissue engineering scaffolds. Hence, they are valuable in the field of biomedicine. In this paper, the recent advances chitosan nanoparticles as drug delivery system for delivering anticancer drugs are reviewed, especially the advances of the preparation, passive targeting, active targeting, and stimuli-responsive drug delivery systems of chitosan nanoparticles. 
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    SAS programming for sample size and power calculation of measurement data in non-inferior trials
    WEN Shi-mei, CHEN Yun-fei, LIU Hua
    Chinese Journal of Clinical Pharmacology and Therapeutics    2013, 18 (1): 51-54.  
    Abstract594)      PDF (651KB)(1411)       Save
    AIM: To calculate sample size and power of measurement data in non-inferior trials using SAS programming. METHODS: Two calculation method, formula and SAS programming, were compared based on examples and the SAS macro for power was given as well. RESULTS: The calculation results of SAS programming was consistent with the formula, and SAS programming can directly give the result was more convenient without looking-up table to obtain the relevant parameters.CONCLUSION: It is helpful for investigator to have a better understanding at this programming to calculate sample size and power provided in this paper.
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    Statistical considerations of group sequential design in oncology clinical trials
    GUO Yang, JIANG Zhi-wei, XIA Jie-lai, WANG Yu-kun
    Chinese Journal of Clinical Pharmacology and Therapeutics    2013, 18 (2): 175-180.  
    Abstract873)      PDF (729KB)(1848)       Save
    The group sequential design is a good choice of oncology trial design because of the smaller sample size and the probability of early stopping for efficacy/futility. To design and apply the group sequential trials scientifically, we illustrate how to choose the number, timing of interim analysis, alpha spending function and optimal trial parameters by employing Monte Carlo simulation. The simulation results show that the three-stage design of 2∶1∶1 time point, whose expected sample size is 420.53, is the best choice in the group sequential design. And the expect sample size is only 420.53. Among the five α spending functions proposed by Lan and DeMets, the 1.5th power and quadratic α spending function, which have the smallest expect sample size of 393 cases, are better than O'Brien-Fleming and Pocock design.
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    Discussion on dose and dosage regimen exploring and confirming in new drug clinical trials
    YANG Jin-bo
    Chinese Journal of Clinical Pharmacology and Therapeutics    2008, 13 (8): 841-846.  
    Abstract307)      PDF (237KB)(1886)       Save
    It is generally concerned by industries that some important questions in new drug clinical trials from designing the first dose in human to confirm the last dosage regimen, which is also one of the key bottlenecks to restrict the promotion of new drug research and development in China.Based on some references and review experience, this article is to discuss dose and dosage regimen exploring and confirming in new drug clinical trials.
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    Prediction of key pharmacokinetic parameters in human
    ZHU Jian-ping, SUN Jian-guo, PENG Ying, WANG Guang-ji
    Chinese Journal of Clinical Pharmacology and Therapeutics    2011, 16 (6): 699-709.  
    Abstract853)      PDF (343KB)(2486)       Save
    Volume of distribution, clearance, half of life and bioavailability are crucial pharmacokinetic parameters determining the extent and sustained time of drugs exposed in vivo. Thus, in the stage of drug discovery and development, it is of particular interest to estimate the pharmacokinetic parameters of drug candidates in human as early as possible to select the most promising compounds for further development. This paper reviews recent developments in prediction of human key pharmacokinetic parameters based upon preclinical animal pharmacokinetic data, absorption and metabolism data in vitro, physico-chemical property and in silico prediction.
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    Research progress on the pharmacokinetic profile of borneol
    TENG Yi, YANG Hai-ling
    Chinese Journal of Clinical Pharmacology and Therapeutics    2015, 20 (4): 469-475.  
    Abstract372)      PDF (261KB)(1688)       Save
    In recent years, the research for their own properties of borneol and its impact on the rest of the drug in vivo is more. Therefore, it is necessary to summarize the research of borneol in recent years. This paper reviews the progress of borneol and promote other drug on absorption, distribution, metabolism and excretion of pharmacokinetic aspects. The results showed that the borneol can change the blood brain barrier (BBB) ,cornea, skin and other mucous membrane structure, and to promote other drugs through these structures to reach the site of action. But the study of metabolism of borneol is still inadequate,in synthetic borneol is vented or prototype components to be converted into camphor discharge are divided on the issue. More serious problem is that a lot of research ignores the composition owing to the different varieties of characteristics of borneol, making it is impossible to refer to each other, and even inconsistencies between the various research results. These problems are to be solved.
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