摘要
目的分析药物临床试验登记与信息公示平台(CDE)登记的中药治疗冠心病心绞痛的临床试验,为今后治疗冠心病心绞痛中成药的研发与临床试验设计提供参考。方法于2020年10月1日,在国家药品监督管理局药品审评中心的CDE平台中提取冠心病心绞痛中药研发的相关临床试验,对其基本信息、人群特征、试验设计和疗效评价进行分析,总结该领域中药新药研发特点和趋势。结果截止2020年10月CDE平台共登记53项冠心病心绞痛临床试验,涉及40个品种;研究药物剂型包括注射液、胶囊、片剂、滴丸和颗粒,分别有10个、9个、11个、8个和2个品种;研究阶段包括Ⅰ期15项、Ⅱ期26项、Ⅲ期10项和Ⅳ期2项;中医证型有13个,其中以心血瘀阻证和气虚血瘀证研究最多,分别有8个和7个;有14个研究进行剂量探索;试验疗程1~12周,其中疗程是8周的最多;评价指标以心绞痛症状相关指标最多,有37个项目。结论目前治疗冠心病心绞痛的中成药种类繁多,但纳入人群、评价指标等方面重复性较高;从研究设计看,很难突出药物作用特点。期望今后在以临床价值为导向的研发理念下,通过合理的临床设计与疗效评价,体现中药的临床价值和优势。
Objective To analyze the clinical trials of traditional Chinese medicines registered on the drug clinical trial registration and information disclosure platform(CDE)for the treatment of coronary heart disease angina pectoris,and to provide references for the future development and clinical trial design of Chinese patent medicines for the treatment of coronary heart disease angina pectoris.Methods On October 1,2020,the CDE platform of the Drug Evaluation Center of the National Medical Products Administration extracted relevant clinical trials for the development of Chinese medicine for coronary heart disease and angina pectoris,and analyzed its basic information,population characteristics,trial design and efficacy evaluation.Summarize the characteristics and trends of new Chinese medicine research and development in this field.Results As of October 2020,a total of 53 coronary heart disease angina pectoris clinical trials were registered on the CDE platform,involving 40 varieties;The research drug dosage forms included injections,capsules,tablets,dripping pills and granules,with 10,9,11,8 and 2 varieties respectively;The research phase included 15 items in phase I,26 items in phase II,10 items in phaseⅢand 2 items in phase IV;There were 13 TCM syndrome types,among which the heart and blood stasis syndrome and the qi deficiency and blood stasis syndrome were the most studied,with 8 and 7 respectively;There were 14 studies to explore the dose;the trial course of treatment was 1 to 12 weeks,of which the treatment course was 8 weeks the most;the evaluation index was the most relevant index of angina pectoris,with 37 items.Conclusion At present,there are many kinds of Chinese patent medicines for the treatment of angina pectoris of coronary heart disease,but the inclusion population and evaluation indicators are highly reproducible;From the perspective of research design,it is difficult to highlight the characteristics of drug action.It is hoped that in the future,under the clinical value-oriented research and development concept,the clinical value and advantages of traditional Chinese medicine can be reflected through reasonable clinical design and efficacy evaluation.
作者
肖扬
李国政
刘莹
XIAO Yang;LI Guo-zheng;LIU Ying(Department of Pharmacy,the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300000,China;Classic Ward of Traditional Chinese Medicine,the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300000,China)
出处
《医学信息》
2021年第9期23-27,共5页
Journal of Medical Information
关键词
冠心病
心绞痛
中药
Coronary heart disease
Angina pectoris
Chinese medicine
