中药新药用于慢性稳定性劳力型心绞痛主要终点的考虑  

Consideration on the primary outcome measures of new traditional Chinese medicines for chronic stable exertional angina pectoris

作　　者：贾志超 薛斐然 安娜 宋彩梅 韩玲 JIA Zhi-chao;XUE Fei-ran;AN Na;SONG Cai-mei;HAN Ling(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2021年第8期1016-1020,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：治疗慢性稳定性劳力型心绞痛是中医的优势特色之一,也是中药新药研发的热点之一。笔者通过梳理心绞痛相关适应症历年受理情况,发现中药新药在治疗该疾病上主要定位于减少心绞痛的发作频率、减轻疼痛程度,改善相关症状和中医证候,针对上述临床定位,国内外药品监管机构均重点推荐运动负荷试验作为疗效评价指标。笔者分析了运动负荷试验的优势与不足,鼓励业界结合产品自身特点及既往人用经验,设定符合中医药特点,多元化的临床定位。可根据临床定位的特点,建立除运动负荷试验外,更为安全、依从性更好,且能被业界普遍接受的评价方法。The treatment of chronic stable exertional angina pectoris is one of the advantages of traditional Chinese medicine(TCM),and it is also one of the hot spots in the research and development of new Chinese medicine.In this paper,through carding the acceptance of angina pectoris related indications over the years,new Chinese medicine in the treatment of the disease is mainly aimed at reducing the frequency of angina pectoris,reducing the degree of pain,improving the related symptoms and TCM syndromes.Drug administrations recommend exercise test as the efficacy evaluation index for the above clinical positioning drugs.This paper analyzes the advantages and disadvantages of exercise test,and encourages the industry to combine the characteristics of products and past human experience to set up a diversified clinical positioning in line with the characteristics of TCM.According to the characteristics of clinical positioning,we can establish an evaluation method which is safer,more compliant and generally accepted by the industry besides exercise test.

关 键 词：中药新药 慢性稳定性劳力型心绞痛 运动负荷试验 

分 类 号：R97[医药卫生—药品]