关注中药新药临床研究中的心脏安全性  

Spotlight on the cardiac safety of new traditional Chinese medicines in clinical trials

作　　者：朱贤慧[1] 刘炳林[2] 唐健元[2] 薛斐然[2] 

机构地区：[1]南京中医药大学附属医院,南京210029 [2]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2017年第13期1498-1502,共5页Chinese Journal of New Drugs

摘　　要：新药心脏安全性评价是新药临床研究中的重点之一,目前,中药新药临床研究中对心脏安全性的关注尚比较欠缺,存在设计欠规范、实施欠严谨、随访欠充分等问题,这与研究者的重视程度、中药新药的影响因素繁多、作用机制复杂等因素有关。在临床研究中,科学、合理、规范地评价中药新药的心脏安全性需要中西合璧、博古通今,注重临床研究两"期"(早期与长期),设计规范、合理、完善、具备可操作性的临床试验方案,客观、科学、均一地分析心脏安全性数据。Cardiac safety is one of the emphases which should be focused on in the clinical trials of new traditional Chinese medicines. However,there is little attention paid to this issue currently. Besides,there are some problems in the designing,processing and follow up of clinical trials because of the attitudes of the investigators,various influencing factors of new traditional Chinese medicines,and complicated mechanism and so on. It is important to evaluate the cardiac safety of new traditional Chinese medicines in a scientific,rational and standardized way by integrating the western and Chinese technology and learning from the ancient and modern theories. It is crucial to pay more attention to the early stage and long-term research of clinical trials. Besides,a standardized,rational,complete and practical protocol of clinical trial and an objective,scientific and consistent evaluation of cardiac safety data are very important.

关 键 词：中药新药 临床研究 心脏安全性 

分 类 号：R95[医药卫生—药学]