基于循证证据的上市后中药注射剂有效性评价思考  

Thought on the effectiveness evaluation of post-marketing traditional Chinese medicine injection based on evidence-based review

作　　者：李睿[1] 訾明杰[1] 陆芳[1] 高蕊[1] LI Rui;ZI Mingjie;LU Fang;GAO Rui(Institute of Clinical Pharmacology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China)

机构地区：[1]中国中医科学院西苑医院临床药理研究所,北京100091

出　　处：《中华中医药杂志》2025年第1期24-27,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：中国中医科学院科技创新工程项目(No.CI2021A04703,No.CI2021A04701);北京市研究型病房示范建设项目(No.BCRW202108)。

摘　　要：中药注射剂作为我国特有的药品种类曾经在治疗急危重症方面发挥了重要作用,但大多数中药注射剂上市年代久远,之前的有效性数据是否能满足现在的临床治疗需求,药品的功能定位和适用人群是否发生变化,都是需要重新评估和研究的问题。文章通过上市后丹参多酚酸盐注射剂的循证评价研究,提出了中药注射剂的有效性评价原则、定性评价结合定量评价的评价方案以及定量评价标准,可指导企业通过临床文献资料、临床经验数据、临床试验等信息,开展基于循证证据疗效评价,为药企及药品监管部门确认中药注射剂是否满足临床应用要求提供循证证据。Traditional Chinese medicine(TCM) injection,as the unique type of medicine,plays an important role in severe acute disease treatment.However,most TCM injections,have appeared on the market for long time,whether the prior efficacy data could meet the current requirement of clinical therapeutics,the function and target population could have changed,these questions need to be reevaluated and studied.The evaluation principle,qualitative combined with quantitative evaluation scheme,and quantitative evaluation standard have been proposed based on evidence-based review of Salvianolic acid injection.This scheme could guide the process that enterprise conducts evidence-based review based on clinical literature,clinical empirical data,clinical trial information,and furthermore provide the evidence to confirm whether TCM injection could meet the requirement of clinical application to the National Medical Products Administration(NMPA) and pharmaceutical company.

关 键 词：中药注射剂有效性评价 循证评价 定性评价 定量评价 注射用丹参多酚酸盐 

分 类 号：R288[医药卫生—中药学]