中华中医药杂志2025，Vol.40Issue(1)：24-27,4.
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
摘要
Abstract
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Key words
Effectiveness evaluation of traditional Chinese medicine injection/Evidence-based review/Qualitative evaluation/Quantitative evaluation/Salvianolic acid injection引用本文复制引用
李睿,訾明杰,陆芳,高蕊..基于循证证据的上市后中药注射剂有效性评价思考[J].中华中医药杂志,2025,40(1):24-27,4.基金项目
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) （No.CI2021A04703,No.CI2021A04701）
