中成药临床综合评价方法的研究现状  

Research Status of Clinical Comprehensive Evaluation Methods of Chinese Patent Medicine

作　　者：甘雪峰 李根林[1,3] 崔永霞 吴宿慧[1,3] 李寒冰[1,3] GAN Xuefeng;LI Genlin;CUI Yongxia;WU Suhui;LI Hanbing(Henan University of Chinese Medicine,Zhengzhou 450046,Henan,China;Shaanxi Provincial Hospital of Traditional Chinese Medicine,Xi'an 710003,Shaanxi,China;Henan Health Aging Industry Engineering Research Center,Zhengzhou 450046,Henan,China)

机构地区：[1]河南中医药大学,河南郑州450046 [2]陕西省中医医院,陕西西安710003 [3]河南省健康衰老产业工程研究中心,河南郑州450046

出　　处：《中华中医药学刊》2024年第7期234-238,共5页Chinese Archives of Traditional Chinese Medicine

基　　金：河南省科技攻关计划项目(202102310188);河南省中医药科学研究专项(20-21ZY1038)。

摘　　要：近年来药品临床综合评价在中国进入快速发展阶段,在临床治疗药物中占半壁江山的中成药开展临床综合评价也势在必行,近日《中成药临床综合评价指南(2022年试行版)》已发布。相比较于化学药品、生物制剂等现代药物,中成药有其自身特色,目前符合中医药特色的中成药临床综合评价方法尚在建立之中,并亟待规范和完善。通过对现有报道的中成药临床综合评价方法(包括证据收集与决策两个层面)进行归纳总结,并对应用结果进行分析讨论,在此基础上,针对中成药自身特点,提出了自己的观点,为广泛开展中成药临床综合评价提供方法学参考。In recent years,the comprehensive clinical evaluation of drugs has entered a rapid development stage in our country,and it is imperative to carry out comprehensive clinical evaluation of Chinese patent medicine,which accounts for half of the total clinical therapeutic drugs.Recently,the Guidelines for Clinical Comprehensive Evaluation of Traditional Chinese Patent Medicine(2022 trial edition)has been released.Compared with modern drugs such as chemical drugs and biological preparations,Chinese patent medicine has their own characteristics.At present,the clinical comprehensive evaluation method of Chinese patent medicine is still being established and needs to be standardized and perfected.This study summarized the methods of clinical comprehensive evaluation of Chinese patent medicine(including evidence collection and decision-making),and discussed the application results in view of the characteristics of Chinese patent medicine.The author put forward his own views,providing methodological reference for comprehensive clinical evaluation of Chinese patent medicine.

关 键 词：中成药 临床综合评价 评价维度 评价方法 研究现状 

分 类 号：R286[医药卫生—中药学]