中药临床研究联合用药安全性评价的思考和建议  

Thoughts and Suggestions on Safety Evaluation of Combined use of Traditional Chinese Medicine in Clinical Research

作　　者：程金莲[1] 欧阳绘天 靳洪涛[3] 朱雪琦[1] 肖爽[1] 雷翔 高春升[2] 刘清泉[1] CHENG Jinlian;OUYANG Huitian;JIN Hongtao;ZHU Xueqi;XIAO Shuang;LEI Xiang;GAO Chunsheng;LIU Qingquan(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Beijing Qihuang Clinical Research Center,Beijing 100058,China;New Drug Safety Evaluation Center,Institute of Materia Medica,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]北京岐黄药品临床研究中心,北京100058 [3]中国医学科学院北京协和医学院药物研究所新药安全评价研究中心,北京100050

出　　处：《中国药物警戒》2021年第1期4-10,共7页Chinese Journal of Pharmacovigilance

基　　金：国家“十三五”重大新药创制专项(2019ZX09734001)。

摘　　要：目的探讨中药临床研究联合用药安全性评价方法,以满足临床安全、有效用药的需求。方法从中药临床研究入手,分析中药临床研究联合用药安全性存在的问题,并对其关键问题提出适当的建议。结果中药联合用药安全性评价体系需要建设和完善。结论中药联合用药的安全性评价需要从研发早期开始,贯穿临床试验至上市后评价的药品全生命周期;重视研究设计和风险-获益评估,搭建研究设计-监测评价-分析预测-风险管理的动态研究模式,建立多学科的综合评估体系。Objective To study methods for safety evaluation of combined use of traditional Chinese medicine in clinical research in order to meet the needs of clinically safe and effective medication.Methods Starting with the clinical study of Traditional Chinese medicine,this paper analyzes the problems with the safety of combined use of traditional Chinese medicine in clinical study,and offers solutions to the major problems.Results A safety evaluation system for drug combination of TCM and Western medicine needed to be established and improved.Conclusion The safety evaluation of drug combination of TCM and Western medicine should start with the early stage of development and run through the life cycle of new drugs from clinical trial to postmarketing evaluation.Importance should be attached to research design and risk-benefit assessment.A dynamic research model of research design-monitoring evaluation-analysis prediction-risk management is to be adopted,and a multidisciplinary comprehensive assessment system established.

关 键 词：中药 临床研究 联合用药 药物相互作用 安全性评价 

分 类 号：R288[医药卫生—中药学] R969.3[医药卫生—中医学]