精确循证促进中药注射剂合理合法应用的策略与路径  

Strategy and Path of Precision and Evidence-based Medicine Promoting the Rational and Legal Application of Traditional Chinese Medicine Injection

作　　者：郑蕊 赵晨 陈诗琪[1] 张晓雨[1] 商洪才[1] Zheng Rui;Zhao Chen;Chen Shiqi;Zhang Xiaoyu;Shang Hongcai(Dongzhimen Hospital Affiliated to Beifing University of Chinese Medicine,Beijing 100700,China;School of Chinese Medicine,Hong Kong Baptist University,Hongkong 999077,China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]香港浸会大学中医药学院,香港999077

出　　处：《世界科学技术-中医药现代化》2018年第10期1713-1717,共5页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：中共中央组织部第二批国家"万人计划"(2016)经费资助项目(W02020052);第二批国家高层次人才特殊支持计划领军人才;负责人:商洪才

摘　　要：中药注射剂临床应用主要存在两大问题:说明书对临床用药指导不足和临床应用环节不合理。问题的核心是缺少精确循证研究的推进。针对当前问题,应采取由政府药政部门主导,逐步形成医疗机构-研究者-企业多方协作平台共同开展精确、循证研究的策略。精确临床定位、完善药品不良反应监测体系、评估用药风险,医疗机构充分实践精确循证研究产出的证据可为具体实现路径。中药注射剂做到临床定位清晰、具体,同时机制清晰,靶点明确。优胜劣汰,从而增强中药注射剂优势品种的核心竞争力,在保护人类生命健康事业中做贡献。There are two major problems in the clinical application of Traditional Chinese Medicine injection: inadequate instruction for clinical medication and unreasonable clinical application. The key of the problem is the lack of precise and evidence-based research. In view of the current problems, we should adopt the strategy of government drug administration department leading and gradually taking shape that a multi-collaboration platform of medical institutions,researchers and enterprises to jointly carry out precise and evidence-based research. The specific implementation path is the precise clinical positioning, improving monitoring and assessment system of adverse drug reactions. The medical institutions fully put into the evidence. Chinese medicine injection will be clear and specific in clinical location, with clear mechanism. Survival of the fittest enhances the core competitiveness of Chinese medicine injections and makes contributions to the cause of protecting human life and health.

关 键 词：中药注射剂 安全性 合理 合法 精确 循证 

分 类 号：R283.6[医药卫生—中药学]