中药注射剂临床应用存在问题及说明书的相关思考与建议  

Problems of Using Traditional Chinese Medicine Injections in Clinical Practice and the Suggestions about Making the Package Inserts

作　　者：陈诗琪[1] 郑蕊 李幼平[2] 商洪才[1] Chen Shiqi;Zheng Rui;Li Youping;Shang Hongcai(Key Laboratory of Chinese Medicine of Ministry of Education,Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing 100700,China;Cochrane China,Chinese Evidence-Based Medicine Center,West China Hospital,Sichuan University,Chengdu,610041,P.R.China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]四川大学华西医院中国Cochrane中心/中国循证医学中心,成都610041

出　　处：《世界科学技术-中医药现代化》2018年第10期1718-1722,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存在成分复杂、辅料热原不清、功能广泛、主治不清、用法用量含糊、操作过程不规范、药物相互作用不清等问题,限制了中药注射剂的应用和发展。根据2006年以来中药注射剂药品说明书制定的相关政策,结合临床应用中的问题加以思考,为建立严格、规范、基于证据的中药注射剂药品说明书提供建议。In clinical practice, the application of Traditional Chinese Medicine injections(TCMIs) has several problems,for example, at some time, the components are complicated, the ingredients and pyrogen are uncontrollable, the usage,the dosage, and the drug interactions are unclear and the method of application is also ambiguous and non-standard. The factors have restricted the development of TCMIs. Based on the policies of the TCMI package inserts since 2006, this paper takes consideration of the problems and gives suggestions of making strict, normal and evidence-based TCMI package inserts.

关 键 词：中药注射剂 药品说明书 政策 建议 

分 类 号：R283.6[医药卫生—中药学]