中药注射剂不良反应／不良事件的反思

中药注射剂是一类主要在中国大陆地区临床实践中被广泛使用的重要新药。然而最近一段时间,中药注射剂不良反应/不良事件的报告备受关注,甚至有专家提出禁止使用中药注射剂。对此,我们认为应该认真研究,正确对待。我们建议,首先应明晰不良反应和不良事件的概念,以助于鉴别安全性事件;其次,提高中药注射剂注册和审批要求,加强基础研究,更加重视中药注射剂的循证研发和审批;第三,加强中西药相互作用的基础研究;第四,明细中药注射剂审批机构、生产企业、医生和患者的法律责任;第五,加强对卫生保健人员使用中药注射剂的培训;第六,加强监控中药注射剂使用说明书的质量。

Review of Adverse Reactions to Chinese Medicine Injections

Using Chinese Materia Medica(CM)as injections is an innovation that is proving effective in extensive clinical use in Mainland China.However,recent reports have focused on adverse reactions,ignoring the considerable successes of these preparations.In order to achieve balance in the media and in the minds of the public,we suggest the first step is to clarify the concepts of and differences between adverse drug reactions(ADR)and adverse events(AE)for all concerned-the public,medical practitioners,government officials,and lawmakers.Second,the State Food and Drug Administration should raise the requirements for Chinese Medicine Injection(CMI)registration and license approval and emphasize the importance of evidence-based CMI development and evidence-based CMI license approval.Thirdly,drug companies and institutions should reinforce basic research about the quality control of herbs and CMI-drug interactions.Fourth,the Government should clarify the legal responsibilities for CMI approval agencies,CMI developers,medical doctors,and patients.Fifth,the medical association and Government should enhance training for health care professionals concerning the usage of CMIs.And finally sixth,State Food and Drug Administration should monitor the content and quality of the directions for use of CMI.