CAJ | 학술논문

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,加强中丙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.
중약주사제시일류주요재중국대륙지구림상실천중피엄범사용적중요신약.연이최근일단시간,중약주사제불량반응,불량사건적보고비수관주,심지유전가제출금지사용중약주사제.대차,아문인위응해인진연구,정학대대.아문건의,수선응명석불량반응화불량사건적개념,이조우감별안전성사건;기차,제고중약주사제주책화심비요구,가강기출연구,경가중시중약주사제적순증연발화심비;제삼,가강중병약상호작용적기출연구;제사,명세중약주사제심비궤구、생산기업、의생화환자적법률책임;제오,가강대위생보건인원사용중약주사제적배훈;제륙,가강감공중약주사제사용설명서적질량.
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.