CAJ | 학술논문

目的对《国家基本医疗保险、工伤保险和生育保险药品目录》( 2009 年版,本文简称《医保目录》)中西药复方制剂近30年来存在的安全问题进行分析,探讨该类制剂发生ADR/ADE的原因,并提出相关建议,指导临床合理用药. 方法采用回顾性研究方法,检索和查阅中西药复方制剂的 ADR/ADE文献及 CFDA药品不良反应信息通报,应用统计学方法对资料进行整理和分析. 结果共检索到最新版医保目录中西药复方制剂(包括同一药品的不同剂型)的ADR/ADE 3 350例,涉及药物品种39种,其中详细案例1 470例. 由于该类制剂自身的特殊性,不良反应的发生率高,危害涉及人体多个器官及系统. 此外,说明书信息不完善,使用过程存在超剂量、用药时间长、联合用药等问题,增加了该类制剂出现不良反应的风险. 结论应对中西药复方制剂的安全问题引起高度重视,开展相关药品监管工作,增加药品安全性、有效性的基本评价,为临床安全、合理用药提供参考依据.
목적 대《국가기본의료보험、공상보험화생육보험약품목록》( 2009 년판,본문간칭《의보목록》)중서약복방제제근30년래존재적안전문제진행분석,탐토해류제제발생ADR/ADE적원인,병제출상관건의,지도림상합리용약. 방법 채용회고성연구방법,검색화사열중서약복방제제적 ADR/ADE문헌급 CFDA약품불량반응신식통보,응용통계학방법대자료진행정리화분석. 결과 공검색도최신판의보목록중서약복방제제(포괄동일약품적불동제형)적ADR/ADE 3 350례,섭급약물품충39충,기중상세안례1 470례. 유우해류제제자신적특수성,불량반응적발생솔고,위해섭급인체다개기관급계통. 차외,설명서신식불완선,사용과정존재초제량、용약시간장、연합용약등문제,증가료해류제제출현불량반응적풍험. 결론 응대중서약복방제제적안전문제인기고도중시,개전상관약품감관공작,증가약품안전성、유효성적기본평개,위림상안전、합리용약제공삼고의거.
Objective To analyze the existing safety problems of Chinese-western medicine compound prepa-rations in the latest edition of medical insurance directory in order to investigate the causes of ADR/ADE and provide suggestions and references for the supervision and policy-making as well as the rational use of drugs.Methods Based on the related literature retrieval of domestic periodicals and the adverse drug reactions information bulletin of CFDA,which were analyzed by retrospective study method and statistic method.Results Totally 3 350 ADR/ADE cases a-bout Chinese-western medicine compound preparations ( including the same drug in different dosage forms) in medical insurance directory were retrieved,of which 1 470 detailed ADR/ADE cases were induced by 39 kinds of Chinese-west-ern medicine compound preparations. Due to the particularity of the drugs,it led to high incidence of adverse reactions and harmful to multiple organs and systems. In addition,imperfect instruction information,overdose,long duration,combination use of drugs could increase the risk of adverse reactions.Conclusion We should pay more attention to the safety problems of Chinese-western medicine compound preparations,promote related supervision measures and in-crease the basic evaluation of drug safety and effectiveness so as to provide reference for the safety of clinic and the ra-tional use of drugs.