CAJ | 학술논문

目的：探讨丹参酮ⅡA 磺酸钠注射液所致不良反应的流行病学特点，为临床安全用药提供参考。方法以“丹参酮”“不良反应”“安全性”等为检索词，检索中国医院知识仓库（CHKD）和万方数据库收录的1994年至2013年所有中文文献。阅读、筛选所有描述丹参酮ⅡA 磺酸钠注射液不良反应的文献资料，按纳入和排除标准筛选后进行统计、分析。结果共检索报道丹参酮ⅡA 磺酸钠注射液不良反应的文献22篇，收集其不良反应27例。丹参酮ⅡA 磺酸钠注射液所致不良反应在高年龄组发生率较高；不良反应累及机体多个系统，临床表现复杂多样，主要表现为皮肤及其附件损害、全身性反应，严重者可出现过敏性休克。不良反应/事件多发生在给药后30 min 以内，绝大多数经治疗后转归良好。结论丹参酮ⅡA 磺酸钠注射液可致过敏性休克等严重不良反应，应提高临床合理用药水平，加强用药监护，以避免或减少不良反应的发生，保障患者用药安全。
목적：탐토단삼동ⅡA 광산납주사액소치불량반응적류행병학특점，위림상안전용약제공삼고。방법이“단삼동”“불량반응”“안전성”등위검색사，검색중국의원지식창고（CHKD）화만방수거고수록적1994년지2013년소유중문문헌。열독、사선소유묘술단삼동ⅡA 광산납주사액불량반응적문헌자료，안납입화배제표준사선후진행통계、분석。결과공검색보도단삼동ⅡA 광산납주사액불량반응적문헌22편，수집기불량반응27례。단삼동ⅡA 광산납주사액소치불량반응재고년령조발생솔교고；불량반응루급궤체다개계통，림상표현복잡다양，주요표현위피부급기부건손해、전신성반응，엄중자가출현과민성휴극。불량반응/사건다발생재급약후30 min 이내，절대다수경치료후전귀량호。결론단삼동ⅡA 광산납주사액가치과민성휴극등엄중불량반응，응제고림상합리용약수평，가강용약감호，이피면혹감소불량반응적발생，보장환자용약안전。
Objective To investigate the epidemiological characteristics of adverse drug reactions / events(ADR / ADE)induced by Sodium Tanshinone ⅡA Sulfonate Injection to provide reference for its rational use in clinic. Methods Sodium Tanshinone ⅡA Sulfonate Injec-tion induced ADR case reports were searched from the databases of the Chinese National Knowledge Infrastructure and Wanfang Data from 1994 to 2013 with the terms of tanshinone,adverse drug reaction and safety. All literatures associated with ADR of Sodium Tan-shinone ⅡA Sulfonate Injection were reviewed and screened according to the inclusion and exclusion criteria. Results Total 27 cases of ADR were collected from 22 articles. The higher occurrence rate of ADR was occurred in the high age group;multiple organs and sys-tems were involved in ADR and the clinical manifestations were various and complex. The lesions of ADR were primarily involved in skin and its accessories,followed by systemic reactions. The allergic shock was observed in some severe ADR. The onset time of most ADR / ADE was within 30 min after medication and most ADR / ADE had good prognosis after treatment. Conclusion Sodium Tanshi-none ⅡA Sulfonate Injection could lead to severe ADR / ADE,such as allergic shock. The level of rational drug use should be increased and the medication monitoring should be strengthened so as to avoid or decrease the occurrence of ADR / ADE and ensure the patient's medication safety.