CAJ | 학술논문

目的：探讨中药不良反应的发生情况、特点及规律，为临床合理用药提供参考。方法：采用回顾性研究方法，对2009–2013年解放军药品不良反应监测中心收集的中药不良反应报告进行统计和分析。结果：5188例中药ADR来自123所医院，共涉及注射剂3743例，非注射剂1445例，共679个品种，34种剂型。ADR发生时间多数集中在用药后30 min以内，其构成比为43.35%，累及系统/器官的主要表现以皮肤及附件损害（29.74%）、全身性损害（16.22%）、胃肠系统损害（16.03%）为主。发生严重ADR例次靠前的中药品种依次为冠心苏合丸、何首乌饮片、参麦注射液、肾康注射液、血必净注射液、龙胆泻肝丸。结论：应重视中药的不良反应，重点关注易导致严重ADR的中药品种，最大限度减少中药ADR的发生。
목적：탐토중약불량반응적발생정황、특점급규률，위림상합리용약제공삼고。방법：채용회고성연구방법，대2009–2013년해방군약품불량반응감측중심수집적중약불량반응보고진행통계화분석。결과：5188례중약ADR래자123소의원，공섭급주사제3743례，비주사제1445례，공679개품충，34충제형。ADR발생시간다수집중재용약후30 min이내，기구성비위43.35%，루급계통/기관적주요표현이피부급부건손해（29.74%）、전신성손해（16.22%）、위장계통손해（16.03%）위주。발생엄중ADR례차고전적중약품충의차위관심소합환、하수오음편、삼맥주사액、신강주사액、혈필정주사액、룡담사간환。결론：응중시중약적불량반응，중점관주역도치엄중ADR적중약품충，최대한도감소중약ADR적발생。
Objective: To analyze the characteristics of ADRs caused by traditional Chinese medicine (TCM) and provide reference for rational drug use in clinic. Methods:All the adverse reactions of TCM collected by the PLA center of ADR monitoring from 2009 to 2013 were retrospectively analyzed. Results:A total of 5188 ADR cases of TCM from 123 hospitals were analyzed, including 3743 cases of injections and 1445 cases of non-injections. These reports involved 679 species and 34 dosage forms. Most ADRs happened within 30 minutes, accounting for 43.35%. The main clinical manifestations of these ADRs were skin and its accessories damage (29.74%), systemic damage (16.22%) and gastrointestinal system damage (16.03%). Top six species of TCM which caused serious ADR were Guanxinsuhe pills, Heshouwu pieces, Shenmai injections, Shenkang injections, Xuebijing injections and Longdanxiegan pills. Conclusion:It is important to be aware of the ADR caused by TCM and strengthen rational drug use. Special attention should be paid to the TCM that easily lead to severe ADRs in order to minimize the occurrence of ADR.