CAJ | 학술논문

目的：了解中药注射剂不良反应（ ADR ）的发生特点和一般规律。方法对石家庄市第三医院2014年1月至2014年11月上报国家药品不良反应监测中心的63例ADR报告，从患者性别、年龄、不良反应史、联合用药的情况、药品种类及数量、累及器官／系统、ADR发生的时间、给药途径、ADR的关联性分析及预后等进行统计分析。结果63例ADR病例中有60例用静脉给药，以中老年患者（≥40岁）居多。不良反应临床表现以皮疹、瘙痒多见，其次为消化系统症状。63例ADR报告中共涉及7类15个品种，多为活血化瘀与清热解毒类药物。结论中药注射剂已广泛应用于临床，其不良反应也较常见，应给予足够重视，加强合理用药管理，确保患者用药安全。
목적：료해중약주사제불량반응（ ADR ）적발생특점화일반규률。방법대석가장시제삼의원2014년1월지2014년11월상보국가약품불량반응감측중심적63례ADR보고，종환자성별、년령、불량반응사、연합용약적정황、약품충류급수량、루급기관／계통、ADR발생적시간、급약도경、ADR적관련성분석급예후등진행통계분석。결과63례ADR병례중유60례용정맥급약，이중노년환자（≥40세）거다。불량반응림상표현이피진、소양다견，기차위소화계통증상。63례ADR보고중공섭급7류15개품충，다위활혈화어여청열해독류약물。결론중약주사제이엄범응용우림상，기불량반응야교상견，응급여족구중시，가강합리용약관리，학보환자용약안전。
Objective To study the characteristics and general regulari-ty of adverse reactions of the traditional Chinese medicine injection.Methods A total of 63 cases of adverse reaction reports were collected, reported to the national adverse drug reaction monitoring center, from January 2014 to November 2014 in the third hospital of Shijiazhuang city.The data of the patient gender, age, history of adverse reactions, combi-nation therapy, the type and quantity of drugs, involving the organ/system, the time adverse reaction occurred, route of administration and association analysis and prognosis of adverse reaction were statistically analyzed.Results Among 63 cases, 60 cases of them were administered with drugs intravenously and most of them were elderly patients (≥40 years).Clinical manifestations of adverse reactions were skin rash, itching common, followed by digestive symptoms.All the cases involved 7 categories and 15 varieties, mostly being blood circulation and detoxification drugs.Conclusion Traditional Chinese medicine injections have been widely used , with frequent adverse reactions.Adequate attention should be given, and rational drug management to ensure patient medication safety be strengthened.