731例药品不良反应报告分析

Analysis on 731 ADR case reports in our hospital

目的:分析药品不良反应(ADR)发生的规律及特点,为临床合理用药及药物安全性评价提供依据。方法:对我院2008-2010年收集的731例ADR报告就患者性别和年龄分布、既往过敏史、ADR因果关系评价、给药途径、引发ADR的药品种类、ADR累及器官或系统及临床表现等进行分类统计和分析。结果:药品不良反应涉及19类药物,155个品种,抗感染药物占首位(333例,占45.55%),其中发生ADR次数较多的药物依次为左氧氟沙星注射液(36例,占4.92%),奥硝唑注射液(26例,占3.56%),注射用乳糖酸阿奇霉素(21例,占2.87%);其次是抗肿瘤药物(61例,占8.34%)和心血管系统药物(52例,占7.11%),发生ADR次数较多的药物分别为注射用顺铂(9例,占1.23%)和单硝酸异山梨酯注射液(19例,占2.60%);静脉用药引发ADR为426例(58.28%);ADR可发生于人体各个系统,但主要为皮肤及附件损害(280例,占38.30%),其次为消化系统损害(154例,占21.70%),重度ADR 23例(3.15%),其中新的、严重的ADR 6例(0.82%),药物为左氧氟沙星注射液、注射用干扰素α、注射用美洛西林、注射用克林霉素磷酸酯、注射用多西他赛、注射用脑蛋白水解物。结论:临床应重视ADR的报告和监测工作,以减少和避免ADR的发生,促进临床合理用药。

Objective：To investigate the features and regularity of adverse drug reactions（ADRs） occurred in our hospital in order to provide reference for rational medication in clinic.Methods：A total of 731 ADR cases collected in our hospital from 2008 to 2010 were classified and analyzed statistically,in respect of gender,age distribution,allergy history,causation assessment of ADR,route of administration,the type of ADR-inducing drugs,organ or system involved in ADRs and clinical manifestation.Results：The adverse drug reactions involved in 19 types of drugs,155 varieties,with 333 cases（45.55%） induced by 47 kinds of antibiotics.The drugs that induced most ADRs were levofloxacin injection（36 cases,4.92%）,ornidazole injection（26 cases,3.56%）,and lactose acid azithromycin for injection（21 cases,2.87%）.Then followed by anti-cancer drugs（61 cases,8.34%） and the cardiovascular system drugs（52 cases,7.11%）,including cisplatin（9 cases,1.23%） and isosorbide mononitrate（19 cases,2.60%）.There were 426 cases（58.28%） induced by intravenous drugs.ADR may occur in any system of human body,mainly for skin system and accessories damage（280 cases,38.30%）,followed by digestive system damage（154 cases,21.70%）.There were 23 severe ADR cases（3.15%）,including 6 new,serious ADR cases（0.82%）,as levofloxacin injection,interferon for injection,meziocillin for injection and clidamycin phosphate for injection,docetaxel for injection,cerebroprotein hydrolysate for injection.Conclusion：More attention should be paid to reporting and monitoring of ADRs in order to avoid or reduce the occurrence of ADRs for ensuring safe medication.