医院81例严重药品不良反应/不良事件报告分析

Analysis of Serious Adverse Drug Reaction/Event Reports in 81 Cases

目的分析医院严重药品不良反应(ADR)发生的特点及影响因素,为临床合理用药及用药安全提供依据。方法回顾性分析2013年至2015年医院上报的81例严重ADR的患者基本情况、涉及药品类型、给药途径、累及系统/器官及临床表现、转归及其他。结果收集的81例严重ADR,以50岁以上患者最多见(66.67%);涉及药品种类以降糖降压等心血管药物(27.16%)、抗肿瘤药物(25.93%)、抗菌药物(17.28%)最常见;药品剂型以注射剂(56.79%)和口服药(43.21%)为主;累及器官/系统主要为血液系统(29.63%)、消化系统(17.28%)、皮肤及附件(14.81%);临床转归好转60例(74.07%),痊愈17例(20.99%),未好转3例(3.70%),死亡1例(1.23%)。结论发生严重ADR与患者年龄大、并发多种疾病、药品联合应用、药品本身毒性等因素相关。为提高医院合理用药水平,减少和避免严重ADR的发生,应加强对中老年人用药、抗肿瘤药物及静脉给药的监测,加强用药教育和用药指导。

Objective To analyze the serious ADR in the hospital,to explore the characteristics and the factors of its occurrence,so as to provide the basis for rational drug use and safe drug in clinic. Methods 81 cases of serious ADR reports in 2013-2015 of the hospital were collected and analyzed retrospectively. Comprehensive analysis was conducted on the basic situation of the patient,the type of drugs involved the route of administration,the clinical manifestations and the outcomes. Results A total of 81 cases of serious ADR were collected,most of which（66.67% ） occurred at the age over 50;and the most common were mainly caused by hypoglycemic blood pressure and cardiovascular drugs（27. 16% ）,anticancer drugs（25.93% ） and antibacterial drugs（17.28% ）;injection（56.79% ） and oral （43.21%） were the main drug types;involved organ or system were mainly blood system damage（29. 63% ）,digestive system damage （17.28%）, skin and appendages（14.81% ）;improved clinical outcomes 60 cases（74.07% ）,cured 17 cases（20. 99% ）, no improvement 3 cases（3.70% ）,died 1 case（1.23% ）. Conclusion Age,various diseases,drug combination,the toxicity of the drug and other factors lead to the serious ADR. To improve the level of rational drug in hospital,prevent and reduce the incidence of serious ADR the hospi- tal should strengthen monitoring the elderly＇s drugs,anticancer drugs and intravenous administration,strengthen drug education and medi- cation guide on the patient.