2008-2012年我院严重药品不良反应报告分析

Clinical Analysis of Serious Adverse Drug Reactions in Peking Union Medical College Hospital in 2008-2012

目的：分析我院严重药品不良反应（ADR）的药品、发生机制、高危因素、防治措施,为临床安全用药提供参考。方法：收集2008年1月-2012年12月我院上报北京市药品不良反应监测中心的药品不良反应,根据《常见严重药品不良反应技术规范及评价标准》确定严重药品不良反应,并对怀疑药品、ADR类型、发生时间、住院费用及转归进行回顾性分析。结果：2008年1月-2012年12月上报的药品不良反应共545例,其中42例为严重不良反应,包括过敏性休克、再生障碍性贫血、粒细胞缺乏症、血小板减少症、全血细胞减少症、急性肝衰竭、急性胰腺炎、急性肾衰竭、中毒性表皮坏死松解症等。引起严重ADR前3位的药品分别是对比剂、抗菌药物和抗肿瘤药物。涉及男22例,女20例,平均年龄46岁,住院时间平均41 d,住院费用平均273 015.39元,住院药物费用平均80 135.69元。5例既往有食物或药物过敏史,3例死亡,39例患者停药或对症治疗后均好转出院。结论：医院应不定期开展医疗安全案例警示培训,重点关注药品不良反应,尤其是新的和严重的不良反应。

Objective：To analyze the mechanisms,risk factors and preventions of serious adverse drug reactions（ADRs） in Peking Union Medical College Hospital（PUMCH） in order to provide the basis for safe drug use in clinical practice. Methods：The ADRs were collected from doctors,pharmacists and nurses from January 2008 to December 2012 in PUMCH. The serious ADRs were diagnosed according to the clinical manifestations and the＂Serious Adverse Drug Reaction Technology Standards and Evaluation Criterion＂of Ministry of Public Health in China. The type and time of ADR,drugs associated with adverse reactions,duration of hospitalization,cost of hospitalization and outcome of patients were retrospectively analyzed. Results： A total of 545 ADRs were reported in the period between January 2008 and December 2012 in PUMCH. According to the evaluation criterion,42 reports were determined as serious ADRs. They comprised 22 males and20 females with an average age of 46 years,an average duration of hospitalization of 41 days,and an average cost of273 015. 39 yuan. Five patients had their drug or food allergic history. The type of serious ADRs included anaphylactic shock,aplastic anemia,agranulocytosis,thrombocytopenia,pancytopenia,acute liver failure,acute pancreatitis,acute renal failure and toxic epidermal necrolysis. Thirty-nine patients improved and were discharged after drug withdrawal and symptomatic treatment,and three patients died. The top three drugs caused serious ADRs were contrast agent,antineoplastic drug and antibiotics. Conclusion：The hospital needs to have medical alart training regularly,and establishs the rescue proscess and emergency measures. The clinicians and pharmacists need to closely moniter the signs and symptoms of adverse reactions especially new and serious ADRs.