2013-2015年北京协和医院严重药品不良反应的临床分析

Clinical analysis of severe adverse drug reactions in Peking Union Hospital from 2013 to 2015

目的:分析北京协和医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2013年1月至2015年12月上报的药品不良反应病例,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:2013年1月至2015年12月上报的药品不良反应共330例,按照ADR报告评价标准确定35例为严重不良反应,包括过敏性休克、脊髓休克、横纹肌溶解、心绞痛、上消化道出血、室上性心动过速、急性胰腺炎、QT间期延长、中毒性表皮坏死松解症等。引起严重ADR前3位的药品分别是抗菌药物、抗肿瘤药物和对比剂。涉及男性14例,女性21例,平均年龄38岁,住院时间平均35 d。5例既往有食物或药物过敏史,1例放弃治疗后死亡,34例患者停药或对症治疗后均好转出院。结论:预防和减少严重药品不良反应对患者的伤害是药师服务的主要目的。

Objective： Analyze the mechanisms, risk factors and preventions of severe adverse drug reports s（ADRs） in Peking Union Medical College, in order to provide the evidence for rational drug use in clinical practice. Methods： The ADRs were collected from physicians, pharmacists and nurses from January 2013 to December 2015 in PUMC. The severe ADRs were diagnosed according to the clinical manifestations and the ＂severe adverse drug reaction technology standards and evaluation criterion＂. The type and time of ADR, the suspected drugs, duration of hospitalization and outcome of patients were retrospectively analyzed. Results： A total of 330 ADRs reported in the period between January 2013 and December 2015 in PUMC. According to the evaluation criterion, 35 reports were determined as severe ADRs. They comprised 14 males and 21 females with an average age of 38 years, an average duration of hospitalization of 35 days. Five patients had histories of drug or food allergy. The type of severe ADRs included anaphylactic shock, spinal shock, rhabdomyolysis, angina pectoris, upper gastrointestinal hemorrhage, supraventricular tachycardia, acute pancreatitis, QT interval prolongation, and toxic epidermal necrosis. Thirty-four patients improved and discharged after drug withdrawal and symptomatic treatment, and one patient died. The top three drugs caused severe ADRs were contrast agent, antineoplastic drug and antibiotics. Conclusion： Reducing and prevating the harm for severe ADRs to patients is the main aim for pharmaceutical care.