588例药品不良反应报告

588 Cases of Adverse Drug Reaction Reports

目的:了解厦门市仙岳医院(以下简称"我院")药品不良反应(dverse drug reaction,ADR)的发生情况、特点及规律,以促进临床合理用药,提高药物治疗的安全性。方法:利用全国药品不良反应监测网络管理平台,对我院2014年7月—2016年6月588例ADR报告中患者的年龄与性别、药物种类、累及器官和(或)系统及临床表现等方面进行回顾性分析。结果:588例ADR报告中,一般的ADR 577例(占98.13%),其中新的一般的ADR 89例(占15.14%);严重的ADR 11例(占1.87%),无死亡病例。男性患者311例(占52.89%),女性患者277例(占47.11%),男性多发于21~40岁,女性则多发于41~50岁。神经系统用药引起的ADR为539例(占91.67%),其他药物为49例(抗菌药物4例)。引发ADR病例数排序居前20位的药品中,除丙泊酚外,其他均为神经系统用药,居前3位的药品分别为奥氮平、利培酮、氯氮平,三者均为非经典抗精神病药,此类药物所致ADR最为多见(408例,占69.39%),其中严重的ADR 7例,主要累及外周神经系统。经典抗精神病药、抗抑郁药、抗癫痫药所致ADR病例数较少。结论:精神专科医院应加强对ADR的监测,加强合理用药监管,保证患者用药安全。

OBJECTIVE ：To investigate the characteristics and regularity of adverse drug reactions （ADR） in Xiamen Xianyue Hospital （hereinafter referred to as ＂our hospital＂）, so as to promote clinical rational medication and improve medication safety. METHODS： With the help of the Nationwide Adverse Drug Reaction Monitoring Network, 588 cases of ADR reports in our hospital from Jul. 2014 to Jun. 2016 were retrospectively analyzed in terms of patients＇ age and gender, categories of drugs, ADR involved organs and （or） systems, and clinical manifestations. RESULTS ： Among the 588 cases of ADR, 577 cases were common ADR （98. 13% ）, with 89 cases of new ADR （15.14%） and 11 cases of severe ADR （1.87%）, no death reports. 311 cases were male patients （52. 89% ） with mostly aged 21-40 years, and 277 cases were females （47. 11% ） with mostly aged 41-50 years. 539 cases of ADR （ 91.67% ） were caused by psychotropic drugs, of the rest 49 cases, 4 cases were caused by antibacterial drugs. Among the top 20 ADR-reducing drugs, all of them were psychotropic drugs except for propofol; the top 3 were respectively olanzapine, risperidone and clozapine, all three were atypical antipsychotic drugs. 408 cases of ADR （69. 39% ） were caused by antipsychotic drugs, with 7 cases were severe ADR, mostly involved peripheral nervous system. Typical antipsychotic drugs, antidepressant and psychotropic drugs caused less ADR. CONCLUSIONS： Psychiatric hospitals should pay more attention to ADR, reinforce rational drug application and ensure patients＇ safe medication.