淮南朝阳医院431例药品不良反应/事件报告分析

Analysis on 431 Cases of Adverse Drug Reactions / Events Reports in Huainan Chaoyang Hospital

目的:了解淮南朝阳医院(以下简称"我院")药品不良反应/事件(adverse drug reaction/adverse event,ADR/ADE)发生的特点及相关因素,为患者安全、合理用药提供参考。方法:对我院2013年1月—2015年6月收集到的431例ADR/ADE报告,分别从患者性别与年龄、给药途径、药物种类、累及器官和(或)系统及临床表现,以及存在的不合理用药情况进行回顾性分析。结果:431例ADR/ADE中,ADR有424例,ADE有7例;以儿童和40岁以上中、老年人为主,共有363例,占84.22%;静脉滴注引起的病例数最多,有264例,占61.25%;抗微生物药引起的有161例,占37.35%;中药制剂引起的有118例,占27.38%;存在不合理用药情况的有58例,占13.68%。结论:ADR/ADE的发生与多种因素相关,临床应重视ADR/ADE的报告和监测工作,尤其重视注射剂、抗微生物药、中药制剂的使用,并加强不合理用药监测,提高医疗质量,减少ADR的发生。

OBJECTIVE： To investigate the characteristics and related factors of adverse drug reactions / events（ ADR/ADE） in Huainan Chaoyang Hospital（ hereinafter referred to as＂our hospital＂）,and to provide reference for the safe and rational drug use in patients. METHODS： Retrospective analysis was conducted on 431 cases of ADR /ADE reports in our hospital from Jan. 2013 to Jun. 2015,in terms of the patients＇ gender and age,route of administration,categories of drugs,the involved organs and（ or） systems and clinical manifestations,and the irrationality of drug use. RESULTS： Of the 431 cases of ADR / ADE,424 cases were ADR and 7 cases were ADE;among which,children and middle-aged and elderly above 40 years-old took the lead,totally 363 cases,accounting for84. 22%. Most cases were caused by intravenous drip,totally 264 cases,accounting for 61. 25%; and 161 cases were caused by antimicrobial drugs,accounting for 37. 35%; 118 cases were caused by traditional Chinese preparation,accounting for 27. 38%; 58 cases had irrational drug use problems,accounting for 13. 68%. CONCLUSIONS： The occurrence of ADR / ADE was related with many factors,the clinic should attach great importance to the reporting and monitoring of ADR / ADE,especially for the injections,the application of antimicrobial drugs and traditional Chinese preparation,and strengthen the monitoring of irrational drug use,improve the medical quality so as to reduce the occurrence of ADR.