孝感市1463例新的/严重的药品不良反应报告回顾性分析  

Retrospective Analysis of 1 463 Cases of New / Serious Adverse Drug Reactions in Xiaogan City

作　　者：郭雪玲[1] 汤松[1] 张万智[1] 唐晓霞[2] 程志[1] 

机构地区：[1]安陆市普爱医院药剂科,湖北安陆432600 [2]孝感市中心医院药学部

出　　处：《药物流行病学杂志》2016年第12期782-786,790,共6页Chinese Journal of Pharmacoepidemiology

摘　　要：目的：分析孝感市上报的新的/严重药品不良反应（ADR）的特点,为ADR监测工作和安全用药提供参考。方法：收集国家ADR监测系统中2011-2015年孝感市上报的新的/严重ADR报告1 463例,对ADR患者情况,怀疑药品种类及给药途经,ADR发生时间、累及器官及临床表现,严重不良反应发生的特点等进行统计分析。结果：抗感染药物的ADR比例最高,其次是中药注射剂;静脉滴注给药所致ADR最多;用药2 h内发生ADR 1088例（74.37%）。新的一般病例以皮肤及其附件损害、胃肠系统损害和全身性损害为主;严重病例以全身性损害、皮肤及其附件损害和中枢及外周神经系统损害为主。新的/严重ADR中发生频率较高的药品为香丹注射液、参麦注射液、左氧氟沙星、头孢曲松、头孢呋辛等。结论：抗感染药物和中药注射剂是新的/严重ADR发生的主要药品,过敏反应是常见的严重ADR,高警示药品的ADR后果严重,在ADR监测要重点关注,尽可能减少ADR的风险。Objective： To analyze the characteristics of adverse drug reactions（ ADR）,in order to provide a reference for ADR monitoring and medication safety. Methods： 1 463 cases of new / serious ADR reporting were collected from the national ADR monitoring system of Xiaogan City from 2011 to 2015. The data of patients＇ sex,age,drug categories,and route of administration,ADR involving organ / system and clinical manifestations were analyzed. Results： Most ADR caused by anti-infectives and traditional Chinese medicine injections in the report of 1 463 cases. 837 cases（ 57. 24%）caused by the intravenous infusion administration. 1 088 cases（ 74. 37%） ADR occurred within 2h of administration.Damage caused by the new general ADR was skin and its appendages,and the gastrointestinal system and systemic. Serious ADR cause the damage of systemic,and skin and its appendages and central and peripheral nervous system. High-frequency drugs of the new / serious ADR were Xiangdan injection,Shenmai injection,levofloxacin,ceftriaxone,cefuroxime etc.Conclusion： The main drug leaded to new / severe ADR happens was anti-infective drugs and traditional Chinese medicine injections,and the common serious ADR was allergies,and the drug caused serious consequences of ADR was High-Alert Medicines,therefore,ADR monitoring must focus on these drugs,so as to minimize the risk of ADR.

关 键 词：药品不良反应 高警示药品 抗感染药物 报告 监测 

分 类 号：R951[医药卫生—药学]