43例刺五加注射液不良事件影响因素分析  

An Analysis of Influencing Factors of 43 Cases of Adverse Drug Events Caused by Ciwujia Injection

作　　者：汪慧芳[1] 汪魏平[1] 栾家杰[1] 江佳[1] 徐振宇[1] 左坚[1] 周德喜[1] 

机构地区：[1]皖南医学院弋矶山医院药剂科,安徽芜湖241001

出　　处：《中国执业药师》2016年第4期43-47,共5页China Licensed Pharmacist

摘　　要：目的：分析我院刺五加注射液不良事件影响因素,促进临床安全用药。方法：对我院2012年1月-2015年1月上报的43例刺五加注射液不良事件报告进行回顾性研究,分析患者性别、年龄、不良事件史、不良事件发生时间、临床表现、超说明书使用率和超说明书用药类型。结果：43例不良事件报告中,男女比例为0.95∶1;40~60（不含60）岁年龄段患者最多,占46.51%;既往有不良事件史者1例（2.33%）;30 min以内发生不良事件36例（83.72%）;不良事件主要为皮肤及附件损害,共32例（28.83%）,其次为全身性损害,共24例（21.62%）;超说明书用药类型主要表现为超单次剂量和超适应证,各占81.40%和13.95%;严重的不良事件10例（23.26%）,其中30%为超适应证用药,80%为超单次剂量用药。结论：超说明书用药是导致我院刺五加注射液不良事件的主要影响因素,临床药师应加强刺五加注射液的医嘱审核,督促临床医师严格按照说明书用药,保障患者用药安全。Objective： To analyze the influencing factors of adverse drug events（ADEs） caused by ciwujia injection in our hospital so as to increase the safety of drug use in clinic. Methods： A total of 43 cases of ADEs caused by ciwujia injection, reported in this hospital from Jan. 2012 to Jan. 2015 were investigated retrospectively on the gender and age of patients, history of ADEs, occurrence time of ADEs, clinical manifestations, as well as the ratio and type of the off-label uses. Results ： The ratio of male to female patients in 43 cases of ADEs was0.95∶1. The patients at ages of 40 ~ 60（not including 60） years accounting for 46.51% of the total cases. Previous history of ADEs was observed in one case（2.33%）. The ADEs appeared within 30 min in 36 cases（83.72%）.The ADEs were mainly the harm to skin and its appendages（32 cases, 28.83%） and systemic damage（24 cases,21.26%）. The types of the off-label uses were mainly super single dose（81.40%） and super indication drug use（ 13.95%）. Ten cases of severe ADEs were observed（ 23.26%）, of which 30% were caused by super indication drug use and 80% by super single dose. Conclusion： Off-label uses is the main reason for ADEs caused by ciwujia injection in our hospital. Clinical pharmacists should strengthen the review on doctor ＇s advice, supervise the strict application of ciwujia injection in accordance with the specifications, and ensure the safety of the drug in clinic.

关 键 词：刺五加注射液 不良事件 影响因素 超说明书用药 

分 类 号：R259.414[医药卫生—中西医结合]