参麦注射液1533例临床不良反应/事件分析  

Analysis of 1 533 cases of adverse drug reactions/events in clinical practice caused by Shenmai Injection

作　　者：向东[1] 黄渊[1] 邓丽[1] 刘金玉[1] 张程亮[1] 贺国芳[1] 

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,湖北武汉430030

出　　处：《中国医院药学杂志》2017年第4期393-396,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:探究参麦注射液不良反应/事件(ADR/ADE)的特点,为临床合理用药提供参考。方法:以患者性别、年龄、发生时间、过敏史、ADR/ADE临床表现及转归等指标作为考查项,采用回顾性研究,对2012年1月-2014年12月湖北省药品不良反应监测中心收集的1 533例参麦注射液不良反应报告进行分析。结果:1 533例ADR/ADE患者中,男女比例为1∶1.46,主要发生在40岁以上的患者(87.28%),发生时间主要集中在30 min以内(72.08%)。临床表现主要为皮肤及其附件损害(20.22%)、全身性损害(18.74%)、中枢及外周神经系统损害(17.78%)等。结论:提示参麦注射液可引起不同程度的不良反应,临床用药时要给予足够重视,确保合理用药,密切关注患者的用药变化,加强ADR/ADE监测,提高用药安全性。OBJECTIVE To explore the characteristics and regularities of adverse drug reactions/events（ ADR/ADE） of Shenmai Injections and provide references for rational clinical medication. METHODS With patient＇s gender,age,occurrence time of ADR/ADE,allergic history,clinical manifestations and prognosis as reference items,a retrospective study was performed to analyze 1533 cases of ADR/ADE induced by Shenmai Injection in Hubei province from January 2012 to December 2014. RESULTS The results indicated that among the 1 533 cases of ADR/ADE,the ratio of male to female was 1∶ 1. 46,most of them（ 87. 28%） were aged above 40 and the occurrence time of ADR/ADE cases mainly happened within 30 min（ 72. 08%）. The mainly affected systems included skin and appendages（ 20. 22%）,systemic lesion（ 18. 74%）,central and peripheral nervous systems（ 17. 78%）,etc. CONCLUSION It is suggested that varying degrees of ADR/ADE can be induced by Shenmai Injection,while enough attention should be paid to the clinical use of Shenmai Injection. To ensure rational use of the drugs,more close attention must be paid to the changes in patient＇s medication,ADR/ADE monitoring also should be strengthened to improve the safety of medication.

关 键 词：参麦注射液 中药注射液 不良反应 分析 

分 类 号：R969[医药卫生—药理学]