185例棓丙酯注射剂药品不良反应报告分析  

185 Cases of Adverse Drug Reactions Indued by Propylgallate Injection

作　　者：沈晓华[1] 何建平 常鸿渐 林强[1] SHEN Xiaohua;HE Jianping;CHANG Hongjian;LIN Qiang(Center for ADR Monitoring of Fujian,Fuzhou Fujian 350003,China;Fujian University of Traditional Chinese Medicine,Fuzhou Fujian 350122,China)

机构地区：[1]福建省药品不良反应监测中心,福建福州350003 [2]福建中医药大学,福建福州350122

出　　处：《中国药物警戒》2020年第12期900-903,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的探讨棓丙酯注射剂不良反应的规律及特点。方法采用回顾性分析方法,对185例棓丙酯注射剂不良反应报告进行统计分析。结果185例报告中,60岁以上患者占64.86%,有159例(85.95%)发生于用药过程中,不良反应主要涉及神经系统、心血管系统和呼吸系统的损害,均为说明书未提及的不良反应。其中严重不良反应主要表现为过敏反应、过敏性休克和肝功能异常。结论临床使用过程中应重视过敏反应、过敏性休克和肝功能异常等严重不良反应,生产企业应加强对该产品上市后安全性监测,并在此基础上对说明书进行修改和完善。Objective To explore the regularity of adverse reactions caused by propylgallate injection.Methods One hundred and eighty-five reports of adverse reactions caused by propylgallate injection were analyzed retrospectively.Results Of the 185 reports,64.86%of the patients involved were over 60 years old,Adverse reactions occurred during intravenous drip in 159 patients(85.95%).Adverse reactions mainly involved the nervous system,cardiovascular system and respiratory system.Serious adverse reactions included allergic reactions,anaphylactic shock and abnormal liver function.Conclusion During clinical use of propylgallate injection,clinicians should be vigilant about the serious adverse reactions such as anaphylaxis,anaphylactic shock and abnormal liver function.The manufacturer should strengthen the safety monitoring of the product,modify and improve the instructions accordingly.

关 键 词：棓丙酯 不良反应 过敏反应 

分 类 号：R994.11[医药卫生—毒理学]