208例骨瓜提取物注射剂严重不良反应报告分析  

Analysis of 208 Cases of Serious Adverse Drug Reactions Induced by Gugua Extracts Injection

作　　者：沈晓华[1] 罗凌凤[2] 黄亦彬[1] 

机构地区：[1]福建省药品不良反应监测中心,福建福州350003 [2]福建医科大学,福建福州350108

出　　处：《中国药物警戒》2015年第8期491-493,共3页Chinese Journal of Pharmacovigilance

摘　　要：目的探讨骨瓜提取物注射剂致严重药品不良反应的规律及特点。方法采用回顾性研究方法 ,对208份骨瓜提取物注射剂的严重不良反应报告进行统计分析。结果骨瓜提取物注射剂严重不良反应主要表现为过敏性休克、过敏样反应、寒战、呼吸困难和发热等;严重不良反应多在30 min内发生,其中过敏性休克主要集中在15 min内发生。结论有必要对骨瓜提取物注射剂说明书进行修改和完善。Objective To explore the characters of the serious adverse reactions caused by Gugua extracts injection. Methods 208 reports of the serious adverse reactions caused by Gugua extracts injection were analyzed via retrospective study. Results Gugua extracts injection may lead to serious adverse reactions such as anaphylactic shock, anaphylactoid reaction,rigors,dyspnea,fever, etc. The serious adverse reactions occurred within 30 min, and anaphylactic shock occurred within 15 min. Conclusion It is necessary to re-evaluate the risk of serious adverse reactions caused by Gugua extracts injection and modify the drug instructions on this basis.

关 键 词：骨瓜提取物 严重不良反应 过敏性休克 

分 类 号：R994.11[医药卫生—毒理学]