双黄连口服制剂安全性风险分析  

Risks of Shuanghuanglian Oral Preparation

作　　者：于洪礼 于冬梅 逄瑜 邵波 宋海波 YU Hongli;YU Dongmei;PANG Yu;SHAO Bo;SONG Haibo(Center for Drug Reevaluation,NMPA,Beijing 100022,China;Center for Food Evaluation,State Administration for Market Regulation,Beijing 100070,China)

机构地区：[1]国家药品监督管理局药品评价中心,北京100022 [2]国家市场监督管理总局食品审评中心,北京100070

出　　处：《中国药物警戒》2021年第7期683-685,共3页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项(2015ZX09501004-001-001);中医药行业科研专项(201507004)。

摘　　要：目的分析双黄连口服制剂安全性风险,为临床合理用药提供参考。方法整理分析我国药品不良反应监测数据库、国内文献数据库中的双黄连口服制剂相关不良反应。结果国家药品不良反应监测系统收到的双黄连口服制剂不良反应/事件报告和文献报道显示,双黄连口服制剂不良反应累及多个系统-器官,临床表现包括皮疹、瘙痒、恶心、呕吐等。结论合理选用双黄连口服制剂,关注其相关不良反应。Objective To analyze the risk of Shuanghuanglian oral preparation in order to provide reference for rational clinical use.Methods Cases of adverse reactions related to Shuanghuanglian oral preparation that were retrieved from China adverse drug reaction database and domestic literature were analyzed.Results The adverse drug reaction/adverse event(ADR/AE)reports from the national ADR monitoring system and literature showed that the ADR of Shuanghuanglian oral preparation involved multiple systems and organs,and that the clinical manifestations included rash,pruritus,nausea and vomiting,etc.Conclusion Shuanghuanglian oral preparation should be used with caution and related adverse reactions deserve attention.

关 键 词：双黄连 口服制剂 不良反应 

分 类 号：R994.11[医药卫生—毒理学]