青黛制剂致缺血性结肠炎病例分析及对药品说明书修订的思考  

Analysis of the Ischemic Colitis Caused by Indigo Naturalis Preparations and Reflection on Revision of Drug Instructions

作　　者：崔小康[1] 路长飞 刘文文 张华琦 李霞 CUI Xiaokang;LU Changfei;LIU Wenwen;ZHANG Huaqi;LI Xia(Shandong Center for Adverse Drug Reaction Monitoring,Jinan 250013,Shandong,China)

机构地区：[1]山东省药品不良反应监测中心,山东济南250013

出　　处：《中国药物滥用防治杂志》2024年第7期1217-1219,共3页Chinese Journal of Drug Abuse Prevention and Treatment

摘　　要：随着青黛制剂在临床的广泛应用,其导致的药品不良反应也日趋增加,特别是严重的消化道不良反应更是引起关注。本文对常见的青黛制剂-升血小板胶囊致缺血性结肠炎典型病例进行分析,并对药品说明书的安全信息修订进行探讨,以期为临床合理用药、持有人修订完善说明书提供参考。With the widespread application of Indigo Naturalis naturalis preparations in clinical practice,the number of adverse drug reactions caused by them is also increasing,especially serious gastrointestinal adverse reactions.This article analyzes typical cases of ischemic colitis caused by Shengxuexiaoban capsule which is one of common indigo naturalis preparations,and explores the revision of safety information in drug instructions,in order to provide reference for rational clinical use and the revision and improvement of instructions by marketing authorization holders.

关 键 词：青黛 升血小板胶囊 缺血性结肠炎 不良反应 说明书 安全信息 修订 

分 类 号：R285.6[医药卫生—中药学]