消核片相关肝损害回顾性研究及风险控制措施探讨  

Retrospective study on Xiaohe tablet-related liver damage and discussion on risk control

作　　者：张力[1] 杨晓晖[2] 郭朋[3] 童元元[4] 

机构地区：[1]国家食品药品监督管理局药品评价中心,北京100045 [2]中国中医科学院西苑医院,北京100091 [3]北京中医药大学东方医院,北京100078 [4]中国中医科学院中医药信息研究所,北京100700

出　　处：《中国中药杂志》2010年第16期2199-2203,共5页China Journal of Chinese Materia Medica

摘　　要：调查与消核片相关肝损害病例的临床特征和影响因素以提出风险控制措施。检索1978—2009年国内公开发表的与消核片相关肝损害个案及群案病例报告信息,进行调查登记、数据整理、统计分析。结果消核片相关肝损害病例共194例,其中个案病例9例,群案病例185例,与消核片相关肝损害临床主要表现为消化道症状;皮肤、巩膜黄染以及肝功能异常,并有肝衰竭病例发生。相关肝损害病例多为可逆性,停药后经过积极治疗临床痊愈。消核片与肝损害之间存在一定相关性。在医师指导下严格按照说明书推荐剂量和适应症用药、临床用药过程中密切监测肝功能,同时加强安全性相关基础研究是控制消核片用药风险的有效措施。To investigate the clinical characteristics and risk factors of liver damage cases related to Xiaohe tablet so as to propose risk control measures.We search literatures on cases and group cases reports of Xiaohe tablet-related liver damage published domestically from 1978 to 2009,and then conduct a statistical analysis on the data.The 194 reports（9 cases reports and 185 group cases） of Xiaohe tablet-related liver damage are involved,the main clinical manifestations are gastrointestinal symptoms,skin stained yellow,icteric sclera,abnormal hepatic function and even hepatic failure.Most liver damage cases are reversible and can be cured by timely treatment after stopping use of this drug.There is a certain correlation between Xiaohe tablet and liver damage.Therefore,the following measures may be effective for risk control of Xiaohe tablet： to use drug under the guidance of physician,according to the recommended dose and indications in drug specification;to closely monitor liver function during the clinical treatment;to strengthen safety-related basic study.

关 键 词：消核片 安全性评价 肝损害 回顾性研究 风险控制 

分 类 号：R595.3[医药卫生—内科学]