14例痔血胶囊致肝损害不良反应／事件报告分析

目的探讨痔血胶囊致肝损害的特点和规律。方法采用回顾性研究方法，对2003年12月到2008年12月江苏省药品不良反应监测中心收到的14例痔血胶囊致肝损害不良反应／事件报告进行综合分析。结果14例患者均口服用药，用药剂量为每日2次，每次2粒，平均用药时间为22-15天；临床表现为黄疸、乏力、发热、腹胀、纳差、食欲减退；肝功能检查：丙氨酸氨基转移酶在182～1973U／L之间，总胆红素在7．5～118．0umol／L之间。结论应加强痔血胶囊致肝损害的研究及再评价。

Analysis of 14 Adverse Drug Reaction/Event Reports on Liver Damage Induced by Zhixue Capsule

Objective To investigate the epidemiological characteristics of liver damage induced by Zhixue Capsule. Methods Fourteen adverse drug reaction/event （ADR/ADE） reports on liver damage induced by Zhixue Capsule collected by Jiangsu Center for ADR Monitoring from December 2003 to December 2008 have been analyzed retrospectively. Results Fourteen patients taked oral medication, and their average medication time was 22±15 days. The clinical manifestations of the liver damage were jaundice, fatigue, fever, abdominal distension, anorexia and poor appetite. Liver function examination results of fourteen patients showed that the alanine aminotransferase was in 182-1 973U/L, and total bilirubin was in 7.5-118.0umol/L. Conclusion The observation and evaluation of Zhixue Capsule should be strengthened.