国内利福昔明不良反应的回顾性分析

Retrospective analysis of adverse drug reactions of rifaximin reported in literature in China

目的根据国内临床应用利福昔明引起药品不良反应（ADR）的文献,考查利福昔明的安全性。方法通过检索《中国医院数字图书馆》、《中文科技期刊数据库（维普）》,收集2002-2008年临床使用利福昔明的资料,进行统计分析。结果25个临床研究资料共计有1759个临床患者使用利福昔明的病例参加安全性评价,结果发生不良反应计55例次,涉及消化系统、神经系统、心血管系统、泌尿系统、血液系统以及皮肤等多个系统和器官,ADR发生率为3.13%（55/1759）。结论临床使用中,应特别注意利福昔明消化系统、肝胆系统与神经系统方面的ADR,密切监测肝功能。

Aim To explore the safety profile of rifaximin based on the data from the literature about its adverse drug reactions（ADRs）.Methods The literature about clinical data of ADRs of rifaximin from 2002 to 2008 in China,which was collected through the database of China Hospital Digital Library and VIP Information,was analyzed statistically.Results 25 clinical studies of a total of 1759 clinical use of rifaximin were evaluated in safety.55 cases of ADR involes the digestive system,nervous system,cardiovascular system, urinary system,blood systems,as well as skin and other systems and organs,with an incidence rate of 3.13% （55/1759）. Conclusion In clinical application of rifaximin, special attention should be paid to the ADRs of digestive system, hepatobiliary system and nervous system, It is necessary to closely observe the laboratory examination of liver function.