国内莫西沙星不良反应文献分析

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

目的:根据国内临床应用莫西沙星引起药品不良反应(ADR)的文献,考查莫西沙星的安全性。方法:通过中国生物医学文献数据库(CBMdisc)、万方数据库、中文科技期刊数据库(维普)收集1997-2006年国内临床资料,进行汇总、分析。结果:作者汇总临床应用莫西沙星的2 125例病人共发生ADR 243例(11.44%),涉及消化系统、神经系统、心血管系统等8个系统。口服给药ADR发生率12.12%(207/1 708),静滴给药和静滴+口服序贯疗法给药ADR发生率分别为8.85%(34/384)和6.06%(2/33)。因ADR被迫停药共9例(0.42%)。口服给药易引起恶心、呕吐;静滴给药更易导致肝功能异常。结论:临床使用中,应特别注意莫西沙星消化系统和神经系统方面的ADR,密切关注血液系统实验室检查,监测肝、肾功能。

Objective： To explore the safety profile of moxifloxacin based on the data from the literature about its adverse drug reactions （ADRs）. Methods： The literature about clinical data of ADRs of moxifloxacin from 1997 to 2006 in China, which was collected through the database of China Biomedical Literature on disc （CBMdisc）, Wanfang Data and VIP Information, was reviewed. Results： Of 2 125 patients receiving moxifloxacin, 243 （11.44%） had ADRs involving eight systems such as digestive system, nervous system and cardiovascular system. The incidence of ADRs was 12. 12% （207/1 708） for oral administration, 8.85% （34/384） for intravenous administration, and 6.06% （2/33） for sequential therapy （intravenous therapy followed by oral administration）, respectively. Nine cases （0.42%） discontinued treatment due to ADRs. Administration through oral route was apt to cause nausea and vomiting, and through intravenous route was more likely to lead to abnormal liver function. Conclusion： In clinical application of moxifloxacin, special attention should be paid to the ADRs of digestive system and nervous system. It is necessary to closely observe the laboratory examination of the blood system and to monitor the liver and kidney functions.