101例环丙沙星不良反应报告回顾性分析

Retrospective analysis of 101 ADR reports associated with ciprofloxacin

目的:了解环丙沙星不良反应发生的特点和规律,为临床合理用药提供参考。方法:采用回顾性方法,收集2007年1月1日–2011年12月31日北京市药品不良反应监测中心接收的101例环丙沙星不良反应报告资料,按照患者性别、年龄、用药情况、不良反应累及系统/器官及临床表现等数据进行描述性统计分析。结果:101例环丙沙星不良反应报告中,男性患者42例(41.58%),女性患者59例(58.42%),平均年龄(55.03±18.11)岁;97例环丙沙星不良反应由静脉给药引起,占上报总数的96.04%;环丙沙星不良反应共累及10个器官/系统,其中皮肤及附件损害最多,占38.69%,其次为用药部位损害(18.98%)、神经系统损害(16.79%)、胃肠系统损害(10.22%)等。严重不良反应报告5例,表现为过敏性休克(2例)、中毒性表皮坏死松解型药疹(2例)、急性肾衰竭(1例)。结论:环丙沙星所致不良反应可累及多个系统/器官,应严格根据药品说明书及相关规定用药,同时加强用药监护,警惕药品不良反应的发生。

Objective： To investigate the characteristics and clinical manifestations of adverse drug reaction （ADR） relatedto ciprofloxacin, and provide references for clinical rational drug use. Methods： Using retrospective analysis, a total of 101 ADRcase reports collected from Beijing Centre for ADR Monitoring from January 1, 2007 to December 31, 2011 were statisticallyanalyzed in respect of gender and age of patients, utilization of drug use, organs and systems involved in ADRs as well as clinicalmanifestations, etc. Results： Among the 101 ADR cases, 42 cases （41.58%） were male and 59 cases （58.42%） were female, theaverage age of the patients was （55.03 ± 18.11） years. Ninety-seven ADR cases were caused by intravenous injection （96.04%）.The ADRs involved in 10 organs/systems, with the most frequent in skin and its appendages （38.69%）, followed by applicationsite disorders （18.98%）, nervous system disorders （16.79%）, gastrointestinal system disorders （10.22%）, etc. There were 5 cases ofserious ADRs, with the manifestations of allergic shock （2 cases）, toxic epidermal necrolysis （2 cases） and acute renal failure （1 case）.Conclusion： The ADRs induced by ciprofloxacin could involve in multiple organs/systems. Ciprofloxacin should be used strictlyaccording to the drug instructions and regulations, while monitored intensively in order to avoid or reduce the occurrence of ADRs.