181例抗感染药品严重不良反应报告回顾性分析

目的：了解抗感染药品严重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2012年度北京市药品不良反应监测中心接收的181例抗感染药品严重不良反应报告资料,按照患者性别、年龄、怀疑抗感染药品种类、给药途径、不良反应累及的系统/器官及临床表现等数据进行描述性统计分析。结果：181例抗感染药品严重不良反应报告中,男性患者95例（52.49%）,女性患者86例（47.51%）,平均年龄（51.74±19.37）岁;涉及抗感染药品12类、52个品种;由静脉给药引起严重不良反应共121例次,占上报总数的55.25%;抗感染药品严重不良反应主要累及全身系统（23.65%）、血液系统（14.29%）和消化系统（13.79%）等,临床表现主要为包括过敏性休克在内的过敏反应（44例次）、肝损害（24例次）、血细胞减少（22例次）和肾损害（19例次）等。结论：抗感染药品所致严重不良反应可累及多个系统/器官,应加强用药监护,警惕药品不良反应的发生。

Retrospective analysis of 181 serious ADR reports associated with anti-infective agents

Objective： To investigate the characteristics and clinical manifestations of serious adverse drug reaction（ADR） related to anti-infective agents, and provide reference for clinical rational drug use. Methods： With the retrospective method, a total of 181 serious ADR case reports were collected from Beijing Centre for ADR Monitoring from January 1, 2012 to December 31, 2012. Gender and age of patients, categories of suspected anti-infective agents, route of administration, organs or systems involved in ADRs and clinical manifestations were analyzed. Results： Among the 181 ADR cases, 95 cases（52.49%） were male and 86 cases（47.51%） were female, the average age of the patients was（51.74±19.37） years. The ADRs were related to 52 kinds of anti-infective agents in 12 categories, 121 ADR cases were caused by intravenous injection（55.25%）. The ADRs mainly involved the whole body system（23.65%）, hematological system（14.29%） and digestive system（13.79%）. Main manifestations of ADRs were anaphylactic reactions（44 cases, including allergic shock）, liver injuries（24 cases）, hematocytopenias（22 cases） and kidney injuries（19 cases）.Conclusion： Serious ADRs related to anti-infective agents may involve various organs and systems, drug monitoring should be strengthened in order to avoid or reduce the occurrence of ADRs.