军队医院9819例喹诺酮类药物药品不良反应/事件报告分析

Analysis on 9819 cases of ADR/ADE associated with quinolones in military hospitals

目的:通过对军队医院喹诺酮类药物药品不良反应/事件(ADR/ADE)报告的相关因素分析,了解喹诺酮类药物ADR/ADE发生特点及规律。方法:采用回顾性方法,收集2009–2015年军队ADR监测管理系统中喹诺酮类药物ADR/ADE报告9819例,对患者年龄、性别、药品种类、给药途径、药品剂型,累及系统/器官及临床表现、ADR/ADE报告类型、关联性评价及转归情况等进行描述性统计分析。结果:9819例喹诺酮类药物ADR/ADE中,男女比例为1.02:1,平均年龄为(45.67±22.73)岁,给药途径和药品剂型以静脉滴注和注射剂型为主,共涉及17个药物品种,单品种中左氧氟沙星4660例(47.46%)位于首位,其次为莫西沙星1681例(17.12%)、加替沙星1597例(16.26%)。9819例喹诺酮类药物ADR/ADE共累及多个系统/器官,14 740例次,最常见的为皮肤及其附件损害5731例次(38.88%),其次为胃肠系统损害2749例次(18.65%)和心外血管损害2162例次(14.67%)。结论:喹诺酮类药物品种繁多,所致的ADR/ADE涉及不同年龄段患者,累及多个系统/器官,在使用中应加强用药安全风险防范,及时识别并处理ADR/ADE。

Objective：To analyze adverse drug reaction reports and events（ADR/ADE） of quinolones in military hospitals in order to investigate the characteristics and regular patterns of quinolones related ADR/ADE.Methods：With the retrospective method,a total of 9819 ADR/ADE of quinolones case reports were collected from 2009 to 2015 in the database of PLA ADR monitoring center.Age and gender of patients,categories of suspected quinolones,route of administration,dosage form systems/organs involved and clinical manifestations,relevance evaluation and prognosis were analyzed.Results：Among 9819 ADR/ADE reports,the male to female ratio was 1.02 ：1.The average age of the patients was（45.67 ± 22.73） years.Intravenous infusion and injection type was the main administration route and pharmaceutical forms.The ADRs were related to 17 kinds.Levofloxacin related reports were 4660 cases（47.46%）,followed by moxifloxacin（1681 cases,17.12%） and gatifloxacin（1597 cases,16.26%）.A total of 9819 cases of the ADR/ADE involved multiple systems/organs（14 740 cases）.The most common was the skin and its appendages damage（5731 cases,38.88%）,followed by gastrointestinal system damage（2749 cases,18.65%） and vascular disorders（2162 cases,14.67%）.Conclusion：The ADR/ADE induced by quinolones involved different age of patients,various drug categories and multiple systems/organs.In order to recognize and treat ADR/ADE in time,drug safety risk prevention should be strengthened in the quinolones application.