军队医院9819例喹诺酮类药物药品不良反应/事件报告分析

摘要

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,14740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 (14740 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.