114家医院5411例老年人药品不良反应报告分析

Analysis of 5411 Elderly Patients' Adverse Drug Reactions Reports in 114 Hospitals

目的:分析老年患者的ADR报告,了解老年人ADR的发生特点。方法:对2015年解放军ADR监测中心收到的5 411例老年人ADR报告回顾性调查,统计分析患者年龄、性别,怀疑药品数量、第一怀疑药品种类、累及系统/器官损害、ADR表现、ADR诱导期,关联性评价及转归等项目。结果:5 411例老年人ADR报告中,男女比例1.28∶1,与只有1个怀疑药品相比,多个怀疑药品中严重ADR报告的构成比更高(P<0.001)。ADR累及的系统/器官共6 104频次,排序前三位分别为胃肠疾病1 276频次(20.90%)、皮肤及皮肤附件损害1 110频次(18.18%)和全身性损害877频次(14.37%)。最常见的ADR症状表现为恶心753频次(9.88%),皮疹694频次(9.10%)。57.52%的ADR在用药后6 h内发生。结论:老年人ADR涉及药品品种多,累及多个系统/器官,应加强老年人用药的主动监测并对其用药风险进行评估,尽可能减少老年人ADR的发生。

Objective： To analyze adverse drug reactions（ADRs） occurred in elderly patients in order to study the characteristics of the elderly ADRs. Methods： A total of 5 411 elderly ADRs reports were included in 2015 in the database of PLA ADR monitoring center. The patients＇ age,gender,number of suspected drug,the first suspected drug types,the involved system/damaged organ,ADRs behavior,ADRs induction period,the relevance evaluated and outcome,reported type and occupation distributiion were analyzed statistically. Results： Among 5 411 elderly ADRs reports,ratio of males and females was 1. 28： 1. multiple suspected drug exposure experienced a high proportion of serious ADRs compared with the single suspected drug use（P〈0. 001）. Many systems/organs（6 104 frequencies） were involved in 5 411 ADRs reports,in which the most common is the gastrointestinal disorders（1 276 frequencies,20. 90%）,followed by the skin and appendages disorders（1 110 frequencies,18. 18%） and body as a whole-general disorders（877 frequencies,14. 37%）.Nausea（753 frequencies,9. 88%） and rash（694 frequencies,9. 10%） were the commonest symptoms. 57. 72% ADR occurred within 6 hours after administration. Conclusion： The elderly ADRs reports involved various drug categories and multiple systems/organs. In order to recognize and prevent ADRs in time,It was important to strengthen ADRs monitoring and assess medication risks in elderly patients to ensure their medication safety.