硝酸酯类药物致不良反应/事件的帕累托分析

Pareto analysis of adverse reactions/events caused by nitrates

目的 分析硝酸酯类药物所致不良反应/事件(ADR/ADE)的发生特点及规律,为临床安全用药提供参考和依据。方法 采用帕累托分析法对北部战区总医院2011年1月至2021年1月收集的硝酸酯类药物所致药物不良反应/事件报告进行整理汇总,按照患者性别、年龄、用药情况、ADR/ADE累及的器官/系统及主要临床表现、类型及转归情况等数据进行描述性系统分析。结果 243例硝酸酯类药物所致ADR/ADE中,男女比例为1.79∶1,61~70岁、51~60岁、71~80岁3个年龄段报告占比大,分别为33.74%、23.87%和19.75%;ADR/ADE涉及4个用药品种,其中硝酸异山梨酯最多(66.67%),其次为单硝酸异山梨酯(25.51%);引起ADR/ADE的给药途径主要为静脉滴注(76.54%);ADR/ADE发生的时间集中在1 h内(41.56%),为主要因素;持续时间超过5 h(44.86%)和小于1 h(32.92%)的报告占比大;ADR/ADE累及多个器官、系统,神经系统损害例数最多(77.86%);所有上报不良反应评价均为一般不良反应,未发现新的不良反应。结论 硝酸酯类药物所致的ADR/ADE与患者年龄、给药途径有关,尤其需关注老年患者的用药安全。

Objective To analyze the occurrence characteristics and regularity of adverse reactions/events caused by nitrates,and to provide references and basis for safe clinical drug use.Methods The reports of adverse drug reactions/events caused by nitrates collected from General Hospital of Northern Theater Command from January 2011 to January 2021 were summarized by Pareto analysis method,and descriptive systematic analysis was conducted according to the data of patients′gender,age,drug use,organs/systems involved in ADR/ADE,main clinical manifestations,types and outcomes.Results Among the 243 cases of adverse reactions/events caused by nitrates,the ratio of male to female was 1.79∶1,and the three age groups,including 61~70 years old(33.74%),51~60 years old(23.87%)and 71~80 years old(19.75%),accounted for a large proportion.ADR/ADE involved 4 kinds of drugs,among which isosorbide nitrate was the most(66.67%),followed by isosorbide mononitrate(25.51%).The main route of ADR/ADE was intravenous drip(76.54%).ADR/ADE mostly occurred within 1 hour(41.56%),which was the main factor.The duration of more than 5 hours(44.86%)and less than 1 hour(32.92%)accounted for a large proportion of reports.ADR/ADE involved multiple organs and systems,with the most cases being nervous system damage(77.86%).All reported adverse reactions were evaluated as general adverse reactions,and no new adverse reactions were found.Conclusion The ADR/ADE induced by nitrates is related to the age of patients and route of administration;especially,attention should be paid to the medication safety in elderly patients.