摘 要 目的：了解我院藥品不良反应/事件（ADR/ADE）发生的特点及规律，为临床合理用药提供参考。方法：收集河南中医药大学第一附属医院2011年5月-2018年1月上报国家药品不良反应监测中心的1 305 例ADR/ADE报告，统计分析发生ADR/ADE的患者性别、年龄、给药途径、ADR/ADE类型、发生时间、联合用药情况、药品种类、ADR/ADE累及器官/系统的主要临床表现和主要涉及药品、ADR/ADE转归情况、严重的ADR/ADE情况等。结果：在1 305 例ADR/ADE报告中，男性522 例（40%）、女性783 例（60%），18～65 岁年龄段的患者发生ADR/ADE比例最高（712例，占54.56%）；静脉滴注给药引起的ADR/ADE最多（967例，占74.10%）；一般ADR/ADE 965例（73.26%），新的ADR/ADE 331例（23.83%），严重的ADR/ADE 38例（2.91%）；多数患者ADR/ADE发生在用药后5～30 min内（602例，占46.13%）；单一用药引起ADR/ADE的有1 102 例（84.44%），2药联用的有149 例（11.42%）；感染疾病用药为引起ADR/ADE最多的药物（567种引起528例），其次为中药注射剂（342种引起271例），其中阿奇霉素（注射剂、片剂）引起的ADR/ADE最多（137例，10.50%）；ADR/ADE主要累及的器官/系统为皮肤及其附件损害（491例次，占28.09%）；1 282例（98.24%）ADR/ADE转归结果为好转和痊愈；严重的ADR/ADE有38 例（2.91%），主要表现为全身性损害，以中药注射剂发生率最高。结论：临床应加强静脉给药、感染疾病用药及中药注射剂使用的监管，及时发现药品使用安全风险，保障公众用药安全，促进临床合理用药。
关键词 药品不良反应；药品不良事件；分析；合理用药
中图分类号 R969.3 文献标志码 A 文章编号 1001-0408（2018）21-2970-07
DOI 10.6039/j.issn.1001-0408.2018.21.21
ABSTRACT OBJECTIVE： To investigate the characteristics and regularities of adverse drug reactions （ADR/ADE） in our hospital and provide reference for rational drug use in clinic. METHODS： Totally 1 305 ADR/ADE reported to National Center for Adverse Drug Reaction Monitoring were collected from the First Affiliated Hospital of Henan University of TCM during May 2011-Jan. 2018. Those ADR/ADE were analyzed statistically in terms of gender and age of patients， route of administration， types， occurrence time of ADR/ADE， drug combination， drug type， main clinical manifestations and drugs of organs/systems involved in ADR/ADE， outcome， severe ADR/ADE， etc. RESULTS： Among 1 305 ADR/ADE reports， there were 522 male （40%） and 783 female （60%）. The highest proportion of ADR/ADE occurred in 18-65 year old patients （712 cases， 54.56%）. The most ADR/ADE was caused by intravenous drip administration （967 cases， 74.10%）. 965 cases （73.26%） were general ADR/ADE， 331 cases （23.83%） were new ADR/ADE and 38 cases （2.91%） were serious ADR/ADE. The most ADR/ADE occurred within 5-30 min after medication （602 cases， 46.13%）. Totally 1 102 ADR/ADE cases were caused by single drug （84.44%）， and 149 cases were induced by combined with two drugs （11.42%）. The infectious disease drugs were the drugs that caused the most ADR/ADEs （567 kinds， 528 cases）， followed by TCM injection （342 kinds， 271 cases）. Among them， azithromycin （injection， tablet） caused the most ADR/ADE （137 case， 10.50%）. Major organs/systems involved in ADR/ADE were lesion of skin and its appendents （491 cases times， 28.09%）. The results of ADR/ADE outcomes in 1 282 patients （98.24%） were improved and recovered. There were 38 cases of severe ADR/ADE （2.91%）， mainly manifested as systemic damage； the incidence of TCM injection was the highest. CONCLUSIONS： It is necessary to strengthen the supervision of intravenous drug use， infectious drugs and TCM injections， and timely discover and prevent drug safety risks so as to ensure the safety of public medication and promote clinical rational drug use.