2016—2017年我国儿童药品不良反应分析  

Anlysis of adverse drug reactions in children from 2016 to 2017

作　　者：黄贝茹 黄钢花[2] HUANG Bei-ru;HEANG Gang-hua(The First Clinical Medical College,Guangzhou University of Chinese Medicine, Guangzhou 510000 , China;The First Affiliated Hospital,Guangzhou University of Chinese Medicine, Guangzhou 510000,China)

机构地区：[1]广州中医药大学第一临床医学院,广州510000 [2]广州中医药大学第一附属医院,广州510000

出　　处：《中国新药杂志》2019年第6期758-762,共5页Chinese Journal of New Drugs

摘　　要：目的:对2016—2017年原国家食品药品监督管理总局发布的《国家药品不良反应监测报告》中关于儿童药品不良反应/事件的监测数据进行整理。方法:从总体变化趋势、年龄分布情况、药物品种及剂型、累及器官系统等方面描述我国儿童药品不良反应/事件现状。结果:根据数据,总结出我国儿童药品不良反应/事件有以下特征:①儿童药品不良反应/事件占比趋于稳定,严重药品不良反应/事件比例逐年递增。②婴幼儿不良反应/事件占比虽小,但安全用药形势仍然严峻。③抗感染药及注射用药诱发不良反应/事件的风险较高。④中药清热剂所致的儿童不良反应/事件总数高居首位,超过排名第2位的化解表剂1倍以上。⑤生物制品诱发的不良反应/事件以全身性损害为主。结论:从儿童生理特点、药品、临床使用因素等方面探讨导致儿童药品不良反应/事件的因素,以期引起对儿童用药安全的关注,降低儿童用药不良反应/事件发生率。Objective : According to the data of adverse drug reactions/events (ADRs/ADEs) in children that were reported in the National Adverse Drug Reaction Monitoring Reports released by the China Food and Drug Administration from 2016 to 2017. Methods: The current situation of ADRs/ADEs in children were analyzed , and the changing trend, age distribution, varieties of drugs and dosage forms, involved organ systems, etc., were described. Results: The ADRs/ADEs in children in our country showed the following characteristics:① The total proportion tended to be stable , while the proportion of serious ADRs/ADEs increased year by year.② Although the proportion of ADRs/ ADEs in infants and young children was small, the situation of drug safety is still severe.③ Anti-infective and injectable drugs had a higher risk of adverse reactions/events.④ The proportion of ADRs/ ADEs in children due to heat-clearing traditional Chinese medicines was in the first place, and was more than twice of the second-place drugs.⑤ Biological products-induced adverse reactions/events were mainly systemic damages. Conclusion: The factors leading to ADRs/ADEs in children were discussed from the aspects of children's physiological characteristics, drug factors, clinical use factors, etc., aiming to attract attention to children's drug safety and reduce the incidence of ADRs/ADEs in children.

关 键 词：儿童 不良反应 不良事件 特征 原因 

分 类 号：R969.3[医药卫生—药理学]