2016—2017年我国儿童药品不良反应分析
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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.
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.
引文
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[13]初晓阳,高春红,葛成,等.以患者为中心的个体化制剂新技术研究进展[J].中国新药杂志,2018,27(4):409-416.
[14]耿莹,赵德恒,杨志敏.基于新化药注册分类的儿科人群临床研究要求的考虑[J].中国新药杂志,2018,27(11):1245-1248.
[15]孙艳喆,耿莹,赵德恒,等.成人用药数据外推至儿科人群的技术要求及审评考虑[J].中国新药杂志,2018,27(18):2154-2158.
[16]杜雯雯,徐伟,蔡功杰,等.中国儿童用药可及性分析[J].中国现代应用药学,2018,35(1):128-131.
[17]王彬,吴眉,赵汝霞,等.海口市儿童家长用药安全知识认知情况调查分析[J].今日药学,2018,28(7):493-496.
[18]刘玲玲,王盈,吴霖萍,等.全球药品研发进展(2016. 09~2016. 12)[J].中国医药工业杂志,2017,48(3):453-467.
[19]吕训磊,郭琳琳,周伟澄. 2017年美国FDA批准上市的新药简介[J].中国医药工业杂志,2018,49(1):1-28.
[2]翁小红,尚尔宁.儿科用药不良反应特点研究[J].中国现代药物应用,2016,10(23):136-137.
[3]江育仁.中医儿科学[M].上海:上海科学技术出版社,2000:5-7.
[4]米清仙.儿童用药现状及思考[J].中国药物与临床,2017,17(1):136-138.
[5]孙艺方.儿童家庭安全用药存在的问题及应对方法分析[J].中西医结合心血管病电子杂志,2018,6(18):50.
[6]杨林勇,刘新社,萧伟,等.我国常见儿童药物不良反应及对策研究[J].中国中药杂志,2016,41(14):2743-2747.
[7]金丹,田春华,杨月明,等.儿童用药安全现状及政策研究与思考[J].中国药事,2015,29(4):427-431.
[8]朱占胜,王晶,孙亚凌,等.临床用药致儿童不良反应相关性分析[J].医学综述,2013,19(5):935-936.
[9]王瑜歆,王春婷,杨月明,等. 2006年全国儿童严重不良反应报告分析[J].中国新药杂志,2010,19(5):453-456.
[10]刘书琼.儿科的药物合理应用及不良反应回顾分析[J].中国社区医师,2018,34(1):18.
[11]秦丹,宋海波,王爱平,等.我国儿童用药不良反应报告分析模式的文献计量分析[J].药物流行病学杂志,2017,26(2):120-125.
[12]耿莹,赵德恒,杨志敏.我国儿童用药进行上市后真实世界数据收集的考虑[J].中国新药杂志,2018,27(18):2107-2110.
[13]初晓阳,高春红,葛成,等.以患者为中心的个体化制剂新技术研究进展[J].中国新药杂志,2018,27(4):409-416.
[14]耿莹,赵德恒,杨志敏.基于新化药注册分类的儿科人群临床研究要求的考虑[J].中国新药杂志,2018,27(11):1245-1248.
[15]孙艳喆,耿莹,赵德恒,等.成人用药数据外推至儿科人群的技术要求及审评考虑[J].中国新药杂志,2018,27(18):2154-2158.
[16]杜雯雯,徐伟,蔡功杰,等.中国儿童用药可及性分析[J].中国现代应用药学,2018,35(1):128-131.
[17]王彬,吴眉,赵汝霞,等.海口市儿童家长用药安全知识认知情况调查分析[J].今日药学,2018,28(7):493-496.
[18]刘玲玲,王盈,吴霖萍,等.全球药品研发进展(2016. 09~2016. 12)[J].中国医药工业杂志,2017,48(3):453-467.
[19]吕训磊,郭琳琳,周伟澄. 2017年美国FDA批准上市的新药简介[J].中国医药工业杂志,2018,49(1):1-28.