沙利度胺在儿童风湿性疾病应用的安全性  

Safety Analysis of Thalidomide in Systemic Juvenile Idiopathic Arthritis

作　　者：谢婷 孙华君 李志玲 刘红霞 Xie Ting;Sun Huajun;Li Zhiling;Liu Hongxia(Shanghai Children’s Hospital,Children’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200062,China)

机构地区：[1]上海市儿童医院,上海交通大学医学院附属儿童医院,上海200062

出　　处：《儿科药学杂志》2023年第5期6-10,共5页Journal of Pediatric Pharmacy

基　　金：上海市“医苑新星”青年医学人才培养资助计划,沪卫人事[2020]87号。

摘　　要：目的:为遴选国家儿童基本药物目录中消化系统用药提供参考。方法:描述性分析第7版《世界卫生组织(WHO)儿童基本药物目录》(WHO-EMLc)与2018版《国家基本药物目录》(NEML)中消化系统用药在分类与数量、剂型规格、标志符号等方面的异同,比较两目录收录的消化系统用药在我国的上市情况,调查NEML收录的消化系统用药在国内药品说明书中关于儿童用药的规定。结果:WHO-EMLc和NEML中通用名相同的消化系统用药为奥美拉唑、雷尼替丁及甲氧氯普胺。与NEML相比,WHO-EMLc中消化系统用药的剂型和规格更为具体,且包含药物疗效、安全性、年龄限制及注意事项的符号标记。两目录收录的消化系统用药在我国的上市剂型以普通剂型为主,儿童适宜剂型相对较少。NEML收录的消化系统用药中,55.17%的品种在国内药品说明书中规定了儿童适应证的用法用量。结论:以《WHO儿童基本药物目录》和《国家基本药物目录》为基础,遴选我国儿童消化系统基本药物,进一步鼓励儿童消化系统专用药物的研发,保障儿童用药的安全性、有效性、可及性和顺应性。Objective:To analyze the literatures published at home and abroad on thalidomide induced adverse reactions in children,and to provide references for the safety of thalidomide in children with systemic juvenile idiopathic arthritis.Methods:We searched CNKI,Wanfang and PubMed databases with keywords“thalidomide”“children”“adverse reaction”“safety”“pediatric”“case report”and some related Chinese expressions.The drug safety information was extracted from the literature that met the inclusion criteria and conduct the descriptive analysis.Results:A total of 18 articles were included,and 263 cases were accumulated.Thalidomide related adverse reactions involved a wide range of systems,and the top five were mental system,nervous system,blood system,digestive system and skin system,accounting for 85.16%in total.The incidence of peripheral neuropathy was the highest,accounting for 19.39%.Serious adverse reactions accounted for 17.49%,mainly peripheral neuropathy,which was related to the cumulative dose of drugs.Conclusion:Thalidomide is generally safe for children with systemic juvenile idiopathic arthritis.Most of the related adverse reactions can be cured or improved after drug withdrawal or symptomatic treatment.Clinical medication should pay attention to the cumulative dose of drugs and the occurrence of peripheral neuropathy.

关 键 词：世界卫生组织儿童基本药物目录 国家基本药物目录 消化系统用药 

分 类 号：R969.3[医药卫生—药理学]