常用抗肿瘤药物说明书中儿童用药信息的调查分析

Medication information for children in package inserts of children’s commonly used antitumor drug

目的了解常用抗肿瘤药物说明书中儿童信息的标注情况,为临床合理使用提供参考。方法收集2018年3月至2019年3月南京市儿童医院和南京市大厂医院所有儿童用抗肿瘤药物说明书76份,对其中的标注内容进行调查分析(尤其关注儿童信息的标注)。结果各项目中有关儿童信息标注少,其中禁忌、药物过量项下有关儿童信息的标注率低于10.53%;近一半药物未标注儿童剂量换算方式;关于儿童用药项,注射剂与口服剂,进口与国产说明书标注情况基本相同;同一成分、给药途径,不同生产厂家药物说明书中关于儿童信息标注差异大。结论抗肿瘤药物说明书中儿童信息的标注存在不完整现象严重,有待进一步规范、完善,以保障临床用药安全、合理。

Objective To know about the medication information marked for children in package inserts of children’s commonly used antitumor drug and to provide reference for rational clinical use.Methods Seventy-six package inserts of children’s commonly used antitumor drug were collected in Children’s Hospital of Nanjing Medical University and Dachang Hospital of Nanjing from March 2018 to March 2019,and the contents were analyzed(especially the information marked for children).Results Medication information for children in each project was low,and the rate of children’s information about taboos and drug overdose was lower than 10.53%.Nearly half of the drugs were not marked with conversion method for children’s dose.Regarding children’s use of drug,there was almost the same information about injections and oral preparations between imported and domestic drug specifications,while there was a big difference between different manufacturers’ instructions about ingredients and route of administration.Conclusion There is universally incomplete medication information for children in package inserts of children’s commonly used antitumor drug,which needs to be further regulated and improved in order to ensure the safe and rational use of clinical drugs.