新生儿用药现况及鼓励研发药品清单调研

Investigation on Current Status of Neonatal Medication and Drug Lists That Encourage Research and Development

目的:对国外广泛使用但国内尚未上市的药品进行调研,在品种或剂型层面鼓励国内企业研发或进口药品,有力补充国内新生儿疾病的治疗药物。方法:根据《Neofax 2020》美国新生儿用药指导手册以及国内22家医院的一线新生儿治疗药物目录,合并后查询中国儿童用药数据库及世界卫生组织(WHO)基本药物情况。根据欧盟颁布的儿童适宜剂型评价表,推荐研发适宜婴幼儿、新生儿、早产儿使用的品种和剂型。根据国家卫生健康委员会发布的三版《鼓励研发申报儿童药品清单》对本清单进行分析。结果:共获得248种不同给药途径的药品进行中国儿童用药数据库调研,其中国内一线使用且《Neofax 2020》推荐的品种有22个。调研发现,目前国内无此品种亟待引进或研发的品种有10个通用名、11种给药途径;国内有此品种但仍无适宜剂型的药物共计31个通用名、44种给药途径、56种剂型。结论:本研究所得出的鼓励研发药品清单是在药品生产层面和剂型规格环节所给出的有益探索和尝试,可以为我国新生儿用药的研发和生产提供一定的帮助。

Objective:To investigate drugs widely used abroad but not yet on the market in China,encourage domestic enterprises to develop or import drugs with different varieties or dosage forms,and effectively supplement the treatment drugs for neonatal diseases in China.Methods:Based on Neofax 2020 US Neonatal Medication Guidelines and the first-line neonatal treatment drug list of 22 domestic hospitals,the Chinese Pediatric Drug Database and World Health Organization(WHO)essential drugs were queried.According to evaluation form of suitable dosage forms for children issued by the European Union,it was recommended to develop varieties and dosage forms suitable for infants,neonates and premature infants.This list was analyzed according to the third edition of list of children’s drugs that encourage research and development issued by the National Health Commission.Results:A total of 248 drugs with different routes of administration were investigated in the Chinese Pediatric Drug Database,including 22 varieties recommended by Neofax 2020 for firstline use in China.The investigation found that there were 10 generic names and 11 routes of administration of drugs that need to be introduced or developed urgently in China.And there were 31 generic names,44 routes of administration and 56 dosage forms of drugs with this variety without suitable dosage forms in China.Conclusion:The list of drugs to encourage research and development derived from this study is a useful exploration and attempt given at the level of drug production and dosage form specifications,which can provide some assistance to the research,development and production of neonatal medication in China.