中国儿童用抗微生物药与WHO EMLc 的比较研究  

Comparative Study of Antimicrobials for Children in China and WHO EMLc

作　　者：李馨雨 邵蓉[1] 颜建周[1] LI Xinyu;SHAO Rong;YAN Jianzhou(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学国际医药商学院,南京211198

出　　处：《中国现代应用药学》2024年第24期3565-3573,共9页Chinese Journal of Modern Applied Pharmacy

基　　金：国家自然科学基金项目(72274217)。

摘　　要：目的在分析研究《世界卫生组织儿童基本药物标准清单》(World Health Organization Model List of Essential Medicines for Children,WHO EMLc)基本情况的基础上,基于中国本土药品上市情况,比较第8版WHO EMLc与2018年版《国家基本药物目录》(National Essential Medicine List,NEML)在抗微生物药类别下药物品种、药物剂型、药物规格的异同,为中国儿童基本药物目录的制定提出政策性建议。方法采用比较分析法对上述2种目录在具体药物品种、剂型和规格等方面展开研究。结果依据药物品种、药物剂型、药物规格及药物在中国上市情况,可将2个目录中抗微生物药分为6类。结论建议在现有NEML收录药品范围的基础上,综合分析WHO EMLc和NEML的比较结果,优先考虑将目前已在2个目录中的药物以及在临床使用方面已有明显证据表明其应用于儿童时获益大于风险的药物等纳入中国儿童基本药物目录。同时基于现有儿童用药的安全性证据,筛掉NEML中不适宜儿童使用的药物品种,考虑将纳入WHO EMLc但未纳入NEML的药物收录在中国《鼓励研发申报儿童药品清单》中,切实提高儿童用药可及性,完善中国儿童用药政策体系。OBJECTIVE Based on the analysis and research of the basic situation of World Health Organization Model List of Essential Medicines for Children(WHO EMLc),and considering the local pharmaceutical market in China,compare the similarities and differences between WHO EMLc and National Essential Medicine List(2018 edition)in terms of drug varieties,drug dosage forms,drug specifications,and antimicrobial drug categories,and put forward suggestions for the formulation of Chinese essential medicines list for children.METHODS Comparative analysis was used to study the specific drug varieties,dosage forms and specifications of the above two catalogues.RESULTS According to drug varieties,drug dosage forms,drug specifications and drug marketing in China,antimicrobials in the 2 catalogs was divided into 6 categories.CONCLUSION It is recommended to base on the scope of drugs included in NEML,comprehensively analyze the comparison results between WHO EMLc and NEML.Priority should be given to including drugs currently listed in the two categories and drugs with clear evidence of clinical use that their benefits outweigh the risks when applied to children in the list of essential drugs for children in China.At the same time,based on the existing safety evidence of children’s medication,we will screen out drug varieties that are not suitable for children in NEML,and consider including drugs that are included in WHO EMLc but not included in NEML in China’s"Encouraged Research and Development of Children’s Drug List",effectively improving the accessibility of children’s medication and improve the drug use policy system for children in China.

关 键 词：《世界卫生组织儿童基本药物标准清单》 国家基本药物目录 儿童用药 抗微生物药 

分 类 号：R95[医药卫生—药学]