我国儿童用抗微生物药与 WHO EMLc的比较研究

A Comparative Study of Antimicrobials for children in China and WHO EMLc

关键词:  WHO EMLc  国家基本药物目录  儿童用药  抗微生物药

Key words:  WHO EMLc  National Essential Medicine List  medication for children  antimicrobial

摘要:

目的 在分析研究《WHO儿童基本药物标准清单》（WHO model list of essential medicines for children - 8th List, WHO EMLc）基本情况的基础上，基于我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，为我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两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、药物规格及药物在我国上市情况，可将2 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 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我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的药物收录在我国《鼓励研发申报儿童药品清单》中，切实提高儿童用药可及性，完善我国儿童用药政策体系。

Abstract:

ABSTRACT: OBJECTIVE Based on the analysis and research of the basic situation of WHO model list of essential medicines for children(WHO EMLc), and based on the market situation of local drugs in China, compare the similarities and differences between WHO EMLc – 8th list 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 can be 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.