各版《WHO儿童基本药物标准清单》及其与《国家基本药物目录》(2012年版)的对比分析  

Comparative analysis of each edition of WHO Model List of Essential Medicines for Children and Chinese National Essential Medicine List(2012 edition)

作　　者：陈哲[1] 谢晓慧[1] 王晓玲[2] 严晗[2] 张萌[2] 崔家玉[1] 

机构地区：[1]北京大学药学院,北京100191 [2]首都医科大学附属北京儿童医院,北京100145

出　　处：《中国新药杂志》2016年第13期1451-1455,共5页Chinese Journal of New Drugs

基　　金：国家卫生计生委药政司委托课题:世界卫生组织用药目录与2012年版国家基本药物目录对比研究

摘　　要：目的:通过对比分析,总结《WHO儿童基本药物标准清单》(简称"EMLc")的遴选及更替原则,并探讨EMLc对制定我国儿童基本药物目录的启示。方法:分别对第1版EMLc与《WHO基本药物标准清单》(第15版)(简称"第15版EML")、各版EMLc、第5版EMLc与《国家基本药物目录》(2012版)(简称"2012版基药目录")进行详细比较,分析对比结果。结果:第1版EMLc收录的类别和活性成分(3个除外)都收录于第15版EML中;几版EMLc收录的类别、活性成分、品种和品规均有轻微波动,在一定范围内,呈缓慢增长趋势;特殊符号标注的活性成分也不断变化,更新及时;第5版EMLc与2012版基药目录收录的活性成分的重合率约41%,品种、品规的重合率也仅有约26%和13%。结论:可考虑以2012版基药目录为基础制定我国的儿童基本药物目录;其遴选和更替原则可借鉴WHO的经验,即综合考虑疾病负担、循证证据、成本效益优势等;部分剂型和规格的收录亦可参照EMLc,但不能照搬。Objective： To summarize the selection and replacement principles of WHO Model List of Essential Medicines for Children（ EMLc） through comparative analysis,and explore the enlightenment to develop our own list of essential medicines for children. Methods： The 1st and 15 th editions of EMLc,each edition of EMLc,and the 5th EMLc and Chinese National Essential Medicine List（ 2012 edition）（ 2012 NEML） were compared in details respectively,then the comparison results were analyzed. Results： The categories and active ingredients（ 3 excepted） included in the 1st EMLc were all included in the 15 th EML. There was a slow rising tendency in the numbers of categories,active ingredients,formulations and strengths in EMLc,and the active ingredients labeled with special symbols were updated timely. About 41% active ingredients in 2012 NEML were included in the 5th EMLc,and the coincidence rates of formulations and strengths were only 26% and 13%.Conclusion： Our essential medicine list for children can be developed based on 2012 NEML. As to the selection and replacement principles,disease burden,evidence of effectiveness and safety,and cost-effectiveness should betaken into consideration,just as EMLc does. Part of dosage forms and strengths in EMLc can be referred to,but cannot be copied completely.

关 键 词：儿童 WHO WHO儿童基本药物标准清单 基本药物 遴选 更替 比较 

分 类 号：R95[医药卫生—药学]