2012版《国家基本药物目录》中儿童用药与《WHO儿童基本药物标准清单》及《母亲和儿童的重点药物目录》的比较分析

Comparative Analysis of 2012 Edition of National Essential Medicines List with WHO Model List of Essential Medicines for Children and Priority Medicines for Mothers and Children

目的:为循证制订中国儿童基本药物目录提供参考。方法:描述性分析比较2012版《国家基本药物目录》中儿童用药与世界卫生组织(WHO)发布的《WHO儿童基本药物标准清单》及《母亲和儿童的重点药物目录》在内容组成、纳入条件、标志符号、药物分类原则、药物种类、药物剂型和年龄限制上的异同。结果:2012版《国家基本药物目录》基本覆盖了儿童常用药类别,但未包含《WHO儿童基本药物标准清单》中的血液制品、消毒剂和新生儿特殊用药;缺乏儿童适宜的剂型和规格以及药物年龄限制和说明。结论:WHO发布的两份目录是基于全球儿童的疾病负担而制定,并不完全适合中国,直接套用存在安全隐患。建议借鉴两份目录的制订标准和方法,并遵循中国国情,依据循证医学和药物经济学制订符合中国国情的儿童基本药物目录,以完善国家基本药物制度,从而保障儿童用药更安全、有效、方便。

OBJECTIVE： To provide reference for the formulation of Essential Medicine List for Children in China. METHODS： National Essential Medicine List （2012 edition） were compared with WHO Model List of Essential Medicines for children and Priority Medicines for Mothers and Children in respects of content composition, inclusion criteria, marker and sign, classification principle, drug categories, drug dosage form and age limit. RESULTS： National Essential Medicine List （2012 edition） basically involved the common medicine category for children while lacked of blood products, disinfectants and specific medicines for neonatal care; National Essential Medicine List （2012 edition） was lack of appropriate children dosage form and specifications as well as age limit and description. CONCLUSIONS： 2 lists of WHO have been established on the basis of global disease burden of children, and it is not suited well for our country and brings out safety risk due to direct application. It is suggested to reference from the formulation standard and methods of 2 WHO lists, follow national situation and formulate essential medicine list for children based on evidence-based medicine and pharmacoeconomics in order to improve essential medicine system and guarantee more safe, effective and convenient use of medicines for children.