中圖分类号 R951文献标志码 A文章编号 1001-0408（2019）17-2311-06
DOI 10.6039/j.issn.1001-0408.2019.17.02
摘 要 目的：为完善我国《国家基本药物目录》（NEML）中儿童用药、建立适合我国儿童的基本药物目录提供参考。方法：比较归纳NEML（2018年版）与《世界卫生组织儿童基本药物标准清单》（WHO EMLc）的目标人群、特殊符号、收录类别及品种、剂型及规格的异同，提出相关建议。结果与结论：WHO EMLc明确适用对象为12岁以下儿童，并详细规定了年龄及体质量，NEML则适用于各年龄人群（含儿童）;WHO EMLc含4类特殊符号，分别为“□”（同类药物中有效性与安全性最佳的药物，与NEML的遴选原则匹配）、“a”（限定使用年龄或体质量，NEML中无）、“*”（特殊用药用量、专门强调的适应证以及不推荐使用年龄，并列出了可替代药品，NEML中无）、“[c]”（置于某药或某规格旁表明仅限儿童使用;置于补充清单旁表明用于儿童时需经专家诊断、监测设备、医疗护理，与NEML的“Δ”类似）;我国NEML收录药品包括化学药品和生物制品、中成药、中药饮片三部分，其中化学药品和生物制品共计26类417个品种，与WHO EMLc相比，NEML无血液制品、新生儿特殊用药，就抗微生物药而言，WHO EMLc有严格的限定和分级，而由于我国儿童专用抗微生物药指南较少，故NEML抗微生物药在儿科的应用限定和分级仍存在一定难度。2个目录重合品种数为149种，重合率为35.2%;在药品剂型方面，WHO EMLc的剂型更加丰富和灵活，如包含NEML中未收录的刻痕片、可压碎片、肌内注射剂，且基本包含适宜儿童服用的口服溶液剂等;在药品规格方面，2个目录基本考虑了儿童小剂量服用的特殊需求，在一定程度上考虑了剂型和规格的互补性。笔者建议我国相关部门应借鉴WHO EMLc的成熟经验，在NEML中新增标注符号、扩宽药物剂型、实施抗微生物药分类管理，并适时推出中国版儿童基本药物目录，从而为进一步提升我国儿童基本药物的可及性、安全性打下坚实的基础。
关键词 儿童;国家基本药物目录;世界卫生组织儿童基本药物标准清单;比较
Analysis and Consideration of Pediatric Medication in National Essential Medicine List（2018 Edition）
LU Mengqing，CHEN Liangjiang，HE Siyu，XI Xiaoyu（Research Center of National Drug Policy&Pharmaceutical Industrial Economics， China Pharmaceutical University， Nanjing 211198， China）
ABSTRACTOBJECTIVE： To provide reference for improving pediatric medication of National Essential Medicine List （NEML） and establishing Chinese essential medicine list for children. METHODS： NEML （2018 edition） were compared with WHO Essential Medicines List for Children （WHO EMLc） in respects of target population， special symbols， categories and varieties， dosage form and specification. The related suggestions were put forward. RESULTS & CONCLUSIONS： WHO EMLc is specifically used for children under 12 years old， and defines specific age and body mass. NEML is applicable to all age groups （including children）. WHO EMLc includes 4 types of special symbols， i.e. “□” （the drug with the best efficacy and safety in the same kind of drugs， which matches the selection principle of NEML）， “a” （limited age or body weight， not found in NEML）， “*” （special dosage， specially emphasized indications and age not recommended for use， listing substitute drugs， not found in NEML）， “[c]” （placed next to a drug or a specification indicating that they are only used by children; and placed next to a supplementary list indicating that they need expert diagnosis， monitoring facilities， medical care for children， similar to the “Δ” in NEML）. NEML in China includes chemical drugs and biological products， Chinese patent medicines and TCM decoction pieces. Among them， there are 26 categories and 417 types of chemical drugs and biological products. Compared with WHO EMLc， NEML has no blood products and special drugs for newborns. As far as antimicrobial agents are concerned， WHO EMLc has strict limits and classifications. However， due to the lack of guidelines for special antimicrobial agents for children in China， the application of NEML antimicrobial agents in pediatrics is still difficult to define and classify. The number of coincident varieties in the 2 lists was 149， and the coincidence rate was 35.2%. In terms of drug dosage， WHO EMLc’s dosage form are more abundant and flexible， such as scored tablet， compressible fragments， intramuscular injections， and oral solutions suitable for children which are not included in NEML. In terms of drug specifications， 2 lists basically consider about the special needs of children taking small dosage and to some extent take into account the complementarity of dosage forms and specifications. The author suggests that the relevant departments in China should draw lessons from the mature experience of WHO EMLc， add new labeling symbols in NEML， expand drug dosage forms， implement classified management of antimicrobial drugs， and timely launch Chinese Essential Medicines List for Children so as to lay a solid foundation for further improving the accessibility and safety of essential medicines for children in China.