WHO、英国、中国国家处方集儿童版的比较研究与借鉴

摘 要 目的：为我国儿童处方集的更新修订提供参考，为我国医疗机构制订本机构的处方集提供借鉴。方法：通过比较《世界卫生组织（WHO）儿童示范处方集》（2010版）（WMFc）、《英国国家处方集（儿童版）》（2016-2017版）（BNFc）、《中国国家处方集（儿童版）》（2013版）（CNFc）的遴选原则、目录、章节、药品项目、处方集数量和重合药品，提出我国处方集更新修订和医疗机构处方集制订的意见。结果与结论：WMFc为安全、有效和经济，BNFc为准确、最新，CNFc的遴选原则为安全、有效、经济、适宜；三个处方集的目录包括引言、总论、各论等内容，但具体内容或描述有所不同，如在各论中，WMFc分為27章、BNFc分为16章、CNFc分为20章；WMFc章节目录按照解剖-治疗-化学代码分类（ATC）法进行分类，BNFc按器官系统和疾病排列，CNFc章节则是根据疾病治疗系统进行分类，三本处方集均有的章节包括神经系统疾病用药、内分泌系统用药、呼吸系统用药等15章，CNFc独有的章节为“口腔科疾病用药”；三本处方集药品项目均包括药品名称、适应证、用法用量、禁忌证、不良反应、注意事项、制剂与规格等，与CNFc比较，WMFc独有的包括ATC法编号、相互作用、肝损害等项目，BNFc中独有的包括药理作用、相互作用、过敏等项目； WMFc收载药品271种、CNFc收载847种、BNFc收载955种，其中WMFc与CNFc重合166种、BNFc与CNFc重合359种、WMFc与BNFc重合174种，三本处方集均重合药品有141种。在修订或制订处方集时，不能生搬硬套，而要根据我国国情修订处方集，合理参考WMFc、BNFc处方集遴选原则，定期或实时更新我国处方集，规范处方集药品准入标准，合理增加药品品种，同时呼吁国家相关部门提高对儿童药品说明书的制订标准。

关键词 英国国家处方集（儿童版）；WHO儿童示范处方集；中国国家处方集（儿童版）；更新修订；比较；研究

Comparative Study and Reference of Children’s Edition of WHO， British and Chinese National Formulary

MENG Xiu1，2，HUO Jiping1，SHI Weizhong1，ZHAO Zhigang1（1.Dept. of Pharmacy， Beijing Tiantan Hospital Affiliated to Capital Medical University， Beijing 100050， China；2.Dept. of Pharmacy， Beijing New Century Women’s and Children’s Hospital， Beijing 100102， China）

ABSTRACT OBJECTIVE： To provide reference for the revision of China National Formulary for Children and make a sample for Chinese medical institutions to formulate their own formulary. METHODS： The suggestions on formulary revision and the formulation of formulary in medical institutions were put forward through comparing the selection principle， catalogues， chapters， drug items， formulary quantity and coincident drugs of World Health Organization （WHO） Model Formulary for Children （2010 edition） （WMFc）， British National Formulary （Children edition） （2016-2017 edition） （BNFc）， Chinese National Formulary （Children edition） （2013 edition） （CNFc）. RESULTS & CONCLUSIONS： The selection principle of WMFc was safe， effective and economical； that of BNFc was accurate and up-to-date， that of CNFc was safe， effective， economical and appropriate. The catalogues of three formularies included introduction， outline and separated section， but the contents or descriptions were different. For example， in separated section， WMFc was divided into 27 chapters， BNFc was divided into 16 chapters and CNFc was divided into 20 chapters. The chapters and catalogues of WMFc were classified according to ATC； those of BNFc were classified according to organ system and disease arrangement； those of CNFc were classified according to disease treatment system. 15 chapters of three formularies were the same， such as drug for nervous system diseases， drug for endocrine system and drug for respiratory system. The unique chapter of CNFc was “drugs for stomatological diseases”. The drug items of three formularies included drug name， indications， usage and dosage， contraindication， ADR， matters need attention， preparation and specifications， etc. Compared with CNFc， unique chapters of WMFc included ATC numbering， drug interaction， liver injury， etc.； those of BNFc included pharmacological action， interaction， allergy， etc. WMFc contained 271 drugs， CNFc 847 drugs and BNFc 955 drugs. Among them， there were 166 overlaps between WMFc and CNFc， 359 between BNFc and CNFc， 174 between WMFc and BNFc. There were 141 same drugs in the three formularies. When revising or formulating formulary， our country should not copy them mechanically， but should revise formulary according to our national conditions. It is necessary to refer to selection principles of WMFc and BNFc， update our children’s formulary in certain or real time， standardize drug access criteria of formulary， rationally increase the variety of drug and call on the relevant departments of the state to improve the standards for the formulation of drug instructions for children.

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