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作 者:周瑞瑞 谢晓慧[1] 陈哲 王晓玲[3] 张萌[3] ZHOU Rui-rui;XIE Xiao-hui;CHEN Zhe;WANG Xiao-ling;ZHANG Meng(Peking University School of Pharmaceutical Sciences,Beijing 100191,China;The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;Beijing Children's Hospital,Capital Medical University,Beijing 100045,China)
机构地区:[1]北京大学药学院,北京100191 [2]郑州大学第一附属医院,郑州450052 [3]首都医科大学附属北京儿童医院,北京100045
出 处:《中国新药杂志》2018年第19期2221-2226,共6页Chinese Journal of New Drugs
摘 要:目的:通过对比分析,总结第6版与第5版《WHO儿童基本药物标准清单》(简称"WHO EMLc")的异同,归纳第6版WHO EMLc与2012年版《国家基本药物目录》(简称"NEML")的差别,并探讨WHO EMLc对制定我国儿童基本药物目录的启示。方法:分别对第5版和第6版WHO EMLc、第6版WHO EMLc和NEML进行详细比较,分析对比结果。结果:和第5版相比,第6版WHO EMLc收录的类别、活性成分、品种和品规均有增加;特殊符号标注的活性成分也有变化,更新及时;第6版首次将抗菌药物分为3类:可用类、慎用类、备用类。第6版WHO EMLc与2012年NEML有23个分类重合;收录的活性成分的重合率约40%,品种、品规的重合率较低;相比NEML,WHO EMLc纳入的剂型更加丰富多样。结论:我国儿童基本药物目录不能直接套用WHO EMLc,可借鉴其相对成熟的遴选原则;我国亦需鼓励适宜儿童使用的剂型、规格的研发,配合相应的政策,推动儿童基本药物目录的出台。Objective: To provide reference for the formulation of essential medicines list for children in China through comparative analysis of WHO Model List of Essential Medicines for Children( the 5 th and 6 th editions)( WHO EMLc) and Chinese National Essential Medicine List( 2012 edition)( 2012 NEML). Methods:The 5 th and 6 th EMLc,the 6 th EMLc and 2012 NEML were compared in details respectively and the comparison results were analyzed. Results: There was an increase in the numbers of categories,active ingredients,formulations and strengths in the 6 th EMLc compared with the 5 th EMLc,and the active ingredients labeled with special symbols were updated timely. The biggest revision in the 6 th EMLc was the antibiotics section: WHO has grouped antibiotics into three categories-access,watch and reserve. 23 categories were coincident in the 6 th EMLc and NEML. About40% active ingredients in NEML were included in the 6 th EMLc,and the coincidence rates of formulations and strengths were much lower. The formulations included in the 6 th EMLc were much more various than NEML.Conclusion: Our essential medicine list for children cannot copy WHO EMLc completely,but the selection and replacement principles of WHO EMLc should be taken into consideration. Moreover,with the promulgation of some related policies by the government,suitable dosage forms and strengths for children should be taken into account,in order to push the progress of the essential medicines list for children in China.
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