【摘要】 目的:为我国儿童基本药物目录的制定提供参考。方法:采用描述性分析方法,比较2023年版《世界卫生组织儿童基本药物目录》(EMLc)和2018年版《国家基本药物目录》(NEML)中收录的抗肿瘤药物的品种、剂型、规格、适应证等方面的差异,并对EMLc收录特有的抗肿瘤药物在我国的上市情况进行统计分析。结果:品种方面,两目录共同收录的抗肿瘤药物有26种,EMLc收录的博来霉素等18种抗肿瘤药物未被NEML收录;剂型方面,EMLc收录的抗肿瘤药物剂型更为丰富;规格方面,EMLc和NEML均收录有适合儿童使用的规格;适应证方面,NEML所有药物均未标注适应证,仅三氧化二砷的适应证在EMLc、国产制剂说明书和美国食品药品监督管理局说明书中完全相同;EMLc收录的特有抗肿瘤药物除了非格司亭和拉布立酶,其余均在我国上市,但上市的剂型主要是注射剂、片剂、胶囊,不能满足儿童用药需求。结论:NEML收录的抗肿瘤药物已不能完全满足我国儿童的用药需求,建议参考EMLc,加快制定适宜我国的儿童基本药物目录;同时,建议国家出台相关激励政策,激励生产企业研发儿童药品,保障儿童用药的安全、有效和可及。更多还原

【Abstract】 Objective: To provide reference for the formulation of the National Essential Medicines List for children in China. Methods: A descriptive analysis was used to compare the differences in varieties, dosage forms, specifications, and indications of anti-tumor drugsincludedinthe2023editionoftheWorldHealthOrganization(WHO)EssentialMedicinesListforChildren(EMLc)andthe2018editionoftheNationalEssentialMedicinesList(NEML).Statisticalanalysiswasperformedonthemarketavailabilityoftheanti-tumor drugs specifically included in EMLc. Results: In terms of varieties, there were 26 drugs jointly listed in both directories, and 18 kinds ofanti-tumordrugs,suchasbleomycinincludedintheEMLc,werenotincludedintheNEML.Regardingdosageforms,theEMLc includedamorediverserangeofanti-tumordrugformulations.Intermsofspecifications,boththeEMLcandNEMLincluded specificationssuitableforchildren.Concerningindications,noneofthedrugsintheNEMLwerelabeledwithindications,onlythe indicationsforarsenictrioxidewerecompletelyidenticalintheEMLc,domesticformulationinstructions,andtheU. S.FoodandDrug Administrationinstructions.Exceptforfilgrastimandrasburicase,alltheuniqueanti-tumordrugslistedintheEMLcwereavailablein China,buttheavailableformulationsweremainlyinjections,tablets,andcapsules,whichdidnotfullymeettheneedsofmedicationfor children. Conclusion: The anti-tumor drugs listed in the NEML couldn’t fully meet the medication needs of children in China, and it is recommendedtoacceleratethedevelopmentofalistofessentialmedicinesforchildrentailoredtoChinabyreferencingEMLc.Additionally,thegovernmentshouldintroducerelevantincentivepoliciestoencouragepharmaceuticalmanufacturerstoinvestinthe researchanddevelopmentofpediatricdrugs,therebyensuringthesafety,efficacy,andaccessibilityofmedicationforchildren.更多还原