2021年版WHO儿童基本药物示范目录与2018年版国家基本药物目录中抗菌药物的比对分析
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篇名: 2021年版WHO儿童基本药物示范目录与2018年版国家基本药物目录中抗菌药物的比对分析
TITLE: Comparative analysis of antibacterial drugs between the 2021 edition of WHO Model List of Essential Medicines for Children and the 2018 edition of National Essential Medicines List of China
摘要: 目的比较2021年版《WHO儿童基本药物示范目录》(WHOEMLc)与2018年版《国家基本药物目录》(NEML)中收录的抗菌药物,为我国儿童基本药物目录药品遴选提供参考。方法采用描述性分析方法,比较两个目录中抗菌药物的分类方法、特殊标注、品种、剂型、规格等方面的异同。结果WHOEMLc对抗菌药物实行严格的限定和分级,标注了儿童限制使用的年龄及体质量,更注重儿童用药的耐药性和安全性;品种方面,NEML共收录抗菌药物51种,WHOEMLc共收录抗菌药物62种,两个目录共同收录的抗菌药物达36种,WHOEMLc收录的氯唑西林、普鲁卡因青霉素、头孢他啶阿维巴坦等未被NEML收录;剂型方面,WHOEMLc收录的抗菌药物剂型更为丰富和灵活,如包含了NEML未收录的口服液、粉末口服液及刻痕片等,可提高儿童用药的依从性及剂量的准确性;规格方面,两目录共同收录的抗菌药物规格总数接近,但NEML中部分药物收录的规格种类更丰富,且其收录的最小规格要更小;WHOEMLc收录的一些特有抗菌药物虽在我国上市,但因缺乏我国儿童用药数据而规定不能用于儿童,如氯法齐明、贝达喹啉及德拉马尼等。结论NEML中收录的抗菌药物不能完全满足我国儿童的用药需求。WHOEMLc作为儿童专用目录具有一定的优势及合理性。我国相关部门可借鉴WHO的优秀经验,完善NEML中的儿童用药信息,并尽快推出我国儿童基本药物目录。
ABSTRACT: OBJECTIVE To compare the antibacterial drugs between the 2021 edition of WHO Model List of Essential Medicines for Children (WHO EMLc) and the 2018 edition of National Essential Medicines List of China (NEML), and provide reference for the drug selection of Chinese essential medicine list for children. METHODS By means of descriptive analysis, the similarities and differences in classification methods, special markers, the varieties, dosage forms and specifications were compared between WHO EMLc and NEML. RESULTS WHO EMLc had strict limits and classifications on the antibacterial drugs, marked the age and weight of children who were restricted to use, and focused on the drug resistances and safety in children. In terms of varieties, there were 51 kinds of antibacterial drugs in NEML and 62 in WHO EMLc; 36 kinds of antibacterial drugs were both included in NEML and WHO EMLc; some antibacterial drugs, such as cloxacillin, procaine penicillin and ceftazidime avibactam, were listed in WHO EMLc but not in NEML. In terms of dosage forms, the dosage forms of antibacterial drugs included in WHO EMLc were more abundant and flexible, such as oral liquids, powder for oral liquids and scored tablets which were not included in NEML, and could improve the compliance of children’s medication and the accuracy of dosage. In terms of specifications, the total numbers of the specifications of antibacterial drugs both included in the two lists were close, but the specifications of some drugs included in NEML were more abundant, and the minimum specifications included in NEML were smaller. Although some of the unique antibacterial drugs included in WHO EMLc were listed in China, they could not be used in children due to the lack of drug data on children in China, such as clofazimine, bedaquinoline and delamanid. CONCLUSIONS The antibacterial drugs included in NEML can not fully meet the medication needs of children in China. WHO EMLc has certain advantage and rationality as a special list for children. The relevant departments in China can learn from the excellent experience of WHO EMLc, improve the information of pediatric medication of NEML and launch Chinese Essential Medicine List for Children as soon as possible.
期刊: 2022年第33卷第22期
作者: 张金芬,佟若菲,董继刚,孙燕燕
AUTHORS: ZHANG Jinfen,TONG Ruofei,DONG Jigang,SUN Yanyan
关键字: WHO儿童基本药物示范目录;国家基本药物目录;儿童;抗菌药物
KEYWORDS: WHO Model List of Essential Medicines for
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