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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



                *
          张金芬 ,佟若菲,董继刚,孙燕燕(天津市儿童医院/天津大学儿童医院药剂科,天津 300134)
                                        #
          中图分类号  R95      文献标志码  A      文章编号  1001-0408(2022)22-2694-06
          DOI  10.6039/j.issn.1001-0408.2022.22.02

          摘   要  目的 比较2021年版《WHO儿童基本药物示范目录》(WHO EMLc)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  WHO EMLc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,WHO EMLc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,WHO EMLc 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,
          WHO EMLc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;WHO EMLc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。WHO EMLc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。
          关键词  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


          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
          ZHANG Jinfen,TONG Ruofei,DONG Jigang,SUN Yanyan(Dept.  of  Pharmacy,  Tianjin  Children’s  Hospital/
          Tianjin University Children’s Hospital, Tianjin 300134, China)

          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.
                                                              KEYWORDS    WHO  Model  List  of  Essential  Medicines  for
              *第一作者 药师,硕士。研究方向:药剂学、儿童合理用药。                    Children;  National  Essential  Medicines  List  of  China;
          E-mail:zjfyouyou@163.com
                                                              children; antibacterial drug
              # 通信作者 主任药师,硕士生导师,硕士。研究方向:药事管理。
          电话:022-87787305。E-mail:syytjcn@sina.com


          · 2694 ·    China Pharmacy  2022 Vol. 33  No. 22                            中国药房  2022年第33卷第22期
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