WHO儿童基本药物目录与国家基本药物目录中的抗癫痫药对比分析
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篇名: WHO儿童基本药物目录与国家基本药物目录中的抗癫痫药对比分析
TITLE: Comparative Analysis of Antiepileptic Drugs between WHO Model List of Essential Medicines for Children and the National Essential Drug List of China
摘要: 目的:比较2019年版WHO儿童基本药物目录(以下简称“WHO-EMLc”)和2018年版我国国家基本药物目录(以下简称“NEML”)中抗癫痫药的异同,为我国基本药物目录的完善和儿童基本药物目录的制订提供参考。方法:采用描述性分析法,比较WHO-EMLc和NEML中收录的抗癫痫药的品种、剂型、规格、标记符号等方面的差异,并对WHO-EMLc收录的和NEML特有的抗癫痫药在我国的上市情况进行统计分析。结果与结论:WHO-EMLc收录的抗癫痫药有9种,均归于抗惊厥药/抗癫痫药项下;我国NEML收录在抗癫痫药项下的有6种,WHO-EMLc收录的另外3种药物则收录在NEML治疗精神障碍药分类下。NEML和WHO-EMLc中共有的抗癫痫药有8种,分别是卡马西平、丙戊酸、苯妥英钠、苯巴比妥、拉莫三嗪、地西泮、劳拉西泮和咪达唑仑;NEML中特有的抗癫痫药是奥卡西平,WHO-EMLc中特有的抗癫痫药是乙琥胺。WHO-EMLc中涉及的口服剂型有口服溶液、普通片、肠溶片、分散片等多种剂型,而NEML中涉及的口服剂型只有普通片、分散片和口服溶液;就单种药品的某种剂型来看,WHO-EMLc中的药品规格比NEML更为全面。WHO-EMLc中,劳拉西泮标注了“□”,即WHO认为其在同类药品中更具有效性和安全性;拉莫三嗪、咪达唑仑注射液和苯妥英(25mg∶5mL和30mg∶5mL)标记了“*”,提示该药或者该剂型规格有特殊的注意事项。NEML中,地西泮标注了“*”,地西泮注射液标记了“△”,表示地西泮在不同分类项下重复出现,地西泮注射液应在具备相应处方资质的医师或在专科医师指导下使用,并应加强使用监测和疗效评价。此外,WHO-EMLc收录的抗癫痫药大部分虽然在我国已上市销售,但上市的剂型较单一,不能满足儿童用药需求。我国可借鉴WHO-EMLc的遴选方法,进一步完善国家基本药物目录,并结合疾病谱和药品临床综合评价,尽早制订适合我国国情的儿童基本药物目录;同时,政府应鼓励儿童用药的研发和生产,以保证儿童基本药物的安全可及。
ABSTRACT: OBJECTIVE:To compare the similarities and differences of antiepileptic drugs between 2019 edition of WHO Model List of Essential Medicines for Children (called“WHO-EMLc”for short )and 2018 edition of the National Essential Medicines List (called“NEML”for short ),and to provide reference for the improvement of national essential medicines list and formulation of essential medicines list for children. METHODS :By means of descriptive analysis ,the differences in the varieties , dosage forms ,specifications and marker symbols of antiepileptic drugs were compared between WHO-EMLc and NEML. The marketing status of antiepileptic drugs included in WHO-EMLc and NEML were analyzed statistically. RESULTS & CONCLUSIONS:There were 9 kinds of antiepileptic drugs included in WHO-EMLc ,all of which were under the category of anticonvulsant/antiepileptic drugs. There were 6 kinds of antiepileptic drugs in NEML of China ,and the other three kinds of drugs included in WHO-EMLc were included in the category of psychotherapy drugs in NEML. Eight kinds of antiepileptic 126 drugs were shared by NEML and WHO-EMLc , namely 109614043@qq.com carbamazepine, valproic acid , phenytoin sodium , pheno- barbital,lamotrigine,diazepam,lorazepam and midazolam. The special antiepileptic drug in NEML was ocazepine ,and edu.cn the special antiepileptic drug in WHO-EMLC was ethylsu c- cinate. Oral dosage forms involved in WHO-EMLc included oral solution ,ordinary tablet,enteric-coated tablet ,dispersed tablet , etc.,while oral dosage forms involved in NEML included ordinary tablet ,dispersed tablet and oral solution. In terms of dosage form of a single drug ,the drug specifications in WHO-EMLc were more comprehensive than those in NEML. In WHO-EMLc , lorazepam was labeled with “□”,indicating that it was more effective and safe in similar drugs . Lamotrigine ,midazolam injection and phenytoin (25 mg∶5 mL and 30 mg∶5 mL)were labeled with “*”,indicating that there were special precautions for the drug or dosage form and specification. In NEML ,diazepam was marked with “*”,and diazepam injection was marked with “△”, indicating that diazepam appeared repeatedly under different classifications ;diazepam injection should be used under the guidance of doctors with corresponding prescription qualifications or under the guidance of specialists ,and the use monitoring and efficacy evaluation should be strengthened. In addition ,most of the antiepileptic drugs included in WHO-EMLc had been marketed in China,but the dosage forms on the market were relatively simple ,which could not meet the drug demand of children. Our country could learn from WHO-EMLc selection method to further improve the national essential medicine list ,formulate essential medicine list for children which was suitable for Chinese national conditionsas soon as possible on the basis of disease spectrum and drug clinical comprehensive evaluation. At the same time ,the government should also encourage the development and production of children’s medicines to ensure that children fairly access to drugs.
期刊: 2020年第31卷第20期
作者: 王慧玲,张涛志,尹续续,王艳文,李萌,辛红霞,刘伟
AUTHORS: WANG Huiling ,ZHANG Taozhi ,YIN Xuxu,WANG Yanwen ,LI Meng,XIN Hongxia ,LIU Wei
关键字: WHO儿童基本药物目录;国家基本药物目录;抗癫痫药
KEYWORDS: WHO Essential Medicine List for Childre n;National Essential Medicine List ;Antiepileptic drugs
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