| 摘要: |
| 目的:为遴选国家儿童基本药物目录中消化系统用药提供参考。方法:描述性分析第7 版《世界卫生组织(WHO) 儿童
基本药物目录》(WHO-EMLc)与2018 版《国家基本药物目录》(NEML)中消化系统用药在分类与数量、剂型规格、标志符号等方
面的异同,比较两目录收录的消化系统用药在我国的上市情况,调查NEML 收录的消化系统用药在国内药品说明书中关于儿童
用药的规定。结果:WHO-EMLc 和NEML 中通用名相同的消化系统用药为奥美拉唑、雷尼替丁及甲氧氯普胺。与NEML 相比,
WHO-EMLc 中消化系统用药的剂型和规格更为具体,且包含药物疗效、安全性、年龄限制及注意事项的符号标记。两目录收录
的消化系统用药在我国的上市剂型以普通剂型为主,儿童适宜剂型相对较少。NEML 收录的消化系统用药中,55. 17%的品种
在国内药品说明书中规定了儿童适应证的用法用量。结论:以《WHO 儿童基本药物目录》和《国家基本药物目录》为基础,遴选
我国儿童消化系统基本药物,进一步鼓励儿童消化系统专用药物的研发,保障儿童用药的安全性、有效性、可及性和顺应性 |
| 关键词: 世界卫生组织儿童基本药物目录 国家基本药物目录 消化系统用药 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2023.05.001 |
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| 基金项目: |
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| Analysis and Enlightenment of Digestive System Medicines in World Health Organization Model List of Essential Medicines for Children and National Essential Medicines List |
| Gao Shiman, Liu Chang, Yan Meixing |
| (Women and Children’s Hospital, Qingdao University, Qingdao Women and Children’s Hospital, Shandong Qingdao 266034, China) |
| Abstract: |
| Objective: To provide references for the selection of digestive system medicines in National List of Essential Medicines for
children. Methods: A descriptive analysis was conducted to compare the similarities and differences between the 7th edition of World
Health Organization Model List of Essential Medicines for Children (WHO-EMLc) and the 2018 edition of National Essential Medicines
List (NEML) in terms of classification, quantity, dosage form, specification, symbol, etc. Besides, the marketing situation of digestive
system medicines included in WHO-EMLc and NEML in China was compared, and the regulations on children’s usage in domestic
medicine specifications of digestive system medicines included in NEML were investigated. Results: In WHO-EMLc and NEML,
digestive system medicines with the same generic name were Omeprazole, Ranitidine and Metoclopramide. Compared with NEML, the
dosage form and specification of digestive system medicines in WHO-EMLc were more specific, and symbols of efficacy and safety, age
restrictions and precautions were marked in WHO-EMLc. The marketed dosage forms of digestive system medicines in the two lists were
mainly ordinary dosage forms in China, and relatively few dosage forms were suitable for children. And 55. 17% of digestive system
medicines included in NEML prescribed the usage and dosage for children in domestic medicine specifications. Conclusion: The
selection of digestive system essential medicines for children in our country could be carried out on the basis of WHO-EMLc and NEML,
and scientific research and development of special digestive system medicines for children should be further encouraged, so as to ensure
the safety, effectiveness, accessibility and compliance of medication for children. |
| Key words: World Health Organization Model List of Essential Medicines for Children National Essential Medicines List digestive
system medicine |
