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目的比较全球现有儿童基本药物目录与中国2012年版国家基本药物目录的异同,为建立中国儿童基本药物目录提供参考依据。方法计算机检索世界卫生组织(WHO)官网及英文、中文国家卫生部及药品监督管理部门网站,查找已颁布的儿童基本药物目录(essential medicine list for children,EMLc),对比各国EMLc与中国2012年版国家基本药物目录的更新情况、药物数量、分类、药物剂型等的异同。结果截至2013年8月,WHO、印度和南非已建立儿童基本药物目录。中国目录因未限制使用人群,数量居所有目录首位。WHO、印度和中国均采用药理学分类;南非采用解剖学、治疗学及化学分类法(anatomical therapeutic chemical,ATC)分类。除WHO外,印度、南非和中国目录均无新生儿用药和关节疾病用药分类。四版目录均以口服、注射和局部皮肤给药为主。WHO与印度目录有药物使用限制,南非、中国无使用限制。结论中国2012年版国家基本药物目录下药物种类与儿童疾病负担不适应、儿童适用剂型缺乏、未制定用药限制,此版目录于儿童适用性存在较大局限。
Objective To compare the similarities and differences between the existing list of essential medicines for children in the world and the 2012 edition of the national essential medicines list in China and provide references for the establishment of the directory of essential medicines for children in China. Methods The website of the World Health Organization (WHO) and English, Chinese Ministry of Health and Drug Administration were searched by computer to find out the EMRs of EMLc and the 2012 edition of China Similarities and differences in the update of essential medicines list, quantity of medicines, classification, medicine dosage forms, etc. Results As of August 2013, WHO, India and South Africa have established a directory of essential medicines for children. China directory due to unrestricted use of the population, ranking first in all directories. Pharmacological classification is used by WHO, India and China; anatomical, therapeutic and chemical classification (ATC) categories are used in South Africa. In addition to the WHO, there are no neonatal and joint disease drug classes in India, South Africa and China. The fourth edition of the directory are oral, local skin and injection-based. WHO and India directory has drug restrictions, South Africa, China without restrictions. Conclusions China’s 2012 edition of the National Essential Medicines List does not meet the drug burden of childhood diseases. There is a lack of suitable dosage forms for children and there is no drug restriction. This version of the catalog has limited applicability in children.