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| 麻醉用药药品说明书儿童用药信息标注情况现状调研 |
| 张潇月1,王奇巍2,王芳3,张悦1,邹婧1,刘爽1,王家明1,贾英萍1,王媛1,张胜男1,王晓玲3 |
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|
| (1. 郑州大学附属儿童
医院,郑州 450000;2. 中国医药工业信息中心,上海 200040;3. 首都医科大学附属北京儿童医院,北京 100045) |
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| 摘要: |
| 目的:全面调研麻醉用药国内外药品说明书中儿童用药信息标注情况,揭示当前药品说明书中儿童用药信息标注方面
存在的问题。方法:收集常用麻醉用药国内外药品说明书,使用Excel 软件进行数据的统计与整理,对说明书中儿童用药信息
标注情况进行分析。结果:共收集46 份常用麻醉用药国内外药品说明书,均无儿童专用品种;原研企业和国内企业药品说明书
中儿童用法用量、儿童用药项标注率差异不大;原研企业药品说明书中儿童适应证、儿童注意事项和儿童药代动力学标注率明显
高于国内企业药品说明书。结论:临床常用麻醉用药中,儿童专用品种匮乏。麻醉用药国内药品说明书中儿童用药信息标注有待
完善。国内药品说明书中儿童安全用药数据缺乏。建议相关部门加强监管、鼓励临床研究,以促进儿童合理用药,保障用药安全。 |
| 关键词: 麻醉用药 药品说明书 儿童用药信息 合理用药 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2026.02.001 |
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| 基金项目:基金项目:国家卫生健康委医院管理研究所2024 年度医院药学高质量发展研究项目专项课题,编号NIHAZX202435。 |
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| Investigation and Analysis on Annotation of Medication Information for Children in Instructions of AnestheticDrugs |
| Zhang Xiaoyue1, Wang Qiwei2, Wang Fang3, Zhang Yue1, Zou Jing1, Liu Shuang1, Wang Jiaming1, Jia
Yingping1, Wang Yuan1, Zhang Shengnan1, Wang Xiaoling3 |
| (1. Children’ s Hospital Affiliated to Zhengzhou University,
Zhengzhou 450000, China; 2. China National Pharmaceutical Industry Information Center, Shanghai 200040, China; 3. Beijing
Children’s Hospital, Capital Medical University, Beijing 100045, China) |
| Abstract: |
| Objective: To comprehensively investigate the annotation of medication information for children in domestic and foreign
instructions of anesthetic drugs, and to reveal the problems in the annotation of medication information for children in current drug
instructions. Methods: The domestic and foreign instructions for commonly used anesthetic drugs were collected, Excel software was
used for data statistics and organization, and the annotation of drug information for children in drug instructions was analyzed. Results:
A total of 46 domestic and foreign drug instructions for commonly used anesthetic drugs were collected, and there were no varieties
specifically for children. There was no significant difference in the dosage and usage for children and the annotation rate of children’s
medication items in drug instructions of the original research enterprises and domestic enterprises. The annotation rates of indications,
cautions and pharmacokinetics for children in drug instructions of original enterprise were significantly higher than those in the domestic
enterprise. Conclusion: There is a lack of varieties of anesthetic drugs specifically for children in the clinic. The annotation of
medication information for children in domestic instructions of anesthetic drugs needs to be further improved. There is a lack of data on
safe use for children in domestic drug instructions. It is suggested that relevant departments strengthen the supervision and encourage the
clinical research to promote rational drug use and ensure drug safety for children. |
| Key words: anesthetic drugs drug instructions medication information for children rational drug use |
