| 摘要: |
| 目的:调查国内 20 家三级甲等儿童医院抗病毒药品说明书中儿童用药信息标注情况及存在的问题,为完善抗病毒药品
儿童用药信息提供参考。 方法:搜集 110 种抗病毒药品,对药品说明书中儿童用药信息进行调查与分析。 结果:20 家三级甲等
儿童医院儿童均无抗病毒专用药;110 份抗病毒药品中注射剂有 56 份(50. 9%),占比最高;儿童适宜剂型咀嚼片、颗粒剂、分散
片、混悬剂合计 16 份(14. 6%)。 110 份抗病毒药品说明书中儿童适应证、儿童用法用量、儿童用药、儿童禁忌、儿童注意事项、儿
童药代动力学、儿童不良反应标注率分别 8. 2%、37. 3%、50. 6%、0. 9%、12. 7%、38. 2%、23. 6%。 国产抗病毒药品较进口药品儿
童用药信息缺失严重;抗病毒外用制剂较其他剂型儿童用药信息缺失更为严重;抗病毒药品说明书中儿童用药信息标注不规
范,部分儿童用药信息缺乏实际指导意义。 结论:儿童专用抗病毒药品匮乏,抗病毒药品说明书存在儿童用药信息严重缺失、儿
童用药信息标注不规范、缺乏实际指导意义等问题。 建议相关部门鼓励药品生产企业积极开展各年龄段药物临床试验,加强药
品说明书规范管理,积极提高儿童合理用药水平。 |
| 关键词: 抗病毒药品 儿童 药品说明书 用药信息 合理用药 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2025.02.005 |
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| 基金项目: |
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| Investigation and Analysis of Medication Information for Children in Antiviral Drugs in Children in 20Children’s Hospitals |
| Wang Liangfang
1
, Ding Zhen
1
, Li Min
2
, Cai Heping
1 |
| (1. Anhui Children’ s Hospital, Hefei 230032, China; 2. the First
Affiliated Hospital of the University of Science and Technology of China, Hefei 230032, China) |
| Abstract: |
| Objective: To investigate the information labeling of antiviral drugs for children in drug instructions of 20 grade Ⅲ, level A
children’s hospitals in China and the existing problems, so as to provide reference for improving the information of antiviral drugs for
children. Methods: Totally 110 kinds of antiviral drugs were collected and the medication information for children in the drug
instructions was investigated and analyzed. Results: The number of specific antiviral drugs only for children used in 20 grade Ⅲ, level
A children’ s hospitals was 0. And 56 cases (50. 9%) of antiviral drugs were injected, accounting for the highest proportion. The
appropriate dosage forms for children, such as chewable tablets, granules, dispersed tablets and suspension, were 16 cases (14. 6%).
The labeling rates of pediatric indications, pediatric usage and dosage, pediatric medication, pediatric contraindications, pediatric
precautions, pediatric pharmacokinetics, and pediatric adverse drug reactions in the drug instructions of 110 cases of antiviral drugs were
respectively 8. 2%, 37. 3%, 50. 6%, 0. 9%, 12. 7%, 38. 2%, and 23. 6%. The information of domestic antiviral drugs was less than
that of imported drugs in children. The lack of medication information of antiviral external preparation was more severe than that of other
dosage forms in children. Medication information for children in drug instructions of antiviral drugs was not standardized, and some
medication information for children had no practical guiding significance. Conclusion: There is a shortage of antiviral drugs for children,
and there are some problems such as severe lack of medication information for children in drug instructions of antiviral drugs, non-standard
labeling of medication information for children, and lack of practical guiding significance. It is recommended that the relevant
departments encourage drug manufacturers to actively carry out clinical trials of drugs for all age groups, strengthen the standardized
management of drug specifications, and actively improve the rational medication in children. |
| Key words: antiviral drugs children drug instructions medication information rational medication |
