| 刘彦会,阮文懿,陈慧颖,郭锐,王晓玲,赵志刚,蔡和平.34家儿童/妇幼医院抗深部真菌药品说明书儿童用药信息标注情况分析[J].中国药事,2023,(11):1244-1251 |
| 34家儿童/妇幼医院抗深部真菌药品说明书儿童用药信息标注情况分析 |
| Analysis of Medication Information for Children in Drug Instructions of Antifungal Drugs in 34 Children's/Maternal Hospitals |
| 投稿时间：2023-05-17 |
| DOI：10.16153/j.1002-7777.2023.11.004 |
| 中文关键词: 抗深部真菌药品 药品说明书 儿童用药信息 合理用药 |
| 英文关键词: antifungal drugs drug instructions medication information for children rational drug use |
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| 中文摘要: |
| 目的：了解我国儿童/妇幼医院常用抗深部真菌药品说明书中儿童用药信息标注情况，为规范药品说明书和临床合理用药提供参考。方法：收集我国34家儿童/妇幼医院常用抗深部真菌药品共计56个品规，对其说明书中儿童用药信息标注情况进行调查分析。结果：34家医院均无儿童专用抗深部真菌药； 56个品规抗深部真菌药中，注射剂和片剂占比较高，分别为50.0%和28.6%；其中，三唑类药品有40个， 占比最高（71.4%）。与原研药品（16个）相比，仿制药品（40个）在儿童用法用量项、儿童不良反应项和儿童药动学参数项中标注占比均较低，分别为67.5%、42.5%和50.0%。此外，56个品规抗深部真菌药物中儿童用药信息具体标注位置欠规范。其中，3个同品种不同生产厂家药品说明书的儿童用药信息标注内容存在差异。结论：我国儿童/妇幼医院尚缺乏儿童专用抗深部真菌药及适宜剂型，尤其说明书标注内容存在儿童用药相关信息缺失、指导意见表述混乱、儿童用药信息修改更新滞后等问题，希望引起药品监督管理部门、药品生产企业和儿科相关医疗机构的重视，不断加强对说明书的管理和规范。 |
| 英文摘要: |
| Objective: To investigate and analyze the children’s medication information in antifungal drug’s instructions in children’s/maternal hospitals, so as to provide references for standardizing drug instructions and rational drug use in clinic. Methods: 56 kinds of drug instructions of antifungal drugs in thirty-four children's/ maternal hospitals were collected, and the labeling information for children medication was investigated and analyzed. Results: In all of 34 hospitals, there were no special antifungal drugs for children. In all 56 drugs, injection and tablet accounted for 50.0% and 28.6% respectively. Among them, there were 40 triazole drugs, accounting for the highest proportion (71.4%). Compared with original drugs (n=16), the generic drugs (n=40) accounted for the lower proportion of labeling in children's usage and dosage terms, children's adverse reactions terms and children's pharmacokinetic parameters terms, accounting for 67.5%, 42.5% and 50.0%, respectively. In addition, the specific labeling positions of children's medication information in 56 antifungal drugs were not standardized. Among them, there were differences in the labeling content of children's medication information in 3 drug instructions of the same variety and different manufacturers. Conclusion: There is a lack of specific antifungal drugs for children and suitable drug dosage forms for children in children's/maternal hospitals in China. There are some problems in the labeling content of drug instructions, such as missing information about children's medication, confusing expression of guidance opinions, delayed modification and update of children's medication information, which should attract the attention of drug regulatory authorities, drug manufacturers and relevant pediatric medical institutions, and continue to strengthen the management and standardization of the instructions. |
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