| 本文已被：浏览 160次 下载 112次 |
码上扫一扫！ |
| 中国儿科麻醉超说明书用药情况调研 |
| 张莹1,贺思洁1,覃娴雅1,王芳2,陈林1,徐恒1,张潇月3,张胜男3,万蒞1,王晓玲2 |
|
|
| (1. 湖北省妇幼保健院,武汉
430070;2. 首都医科大学附属北京儿童医院,北京 100045;3. 郑州大学附属儿童医院,郑州 450000) |
|
| 摘要: |
| 目的:调查我国儿科麻醉领域超说明书用药(OLDU)的现状与核心特征,分析驱动因素与风险,并提出系统性管理策略。
方法:采用横断面调查设计,于2025 年7-12 月,在全国6 大行政区抽取24 所三级甲等儿童专科医院或妇幼保健院。通过自拟
问卷,对麻醉医师、药师等专业人员展开调查。结果:本调研共发放问卷32 份,回收有效问卷32 份,有效回收率100. 0%。涉及
37 种常见麻醉用药,其中超年龄使用25 种(67. 6%),超剂量使用14 种(37. 8%),超适应证使用7 种(18. 9%),超给药途径使用
6 种(16. 2%)。超年龄以低龄儿童群体为主,尤其是新生儿;超剂量多因药品说明书儿童剂量信息缺失;超适应证与超给药途
径则主要源于临床实际需求。主要驱动因素包括儿童专用制剂缺乏、说明书更新滞后及危重症救治急需。结论:儿科麻醉中
OLDU 现象普遍且风险集中,其根源在于儿童用药证据缺失。亟待构建“政策激励、标准引导、实践优化”三位一体的系统应对
策略,从源头鼓励研发、中端规范实践、末端强化监测,形成管理闭环,以规范临床用药行为,保障患儿安全。 |
| 关键词: 儿科麻醉 超说明书用药 横断面调查 合理用药 管理策略 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2026.05.006 |
|
| 基金项目: |
|
| Investigation on Off-Label Drug Use in Pediatric Anesthesia |
| Zhang Ying1, He Sijie1, Qin Xianya1, Wang Fang2, Chen Lin1, Xu Heng1, Zhang Xiaoyue3, Zhang Shengnan3,
Wan Li1, Wang Xiaoling2 |
| (1. Maternal and Child Health Hospital of Hubei Province, Wuhan 430070, China; 2. Beijing Children’s
Hospital, Capital Medical University, Beijing 100045, China; 3. Children’s Hospital Affiliated to Zhengzhou University, Zhengzhou
450000, China) |
| Abstract: |
| Objective: To investigate the current status and core characteristics of off-label drug use in pediatric anesthesia in China,
analyze driving factors and risks, so as to propose systematic management strategies. Methods: A cross-sectional survey design was
employed from Jul. to Dec. 2025, selecting 24 grade Ⅲ, level A children’s hospitals or maternal and child health hospitals across six
major administrative regions nationwide. A self-designed questionnaire was administered to anesthesiologists, pharmacists, and other
relevant professionals. Results: A total of 32 questionnaires were distributed, and 32 valid questionnaires were retrieved, with an
effective recovery rate of 100%. Among 37 commonly used anesthetic drugs, off-label use by age was observed in 25 drugs (67. 6%),
off-label use by dose in 14 drugs (37. 8%), off-label use by indication in 7 drugs (18. 9%), and off-label use by route of administration
in 6 drugs (16. 2%). Off-label use by age was predominantly observed in younger pediatric populations, especially newborns. Off-label
use by dose was mainly due to missing pediatric dosage information in drug instructions. Off-label use by indication and route mainly
stemmed from clinical needs. The primary driving factors included the lack of pediatric-specific formulations, delays in updating drug
instructions, and urgent need for critical care treatment. Conclusion: Off-label drug use in pediatric anesthesia is prevalent with
concentrated risks, fundamentally stemming from insufficient evidence for pediatric drug use. It is urgent to establish a three-pronged
systematic strategy of “ policy incentives-standard guidance-practice optimization”, forming a closed-loop management system that
encourages research at the source, standardizes practices at the intermediate level, and strengthens monitoring at the final stage, in order
to standardize clinical medication practices and ensure the safety of pediatric patients. |
| Key words: pediatric anesthesia off-label drug use cross-sectional survey rational drug use management strategy |
