| 摘要: |
| ［摘要］ 目的 分析5 kg以下婴儿头颅磁共振成像（MRI）检查中咪达唑仑口腔黏膜给药镇静的90%有效剂量（ED90）。方法 招募2024年3月至10月于广西壮族自治区妇幼保健院行镇静下头颅MRI检查的体质量<5 kg的婴儿。根据有偏硬币设计法依次对纳入婴儿进行镇静干预。第一例婴儿的咪达唑仑口服液的口腔黏膜给药剂量为0.15 mg/kg，后续婴儿的药物剂量根据前一例婴儿的镇静结果选择：（1）如前一例婴儿镇静失败，则该例婴儿咪达唑仑口服液口腔黏膜给药的剂量在前一例婴儿药物剂量的基础上增加一个单位剂量（0.05 mg/kg）；（2）如前一例婴儿镇静成功，则该婴儿所用咪达唑仑剂量依有偏硬币随机方法保持原药物剂量（概率为89%）或减少一个单位剂量（概率为11%）。当镇静成功例数达到45例时停止试验，计算ED90，并采用保序回归与自助算法推算95%有效剂量（ED95）和99%有效剂量（ED99）。结果 该研究共纳入53例婴儿，其中45例镇静成功，8例镇静失败。5 kg以下婴儿MRI检查中咪达唑仑口腔黏膜给药镇静的ED90为0.295 mg/kg（95%CI=0.236～0.335 mg/kg），经保序回归与自助算法推算，其ED95为0.325 mg/kg（95%CI=0.289～0.345 mg/kg），ED99为0.347 mg/kg（95%CI=0.340～0.364 mg/kg）。结论 5 kg以下婴儿头颅MRI检查中咪达唑仑口腔黏膜给药镇静的ED90为0.295 mg/kg（95%CI=0.236～0.335 mg/kg）。 |
| 关键词: 咪达唑仑 口腔黏膜给药 磁共振成像 镇静 90%有效剂量 婴儿 |
| DOI：10.3969/j.issn.1674-3806.2025.10.16 |
| 分类号: |
| 基金项目:广西壮族自治区卫生健康委科研项目（编号：Z-A20230359） |
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| The 90% effective dose of midazolam for oral mucosal administration for sedation during head magnetic resonance imaging examination in infants weighing less than 5 kg |
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LAN Jiangli, ZHENG Jianqiu, DENG Lingyan, CHEN Ying, HONG Wei, PAN Lixia, FENG Jifeng
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Department of Anesthesiology, Maternity and Child Health Care of Guangxi Zhuang Autonomous Region, Nanning 530000, China
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| Abstract: |
| ［Abstract］ Objective To analyze the 90% effective dose(ED90) of midazolam for oral mucosal administration for sedation during head magnetic resonance imaging(MRI) examination in infants weighing less than 5 kg. Methods The infants who underwent head MRI examination under sedation in Maternity and Child Health Care of Guangxi Zhuang Autonomous Region from March 2024 to October 2024 were recruited. Sedative intervention was conducted on the included infants in sequence using a biased-coin design method. The first infant received midazolam oral solution at a dose of 0.15 mg/kg through oral mucosal route of administration. The dose for each subsequent infant was determined based on the sedation outcome of the previous infant: (1)If the previous infant experienced sedation failure, the current infant received midazolam oral solution at a dose increased by 1 unit(0.05 mg/kg) through oral mucosal route of administration compared to the previous dose given to the the previous infant. (2)If the previous infant achieved success of sedation, the dose for the current infant was either maintained(with 89% probability) or reduced by 1 unit(with 11% probability) using a biased-coin design method. The trial was terminated when the number of successful sedation cases reached 45. The ED90 was calculated, and isotonic regression with bootstrap resampling was employed to estimate the 95% effective dose(ED95) and the 99% effective dose(ED99). Results A total of 53 infants were included in this study, among whom 45 infants were successfully sedated and 8 infants failed to be sedated. The ED90 of midazolam administered via the oral mucosal route for sedation during MRI examination in the infants weighing less than 5 kg was 0.295 mg/kg(95%CI=0.236-0.335 mg/kg). After calculation using isotonic regression and bootstrap resampling, the ED95 was estimated to be 0.325 mg/kg(95%CI=0.289-0.345 mg/kg) and the ED99 was estimated to be 0.347 mg/kg(95%CI=0.340-0.364 mg/kg). Conclusion The ED90 of midazolam administered via oral mucosal route for sedation during head MRI examination in infants weighing less than 5 kg is 0.295 mg/kg(95%CI=0.236-0.335 mg/kg). |
| Key words: Midazolam Oral mucosal administration Magnetic resonance imaging(MRI) Sedation 90% Effective dose(ED90) Infants |
