2023 年第 12 期 第 18 卷

复合阿芬太尼时甲苯磺酸瑞马唑仑用于无痛人工流产的半数有效量研究

Study on the median effective dose of remimazolam tosilate for painless induced abortion when combined with alfentanil

作者：秦勤

英文作者：Qin Qin

单位：广东省广州市中西医结合医院麻醉二区，广州510800，Email：1103987469@qq.com

英文单位：Second Division Department of Anesthesiology Guangzhou Hospital of Integrated Traditional and Western Medicine Guangdong Province Guangzhou 510800 China Email: 1103987469@qq.com

关键词：人工流产；甲苯磺酸瑞马唑仑；阿芬太尼；半数有效量

英文关键词：Inducedabortion;Remimazolamtosilate;Alfentanil;Medianeffectivedose

• 摘要：

• 目的  确定复合阿芬太尼时甲苯磺酸瑞马唑仑用于无痛人工流产的半数有效量（ED50），为临床合理用药提供参考。方法  选择2022年4—5月广东省广州市中西医结合医院无痛人工流产患者28例。依据改良Dixon序贯试验法，静脉推注阿芬太尼10 μg/kg后，再静脉推注甲苯磺酸瑞马唑仑，初始剂量为0.2 mg/kg，1 min后开始无痛人工流产手术，若手术过程中患者出现体动，下一位患者增加甲苯磺酸瑞马唑仑用药剂量到高一级，否则使用低一级，剂量梯度为0.01 mg/kg，直到出现6次折返停止试验。计算复合阿芬太尼10 μg/kg时甲苯磺酸瑞马唑仑用于无痛人工流产的ED50及95%置信区间。比较入室后即刻和吸宫时患者的平均动脉压、心率、呼吸频率、脉搏血氧饱和度、改良警觉/镇静评分，记录手术结束至患者清醒时间和注射痛、肌肉僵直、恶心呕吐、过敏等药物不良反应发生情况。结果  28例患者手术操作时间(7.1±1.4)min。复合阿芬太尼10 μg/kg时单次静脉推注甲苯磺酸瑞马唑仑用于无痛人工流产的ED50为0.263 mg/kg（95%置信区间：0.252～0.281 mg/kg）。患者吸宫时心率、脉搏血氧饱和度与入室后即刻差异均无计学意义［（76±12）次/min比（77±13）次/min、（99.2±0.8）%比（98.9±1.0）%］(均P>0.05)；吸宫时平均动脉压、呼吸频率、改良警觉/镇静评分低于入室后即刻，差异均有统计学意义（均P<0.05)，但平均动脉压、呼吸频率下降幅度均在基础值20%以内。手术结束至患者清醒时间为（2.2±1.0）min。有1例患者出现静脉注射痛，4例出现恶心呕吐，对症处理后好转。结论  复合阿芬太尼10 μg/kg时甲苯磺酸瑞马唑仑用于无痛人工流产的ED50为0.263 mg/kg，该方法安全有效。

• Objective To determine the median effective dose(ED50) of remimazolam tosilate for painless induced abortion when combined with alfentanil, so as to provide reference for clinical rational drug use. Methods From April to May 2022, 28 patients undergoing painless induced abortion at Guangzhou Hospital of Integrated Traditional and Western Medicine, Guangdong Province were selected. According to the improved Dixon sequential test method, after intravenous infusion of alfentanil 10 μg/kg, remimazolam tosilate was administered intravenously, with an initial dose of 0.2 mg/kg. Painless induced abortion surgery began 1 min later. If the patient experienced physical activity during the surgery, the next patient increased the dosage of remimazolam tosilate to a higher level. Otherwise, a lower level was used, with a dose gradient of 0.01 mg/kg until 6 reversals occurred and the trial was stopped. Calculate the ED50 and 95% confidence interval of remimazolam tosilate for painless induced abortion when combined with 10 μg/kg of alfentanil. The average arterial pressure, heart rate, respiratory rate, pulse oxygen saturation, and improved vigilance/sedation scores of the patients were compared immediately after admission and at the time of uterine aspiration. The time from the end of surgery to patients awakening and the occurrence of adverse drug reactions such as injection pain, muscle stiffness, nausea, vomiting, and allergy were recorded. Results  The surgical procedure time for 28 patients was (7.1±1.4)min. Combined alfentanil 10 μg/kg, the ED50 of a single intravenous injection of remidazolam tosilate for painless induced abortion was 0.263 mg/kg(95% confidence interval: 0.252-0.281 mg/kg). The heart rate and pulse oxygen saturation at the time of uterine aspiration had no statistically significant differences compared with those immediately after admission［(76±12)times/min vs (77±13)times/min, (99.2±0.8)% vs (98.9±1.0)%］(both P>0.05); the mean arterial pressure, respiratory rate, and improved vigilance/sedation scores during uterine aspiration were significantly lower than those immediately after admission(all P<0.05), while the mean arterial pressure and respiratory rate decreased within 20% of the base value. The time from the end of the surgery to patients awakening was (2.2±1.0) min. There was 1 case of intravenous injection pain and 4 cases of nausea and vomiting, which improved after symptomatic treatment. Conclusion When combined with alfentanil 10 μg/kg, the ED50 of remimazolam tosilate in patients undergoing induced abortion was 0.263 mg/kg. It is safe and effective.