【摘要】 目的评价国产纳美芬注射液拮抗芬太尼复合麻醉呼吸抑制的有效性和安全性。方法采用多中心、随机、单盲、阳性药物平行对照试验设计。芬太尼复合静脉麻醉患者,手术结束停止丙泊酚输注时,无自主呼吸或呼吸频率<10次·min^-1,或呼吸末二氧化碳分压>6 kPa。试验组予纳美芬0.25μg·kg^-1,累积剂量不超过1μg·kg^-1;对照组予纳洛酮1μg·kg^-1,累积剂量不超过1mg。观察比较2组呼吸恢复率、拔管时间等,并对实验室指标进行评估。结果共入组病例218例,其中试验组110例,对照组108例,无脱落和剔除病例。试验组在用药后10min呼吸恢复率为96.4%,高于对照组（88.0%）,差异显著（P<0.05）。试验组用药后拔管时间（5.4±0.3）min,对照组（6.1±0.4）min,2组差异无显著意义（P>0.05）。试验组不良反应率0.9%（1/110）,对照组2.8%（3/108）,组间无显著差异（P>0.05）,且均可自行缓解。结论纳美芬治疗术后芬太尼过量引起的呼吸抑制,患者呼吸恢复率优于纳洛酮,安全性相似。更多还原

【Abstract】 AIM To evaluate the efficacy and safety of nalmefene injection in the treatment of postoperative respiratory depression after fentanyl general anesthesia.METHODS The study was designed as a randomized,single-blind,positive controlled,parallel and multicenter trial.The patients in the control group were given naloxone with 1μg·kg^-1（cumulative dose less than 1 mg）,while the patients in the trial group were given nalmefene with 0.25μg·kg^-1(cumulative dose less than 1μg·kg^-1) when stopping propofol infusion at the end of operation and the patients with no spontaneous breathing,respiratory rate<10 bmp or PetCO₂>6 kPa under fentanyl intravenous anesthesia.The rate of breathing recovery or extubation time was observed and laboratory indicators were assessed in both groups.RESULTS Two hundred and eighteen patients were enrolled in this study（110 patients in the trial group,108 patients in the control group）.Ten minutes after the treatment,respiratory recovery rate was 96.4%in the trial group and was 88.0%in the control group,with significant difference between the two groups（P<0.05）.Extubation time after the treatment was（5.4±0.3） min in the trial group and（6.1±0.4） min in the control group,and there was no significant difference between the two groups（P>0.05）.The adverse drug reaction rate of nalmefene and naloxone was 0.9%（1/ 110） and 2.8%（3/108） respectively,and there was no significant difference between the two groups（P>0.05）.CONCLUSION Halmefene are effective and safe in the treatment of postoperative respiratory depression caused by fentanyl overdose,but nalmefene is superior to naloxone in respiratory recovery.更多还原