国产与进口舒更葡糖钠拮抗成人患者罗库溴铵深度肌松效果的对比分析  

Comparative analysis of the efficacy of domestic and imported sugammadex for reversal of rocuronium-induced deep neuromuscular block in adult patients

作　　者：杨雪媛[1] 耿志宇[1] 王东信[1] 吴新民[1] 李雪迎[2] Yang Xueyuan;Geng Zhiyu;Wang Dongxin;Wu Xinmin;Li Xueying(Department of Anesthesiology,Peking University First Hospital,Beijing 100034,China;Department of Biomedical Statistics,Peking University First Hospital,Beijing 100034,China)

机构地区：[1]北京大学第一医院麻醉科,北京100034 [2]北京大学第一医院医学统计室,北京100034

出　　处：《中华医学杂志》2025年第3期233-239,共7页National Medical Journal of China

摘　　要：目的分析国产与进口舒更葡糖钠拮抗成人罗库溴铵深度肌松患者的效果。方法前瞻性纳入北京大学第一医院2023年6月至2024年6月择期行全身麻醉手术且术中需要使用肌松药的成年患者的临床资料,按照随机数字表法分为国产组和进口组。所有患者以丙泊酚、瑞芬太尼和七氟烷维持麻醉,以罗库溴铵辅助气管插管和维持肌松,监测神经肌肉阻滞的效果。在深度肌松(强直刺激后单次刺激肌颤搐计数为1~2)时,分别给予两组国产与进口舒更葡糖钠4 mg/kg。主要结局指标为4个成串刺激比值(TOFr)恢复至0.9的时间,非劣效性界值为1 min(非劣效性界值范围为±1 min)。次要指标为TOFr恢复至0.9的不同时间比率及出现的不良事件。结果共纳入70例患者,国产组35例,男13例,女22例,年龄(46.9±12.7)岁;进口组35例,男13例,女22例,年龄(45.7±11.5)岁。两组患者人口学特征、手术时间、麻醉时间、术中罗库溴铵总量、术后拔管时间差异均无统计学意义(均P>0.05)。所有患者的TOFr均在5 min内恢复到0.9。国产组和进口组TOFr恢复至0.9的时间[M(Q1,Q3)]分别为1.8(1.3,2.6)min和2.0(1.7,2.9)min,两组间差值为-0.40 min(95%CI:-0.75~-0.02,P=0.039),差值在非劣效性界值的区间之内。在给予拮抗药物5 min内,国产组和进口组心动过缓的发生率均为14%(5/35和5/35);两组患者转运至麻醉后恢复室(PACU)皮肤过敏的发生率分别为3%(3/35)和0,差异均无统计学意义(均P>0.05)。两组患者均未见严重的药物相关的不良事件。结论国产舒更葡糖钠拮抗成年患者罗库溴铵深度肌松的效果并不劣于进口舒更葡糖钠,且不增加术后不良事件的发生率。Objective To evaluate the efficacy of domestic and imported sugammadex for reversal of rocuronium-induced deep neuromuscular block(NMB)in adult patients.Methods The clinical data of adult patients who scheduled for elective surgery with general anesthesia that required muscle relaxants in Peking University First Hospital from June 2023 to June 2024 were prospectively included.The patients were devided into domestic group and imported group according to random number table method.Anesthetized patients received rocuronium for intubation and muscle relaxation,and anesthesia was maintained with propofol,sevoflurane,and remifentanil.The effect of neuromuscular block was monitored.During deep muscle relaxation(with a single stimulation muscle twitch count of 1-2 after tetanic stimulation),domestic and imported sugammadex 4 mg/kg was given,respectively.The primary outcome was the recovery time from sugammadex injection to return of the train-of-four ratio(TOFr)to 0.9,with a non-inferiority margin of 1 minute(the range of non-inferiority boundary value is±1 minute).The secondary outcome included the ratios of TOFr to 0.9 at different times and adverse effects.Results A total of 70 patients were included,including 35 patients in the domestic group(13 males and 22 females),aged(46.9±12.7)years,and 35 patients in the imported group(13 males and 22 females),aged(45.7±11.5)years.There was no statistically significant difference in demographic characteristics,surgical time,anesthesia time,total rocuronium dose,and extubation time between two groups.All patients recovered to a TOFr of 0.9 within 5 minutes.Reversal time was 1.8(1.3,2.6)minutes in the domestic sugammadex group and 2.0(1.7,2.9)minutes in the imported sugammadex group respectively.The difference in reversal times between two groups was-0.40 minutes(95%CI:-0.75 to-0.02,P=0.039),which was within the range of non-inferiority threshold.Within 5 minutes of administration of antagonists,the incidence of bradycardia was 14%(5/35 and 5/35)in both domestic and imported g

关 键 词：神经肌肉阻滞 深度肌松 舒更葡糖钠 罗库溴铵 非劣效性 

分 类 号：R614[医药卫生—麻醉学]