Zhao Yanhua, Ren Yuqing, Xie Wenqin, Wang Yulan, Lei Yishan, Zhu Yingxia, Zhang Xiaoqing, Wu Xiaozhi, Guo Xiaoming, Jiang Yingying, Wang Saiying, Lei Qian, You Jiyue, Yu Yonghao, Zhou Yinhui, Zhou Wenjuan, Xu Guohai, Li Chang, Gu Zhengfeng, Luo Foquan, Wang Hongfa, Chen Junping, Wang Ruichun, Qi Youmao, Jie Qing, Su Diansan, Gu Xiyao, Yu Weifeng
Department of Anaesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Key Laboratory of Anaesthesiology (Shanghai Jiao Tong University), Ministry of Education, Shanghai, China.
Department of Anaesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, China.
Br J Anaesth. 2025 Aug;135(2):331-339. doi: 10.1016/j.bja.2025.04.031. Epub 2025 Jun 2.
Adamgammadex, a newly developed modified γ-cyclodextrin derivative, has demonstrated efficacy in reversing deep rocuronium-induced neuromuscular block in early clinical trials.
This multicentre, randomised, double-blind, positive-controlled, noninferiority phase III clinical trial aimed to investigate the efficacy and safety of adamagammadex compared with sugammadex in reversing deep rocuronium-induced neuromuscular block. In total, 321 patients were randomly assigned to either the adamgammadex 8 mg kg group or the sugammadex 4 mg kg group. The primary outcome was the success rate of antagonism, defined as recovery of the train-of-four ratio (TOFR) to 0.9 within 10 min. Standard safety data were collected throughout the trial period.
For the primary efficacy outcome, the success rate for recovery of TOFR to 0.9 was 98.7% in the adamgammadex group and 100% in the sugammadex group, with an observed difference of -1.3% (95% confidence interval [CI] -4.6%, 1.2%). The lower limit of -4.6% was higher than the noninferiority margin of -10%. For the key secondary efficacy outcomes, the median (interquartile range) time from administration of adamgammadex or sugammadex to recovery of TOFR to 0.9 was 2.5 (2.0, 3.2) min and 2.2 (1.7, 2.7) min, respectively. The difference was 0.5 min (95% CI 0.3, 0.7), and the upper limit of 0.7 min was lower than the noninferiority margin of 5 min. We observed no inferiority in secondary efficacy outcomes. There was no significant difference in the safety profile between adamgammadex and sugammadex.
Adamgammadex was noninferior to sugammadex in reversing deep neuromuscular block from rocuronium.
Chinese Clinical Trial Registry (ChiCTR2200056471, registered February 6, 2022; https://www.chictr.org.cn/showproj.html?proj=141077).
阿法伽马环糊精（Adamgammadex）是一种新开发的改性γ-环糊精衍生物，早期临床试验已证明其在逆转深度罗库溴铵诱导的神经肌肉阻滞方面有效。
这项多中心、随机、双盲、阳性对照、非劣效性III期临床试验旨在研究阿法伽马环糊精与舒更葡糖钠相比在逆转深度罗库溴铵诱导的神经肌肉阻滞方面的有效性和安全性。总共321例患者被随机分配至阿法伽马环糊精8 mg/kg组或舒更葡糖钠4 mg/kg组。主要结局为拮抗成功率，定义为四个成串刺激比值（TOFR）在10分钟内恢复至0.9。在整个试验期间收集标准安全性数据。
对于主要疗效结局，阿法伽马环糊精组TOFR恢复至0.9的成功率为98.7%，舒更葡糖钠组为100%，观察到的差异为-1.3%（95%置信区间[CI]-4.6%，1.2%）。-4.6%的下限高于-10%的非劣效界值。对于关键次要疗效结局，从给予阿法伽马环糊精或舒更葡糖钠至TOFR恢复至0.9的中位（四分位间距）时间分别为2.5（2.0，3.2）分钟和2.2（1.7，2.7）分钟。差异为0.5分钟（95%CI 0.3，0.7），0.7分钟的上限低于5分钟的非劣效界值。我们观察到次要疗效结局无劣效性。阿法伽马环糊精和舒更葡糖钠在安全性方面无显著差异。
在逆转罗库溴铵所致深度神经肌肉阻滞方面，阿法伽马环糊精不劣于舒更葡糖钠。
中国临床试验注册中心（ChiCTR2200056471，于2022年2月注册；https://www.chictr.org.cn/showproj.html?proj=141077）。
