中国药物警戒 ›› 2025, Vol. 22 ›› Issue (8): 896-901.
DOI: 10.19803/j.1672-8629.20250342

• 基础与临床研究 • 上一篇    下一篇

舒更葡糖钠对腹腔镜全盆底重建术后患者恢复的影响

李明颖1, 张晓霞1, 孙晓黎1, 赵燕2*, 何苗1, 李艳玲3, 段薇3, 杨鸥3   

  1. 1首都医科大学附属北京朝阳医院麻醉科,北京 100043;
    2国家食品药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100076;
    3首都医科大学附属北京朝阳医院手术室,北京 100043
  • 收稿日期:2025-05-28 出版日期:2025-08-15 发布日期:2025-08-13
  • 通讯作者: *赵燕,女,硕士,高级工程师,医疗器械不良事件监测与评价。E-mail: zhaoyan@cdr-adr.org.cn
  • 作者简介:李明颖,男,博士,副主任医师,临床麻醉与器官保护。
  • 基金资助:
    国家重点研发计划（2021YFC2701300）; 盆底重建手术移植物并发症的登记研究及评价标准化与质量管理（2021YFC2701302）

Effect of Sugammadex on Recovery of Patients after Laparoscopic Total Pelvic Floor Reconstruction

LI Mingying1, ZHANG Xiaoxia1, SUN Xiaoli1, ZHAO Yan2*, HE Miao1, LI Yanling3, DUAN Wei3, YANG Ou3   

  1. 1Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100043, China;
    2Center for Drug Reevaluation, National Center for ADR Monitoring, NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
    3Operating Room, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100043, China
  • Received:2025-05-28 Online:2025-08-15 Published:2025-08-13

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摘要： 目的 评估舒更葡糖钠对腹腔镜全盆底重建术后患者肌松恢复及安全性的影响。方法 采用单中心回顾性队列研究,纳入101例腹腔镜全盆底重建术患者,根据术后肌松拮抗方案分为舒更葡糖钠组（S组,n=20）、新斯的明组（N组,n=33）及无拮抗组（C组,n=48）。主要结局为拔管时间,次要结局包括麻醉恢复室（Post-Anesthesia Care Unit,PACU）停留时间、全麻苏醒期不良事件发生率等。组间比较采用单因素方差分析、χ²检验或Fisher精确概率法（α=0.05）。结果 S组拔管时间较N组和C组显著缩短[（3.1±1.5）min vs（6.9±2.3）min、（5.7±1.2）min,P<0.001];S组PACU停留时间显著短于N组[（29.8±10.1）min vs（36.7±9.5）min,P<0.017]。S组全麻苏醒期不良事件发生率显著低于N组（15% vs 48.5%,P<0.001）,主要表现为N组恶心的发生率及心血管事件如高血压、心动过速等发生率较高。结论 舒更葡糖钠可快速拮抗罗库溴铵的肌松作用,显著缩短腹腔镜全盆底重建术患者拔管时间及PACU停留时间,降低苏醒期不良事件发生率,其临床应用符合加速康复外科理念。

关键词: 舒更葡糖, 腹腔镜, 全盆底重建术, 神经肌肉阻滞药, 治疗效果, 药品不良反应

Abstract: Objective To evaluate the role of sugammadex in neuromuscular blockade (NMB) recovery and safety in patients undergoing laparoscopic total pelvic floor reconstruction (LTPFR) surgery. Methods A single-center retrospective cohort study was conducted. One hundred and one patients undergoing LTPFR were enrolled and divided into three groups based on their postoperative antagonism of NMB, including the sugammadex group (S-group, n=20), neostigmine group (N-group, n=33), and no-antagonism group (C-group, n=48). The primary outcome was the time to extubation, and the secondary outcomes included the length of stay at the post-anesthesia care unit (PACU) and the incidence of adverse events during recovery from general anesthesia. Such statistical methods as one-way ANOVA, χ² test, or Fisher’s exact test were used to make a comparison between the groups with the significance level set at α=0.05. Results The time to extubation in S-group was significantly shorter than that of N-group and C-group [(3.1±1.5) min vs (6.9±2.3) min and (5.7±1.2) min, P<0.001)]. The stay at the PACU in S-group was significantly shorter than that of N-group [(29.8±10.1) min vs (36.7±9.5) min, P<0.017]. The incidence of adverse events during recovery in S-group was significantly lower than that of N-group (15% vs 48.5%,P<0.001). The adverse events primarily manifested as nausea and cardiovascular events such as hypertension and tachycardia in N-group. Conclusion Sugammadex can rapidly reverse rocuronium-induced NMB, significantly shorten the time to extubation and PACU stay in patients undergoing LTPFR, and reduce the incidence of adverse events during recovery. Its clinical applications conform to the principles of Enhanced Recovery After Surgery (ERAS).

Key words: Sugammadex, Laparoscopes, Total Pelvic Floor Reconstruction, Neuromuscular Blocking Agents, Treatment Outcome, Adverse Drug Reactions

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