Lyu Qiang, Ye Pei, Zhang Hewei, Ye Xiaofei, Zheng Yi, Xu Jinfang, Chen Xiao, Chen Chenxin, Guo Xiaojing
Basic Medical College, Naval Medical University, Shanghai, China.
92608 Militang Hospital of PLA, Shanghai, China.
Br J Clin Pharmacol. 2023 Feb;89(2):449-457. doi: 10.1111/bcp.15417. Epub 2022 Jun 8.
Residual neuromuscular blockade is a common complication after general anaesthesia. Sugammadex can reverse the action of aminosteroid neuromuscular blockers. This study aimed to explore sugammadex safety issues in the real world and determine the spectrum of adverse reactions.
All sugammadex-related adverse events reported in VigiBase between 2010 and 2019 were classified by group queries according to the Medical Dictionary for Regulatory Activities. A disproportionality analysis of data was performed using the information component (IC); positive IC values were deemed significant.
Overall, 16 219 410 adverse events were reported and 2032 were associated with sugammadex. The frequent reactions were recurrence of neuromuscular blockade (n = 54, IC 6.74, IC 6.33), laryngospasm (n = 53, IC 6.05, IC 5.64), bronchospasm (n = 119, IC 5.63, IC 5.36) and bradycardia (n = 169, IC 5.13, IC 4.90). Fatal cases were more likely among patients with cardiac disorders, especially those over 65 years. In addition, the common adverse drug reactions (ADRs) differed between different age groups (P < .01). ADRs were higher in the 0-17 years age group than in other age groups. The onset time of common ADRs was typically within 1 day and 68.9% occurred within half an hour after sugammadex administration.
Anaesthesiologists should carefully monitor the anaesthesia recovery period to correct the ADRs caused by sugammadex and recommend monitoring neuromuscular function throughout the anaesthesia process. Sugammadex should be used carefully in patients with cardiovascular diseases, and electrocardiography and hemodynamic changes should be monitored after medication.
残余肌松是全身麻醉后常见的并发症。舒更葡糖钠可逆转氨基甾体类肌松药的作用。本研究旨在探讨舒更葡糖钠在现实世界中的安全性问题，并确定不良反应谱。
根据《药物监管活动医学词典》，通过分组查询对2010年至2019年期间VigiBase中报告的所有与舒更葡糖钠相关的不良事件进行分类。使用信息成分（IC）对数据进行不成比例分析；IC值为正被视为有统计学意义。
总体而言，共报告了16219410例不良事件，其中2032例与舒更葡糖钠有关。常见反应包括肌松恢复（n = 54，IC 6.74，IC 6.33）、喉痉挛（n = 53，IC 6.05，IC 5.64）、支气管痉挛（n = 119，IC 5.63，IC 5.36）和心动过缓（n = 169，IC 5.13，IC 4.90）。心脏疾病患者，尤其是65岁以上患者发生致命病例的可能性更高。此外，不同年龄组的常见药物不良反应（ADR）有所不同（P <.01）。0至17岁年龄组的ADR高于其他年龄组。常见ADR的发生时间通常在1天内，68.9%发生在给予舒更葡糖钠后半小时内。
麻醉医生应在麻醉恢复期仔细监测，以纠正舒更葡糖钠引起的ADR，并建议在整个麻醉过程中监测神经肌肉功能。心血管疾病患者应谨慎使用舒更葡糖钠，用药后应监测心电图和血流动力学变化。
