| アブストラクト | AIM: 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. METHODS: 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. RESULTS: 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(025) 6.33), laryngospasm (n = 53, IC 6.05, IC(025) 5.64), bronchospasm (n = 119, IC 5.63, IC(025) 5.36) and bradycardia (n = 169, IC 5.13, IC(025) 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. CONCLUSIONS: 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. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| 投稿日 | 2022/5/25 |
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| 投稿者 | Lyu, Qiang; Ye, Pei; Zhang, Hewei; Ye, Xiaofei; Zheng, Yi; Xu, Jinfang; Chen, Xiao; Chen, Chenxin; Guo, Xiaojing |
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| 組織名 | Basic Medical College, Naval Medical University, Shanghai, China.;92608 Militang Hospital of PLA, Shanghai, China.;Department of Anaesthesiology, Huadong Hospital Affiliated to Fudan University,;Shanghai, China.;Department of Health Statistics, Faculty of Health Service, Naval Medical;University, Shanghai, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35607986/ |
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