BACKGROUND Although cases of anaphylaxis caused by sugammadex have been reported, its incidence remains uncertain. Conversely, no studies have evaluated the incidence of anaphylaxis to neostigmine. METHODS This was a retrospective multicentre observational study of patients who underwent surgery under general anaesthesia between 2012 and 2016 to compare the incidence of anaphylaxis with sugammadex with that of neostigmine at four tertiary hospitals in Japan. To ensure the quality of diagnosis, only cases with a clinical history suggestive of anaphylaxis, along with positive results from in vitro or in vivo testing, were assessed. RESULTS From a total of 49 532 patients who received general anaesthesia included in this study, 18 cases of anaphylaxis were reported, of which six were attributable to sugammadex and none to neostigmine. There were no fatalities attributable to anaphylaxis. The incidence of anaphylaxis caused by all drugs or by sugammadex was calculated as 0.036% (95% confidence interval [CI]: 0.022-0.057%) and 0.02% (of the number of sugammadex cases) (95% CI: 0.007-0.044%), respectively. CONCLUSIONS The results suggest that neostigmine might be safer than sugammadex when assessing only the incidence of anaphylaxis. We believe that there is room for reconsideration of the choice of reversal agent for neuromuscular blocking agents by all anaesthetists. CLINICAL TRIAL REGISTRATION UMIN000022365; UMIN000033561.

中文翻译：

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Sugammadex与新斯的明之间过敏反应的发生率比较：一项回顾性多中心观察性研究。

背景技术尽管已经报道了由舒玛葡聚糖引起的过敏反应病例，但其发生率仍不确定。相反，没有研究评估新斯的明的过敏反应发生率。方法这是一项回顾性多中心观察性研究，研究对象是在2012年至2016年间接受全麻手术的患者，以比较日本四家三级医院的sugammadex和新斯的明的过敏反应发生率。为了确保诊断的质量，仅评估具有过敏史的临床病史的病例，以及体外或体内试验的阳性结果。结果本研究共纳入49 532例接受全身麻醉的患者，其中有18例发生了过敏反应，其中6例归因于舒美葡糖，而无一归因于新斯的明。没有因过敏反应而导致的死亡。所有药物或sugammadex引起过敏反应的发生率分别计算为0.036％（95％置信区间[CI]：0.022-0.057％）和0.02％（占sugammadex病例数）（95％CI：0.007-0.044％） ）， 分别。结论结果表明，仅评估过敏反应的发生率时，新斯的明可能比舒美葡糖更安全。我们认为，所有麻醉师都有重新考虑神经肌肉阻滞剂逆转剂选择的余地。临床试验注册UMIN000022365; UMIN000033561。分别。结论结果表明，仅评估过敏反应的发生率时，新斯的明可能比舒美葡糖更安全。我们认为，所有麻醉师都有重新考虑神经肌肉阻滞剂逆转剂选择的余地。临床试验注册UMIN000022365; UMIN000033561。分别。结论结果表明，仅评估过敏反应的发生率时，新斯的明可能比舒美葡糖更安全。我们认为，所有麻醉师都有重新考虑神经肌肉阻滞剂逆转剂选择的余地。临床试验注册UMIN000022365; UMIN000033561。