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日本围手术期过敏症的流行病学研究,一项前瞻性全国性研究:全身麻醉期间的过敏原暴露、流行病学和过敏反应的诊断。

The Japanese Epidemiologic Study for Perioperative Anaphylaxis, a prospective nationwide study: allergen exposure, epidemiology, and diagnosis of anaphylaxis during general anaesthesia.

机构信息

Intensive Care Unit, Gunma University Hospital, Maebashi, Japan.

Department of Anesthesiology, Gunma University Graduate School of Medicine, Maebashi, Japan.

出版信息

Br J Anaesth. 2023 Jul;131(1):159-169. doi: 10.1016/j.bja.2023.02.018. Epub 2023 Mar 27.

DOI:10.1016/j.bja.2023.02.018
Abstract

BACKGROUND

Diagnosis of perioperative anaphylaxis is often challenging. This study describes the utility of a newly developed tool for identifying patients with a high possibility of anaphylaxis, and aimed to investigate the frequency of anaphylaxis with each drug during the perioperative period in Japan.

METHODS

This study included patients with anaphylaxis of Grade 2 or higher severity during general anaesthesia at 42 facilities across Japan in 2019 and 2020. We developed and adopted a unique objective evaluation tool yielding a composite score for diagnosing anaphylaxis, which includes the results of skin tests and basophil activation tests, and clinical scores for perioperative anaphylaxis. The number of cases using each drug and the total number of anaphylaxis cases were investigated to calculate the frequency of anaphylaxis.

RESULTS

General anaesthesia was performed in 218 936 cases, which included 55 patients with suspected perioperative anaphylaxis. The developed composite score diagnosed 43 of them with a high probability of anaphylaxis. The causative agent was identified in 32 cases. Plasma histamine levels showed high diagnostic accuracy for anaphylaxis. The top causative agents were rocuronium (10 cases in 210 852 patients, 0.005%), sugammadex (7 cases in 150 629 patients, 0.005%), and cefazolin (7 cases in 106 005 patients, 0.007%).

CONCLUSIONS

We developed a composite tool to diagnose anaphylaxis, and found that the combination of tryptase levels, skin testing, and basophil activation testing results and clinical score improved the certainty of anaphylaxis diagnosis. The incidence of perioperative anaphylaxis in our study was 1 in about 5000 general anaesthesia cases.

CLINICAL TRIAL REGISTRATION

UMIN000035350.

摘要

背景

围手术期过敏反应的诊断常常具有挑战性。本研究描述了一种新开发的工具,用于识别极有可能发生过敏反应的患者,并旨在调查日本围手术期每种药物发生过敏反应的频率。

方法

本研究纳入了 2019 年和 2020 年在日本 42 家机构接受全身麻醉时发生 2 级或更严重过敏反应的患者。我们开发并采用了一种独特的客观评估工具,该工具可得出用于诊断过敏反应的综合评分,包括皮肤试验和嗜碱性粒细胞激活试验的结果以及围手术期过敏反应的临床评分。调查了使用每种药物的病例数和过敏反应总病例数,以计算过敏反应的频率。

结果

全身麻醉共实施了 218936 例,其中 55 例疑似围手术期过敏反应。开发的综合评分诊断出其中 43 例具有高度过敏反应的可能性。在 32 例病例中确定了致病药物。血浆组胺水平对过敏反应具有较高的诊断准确性。最主要的致病药物是罗库溴铵(210852 例患者中有 10 例,0.005%)、舒更葡糖(150629 例患者中有 7 例,0.005%)和头孢唑林(106005 例患者中有 7 例,0.007%)。

结论

我们开发了一种用于诊断过敏反应的综合工具,发现结合了类胰蛋白酶水平、皮肤试验、嗜碱性粒细胞激活试验结果和临床评分,可提高过敏反应诊断的确定性。本研究中围手术期过敏反应的发生率约为每 5000 例全身麻醉病例 1 例。

临床试验注册

UMIN000035350。

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