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双盲、多中心、随机对照临床试验比较胰高血糖素与安慰剂在缓解食管性食物嵌塞中的作用。

Double-Blind Multicenter Randomized Clinical Trial Comparing Glucagon vs Placebo in the Resolution of Alimentary Esophageal Impaction.

机构信息

Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain.

Department of Gastroenterology, Hospital de Cabueñes, Gijón, Spain.

出版信息

Am J Gastroenterol. 2024 Jan 1;119(1):87-96. doi: 10.14309/ajg.0000000000002511. Epub 2023 Oct 27.

DOI:10.14309/ajg.0000000000002511
PMID:37734342
Abstract

INTRODUCTION

The aim of this study was to compare the effectiveness of glucagon vs placebo in resolving esophageal foreign body impaction (EFBI), as well as the length of the procedure and adverse events.

METHODS

This was a multicenter, randomized, double-blind trial involving consecutive patients diagnosed with alimentary EFBI. Participants were randomized to receive either 1 mg of intravenous glucagon or placebo. All patients underwent upper endoscopy, and adverse events were assessed through a protocolized telephonic interview 7 days later.

RESULTS

The study included 72 subjects in the glucagon group and 68 in the placebo group. The foreign body was not identified in 23.6% of subjects in the glucagon group and 20.6% of subjects in the placebo group (difference 3%, 95% confidence interval -10.7% to 16.8%, P = 0.67). The median time required to remove the foreign body was similar in both groups 4 minutes (range 2-10) in the glucagon group and 3.5 minutes (range 2-7) in the placebo group (difference 0.5 minutes, 95% confidence interval -1.3 to 2.3; P = 0.59). The most common adverse event reported in both groups was mild pharyngeal pain.

DISCUSSION

Glucagon is no more effective than placebo in resolving EFBI or shortening the time required to remove the foreign body (EUDRA-CT number 2019-004920-40).

摘要

简介

本研究旨在比较胰高血糖素与安慰剂在解决食管异物嵌塞(EFBI)方面的有效性,以及操作过程的时间和不良事件。

方法

这是一项多中心、随机、双盲试验,涉及连续诊断为食源性 EFBI 的患者。参与者被随机分配接受 1 毫克静脉内胰高血糖素或安慰剂。所有患者均接受上内窥镜检查,并通过 7 天后的电话协议评估不良事件。

结果

该研究包括胰高血糖素组的 72 名受试者和安慰剂组的 68 名受试者。胰高血糖素组有 23.6%的患者和安慰剂组有 20.6%的患者未发现异物(差异 3%,95%置信区间-10.7%至 16.8%,P=0.67)。两组取出异物所需的中位数时间相似,胰高血糖素组为 4 分钟(范围 2-10),安慰剂组为 3.5 分钟(范围 2-7)(差异 0.5 分钟,95%置信区间-1.3 至 2.3;P=0.59)。两组最常见的不良事件均为轻度咽部疼痛。

讨论

胰高血糖素在解决 EFBI 或缩短取出异物所需的时间方面并不优于安慰剂(EUDRA-CT 编号 2019-004920-40)。

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