术前大剂量地塞米松用于急诊剖腹术：随机临床试验。

Preoperative high dose of dexamethasone in emergency laparotomy: randomized clinical trial.

机构信息

Department of Anaesthesiology and Intensive Care Medicine, Hvidovre University Hospital, Copenhagen, Denmark.

Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark.

出版信息

Br J Surg. 2024 Jul 2;111(7). doi: 10.1093/bjs/znae130.

DOI:10.1093/bjs/znae130

PMID:39028763

Abstract

BACKGROUND

Patients undergoing emergency laparotomy present with a profound inflammatory response, which could be an independent pathophysiological component in prolonged recovery. The aim of this study was to investigate the effects of a single preoperative high dose of intravenous dexamethasone on the inflammatory response and recovery after emergency laparotomy.

METHODS

In this double-blinded placebo-controlled trial, patients were prospectively stratified according to surgical pathology (intestinal obstruction and perforated viscus) and randomized to preoperative 1 mg/kg dexamethasone or placebo at a ratio of 1 : 1. The primary outcome was C-reactive protein on postoperative day 1. Secondary outcomes were postoperative recovery, morbidity, and mortality.

RESULTS

A total of 120 patients were included in the trial. On postoperative day 1, the C-reactive protein response was significantly lower in the dexamethasone group (a median of 170 versus 220 mg/l for dexamethasone and for placebo respectively; P = 0.015; mean difference = 49 (95% c.i. 13 to 85) mg/l) and when stratified according to intestinal obstruction (a median of 60 versus 160 mg/l for dexamethasone and for placebo respectively; P = 0.002) and perforated viscus (a median of 230 versus 285 mg/l for dexamethasone and for placebo respectively; P = 0.035). Dexamethasone administration was associated with improved recovery (better haemodynamics, better pulmonary function, less fatigue, and earlier mobilization). Furthermore, the dexamethasone group had a lower 90-day mortality rate (7% versus 23% for dexamethasone and for placebo respectively; relative risk 0.33 (95% c.i. 0.11 to 0.93); P = 0.023) and a decreased incidence of postoperative major complications (27% versus 45% for dexamethasone and for placebo respectively; relative risk 0.62 (95% c.i. 0.37 to 1.00); P = 0.032).

CONCLUSION

A single preoperative high dose of intravenous dexamethasone significantly reduces the inflammatory response after emergency laparotomy and is associated with enhanced recovery and improved outcome.

REGISTRATION NUMBER

NCT04791566 (http://www.clinicaltrials.gov).

摘要

背景

接受急诊剖腹手术的患者会出现严重的炎症反应，这可能是术后恢复时间延长的一个独立的病理生理因素。本研究旨在探讨单次术前大剂量静脉内给予地塞米松对急诊剖腹手术后炎症反应和恢复的影响。

方法

在这项双盲安慰剂对照试验中，根据手术病理（肠梗阻和穿孔性内脏）将患者前瞻性分层，并按 1:1 的比例随机分为术前 1mg/kg 地塞米松或安慰剂组。主要结局是术后第 1 天的 C 反应蛋白。次要结局是术后恢复情况、发病率和死亡率。

结果

本试验共纳入 120 例患者。术后第 1 天，地塞米松组的 C 反应蛋白反应明显低于安慰剂组（中位数分别为 170 与 220mg/L；P=0.015；平均差异=49(95%置信区间 13 至 85)mg/L），且按肠梗阻（中位数分别为 60 与 160mg/L；P=0.002）和穿孔性内脏（中位数分别为 230 与 285mg/L；P=0.035）分层时也是如此。地塞米松的应用与恢复的改善相关（血流动力学更好、肺功能更好、疲劳感更少、更早活动）。此外，地塞米松组 90 天死亡率较低（地塞米松组为 7%，安慰剂组为 23%；相对风险 0.33(95%置信区间 0.11 至 0.93)；P=0.023），术后主要并发症的发生率也较低（地塞米松组为 27%，安慰剂组为 45%；相对风险 0.62(95%置信区间 0.37 至 1.00)；P=0.032）。