小柯机器人

法国南特大学Karim Asehnoune团队研究了地塞米松对非心脏手术后并发症或全因死亡率的影响。2021年6月2日，该成果发表在《英国医学杂志》上。

为了探讨地塞米松对非心脏手术后并发症及全因死亡率的影响，2017年12月至2019年3月，研究组在法国的34个中心进行了一项临床3期、随机、双盲、安慰剂对照试验。研究组共招募了1222名需要进行预计持续时间超过90分钟的大型非心脏手术的成人（>50岁）患者，将其随机分组，分别接受地塞米松或安慰剂。主要结局为术后并发症或术后14天内全因死亡率的综合，在改良意向治疗人群中进行评估（至少给予一种治疗）。

1222名接受随机分组的参与者中，共有1184名（96.9%）被纳入改良意向治疗人群。术后14天，地塞米松组595名受试者中有101名（17.0%）出现并发症或死亡，安慰剂组589名受试者中有117名（19.9%），组间差异不显著。在1038名接受非胸外科手术的受试者中，地塞米松组520名受试者中有69名（13.3%）发生主要结局，安慰剂组518名受试者中有93名（18%）。地塞米松组613名受试者中有288名（47.0%）出现不良事件，安慰剂组609名受试者中有296名（48.6%）。

研究结果表明，地塞米松不能显著降低非心脏手术后14天并发症和死亡的发生率。

附：英文原文

Title: Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial

Author: Karim Asehnoune, Charlene Le Moal, Gilles Lebuffe, Marguerite Le Penndu, Nolwen Chatel Josse, Matthieu Boisson, Thomas Lescot, Marion Faucher, Samir Jaber, Thomas Godet, Marc Leone, Cyrus Motamed, Jean Stephane David, Raphael Cinotti, Younes El Amine, Darius Liutkus, Matthias Garot, Antoine Marc, Anne Le Corre, Alexandre Thomasseau, Alexandra Jobert, Laurent Flet, Fanny Feuillet, Morgane Pere, Emmanuel Futier, Antoine Roquilly

Issue&Volume: 2021/06/02

Abstract:

Objective To assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery.

Design Phase III, randomised, double blind, placebo controlled trial.

Setting 34 centres in France, December 2017 to March 2019.

Participants 1222 adults (>50 years) requiring major non-cardiac surgery with an expected duration of more than 90 minutes. The anticipated time frame for recruitment was 24 months.

Interventions Participants were randomised to receive either dexamethasone (0.2 mg/kg immediately after the surgical procedure, and on day 1) or placebo. Randomisation was stratified on the two prespecified criteria of cancer and thoracic procedure.

Main outcomes measures The primary outcome was a composite of postoperative complications or all cause mortality within 14 days after surgery, assessed in the modified intention-to-treat population (at least one treatment administered).

Results Of the 1222 participants who underwent randomisation, 1184 (96.9%) were included in the modified intention-to-treat population. 14 days after surgery, 101 of 595 participants (17.0%) in the dexamethasone group and 117 of 589 (19.9%) in the placebo group had complications or died (adjusted odds ratio 0.81, 95% confidence interval 0.60 to 1.08; P=0.15). In the stratum of participants who underwent non-thoracic surgery (n=1038), the primary outcome occurred in 69 of 520 participants (13.3%) in the dexamethasone group and 93 of 518 (18%) in the placebo group (adjusted odds ratio 0.70, 0.50 to 0.99). Adverse events were reported in 288 of 613 participants (47.0%) in the dexamethasone group and 296 of 609 (48.6%) in the placebo group (P=0.46).

Conclusions Dexamethasone was not found to significantly reduce the incidence of complications and death in patients 14 days after major non-cardiac surgery. The 95% confidence interval for the main result was, however, wide and suggests the possibility of important clinical effectiveness.

DOI: 10.1136/bmj.n1162

Source: https://www.bmj.com/content/373/bmj.n1162

BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
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