地塞米松与术后恶心呕吐的关系：随机围手术期应用地塞米松与感染（PADDI）试验的预先指定亚研究。

Dexamethasone and clinically significant postoperative nausea and vomiting: a prespecified substudy of the randomised perioperative administration of dexamethasone and infection (PADDI) trial.

机构信息

Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Australia; School of Medicine and Pharmacology, University of Western Australia, Perth, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.

School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.

出版信息

Br J Anaesth. 2022 Sep;129(3):327-335. doi: 10.1016/j.bja.2022.05.018. Epub 2022 Jul 6.

DOI:10.1016/j.bja.2022.05.018

PMID:35803757

Abstract

BACKGROUND

Clinically significant postoperative nausea and vomiting (PONV) is a patient-reported outcome which reflects patient experience. Although dexamethasone prevents PONV, it is unknown what impact it has on this experience.

METHODS

In this prespecified embedded superiority substudy of the randomised Perioperative Administration of Dexamethasone and Infection (PADDI) trial, patients undergoing non-urgent noncardiac surgery received dexamethasone 8 mg or placebo intravenously after induction of anaesthesia, and completed a validated PONV questionnaire. The primary outcome was the incidence of clinically significant PONV on day 1 or day 2 postoperatively. Secondary outcomes included the incidence of clinically significant PONV and severe PONV on days 1 and 2 considered separately.

RESULTS

A total of 1466 participants were included, with 733 patients allocated to the dexamethasone arm and 733 to matched placebo. The primary outcome occurred in 52 patients (7.1%) in the dexamethasone arm and 66 (9%) patients in the placebo arm (relative risk [RR]=0.79; 95% confidence interval [CI], 0.56-1.11; P=0.18). Severe PONV occurred on day 2 in 27 patients (3.9%) in the dexamethasone arm and 47 patients (6.7%) in the placebo arm (RR=0.58; 95% CI, 0.37-0.92; P=0.02; number needed-to-treat (NNT)=36.7; 95% CI, 20-202). In the entire cohort of 8880 PADDI patients, lower nausea scores, less frequent administration of antiemetics, and fewer vomiting events were recorded by patients in the dexamethasone arm up to day 2 after surgery.

CONCLUSIONS

Administration of dexamethasone 8 mg i.v. did not influence clinically significant PONV. Dexamethasone administration did, however, decrease the incidence and severity of PONV, and was associated with less frequent administration of antiemetic agents.

CLINICAL TRIAL REGISTRATION

ACTRN12614001226695.

摘要

背景

临床上显著的术后恶心和呕吐（PONV）是一种反映患者体验的患者报告结局。尽管地塞米松可预防 PONV，但尚不清楚它对这种体验有何影响。

方法

在这项预先设定的、随机的围手术期给予地塞米松和感染（PADDI）试验的嵌入式优势子研究中，接受非紧急非心脏手术的患者在麻醉诱导后静脉注射地塞米松 8 毫克或安慰剂，并完成了一份经验证的 PONV 问卷。主要结局是术后第 1 天或第 2 天出现临床上显著的 PONV 的发生率。次要结局包括第 1 天和第 2 天分别考虑的临床上显著的 PONV 和严重 PONV 的发生率。

结果

共有 1466 名参与者入组，其中 733 名患者分配到地塞米松组，733 名患者分配到匹配的安慰剂组。地塞米松组有 52 名患者（7.1%）发生主要结局，安慰剂组有 66 名患者（9%）（相对风险[RR]=0.79；95%置信区间[CI]，0.56-1.11；P=0.18）。地塞米松组有 27 名患者（3.9%）在第 2 天发生严重 PONV，安慰剂组有 47 名患者（6.7%）（RR=0.58；95%CI，0.37-0.92；P=0.02；需要治疗的人数[NNT]=36.7；95%CI，20-202）。在整个 8880 名 PADDI 患者的队列中，直到术后第 2 天，地塞米松组的患者记录的恶心评分较低、止吐药使用频率较低、呕吐事件较少。