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地塞米松预防甲状腺乳头状癌术后恶心呕吐的随机临床试验

Dexamethasone for Postoperative Nausea and Vomiting in Papillary Thyroid Carcinoma Patients: A Randomized Clinical Trial.

机构信息

From the Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China (Chen, Li, Jiang, Gou, Li, Zhu, Lei).

Laboratory of Thyroid and Parathyroid Disease, Frontiers Science Center for Disease-related Molecular Network, West China Hospital, Sichuan University, Chengdu, Sichuan, China (Chen).

出版信息

J Am Coll Surg. 2022 Sep 1;235(3):454-467. doi: 10.1097/XCS.0000000000000309. Epub 2022 Aug 10.

DOI:10.1097/XCS.0000000000000309
PMID:35972165
Abstract

BACKGROUND

Postoperative nausea and vomiting (PONV) frequently occur after thyroidectomy. Previous studies have investigated the effects of preoperative dexamethasone for alleviating PONV in various cancers, but studies focused on papillary thyroid carcinoma (PTC) were limited. This study aimed to determine the efficacy of a single preoperative dose of dexamethasone to prevent PONV in patients with PTC.

METHODS

This single-center, parallel-group, double-blind, placebo-controlled clinical trial was conducted on patients with PTC in West China Hospital. Patients were randomized 1:1 into Group Dex (preoperative 8-mg dexamethasone) or Group Control (0.9% NaCl as control). The primary outcome was the incidence and severity of PONV. The secondary outcomes included postoperative pain, vocal dysfunction, and adverse events.

RESULTS

Six hundred participants were recruited and randomized. The total incidence of PONV was 33.3% (200 of 600 patients; 95% CI, 29.6-37.1). In the intention-to-treat analysis, PONV occurred in 81 of 300 patients (27.0%; 95% CI, 21.9-32.1) in Group Dex and in 119 of 300 patients (39.7%; 95% CI, 34.1-45.2) in Group Control (p = 0.001), and the absolute risk reduction was 12.7% (95% CI, 5.1-20.0). Patients in Group Dex reported fewer antiemetic requirements than those in Group Control (p = 0.004). Multivariate analysis indicated that dexamethasone administration (OR = 0.546; 95% CI, 0.383-0.777; p = 0.001) was associated with a reduced rate of PONV. Dexamethasone treatment also contributed to alleviating postoperative pain and improving subjective vocal dysfunction, with no increase in adverse events.

CONCLUSIONS

A single dose of dexamethasone is effective and safe for preventing PONV in PTC patients.

摘要

背景

甲状腺手术后常发生术后恶心呕吐(PONV)。先前的研究已经探讨了术前使用地塞米松缓解各种癌症患者 PONV 的效果,但针对甲状腺乳头状癌(PTC)的研究有限。本研究旨在确定术前单次给予地塞米松预防 PTC 患者 PONV 的效果。

方法

这是一项在华西医院进行的单中心、平行分组、双盲、安慰剂对照的临床试验,纳入 PTC 患者。患者按 1:1 随机分为地塞米松组(术前给予 8mg 地塞米松)或对照组(0.9%生理盐水)。主要结局是 PONV 的发生率和严重程度。次要结局包括术后疼痛、嗓音障碍和不良事件。

结果

共纳入 600 名患者并进行随机分组。PONV 的总发生率为 33.3%(600 例患者中有 200 例;95%CI,29.6-37.1)。意向性治疗分析中,地塞米松组 300 例患者中有 81 例(27.0%;95%CI,21.9-32.1)发生 PONV,对照组 300 例患者中有 119 例(39.7%;95%CI,34.1-45.2)发生 PONV(p=0.001),绝对风险降低 12.7%(95%CI,5.1-20.0)。地塞米松组患者需要止吐药物的比例低于对照组(p=0.004)。多变量分析表明,地塞米松给药(OR=0.546;95%CI,0.383-0.777;p=0.001)与 PONV 发生率降低相关。地塞米松治疗还可缓解术后疼痛并改善主观嗓音障碍,且不增加不良事件。

结论

术前单次给予地塞米松可有效预防 PTC 患者 PONV,且安全。

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