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一项采用伐尼克兰的围手术期戒烟干预:一项双盲、随机、安慰剂对照试验。

A perioperative smoking cessation intervention with varenicline: a double-blind, randomized, placebo-controlled trial.

机构信息

Department of Anesthesia, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada.

出版信息

Anesthesiology. 2012 Oct;117(4):755-64. doi: 10.1097/ALN.0b013e3182698b42.

DOI:10.1097/ALN.0b013e3182698b42
PMID:22890119
Abstract

BACKGROUND

The efficacy of perioperative tobacco interventions on long-term abstinence and the safety of smoking cessation less than 4 weeks before surgery is unclear. Our objective was to determine the efficacy and safety of a perioperative smoking cessation intervention with varenicline to reduce smoking in elective surgical patients.

METHODS

In a prospective, multicenter, double-blind, placebo-controlled trial, 286 patients were randomized to receive varenicline or placebo. Both groups received in-hospital and telephone counseling during 12 months. The primary outcome was the 7-day point prevalence abstinence rate 12 months after surgery. Secondary outcomes included abstinence at 3 and 6 months after surgery. Multivariable logistic regression was used to identify independent variables related to abstinence.

RESULTS

The 7-day point prevalence abstinence at 12 months for varenicline versus placebo was 36.4% versus 25.2% (relative risk: 1.45; 95%: CI: 1.01-2.07; P = 0.04). At 3 and 6 months, the 7-day point prevalence abstinence was 43.7% versus 31.9% (relative risk: 1.37; 95% CI: 1.01 to 1.86; P = 0.04), and 35.8% versus 25.9% (relative risk: 1.43; 95%: CI 1.01-2.04; P = 0.04) for varenicline versus placebo, respectively. Treatment with varenicline (odds ratio: 1.76; 95% CI: 1.03-3.01; P = 0.04), and preoperative nicotine dependence (odds ratio: 0.82, 95% CI: 0.68 to 0.98; P = 0.03) predicted abstinence at 12 months. The adverse events profile in both groups was similar except for nausea, which occurred more frequently for varenicline versus placebo (13.3% vs. 3.7%, P = 0.004).

CONCLUSIONS

A perioperative smoking cessation intervention with varenicline increased abstinence from smoking 3, 6, and 12 months after elective noncardiac surgery with no increase in serious adverse events.

摘要

背景

围手术期进行烟草干预对长期戒烟的效果以及在手术前 4 周内戒烟的安全性尚不清楚。我们的目的是确定使用伐尼克兰进行围手术期戒烟干预以减少择期手术患者吸烟的疗效和安全性。

方法

在一项前瞻性、多中心、双盲、安慰剂对照试验中,286 名患者被随机分为接受伐尼克兰或安慰剂组。两组均在 12 个月内接受住院和电话咨询。主要结局是术后 12 个月时的 7 天点流行率戒烟率。次要结局包括术后 3 个月和 6 个月时的戒烟情况。多变量逻辑回归用于确定与戒烟相关的独立变量。

结果

与安慰剂相比,伐尼克兰组在术后 12 个月时的 7 天点流行率戒烟率为 36.4%,安慰剂组为 25.2%(相对风险:1.45;95%置信区间:1.01-2.07;P=0.04)。在 3 个月和 6 个月时,7 天点流行率戒烟率分别为 43.7%比 31.9%(相对风险:1.37;95%置信区间:1.01-1.86;P=0.04)和 35.8%比 25.9%(相对风险:1.43;95%置信区间:1.01-2.04;P=0.04)。伐尼克兰治疗(优势比:1.76;95%置信区间:1.03-3.01;P=0.04)和术前尼古丁依赖(优势比:0.82,95%置信区间:0.68-0.98;P=0.03)预测了 12 个月时的戒烟率。两组的不良反应谱相似,除了伐尼克兰组比安慰剂组更常见的恶心(13.3%比 3.7%,P=0.004)外。

结论

在择期非心脏手术后,使用伐尼克兰进行围手术期戒烟干预可增加术后 3、6 和 12 个月的戒烟率,且无严重不良事件增加。

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