本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2308815

摘要内容如下：

背景

电子尼古丁输送系统——也称为电子烟——被一些吸烟者用来帮助戒烟。需要关于这些系统的有效性和安全性的证据。

方法

在这项开放标签的对照试验中，我们将每天至少吸5支烟并希望设定戒烟日期的成年人随机分配到干预组和对照组，干预组接受免费的电子烟和电子烟液、标准护理戒烟咨询和可选（非免费）尼古丁替代疗法，对照组接受标准咨询和代金券，他们可以将代金券用于任何目的，包括尼古丁替代疗法。主要结果是生化验证，在6个月时持续戒烟。次要结果包括参与者报告的在6个月时戒除烟草和任何尼古丁（包括吸烟、电子烟和尼古丁替代疗法）、呼吸道症状和严重不良事件。

结果

共有1246名参与者接受了随机分组。622名参与者被分配到干预组，624名参与者被分配到对照组。干预组中有效持续戒烟的参与者百分比为28.9%，对照组为16.3%（相对风险为1.77；95%置信区间，1.43至2.20）。干预组和对照组分别有59.6%和38.5%的参与者在6个月访视前7天内戒烟，但干预组和对照组分别有20.1%和33.7%的参与者戒烟。干预组中有25名参与者（4.0%）发生严重不良事件，对照组中有31名参与者（5.0%）发生严重不良事件；不良事件发生率分别为272例（43.7%）和229例（36.7%）。

结论

在标准戒烟咨询中加入电子烟，与单独的戒烟咨询相比，吸烟者的戒烟率更高。（由瑞士国家科学基金会和其他机构资助；EstXends ClinicalTrials.gov编号，NCT03589989。）

英文原文如下：

Abstracts

BACKGROUND  Electronic nicotine-delivery systems - also called e-cigarettes - are used by some tobacco smokers to assist with quitting. Evidence regarding the efficacy and safety of these systems is needed.

METHODS  In this open-label, controlled trial, we randomly assigned adults who were smoking at least five tobacco cigarettes per day and who wanted to set a quit date to an intervention group, which received free e-cigarettes and e-liquids, standard-of-care smoking-cessation counseling, and optional (not free) nicotine-replacement therapy, or to a control group, which received standard counseling and a voucher, which they could use for any purpose, including nicotine-replacement therapy. The primary outcome was biochemically validated, continuous abstinence from smoking at 6 months. Secondary outcomes included participant-reported abstinence from tobacco and from any nicotine (including smoking, e-cigarettes, and nicotine-replacement therapy) at 6 months, respiratory symptoms, and serious adverse events.

RESULTS  A total of 1246 participants underwent randomization; 622 participants were assigned to the intervention group, and 624 to the control group. The percentage of participants with validated continuous abstinence from tobacco smoking was 28.9% in the intervention group and 16.3% in the control group (relative risk, 1.77; 95% confidence interval, 1.43 to 2.20). The percentage of participants who abstained from smoking in the 7 days before the 6-month visit was 59.6% in the intervention group and 38.5% in the control group, but the percentage who abstained from any nicotine use was 20.1% in the intervention group and 33.7% in the control group. Serious adverse events occurred in 25 participants (4.0%) in the intervention group and in 31 (5.0%) in the control group; adverse events occurred in 272 participants (43.7%) and 229 participants (36.7%), respectively.

CONCLUSIONS  The addition of e-cigarettes to standard smoking-cessation counseling resulted in greater abstinence from tobacco use among smokers than smoking-cessation counseling alone. (Funded by the Swiss National Science Foundation and others; ESTxENDS ClinicalTrials.gov number, NCT03589989.).

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