电子烟与伐伦克林在成人戒烟中的对比：一项随机临床试验。

Electronic Cigarettes vs Varenicline for Smoking Cessation in Adults: A Randomized Clinical Trial.

机构信息

Department of Medicine, Lapland Central Hospital, Rovaniemi, Finland.

Institute of Clinical Medicine, University of Oulu and Department of Internal Medicine Division Oulu University Hospital, Oulu, Finland.

出版信息

JAMA Intern Med. 2024 Aug 1;184(8):915-921. doi: 10.1001/jamainternmed.2024.1822.

DOI:10.1001/jamainternmed.2024.1822

PMID:38884987

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11184496/

Abstract

IMPORTANCE

Little is known about the relative effectiveness of nicotine-containing electronic cigarettes (ECs) compared with varenicline as smoking cessation aids.

OBJECTIVE

To determine the relative effectiveness of ECs in smoking cessation.

DESIGN, SETTING, AND PARTICIPANTS: This randomized placebo-controlled single-center trial was conducted in northern Finland. Participants aged 25 to 75 years who smoked daily and had volunteered to quit smoking were recruited from August 1, 2018, to February 20, 2020, via local media. The trial included 52 weeks of follow-up. All data analyses were conducted from September 1, 2022, to January 15, 2024. The participants, study nurses, and researchers were masked to group assignment.

INTERVENTION

The participants were assigned by block randomization to receive 18 mg/mL of nicotine-containing ECs together with placebo tablets, varenicline with standard dosing together with nicotine-free ECs, or placebo tablets together with nicotine-free ECs, all combined with a motivational interview, with the intervention phase lasting for 12 weeks.

MAIN OUTCOME AND MEASURE

The primary outcome was self-reported 7-day conventional cigarette smoking abstinence as confirmed by the exhaled carbon monoxide level on week 26. The analysis followed the intent-to-treat principle.

RESULTS

Of the 561 recruited participants, 458 (81.6%) eligible participants (257 women [56%]; 201 men [44%]; mean [SD] age, 51 [11.6] years) were randomized. The primary outcome occurred in 61 of 152 participants (40.4%) in the EC group, 67 of 153 (43.8%) in the varenicline group, and 30 of 153 (19.7%) in the placebo group (P < .001). In the pairwise comparison, placebo differed statistically significantly from ECs (risk difference [RD], 20.7%; 95% CI, 10.4-30.4; P < .001) and varenicline (RD, 24.1%; 95% CI, 13.7-33.7; P < .001), but the difference was statistically insignificant between ECs and varenicline (RD, 3.4%; 95% CI, -7.6 to 14.3; P = .56). No serious adverse events were reported.

CONCLUSIONS

This randomized clinical trial found that varenicline and nicotine-containing ECs were both effective in helping individuals in quitting smoking conventional cigarettes for up to 6 months.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03235505.

摘要

重要性

关于含有尼古丁的电子烟（ECs）与伐尼克兰作为戒烟辅助手段的相对有效性，我们知之甚少。

目的

确定 ECs 在戒烟方面的相对有效性。

设计、地点和参与者：这是一项在芬兰北部进行的随机安慰剂对照单中心试验。从 2018 年 8 月 1 日至 2020 年 2 月 20 日，通过当地媒体招募年龄在 25 至 75 岁之间、每日吸烟且自愿戒烟的参与者。试验包括 52 周的随访。所有数据分析均于 2022 年 9 月 1 日至 2024 年 1 月 15 日进行。参与者、研究护士和研究人员对分组情况均不知情。

干预措施

参与者按区组随机分配，接受 18mg/ml 尼古丁含量的 ECs 联合安慰剂片、标准剂量的伐尼克兰联合无尼古丁 ECs 或安慰剂片联合无尼古丁 ECs，均联合动机性访谈，干预阶段持续 12 周。

主要结果和测量指标

主要结局为自我报告的 7 天常规香烟吸烟戒除情况，通过第 26 周呼出的一氧化碳水平来确认。分析遵循意向治疗原则。

结果

在招募的 561 名参与者中，458 名（81.6%）符合条件的参与者（257 名女性[56%]；201 名男性[44%]；平均[标准差]年龄为 51[11.6]岁）被随机分配。在 EC 组中，152 名参与者中有 61 名（40.4%）、伐尼克兰组中有 67 名（43.8%）和安慰剂组中有 30 名（19.7%）发生了主要结局（P < .001）。在两两比较中，安慰剂与 ECs（风险差异[RD]，20.7%；95%置信区间，10.4-30.4；P < .001）和伐尼克兰（RD，24.1%；95%置信区间，13.7-33.7；P < .001）差异有统计学意义，但 ECs 与伐尼克兰差异无统计学意义（RD，3.4%；95%置信区间，-7.6 至 14.3；P = .56）。未报告严重不良事件。