一项电子烟与尼古丁替代疗法的随机试验。

A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy.

机构信息

From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).

出版信息

N Engl J Med. 2019 Feb 14;380(7):629-637. doi: 10.1056/NEJMoa1808779. Epub 2019 Jan 30.

DOI:10.1056/NEJMoa1808779

PMID:30699054

Abstract

BACKGROUND

E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments.

METHODS

We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms.

RESULTS

A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath.

CONCLUSIONS

E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support. (Funded by the National Institute for Health Research and Cancer Research UK; Current Controlled Trials number, ISRCTN60477608 .).

摘要

背景

电子烟常被用于戒烟，但与作为戒烟治疗手段的尼古丁产品相比，其有效性证据有限。

方法

我们将参加英国国民保健署戒烟服务的成年人随机分为两组，一组接受他们选择的尼古丁替代产品，包括提供长达 3 个月的产品组合，另一组接受电子烟 starter pack（一种带有一瓶尼古丁电子烟液的第二代可再填充电子烟，尼古丁浓度为每毫升 18 毫克），并建议他们购买自己喜欢口味和尼古丁强度的电子烟液。治疗包括至少 4 周的每周一次的行为支持。主要结局是在 1 年内持续戒烟，最后一次就诊时进行生物化学验证。失访或未提供生物化学验证的参与者被视为未戒烟。次要结局包括参与者报告的治疗使用情况和呼吸道症状。

结果

共有 886 名参与者被随机分组。电子烟组的 1 年戒烟率为 18.0%，而尼古丁替代组为 9.9%（相对风险，1.83；95%置信区间[CI]，1.30 至 2.58；P<0.001）。在 1 年戒烟的参与者中，电子烟组在第 52 周使用指定产品的可能性高于尼古丁替代组（80%[79 名参与者中的 63 名]，而 44 名参与者中的 4 名））。总体而言，电子烟组更常报告喉咙或口腔刺激（65.3%，而尼古丁替代组为 51.2%），尼古丁替代组更常报告恶心（37.9%，而电子烟组为 31.3%）。与尼古丁替代组相比，电子烟组的咳嗽和咳痰发生率从基线到 52 周的下降幅度更大（咳嗽的相对风险为 0.8；95%CI，0.6 至 0.9；咳痰的相对风险为 0.7；95%CI，0.6 至 0.9）。两组间喘息或呼吸急促的发生率无显著差异。