Quigley Joan M, Walsh Cathal, Lee Caitriona, Long Jean, Kennelly Helen, McCarthy Anne, Kavanagh Paul
Health Research Board, Dublin, Ireland.
Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, United Kingdom.
Tob Prev Cessat. 2021 Nov 22;7:69. doi: 10.18332/tpc/143077. eCollection 2021.
This systematic review of randomized controlled trials (RCTs) evaluated the efficacy and safety of electronic cigarettes (e-cigarettes, ENDS) in helping people who smoke to achieve abstinence compared with electronic non-nicotine delivery systems (ENNDS, no nicotine) or any smoking cessation comparator treatment or combination of treatments at 24-26 weeks and at 52 weeks.
Systematic review techniques involved searches of three databases in February 2020 with update searches run on 14 May 2021, two-person independent screening, two-person independent assessment of bias, formal extraction of data with verification by a second person, a feasibility assessment to decide if meta-analysis was appropriate, and network meta-analysis (NMA) of data at 24-26 weeks. Data at 52 weeks were narratively summarized.
Ten RCTs met the inclusion criteria, eight for efficacy and ten for safety. Eight of the nine RCTs were assessed as at high risk of bias. The sample sizes of the RCTs were 30-2012. Using nicotine replacement therapy (NRT) as the reference treatment, the incidences of smoking cessation at 24-26 weeks were comparable between ENDS and NRT groups (RR=1.17; 95% CrI: 0.66-1.86). Three sensitivity analyses were carried out indicating the main findings for 24-26 weeks were robust to assumptions. The findings at 52 weeks were inconclusive.
This systematic review and NMA indicates that there is no clear evidence of a difference in effect between nicotine containing e-cigarettes and NRT on incidences of smoking cessation at 24-26 weeks, and substantial uncertainty remains.
本随机对照试验（RCT）的系统评价评估了电子烟（ENDS）在帮助吸烟者戒烟方面的疗效和安全性，并与电子无尼古丁输送系统（ENNDS，不含尼古丁）或任何戒烟对照治疗或治疗组合在24 - 26周和52周时进行了比较。
系统评价技术包括在2020年2月搜索三个数据库，并于2021年5月14日进行更新搜索，两人独立筛选，两人独立评估偏倚，由第二人进行数据正式提取并验证，进行可行性评估以确定是否适合进行荟萃分析，以及对24 - 26周的数据进行网络荟萃分析（NMA）。对52周的数据进行了叙述性总结。
十项RCT符合纳入标准，八项用于疗效评估，十项用于安全性评估。九项RCT中的八项被评估为高偏倚风险。RCT的样本量为30 - 2012。以尼古丁替代疗法（NRT）作为对照治疗，ENDS组和NRT组在24 - 26周时的戒烟发生率相当（RR = 1.17；95% CrI：0.66 - 1.86）。进行了三项敏感性分析，表明24 - 26周的主要研究结果对假设具有稳健性。关于52周的研究结果尚无定论。
本系统评价和NMA表明，在24 - 26周时，没有明确证据表明含尼古丁电子烟与NRT在戒烟发生率方面存在效果差异，并且仍存在很大的不确定性。
