Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.
Nat Med. 2022 May;28(5):958-964. doi: 10.1038/s41591-022-01808-0. Epub 2022 May 16.
Nicotine replacement therapy, in the form of nicotine patches, is commonly offered to pregnant women who smoke to help them to stop smoking, but this approach has limited efficacy in this population. Electronic cigarettes (e-cigarettes) are also used by pregnant women who smoke but their safety and efficacy in pregnancy are unknown. Here, we report the results of a randomized controlled trial in 1,140 participants comparing refillable e-cigarettes with nicotine patches. Pregnant women who smoked were randomized to e-cigarettes (n = 569) or nicotine patches (n = 571). In the unadjusted analysis of the primary outcome, validated prolonged quit rates at the end of pregnancy in the two study arms were not significantly different (6.8% versus 4.4% in the e-cigarette and patch arms, respectively; relative risk (RR) = 1.55, 95%CI: 0.95-2.53, P = 0.08). However, some participants in the nicotine patch group also used e-cigarettes during the study. In a pre-specified sensitivity analysis excluding abstinent participants who used non-allocated products, e-cigarettes were more effective than patches (6.8% versus 3.6%; RR = 1.93, 95%CI: 1.14-3.26, P = 0.02). Safety outcomes included adverse events and maternal and birth outcomes. The safety profile was found to be similar for both study products, however, low birthweight (<2,500 g) was less frequent in the e-cigarette arm (14.8% versus 9.6%; RR = 0.65, 95%CI: 0.47-0.90, P = 0.01). Other adverse events and birth outcomes were similar in the two study arms. E-cigarettes might help women who are pregnant to stop smoking, and their safety for use in pregnancy is similar to that of nicotine patches. ISRCTN62025374.
尼古丁替代疗法（以尼古丁贴片的形式）常用于帮助吸烟的孕妇戒烟，但这种方法在该人群中的效果有限。电子烟也被吸烟的孕妇使用，但它们在怀孕期间的安全性和效果尚不清楚。在这里，我们报告了一项在 1140 名参与者中进行的随机对照试验的结果，该试验比较了可再填充电子烟与尼古丁贴片。吸烟的孕妇被随机分配到电子烟（n=569）或尼古丁贴片（n=571）组。在主要结局的未调整分析中，两个研究组在妊娠结束时的验证性持续戒烟率没有显著差异（电子烟组为 6.8%，贴片组为 4.4%；相对风险（RR）=1.55，95%CI：0.95-2.53，P=0.08）。然而，一些尼古丁贴片组的参与者在研究期间也使用了电子烟。在一项预先指定的敏感性分析中，排除使用非分配产品的戒烟参与者后，电子烟比贴片更有效（6.8%比 3.6%；RR=1.93，95%CI：1.14-3.26，P=0.02）。安全性结果包括不良事件和母婴结局。两种研究产品的安全性特征相似，但电子烟组的低出生体重（<2500 克）较少（14.8%比 9.6%；RR=0.65，95%CI：0.47-0.90，P=0.01）。两个研究组的其他不良事件和出生结局相似。电子烟可能有助于孕妇戒烟，并且其在怀孕期间的使用安全性与尼古丁贴片相似。ISRCTN62025374。
