科学家完成电子香烟与尼古丁贴片在妊娠期戒烟比较的临床试验-小柯机器人-科学网

科学家完成电子香烟与尼古丁贴片在妊娠期戒烟比较的临床试验

2022-05-22 01:29

英国伦敦玛丽女王大学Francesca Pesola等研究人员完成电子香烟与尼古丁贴片在妊娠期戒烟比较的临床试验。2022年5月16日，《自然—医学》杂志在线发表了这项成果。

研究人员报告了在1140名参与者中进行的随机对照试验的结果，比较了可补充的电子烟和尼古丁贴片。吸烟的孕妇被随机分配到电子烟（n=569）或尼古丁贴剂（n=571）。在对主要结果的分析中，两个研究组在怀孕结束时的有效延长戒烟率没有明显差异（电子烟和贴片组分别为6.8%对4.4%；相对风险（RR）=1.55，95%CI：0.95-2.53，P=0.08）。然而，尼古丁贴片组的一些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，排除了使用非分配产品的参与者，电子烟比贴片更有效（6.8%对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孕产妇及分娩结果。两种研究产品的安全状况相似，但是电子烟组的低出生体重（<2,500克）发生率较低（14.8%对9.6%；RR=0.65，95%CI：0.47-0.90，P=0.01）。其他不良事件和分娩结果在两个研究组中相似。电子烟可能有助于怀孕妇女戒烟，其在怀孕期间使用的安全性与尼古丁贴片相似。

据了解，尼古丁替代疗法，以尼古丁贴片的形式，通常提供给吸烟的孕妇，以帮助她们戒烟，但这种方法在这个人群中的疗效有限。吸烟的孕妇也会使用电子香烟，但它们在怀孕期间的安全性和有效性尚不清楚。

附：英文原文

Title: Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: a randomized controlled trial

Author: Hajek, Peter, Przulj, Dunja, Pesola, Francesca, Griffiths, Chris, Walton, Robert, McRobbie, Hayden, Coleman, Tim, Lewis, Sarah, Whitemore, Rachel, Clark, Miranda, Ussher, Michael, Sinclair, Lesley, Seager, Emily, Cooper, Sue, Bauld, Linda, Naughton, Felix, Sasieni, Peter, Manyonda, Isaac, Myers Smith, Katie

Issue&Volume: 2022-05-16

Abstract: 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 (<2,500g) 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.

DOI: 10.1038/s41591-022-01808-0

Source: https://www.nature.com/articles/s41591-022-01808-0

Nature Medicine：《自然—医学》，创刊于1995年。隶属于施普林格·自然出版集团，最新IF：87.241
官方网址：https://www.nature.com/nm/
投稿链接：https://mts-nmed.nature.com/cgi-bin/main.plex

本期文章：《自然—医学》：Online/在线发表

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