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。
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:30.641
官方网址:https://www.nature.com/nm/
投稿链接:https://mts-nmed.nature.com/cgi-bin/main.plex