Department of Medicine, University of Connecticut School of Medicine, Farmington, CT.
Department of Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, CT.
Am J Obstet Gynecol MFM. 2019 Mar;1(1):10-18. doi: 10.1016/j.ajogmf.2019.03.006. Epub 2019 Mar 27.
Smoking during pregnancy is a serious public health problem in need of better treatments. Nicotine replacement treatment (NRT) (patch or gum) has not been shown in randomized placebo-controlled trials to be efficacious for smoking cessation during pregnancy. However, the nicotine inhaler may have advantages over other NRTs as it replicates some of the sensory effects of smoking.
The purpose of the study was examine the efficacy and safety of the nicotine inhaler for smoking cessation during pregnancy. We hypothesized that the nicotine inhaler compared to placebo would increase quit rates and reduce smoking during treatment and at the end of pregnancy, result in a higher birth weight and gestational age in the offspring, and reduce the incidence of preterm birth and low birth weight infants.
We conducted a randomized, double-blind, placebo-controlled trial of the nicotine inhaler for smoking cessation during pregnancy. Pregnant women who smoked ≥5 cigarettes daily received behavioral counseling and random assignment to a 6-week treatment with nicotine or placebo inhaler, followed by a 6-week taper period. Throughout treatment, we assessed tobacco exposure biomarkers, cessation rates, and adverse events. We also obtained information on birth outcomes. The primary outcome was smoking cessation at 32-34 weeks gestation; secondary outcomes were smoking reduction, birth weight and gestational age, and the incidence of preterm birth or low birth weight infants. We compared treatment groups on these measures using t-tests, Fisher's exact tests, and multivariate linear and logistic regression.
Participants in the placebo (n=67) and nicotine (n=70) groups were comparable on baseline characteristics, though women in the placebo group reported a higher motivation to quit (p=0.016). Biochemically-validated smoking cessation rates were similar with nicotine and placebo (after 6 weeks of treatment: 4% (3/70) vs. 3% (2/67), respectively, p< 0.99, and at 32-34 weeks gestation: 10% (7/70) vs. 18% (12/67), respectively, p=0.220). Cigarettes per day (CPD) decreased over time in both groups (p< 0.001), with the nicotine inhaler group having a greater decrease than the placebo group two (p=0.022) and six weeks after the quit date (=0.042), but not at 32-34 weeks gestation (=0.108). Serum cotinine levels, birth weight, gestational age and reductions in carbon monoxide did not differ by group. However, the incidence of preterm delivery was higher in the placebo than the nicotine group: 15% (10/67) vs. 4% (3/67), respectively, =0.030). The incidence of delivering a low birth weight infant was also higher in the placebo than the nicotine group: 15% (10/67) vs. 6% (4/67), respectively, =0.035, but not after adjusting for preterm delivery p=0.268.
Although the nicotine inhaler group did not have a higher quit rate during pregnancy than the placebo group, the outcome of preterm delivery occurred less frequently in the nicotine group.
怀孕期间吸烟是一个严重的公共卫生问题，需要更好的治疗方法。随机安慰剂对照试验并未显示尼古丁替代疗法（NRT）（贴片或口香糖）对怀孕期间戒烟有效。然而，尼古丁吸入器可能比其他 NRT 具有优势，因为它复制了吸烟的一些感觉效果。
本研究旨在检查尼古丁吸入器在怀孕期间戒烟的疗效和安全性。我们假设，与安慰剂相比，尼古丁吸入器会增加戒烟率，减少治疗期间和怀孕末期的吸烟量，使后代的出生体重和胎龄增加，并降低早产和低出生体重婴儿的发生率。
我们进行了一项随机、双盲、安慰剂对照的尼古丁吸入器治疗孕妇吸烟的试验。每天吸烟≥5 支的孕妇接受行为咨询，并随机分配接受 6 周的尼古丁或安慰剂吸入器治疗，然后进行 6 周的减量期。在整个治疗过程中，我们评估了烟草暴露生物标志物、戒烟率以及不良事件。我们还获得了出生结局的信息。主要结局是 32-34 周妊娠时的戒烟率；次要结局是吸烟减少、出生体重和胎龄，以及早产或低出生体重婴儿的发生率。我们使用 t 检验、Fisher 确切检验以及多元线性和逻辑回归比较了治疗组在这些指标上的差异。
安慰剂（n=67）和尼古丁（n=70）组的参与者在基线特征上相似，尽管安慰剂组的女性戒烟动机更高（p=0.016）。生物验证的戒烟率在尼古丁组和安慰剂组相似（治疗 6 周后：分别为 4%（3/70）和 3%（2/67），p<0.99，32-34 周妊娠时：分别为 10%（7/70）和 18%（12/67），p=0.220）。两组的香烟每日摄入量（CPD）随时间减少（p<0.001），尼古丁吸入器组的减少量大于安慰剂组（p=0.022）和戒烟日期后两周（p=0.042），但在 32-34 周妊娠时无差异（p=0.108）。血清可替宁水平、出生体重、胎龄和一氧化碳减少量在两组之间没有差异。然而，安慰剂组的早产发生率高于尼古丁组：分别为 15%（10/67）和 4%（3/67），p=0.030）。安慰剂组的低出生体重儿发生率也高于尼古丁组：分别为 15%（10/67）和 6%（4/67），p=0.035，但调整早产后无差异（p=0.268）。
尽管尼古丁吸入器组在怀孕期间的戒烟率没有高于安慰剂组，但尼古丁组的早产发生率较低。
