Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy.
Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy.
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DOI：
10.1136/bmj.g1622
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发表时间：
2014-03-11
期刊：
影响因子：
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通讯作者：
Tanguy ML
中科院分区：
文献类型：
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作者：
Berlin I;Grangé G;Jacob N;Tanguy ML
目的确定16小时尼古丁贴片在妊娠吸烟者中的疗效，根据唾液可替宁水平（可能范围10-30 mg/天）单独调整剂量。设计：2007年10月至2013年1月期间的随机、双盲、安慰剂对照、平行组、多中心试验（妊娠期尼古丁贴片研究，SNIPP）。在法国设立了23个产科病房。研究对象为476名年龄在18岁以上、妊娠12 ~ 20周、每天至少吸烟5支的孕妇吸烟者。在排除后，402名妇女被随机分配：203名接受尼古丁贴片，199名接受安慰剂贴片。每个组有192名活产婴儿的数据。干预措施尼古丁和相同的安慰剂贴剂从戒烟日到分娩时间。吸烟时根据唾液可替宁水平调整剂量，以获得100%的替代率。参与者每月接受评估，并接受行为戒烟支持。主要结局指标主要结局为从戒烟至分娩的完全戒烟（通过呼出气体中一氧化碳水平≤8 ppm证实的自我报告）和出生体重。次要结果是戒烟的点患病率、失效（几次抽吸）或复发的时间以及分娩和出生特征。所有数据均在意向治疗基础上进行分析。结果尼古丁贴剂组和安慰剂贴剂组分别有5.5%（n=11）和5.1%（n=10）的女性达到完全戒烟（比值比1.08，95%置信区间0.45至2.60）。两组中目标戒烟日后至首次吸烟的中位时间均为15天（尼古丁贴剂组四分位距为13-18，安慰剂贴剂组为13-20）。尼古丁贴剂组和安慰剂贴剂组的点戒烟率范围分别为8%-12.5%和8%-9.5%，无统计学显著性差异。尼古丁替代率与100%无差异，在1016次访视时评估，尼古丁贴剂组自我报告的中位依从率为85%（四分位距56- 99%），安慰剂贴剂组为83%（56-95%）。尼古丁贴剂组的平均出生体重为3065 g（SE 44 g），安慰剂贴剂组为3015 g（SE 44 g）（P=0.41）。尼古丁贴剂组的舒张压显著高于安慰剂贴剂组。两组之间严重不良事件的频率相似，尽管尼古丁贴片组发生了更多的非严重不良反应，主要是皮肤不良反应。结论：尼古丁贴片没有增加戒烟率或出生体重，尽管调整尼古丁剂量以匹配吸烟时达到的水平，并高于通常剂量。试用注册ClinicalTrials.gov NCT 00507975。
Objective To determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day). Design Randomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013. Setting 23 maternity wards in France. Participants 476 pregnant smokers aged more than 18 years and between 12 and 20 weeks’ gestation, who smoked at least five cigarettes a day. After exclusions, 402 women were randomised: 203 to nicotine patches and 199 to placebo patches. Data were available on 192 live births in each group. Interventions Nicotine and identical placebo patches were administered from quit day up to the time of delivery. Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100%. Participants were assessed monthly and received behavioural smoking cessation support. Main outcome measures The primary outcomes were complete abstinence (self report confirmed by carbon monoxide level in expired air ≤8 ppm) from quit date to delivery, and birth weight. The secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics. All data were analysed on an intention to treat basis. Results Complete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self reported median compliance rate was 85% (interquartile range 56-99%) in the nicotine patch group and 83% (56-95%) in the placebo patch group, assessed at 1016 visits. The mean birth weight was 3065 g (SE 44 g) in the nicotine patch group and 3015 g (SE 44 g) in the placebo patch group (P=0.41). Diastolic blood pressure was significantly higher in the nicotine patch group than in the placebo patch group. The frequency of serious adverse events was similar between the groups, although more non-serious adverse reactions, mainly of skin, occurred in the nicotine patch group. Conclusion The nicotine patch did not increase either smoking cessation rates or birth weights despite adjustment of nicotine dose to match levels attained when smoking, and higher than usual doses. Trial registration ClinicalTrials.gov NCT00507975.