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Use of smoking cessation pharmacotherapies during pregnancy is not associated with increased risk of adverse pregnancy outcomes: a population-based cohort study.
BMC Medicine ( IF 7.0 ) Pub Date : 2020-02-05 , DOI: 10.1186/s12916-019-1472-9
Duong Thuy Tran 1 , David B Preen 2 , Kristjana Einarsdottir 3 , Anna Kemp-Casey 4 , Deborah Randall 5 , Louisa R Jorm 1 , Stephanie K Y Choi 1 , Alys Havard 1
Affiliation  

BACKGROUND Varenicline, bupropion and nicotine replacement therapy (NRT) are three effective pharmacotherapies for smoking cessation, but data about their safety in pregnancy are limited. We assessed the risk of adverse perinatal outcomes and major congenital anomalies associated with the use of these therapies in pregnancy in Australia. METHODS Perinatal data for 1,017,731 deliveries (2004 to 2012) in New South Wales and Western Australia were linked to pharmaceutical dispensing, hospital admission and death records. We identified 97,875 women who smoked during pregnancy; of those, 233, 330 and 1057 were exposed to bupropion, NRT and varenicline in pregnancy, respectively. Propensity scores were used to match exposed women to those who were unexposed to any smoking therapy (1:10 ratio). Propensity scores and gestational age at exposure were used to match varenicline-exposed to NRT-exposed women (1:1 ratio). Time-dependent Cox proportional hazards models estimated hazard ratios (HR) with 95% confidence intervals (95% CI) for any adverse perinatal event (a composite of 10 unfavourable maternal and neonatal outcomes) and any major congenital anomaly. RESULTS The risk of any adverse perinatal event was not significantly different between bupropion-exposed and unexposed women (39.2% versus 39.3%, HR 0.93, 95% CI 0.73-1.19) and between NRT-exposed and unexposed women (44.8% vs 46.3%, HR 1.02, 95% CI 0.84-1.23), but it was significantly lower in women exposed to varenicline (36.9% vs 40.1%, HR 0.86, 95% CI 0.77-0.97). Varenicline-exposed infants were less likely than unexposed infants to be born premature (6.5% vs 8.9%, HR 0.72, 95% CI 0.56-0.92), be small for gestational age (11.4% vs 15.4%, HR 0.68, 95% CI 0.56-0.83) and have severe neonatal complications (6.6% vs 8.2%, HR 0.74, 95% CI 0.57-0.96). Among infants exposed to varenicline in the first trimester, 2.9% had a major congenital anomaly (3.5% in unexposed infants, HR 0.91, 95% CI 0.72-1.15). Varenicline-exposed women were less likely than NRT-exposed women to have an adverse perinatal event (38.7% vs 51.4%, HR 0.58, 95% CI 0.33-1.05). CONCLUSIONS Pregnancy exposure to smoking cessation pharmacotherapies does not appear to be associated with an increased risk of adverse birth outcomes. Lower risk of adverse birth outcomes in varenicline-exposed pregnancies is inconsistent with recommendations that NRT be used in preference to varenicline.

中文翻译:

妊娠期间使用戒烟药物治疗与不良妊娠结局增加的风险无关:一项基于人群的队列研究。

背景技术瓦伦尼克碱,安非他酮和尼古丁替代疗法(NRT)是戒烟的三种有效药物疗法,但有关其在孕妇中安全性的数据有限。我们在澳大利亚评估了围产期不良结局和与使用这些疗法相关的主要先天性异常的风险。方法将新南威尔士州和西澳大利亚州1,017,731例分娩(2004年至2012年)的围产期数据与配药,住院和死亡记录相关联。我们确定了97,875名在怀孕期间吸烟的女性;其中233、330和1057分别在怀孕期间暴露于安非他酮,NRT和伐尼克兰。倾向得分用于将暴露的妇女与未接受任何吸烟疗法的妇女(1:10的比例)匹配。暴露时的倾向得分和胎龄用于使缬氨苄林暴露于NRT暴露的妇女(1:1比例)相匹配。时间相关的Cox比例风险模型对任何不利的围产期事件(由10个不利的母体和新生儿结局综合而成)和任何重大的先天性异常估计出的风险比(HR),其置信区间为95%(95%CI)。结果安非他酮暴露妇女和未暴露妇女发生任何不良围产期事件的风险没有显着差异(39.2%比39.3%,HR 0.93,95%CI 0.73-1.19)以及NRT和未暴露妇女(44.8%比46.3%) ,HR 1.02,95%CI 0.84-1.23),但暴露于伐尼克兰的女性明显更低(36.9%vs 40.1%,HR 0.86,95%CI 0.77-0.97)。与未暴露婴儿相比,暴露于瓦伦尼克的婴儿早产的可能性较小(6.5%比8.9%,HR 0.72,95%CI 0.56-0.92),胎龄较小(11.4%vs 15.4%,HR 0.68、95%CI 0.56-0.83)并有严重的新生儿并发症(6.6%vs 8.2%,HR 0.74、95%CI 0.57- 0.96)。在头三个月初接触缬氨苄林的婴儿中,有2.9%患有严重的先天性异常(未暴露婴儿中为3.5%,HR 0.91,95%CI 0.72-1.15)。相比于接受NRT的妇女,接受瓦伦尼克林的围产期不良事件发生的可能性更低(38.7%对51.4%,HR 0.58,95%CI 0.33-1.05)。结论怀孕期间接受戒烟药物治疗似乎与不良分娩结果的风险增加无关。伐尼克兰暴露的孕妇不良分娩结局的风险较低,这与NRT优先使用伐尼克兰的建议不一致。56-0.83)并有严重的新生儿并发症(6.6%vs 8.2%,HR 0.74,95%CI 0.57-0.96)。在头三个月初接触缬氨苄林的婴儿中,有2.9%患有严重的先天性异常(未暴露婴儿中有3.5%,HR 0.91,95%CI 0.72-1.15)。相比于接受NRT的妇女,接受瓦伦尼克林的围产期不良事件发生的可能性更低(38.7%对51.4%,HR 0.58,95%CI 0.33-1.05)。结论怀孕期间戒烟药物治疗似乎与不良分娩结果的风险增加无关。伐尼克兰暴露的孕妇不良分娩结局的风险较低,这与NRT优先使用伐尼克兰的建议不一致。56-0.83)并有严重的新生儿并发症(6.6%vs 8.2%,HR 0.74,95%CI 0.57-0.96)。在头三个月初接触缬氨苄林的婴儿中,有2.9%患有严重的先天性异常(未暴露婴儿中有3.5%,HR 0.91,95%CI 0.72-1.15)。相比于接受NRT的妇女,接受瓦伦尼克林的围产期不良事件发生的可能性更低(38.7%vs 51.4%,HR 0.58,95%CI 0.33-1.05)。结论怀孕期间戒烟药物治疗似乎与不良分娩结果的风险增加无关。伐尼克兰暴露的孕妇不良分娩结局的风险较低,这与NRT优先使用伐尼克兰的建议不一致。9%的人患有严重的先天性异常(未暴露婴儿中的比例为3.5%,HR 0.91,95%CI 0.72-1.15)。相比于接受NRT的妇女,接受瓦伦尼克林的围产期不良事件发生的可能性更低(38.7%vs 51.4%,HR 0.58,95%CI 0.33-1.05)。结论怀孕期间接受戒烟药物治疗似乎与不良分娩结果的风险增加无关。伐尼克兰暴露的孕妇不良分娩结局的风险较低,这与NRT优先使用伐尼克兰的建议不一致。9%的人患有严重的先天性异常(未暴露婴儿中的比例为3.5%,HR 0.91,95%CI 0.72-1.15)。相比于接受NRT的妇女,接受瓦伦尼克林的围产期不良事件发生的可能性更低(38.7%vs 51.4%,HR 0.58,95%CI 0.33-1.05)。结论怀孕期间戒烟药物治疗似乎与不良分娩结果的风险增加无关。伐尼克兰暴露的孕妇不良分娩结局的风险较低,这与NRT优先使用伐尼克兰的建议不一致。结论怀孕期间接受戒烟药物治疗似乎与不良分娩结果的风险增加无关。伐尼克兰暴露的孕妇不良分娩结局的风险较低,这与NRT优先使用伐尼克兰的建议不一致。结论怀孕期间接受戒烟药物治疗似乎与不良分娩结果的风险增加无关。伐尼克兰暴露的孕妇不良分娩结局的风险较低,这与NRT优先使用伐尼克兰的建议不一致。
更新日期:2020-02-06
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