Division of Primary Care, University Park, University of Nottingham, Nottingham, UK.
Nicotine Tob Res. 2019 Jul 17;21(8):1001-1010. doi: 10.1093/ntr/nty055.
Smoking in pregnancy is a substantial public health issue, but, apart from nicotine replacement therapy (NRT), pharmacological therapies are not generally used to promote cessation. Bupropion and varenicline are effective cessation methods in nonpregnant smokers and this systematic review investigates their safety in pregnancy.
We searched MEDLINE, EMBASE, CINAHL, and PsychINFO databases for studies of any design reporting pregnancy outcomes after bupropion or varenicline exposure. We included studies of bupropion used for smoking cessation, depression, or where the indication was unspecified. Depending on study design, quality was assessed using the Newcastle-Ottawa Scale or Cochrane Risk of Bias Tool. Most findings are reported narratively but meta-analyses were used to produce pooled estimates for the proportion of live births with congenital malformations and of the mean birthweight and gestational age at delivery following bupropion exposure.
In total, 18 studies were included: 2 randomized controlled trials, 11 cohorts, 2 case- control studies, and 3 case reports. Study quality was variable. Gestational safety outcomes were reported in 14 bupropion and 4 varenicline studies. Meaningful meta-analysis was only possible for bupropion exposure, for which the pooled estimated proportion of congenital malformations amongst live-born infants was 1.0% (95% CI = 0.0%-3.0%, I2 = 80.9%, 4 studies) and the mean birthweight and mean gestational age at delivery was 3305.9 g (95% CI = 3173.2-3438.7 g, I2 = 77.6%, 5 studies) and 39.2 weeks (95% CI = 38.8-39.6 weeks, I2 = 69.9%, 5 studies), respectively.
There was no strong evidence that either major positive or negative outcomes were associated with gestational use of bupropion or varenicline. PROSPERO registration number CRD42017067064.
We believe this to be the first systematic review investigating the safety of bupropion and varenicline in pregnancy. Meta-analysis of outcomes following bupropion exposure in pregnancy suggests that there are no major positive or negative impacts on the rate of congenital abnormalities, birthweight, or premature birth. Overall, we found no evidence that either of these treatments might be harmful in pregnancy, and no strong evidence to suggest safety, but available evidence is of poor quality.
孕期吸烟是一个严重的公共卫生问题，但除了尼古丁替代疗法（NRT）之外，一般不使用药物疗法来促进戒烟。安非他酮和伐尼克兰是非孕妇吸烟者戒烟的有效方法，本系统评价调查了它们在孕期使用的安全性。
我们检索了 MEDLINE、EMBASE、CINAHL 和 PsychINFO 数据库，以查找报告安非他酮或伐尼克兰暴露后妊娠结局的任何设计的研究。我们纳入了用于戒烟、治疗抑郁症或未指明适应证的安非他酮的研究。根据研究设计，使用纽卡斯尔-渥太华量表或 Cochrane 偏倚风险工具评估质量。大多数发现以叙述方式报告，但进行了荟萃分析，以产生安非他酮暴露后活产儿先天性畸形比例和出生体重及分娩时孕龄的汇总估计值。
共纳入 18 项研究：2 项随机对照试验、11 项队列研究、2 项病例对照研究和 3 项病例报告。研究质量参差不齐。14 项安非他酮和 4 项伐尼克兰研究报告了妊娠安全性结局。仅对安非他酮暴露进行了有意义的荟萃分析，其中活产婴儿先天性畸形的估计比例为 1.0%（95%CI=0.0%-3.0%，I2=80.9%，4 项研究），出生体重和分娩时孕龄分别为 3305.9 g（95%CI=3173.2-3438.7 g，I2=77.6%，5 项研究）和 39.2 周（95%CI=38.8-39.6 周，I2=69.9%，5 项研究）。
没有强有力的证据表明妊娠期间使用安非他酮或伐尼克兰与任何重大积极或消极结局相关。PROSPERO 注册号 CRD42017067064。
这是第一项调查安非他酮和伐尼克兰在妊娠期间安全性的系统评价。对妊娠期间安非他酮暴露后结局进行的荟萃分析表明，先天性异常、出生体重或早产的发生率没有明显的积极或消极影响。总体而言，我们没有发现这两种治疗方法在妊娠期间可能有害的证据，也没有强有力的证据表明安全性，但现有证据质量较差。
