Zedler Barbara K, Mann Ashley L, Kim Mimi M, Amick Halle R, Joyce Andrew R, Murrelle E Lenn, Jones Hendrée E
Venebio Group, LLC, Richmond, Virginia, USA.
Center for Biobehavioral Health Disparities Research, Division of Community Health, Duke University, Durham, NC, USA.
Addiction. 2016 Dec;111(12):2115-2128. doi: 10.1111/add.13462. Epub 2016 Jun 30.
To assess the safety of buprenorphine compared with methadone to treat pregnant women with opioid use disorder.
We searched PubMed, Embase and the Cochrane Library from inception to February 2015 for randomized controlled trials (RCT) and observational cohort studies (OBS) that compared buprenorphine with methadone for treating opioid-dependent pregnant women. Two reviewers assessed independently the titles and abstracts of all search results and full texts of potentially eligible studies reporting original data for maternal/fetal/infant death, preterm birth, fetal growth outcomes, fetal/congenital anomalies, fetal/child neurodevelopment and/or maternal adverse events. We ascertained each study's risk of bias using validated instruments and assessed the strength of evidence for each outcome using established methods. We computed effect sizes using random-effects models for each outcome with two or more studies.
Three RCTs (n = 223) and 15 cohort OBSs (n = 1923) met inclusion criteria. In meta-analyses using unadjusted data and methadone as comparator, buprenorphine was associated with lower risk of preterm birth [RCT risk ratio (RR) = 0.40, 95% confidence interval (CI) = 0.18, 0.91; OBS RR = 0.67, 95% CI = 0.50, 0.90], greater birth weight [RCT weighted mean difference (WMD) = 277 g, 95% CI = 104, 450; OBS WMD = 265 g, 95% CI = 196, 335] and larger head circumference [RCT WMD = 0.90 cm, 95% CI = 0.14, 1.66; OBS WMD = 0.68 cm, 95% CI = 0.41, 0.94]. No treatment differences were observed for spontaneous fetal death, fetal/congenital anomalies and other fetal growth measures, although the power to detect such differences may be inadequate due to small sample sizes.
Moderately strong evidence indicates lower risk of preterm birth, greater birth weight and larger head circumference with buprenorphine treatment of maternal opioid use disorder during pregnancy compared with methadone treatment, and no greater harms.
评估丁丙诺啡与美沙酮相比治疗阿片类药物使用障碍孕妇的安全性。
我们检索了PubMed、Embase和Cochrane图书馆，检索时间从建库至2015年2月，查找比较丁丙诺啡与美沙酮治疗阿片类药物依赖孕妇的随机对照试验（RCT）和观察性队列研究（OBS）。两名评价者独立评估所有检索结果的标题和摘要，以及报告有关孕产妇/胎儿/婴儿死亡、早产、胎儿生长结局、胎儿/先天性异常、胎儿/儿童神经发育和/或孕产妇不良事件原始数据的潜在合格研究的全文。我们使用经过验证的工具确定每项研究的偏倚风险，并使用既定方法评估每个结局的证据强度。对于每项有两项或更多研究的结局，我们使用随机效应模型计算效应量。
三项RCT（n = 223）和15项队列OBS（n = 1923）符合纳入标准。在使用未调整数据且以美沙酮作为对照的荟萃分析中，丁丙诺啡与较低的早产风险相关[RCT风险比（RR）= 0.40，95%置信区间（CI）= 0.18，0.91；OBS RR = 0.67，95% CI = 0.50，0.90]，出生体重更大[RCT加权均数差（WMD）= 277 g，95% CI = 104，450；OBS WMD = 265 g，95% CI = 196，335]，头围更大[RCT WMD = 0.90 cm，95% CI = 0.14，1.66；OBS WMD = 0.68 cm，95% CI = 0.41，0.94]。对于自然胎儿死亡、胎儿/先天性异常和其他胎儿生长指标，未观察到治疗差异，尽管由于样本量小，检测此类差异的效能可能不足。
适度有力的证据表明，与美沙酮治疗相比，孕期使用丁丙诺啡治疗孕产妇阿片类药物使用障碍可降低早产风险，增加出生体重和增大头围，且危害不大。
