University of Helsinki Doctoral School, P.O. box 4, FI-00014 Helsinki, Finland; Children's Hospital, Pediatric Research Center, HUS Helsinki University Hospital and University of Helsinki, P.O. box 347, FI-00029 HUS, Helsinki, Finland.
Children's Hospital, Pediatric Research Center, HUS Helsinki University Hospital and University of Helsinki, P.O. box 347, FI-00029 HUS, Helsinki, Finland.
Eur J Obstet Gynecol Reprod Biol. 2024 Jun;297:106-110. doi: 10.1016/j.ejogrb.2024.04.003. Epub 2024 Apr 7.
To get information on subcutaneous extended-release buprenorphine as opioid maintenance treatment during pregnancy, we compared it to orally administered buprenorphine and buprenorphine-naloxone treatments. We hypothesized that maternal and neonatal outcomes do not differ between the treatment groups. Study design In this population-based cohort study, 60 pregnant individuals receiving non-changed opioid maintenance treatment for opioid use disorder with a buprenorphine product from the time before conception to the time after delivery and their newborns were included. They were divided into three groups based on the pharmacotherapy with subcutaneous extended-release buprenorphine, sublingual buprenorphine, or buprenorphine-naloxone. Statistical analyses were conducted using Fischer's exact tests, ANOVA tests, and Kruskal-Wallis tests. All the statistical tests were two-tailed.
The frequency of pregnancy or delivery complications did not significantly differ between the group receiving extended-release buprenorphine and the other groups. During pregnancy, 38 % of the women used illicit drugs concomitantly, with equal frequency in the extended-release buprenorphine group and the other groups. Of the neonates, 93 % were born full-term and 90 % got at least eight Apgar points in one minute age, without significant differences between the groups (p = 0.57). The need for pharmacotherapy for neonatal opioid withdrawal syndrome was the lowest in the extended-release buprenorphine group (25 %) and highest in the sublingual buprenorphine group (67 %). Still, the difference between the treatment groups did not reach statistical significance (p = 0.17). Among all neonates, the breastfed infants were less likely to receive pharmacotherapy for withdrawal symptoms than the formula-fed ones (p = 0.048).
Extended-release buprenorphine with steady drug concentration seems to be a promising pharmacotherapy option during pregnancy for mothers. Maternal health during pregnancy may contribute to the well-being of newborns. Larger trials are urgently needed to confirm these results..
为了获取关于皮下持续释放丁丙诺啡作为妊娠期间阿片类药物维持治疗的信息，我们将其与口服丁丙诺啡和丁丙诺啡-纳洛酮治疗进行了比较。我们假设在治疗组之间，产妇和新生儿结局没有差异。
在这项基于人群的队列研究中，纳入了 60 名在妊娠期间继续接受非改变的阿片类药物维持治疗的个体，她们在受孕前至分娩后期间使用丁丙诺啡产品，且她们的新生儿也被纳入研究。根据皮下持续释放丁丙诺啡、舌下丁丙诺啡或丁丙诺啡-纳洛酮的药物治疗，将她们分为三组。使用 Fisher 确切检验、方差分析和 Kruskal-Wallis 检验进行统计分析。所有的统计检验均为双侧检验。
接受持续释放丁丙诺啡治疗的组与其他组之间，妊娠或分娩并发症的发生频率没有显著差异。在妊娠期间，38%的女性同时使用了非法药物，在持续释放丁丙诺啡组和其他组中的频率相等。在新生儿中，93%为足月出生，90%在一分钟龄时至少获得 8 个 Apgar 评分，各组之间无显著差异（p=0.57）。新生儿阿片类药物戒断综合征的药物治疗需求在持续释放丁丙诺啡组最低（25%），在舌下丁丙诺啡组最高（67%）。然而，治疗组之间的差异没有达到统计学意义（p=0.17）。在所有新生儿中，母乳喂养的婴儿接受戒断症状药物治疗的可能性低于配方奶喂养的婴儿（p=0.048）。
持续释放丁丙诺啡具有稳定的药物浓度，似乎是妊娠期间母亲的一种有前途的药物治疗选择。妊娠期间的产妇健康可能有助于新生儿的健康。迫切需要更大规模的试验来证实这些结果。
