de Lima Fernanda Ribeiro, Molino Gabriela Oliveira Gonçalves, Gallo Ruelas Mariano, Barbosa Eduardo Cerchi, Silva Pedro Henrique Costa Matos da, Guimarães Felipe Bandeira de Melo, Petrucci Arthur Bezerra Cavalcanti, Silva Giovanna Hanike Santos da, Sbardelotto Ângelo Eduardo Espíndola, Lança Saulo Bernardo, Garbacka Alicja
Department of Medicine, Pontifical Catholic University of Paraná, Curitiba, Brazil.
Department of Medicine, Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil.
Drug Alcohol Depend. 2025 Jun 1;271:112632. doi: 10.1016/j.drugalcdep.2025.112632. Epub 2025 Feb 28.
The standard of care for treating opioid use disorder (OUD) during pregnancy includes either buprenorphine or methadone. Although buprenorphine-naloxone presents an alternative due to the reduced risk of misuse , evidence regarding its impact on pregnancy and infant health remains limited. This systematic review and meta-analysis aims to compare buprenorphine-naloxone vs buprenorphine alone for OUD during pregnancy, assessing gestational and neonatal outcomes.
We systematically searched MEDLINE, Embase, and Cochrane Library databases to identify studies comparing buprenorphine-naloxone versus buprenorphine for OUD during pregnancy. The primary outcome assessed was neonatal abstinence syndrome (NAS). Pooled risk ratios (RR) and mean differences (MD) with 95 % confidence intervals (CI) were calculated using R statistical software and quality assessment was performed following Cochrane recommendations.
Six retrospective cohorts were included, encompassing 9348 mother-infant dyads, of whom 38.3 % received buprenorphine-naloxone. NAS requiring treatment (RR 0.77; 95 % CI 0.71-0.84; p < 0.01) and small for gestational age infants (RR 0.86; 95 % CI 0.76-0.98; p = 0.03) were significantly less frequent in the buprenorphine-naloxone group. No significant differences were found between the groups for cesarean delivery (RR 1.04; 95 % CI 0.98-1.11; p = 0.20), low birth weight (RR 1.07; 95 % CI 0.91-1.24; p = 0.41), and preterm delivery (RR 1.07; 95 % CI 0.96-1.21; p = 0.22).
Pregnant people treated with buprenorphine-naloxone had neonates with a lower risk of small for gestational age and NAS. Further research is needed to confirm these findings and explore other pregnancy-related and neonatal outcomes.
孕期治疗阿片类物质使用障碍（OUD）的标准治疗方法包括使用丁丙诺啡或美沙酮。尽管丁丙诺啡 - 纳洛酮因滥用风险降低而提供了一种替代方案，但关于其对妊娠和婴儿健康影响的证据仍然有限。本系统评价和荟萃分析旨在比较孕期使用丁丙诺啡 - 纳洛酮与单独使用丁丙诺啡治疗OUD的情况，评估妊娠和新生儿结局。
我们系统检索了MEDLINE、Embase和Cochrane图书馆数据库，以识别比较孕期使用丁丙诺啡 - 纳洛酮与丁丙诺啡治疗OUD的研究。评估的主要结局是新生儿戒断综合征（NAS）。使用R统计软件计算合并风险比（RR）和平均差（MD）以及95%置信区间（CI），并按照Cochrane推荐进行质量评估。
纳入了6项回顾性队列研究，涵盖9348对母婴，其中38.3%接受了丁丙诺啡 - 纳洛酮治疗。在丁丙诺啡 - 纳洛酮组中，需要治疗的NAS（RR 0.77；95% CI 0.71 - 0.84；p < 0.01）和小于胎龄儿（RR 0.86；95% CI 0.76 - 0.98；p = 0.03）的发生率显著较低。两组在剖宫产（RR 1.04；95% CI 0.98 - 1.11；p = 0.20）、低出生体重（RR 1.07；95% CI 0.91 - 1.24；p = 0.41）和早产（RR 1.07；95% CI 0.96 - 1.21；p = 0.22）方面未发现显著差异。
接受丁丙诺啡 - 纳洛酮治疗的孕妇所生新生儿出现小于胎龄和NAS的风险较低。需要进一步研究以证实这些发现并探索其他与妊娠相关和新生儿结局。
