Department of Obstetrics and Gynecology, Mountain Area Health Education Center, Asheville, NC (NM, MR, MG, CCC); Department of Research, UNC Health Sciences at MAHEC, Asheville, NC (SLG); Department of Obstetrics and Gynecology, UNC-Chapel Hill School of Medicine, Chapel Hill, NC (CCC, SLG); OB/GYN Residency Program, Mountain Area Health Education Center, Asheville, NC (KL, BS).
J Addict Med. 2020 May/Jun;14(3):185-192. doi: 10.1097/ADM.0000000000000562.
To compare maternal and fetal outcomes among dyads prescribed buprenorphine and naloxone or buprenorphine during pregnancy.
Retrospective cohort study of patients with opioid use disorder obtaining care in a comprehensive, perinatal program. Patients utilized medication for opioid use disorder: a buprenorphine and naloxone combination product or buprenorphine monotherapy. The primary outcome was neonatal abstinence syndrome requiring treatment. Maternal secondary outcomes included: negative urine drug screen at delivery, obstetrical care attendance, primary cesarean delivery, and preterm delivery. Neonatal secondary outcomes included neonatal biometry, admission to neonatal intensive care, appropriate findings on cord toxicology, and length of stay. Univariate analyses included Chi square, Fisher exact, t-, or Mann-Whitney tests, as appropriate. Multivariate binary logistic regressions examined the association of type of buprenorphine product with diagnosis of neonatal abstinence syndrome requiring treatment and adjusted for variables significantly different in between-group comparisons and correlates of treatments and the primary outcome.
The rate of neonatal abstinence syndrome was significantly higher (P = 0.007) among infants exposed in utero to buprenorphine versus buprenorphine and naloxone: 59/108 (54.6%) versus 30/85 (35.3%), respectively. The combined product, relative to the monoproduct, was associated with lower odds of neonatal abstinence syndrome: odds ratio (OR) = 0.453 (95% confidence interval [CI] 0.253-0.813; P = 0.008). Adjusting for dose of buprenorphine product at delivery, year of expected delivery, type of prescriber, diagnosis of hepatitis C, and preterm delivery negated these results: adjusted OR = 0.627 (95% CI 0.309-1.275). Secondary outcomes were similar.
Compared with buprenorphine monotherapy, the combined buprenorphine and naloxone product was an acceptable alternative pharmacologic treatment for opioid use disorder during pregnancy.
比较孕期同时使用丁丙诺啡和纳洛酮或丁丙诺啡的母婴结局。
这是一项回顾性队列研究，纳入在综合性围产期项目中接受阿片类药物使用障碍治疗的患者。患者使用阿片类药物使用障碍药物：丁丙诺啡和纳洛酮联合产品或丁丙诺啡单药治疗。主要结局是需要治疗的新生儿戒断综合征。产妇次要结局包括：分娩时尿液药物检测阴性、产科护理就诊、初次剖宫产分娩和早产。新生儿次要结局包括新生儿生物测量、新生儿重症监护病房入院、脐带毒理学检查结果适当和住院时间。单变量分析包括卡方检验、Fisher 确切检验、t 检验或 Mann-Whitney 检验，具体取决于适用情况。多变量二元逻辑回归分析检查丁丙诺啡产品类型与需要治疗的新生儿戒断综合征诊断的关联，并调整组间比较中显著不同的变量以及治疗和主要结局的相关性。
与暴露于丁丙诺啡的婴儿相比，暴露于丁丙诺啡-纳洛酮联合产品的婴儿新生儿戒断综合征的发生率显著更高（P=0.007）：分别为 59/108（54.6%）和 30/85（35.3%）。与单产品相比，联合产品与新生儿戒断综合征的可能性降低相关：比值比（OR）=0.453（95%置信区间 [CI] 0.253-0.813；P=0.008）。调整分娩时丁丙诺啡产品剂量、预期分娩年份、处方医生类型、丙型肝炎诊断和早产后，这些结果被否定：调整后的 OR=0.627（95% CI 0.309-1.275）。次要结局相似。
与丁丙诺啡单药治疗相比，丁丙诺啡-纳洛酮联合产品是一种可接受的替代药物治疗选择，可用于治疗妊娠期阿片类药物使用障碍。
