Recovery Pathways, Bay City, Michigan, USA.
Am J Addict. 2013 May-Jun;22(3):252-4. doi: 10.1111/j.1521-0391.2012.12005.x.
Research has indicated that the buprenorphine-mono product yields maternal outcomes similar to methadone and a less severe neonatal abstinence syndrome. However, maternal and neonatal outcomes following buprenorphine + naloxone exposure during pregnancy have not been documented.
Retrospective chart review identified 10 opioid-dependent pregnant women treated with the buprenorphine + naloxone film product between January, 2010-June, 2011. Seven maternal outcome measures - weight gain, fetal presentation at delivery, Cesarean delivery, analgesia during delivery, urine drug screening results at delivery, number of days of maternal hospital stay, and began breastfeeding following delivery-and eleven neonatal outcome measures-gestational age at delivery, 1- and 5-minute Apgar scores, head circumference, length, and weight at birth, treated for neonatal abstinence syndrome (NAS), total amount of morphine sulfate needed to treat NAS, length of hospital stay for NAS treatment, and length of hospital stay-were extracted from medical records.
Maternal findings were unremarkable, and comparable with what might be found following treatment with the buprenorphine-mono product. Neonates were full-term with normal birth parameters. Four neonates were treated for NAS, and number of days treated for NAS and number of hospital days were in line with values reported for the buprenorphine-mono product.
Findings suggest no obvious significant adverse maternal or neonatal outcomes related to the use of buprenorphine + naloxone for the treatment of opioid dependence during pregnancy.
These initial findings underscore the need for future research to systematically examine the relative safety and effectiveness of buprenorphine + naloxone for mother, fetus, and child.
研究表明，丁丙诺啡-纳洛酮单一产品的产妇结局与美沙酮相似，且新生儿戒断综合征的严重程度较轻。然而，目前尚未有文献报道丁丙诺啡-纳洛酮在孕期使用后的产妇和新生儿结局。
回顾性病历分析，共纳入 10 例 2010 年 1 月至 2011 年 6 月期间接受丁丙诺啡-纳洛酮薄膜产品治疗的阿片类药物依赖孕妇。提取了 7 项产妇结局指标（体重增加、分娩时胎儿体位、剖宫产、分娩时镇痛、分娩时尿液药物筛查结果、产妇住院天数和分娩后开始母乳喂养）和 11 项新生儿结局指标（分娩时的胎龄、1 分钟和 5 分钟阿普加评分、头围、出生时的长度和体重、新生儿戒断综合征（NAS）的治疗、治疗 NAS 所需的硫酸吗啡总剂量、NAS 治疗的住院天数和住院总天数）。
产妇的发现无明显异常，与丁丙诺啡单一产品治疗后可能出现的情况相似。新生儿均为足月，出生参数正常。4 例新生儿出现 NAS，NAS 治疗天数和住院天数与丁丙诺啡单一产品报道的值一致。
这些初步发现表明，使用丁丙诺啡-纳洛酮治疗孕期阿片类药物依赖与母婴不良结局无明显关联。
这些初步发现强调了未来需要进行系统研究，以检验丁丙诺啡-纳洛酮在母婴和儿童方面的相对安全性和有效性。
