University of Vermont, Department of Psychiatry, 1 South Prospect Street UHC, Burlington, VT 05401, USA; University of Vermont, Department of Psychology, 1 South Prospect Street UHC, Burlington, VT 05401, USA.
Drug Alcohol Depend. 2013 Nov 1;133(1):266-9. doi: 10.1016/j.drugalcdep.2013.06.004. Epub 2013 Jul 8.
The recommended standard of care calls for treating opioid-dependent pregnant women with methadone and observing neonates exposed in utero for five to seven postnatal days to see if treatment for neonatal abstinence syndrome (NAS) is needed. Data from a large multi-site randomized clinical trial comparing buprenorphine vs. methadone for the treatment of opioid dependence during pregnancy suggest buprenorphine-exposed neonates had less severe NAS, but may require pharmacologic treatment for NAS later than methadone-exposed neonates. The present study examined whether time to pharmacologic treatment initiation differed in a relatively large non-blinded clinical sample of buprenorphine- vs. methadone-exposed neonates treated for NAS.
Medical records for 75 neonates exposed to buprenorphine (n=47) or methadone (n=28) in utero who required treatment for NAS were examined. Time elapsed between birth and initiation of pharmacologic treatment was calculated for each neonate and time to treatment initiation compared between groups.
Median time to treatment initiation (hours:minutes, IQR) was significantly later in buprenorphine- vs. methadone-exposed neonates (71:02, 44:21-96:27 vs. 34:12, 21:00-55:41, respectively, p<.001). Estimates of mean time to treatment initiation from parametric analyses that adjusted for maternal and neonatal characteristics were very similar (73:10 (95% CI: 61:00-87:18) vs. 42:36 (95% CI: 33:06-53:30), respectively, p=.0005). This difference was not dependent on maternal age or neonatal sex, gestational age, or birth weight.
These findings confirm results from randomized clinical trials, adding generality to the observation that buprenorphine-exposed neonates require treatment significantly later than methadone-exposed neonates.
建议的标准护理要求对阿片类药物依赖的孕妇使用美沙酮,并观察子宫内暴露的新生儿 5 至 7 天,以确定是否需要治疗新生儿戒断综合征(NAS)。一项比较丁丙诺啡与美沙酮治疗孕妇阿片类药物依赖的大型多地点随机临床试验的数据表明,丁丙诺啡暴露的新生儿的 NAS 症状较轻,但可能需要比美沙酮暴露的新生儿晚一些开始药物治疗 NAS。本研究检查了在接受 NAS 治疗的相对较大的非盲临床样本中,丁丙诺啡与美沙酮暴露的新生儿开始药物治疗的时间是否存在差异。
检查了 75 名子宫内暴露于丁丙诺啡(n=47)或美沙酮(n=28)并需要治疗 NAS 的新生儿的医疗记录。计算每个新生儿从出生到开始药物治疗的时间间隔,并比较两组之间的治疗开始时间。
丁丙诺啡与美沙酮暴露的新生儿开始治疗的中位时间(小时:分钟,IQR)明显较晚(71:02,44:21-96:27 与 34:12,21:00-55:41,分别,p<.001)。从调整了母亲和新生儿特征的参数分析中估计的平均开始治疗时间非常相似(73:10(95%CI:61:00-87:18)与 42:36(95%CI:33:06-53:30),分别,p=.0005)。这种差异与母亲年龄或新生儿性别、胎龄或出生体重无关。
这些发现证实了随机临床试验的结果,增加了丁丙诺啡暴露的新生儿需要比美沙酮暴露的新生儿晚得多开始治疗的观察结果的普遍性。