Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome
Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome
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DOI：
10.1056/nejmoa1614835
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发表时间：
2017-06-15
影响因子：
158.5
通讯作者：
Ehrlich, Michelle E.
中科院分区：
文献类型：
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作者：
Kraft, Walter K.;Adeniyi-Jones, Susan C.;Ehrlich, Michelle E.
研究背景目前，对新生儿吗啡戒断综合征的药物治疗通常需要较长的疗程和住院时间。丁丙诺啡在这方面可能比吗啡更有效。方法在这项单部位、双盲、双模拟临床试验中，我们随机将63名在宫内接触阿片类药物且有新生儿戒断综合征迹象的足月儿随机分配给丁丙诺啡或口服吗啡。对于症状没有得到最大剂量阿片类药物控制的婴儿，使用辅助性苯巴比妥进行治疗。主要终点是新生儿阿片类药物戒断症状的治疗持续时间。次要临床终点是住院时间、需要苯巴比妥补充治疗的婴儿百分比和安全性。结果丁丙诺啡的中位治疗时间显著短于吗啡(15天对28天)，住院中位时间(21天对33天)(P
BACKGROUNDCurrent pharmacologic treatment of the neonatal abstinence syndrome with morphine is associated with a lengthy duration of therapy and hospitalization. Buprenorphine may be more effective than morphine for this indication.METHODSIn this single-site, double-blind, double-dummy clinical trial, we randomly assigned 63 term infants (>= 37 weeks of gestation) who had been exposed to opioids in utero and who had signs of the neonatal abstinence syndrome to receive either sublingual buprenorphine or oral morphine. Infants with symptoms that were not controlled with the maximum dose of opioid were treated with adjunctive phenobarbital. The primary end point was the duration of treatment for symptoms of neonatal opioid withdrawal. Secondary clinical end points were the length of hospital stay, the percentage of infants who required supplemental treatment with phenobarbital, and safety.RESULTSThe median duration of treatment was significantly shorter with buprenorphine than with morphine (15 days vs. 28 days), as was the median length of hospital stay (21 days vs. 33 days) (P