1] Division of Newborn Medicine, Baystate Children's Hospital, Springfield, MA, USA [2] Department of Neurology, Boston Medical Center, Boston, MA, USA.
J Perinatol. 2013 Dec;33(12):954-9. doi: 10.1038/jp.2013.95. Epub 2013 Aug 15.
To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS).
Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures.
A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted.
Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.
比较可乐定与苯巴比妥治疗新生儿戒断综合征（NAS）减少硫酸吗啡治疗天数的疗效。
在单一层级 III 级新生儿重症监护病房（NICU）进行的前瞻性、非盲、分组随机试验。符合条件的婴儿按方案接受联合药物治疗。主要结局是硫酸吗啡的治疗天数。次要结局是平均总硫酸吗啡剂量、门诊苯巴比妥天数、不良事件和治疗失败。
共有 82 名婴儿符合条件，其中 68 名随机分组，每组 34 名婴儿。调整协变量后，与可乐定相比，苯巴比妥的硫酸吗啡治疗天数更短（-4.6，95%置信区间[CI]：-0.3，-8.9；P=0.037），平均硫酸吗啡总剂量无差异（1.1mg/kg，95%CI：-0.1，2.4；P=0.069）。出院后苯巴比妥的平均持续时间为 3.8 个月（范围 1 至 8 个月）。没有注意到其他显著差异。
与可乐定相比，苯巴比妥作为辅助治疗在住院期间的治疗时间较短，但总体上的治疗时间显著延长。
