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首页> 外文期刊>Journal of perinatology: Official journal of the California Perinatal Association >Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial
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Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial

机译:可乐定与苯巴比妥在减少新生儿戒断综合症的新生儿硫酸吗啡治疗天数方面的疗效。前瞻性随机临床试验

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Objective:To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS).Study Design: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.Results: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.Conclusion:Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.
机译:目的:比较可乐定与苯巴比妥在减少新生儿戒断综合症(NAS)硫酸吗啡治疗天数方面的疗效。研究设计:一项单项III级新生儿重症监护病房(新生儿重症监护病房)的前瞻性,无盲,随机对照试验。根据方案,对符合条件的婴儿进行药物联合治疗。主要结局是用吗啡硫酸盐治疗的天数。次要结局为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。结果:共有82例婴儿入选,其中68例被随机分为每个研究组34例。与可乐定相比,调整苯巴比妥协变量的硫酸吗啡治疗时间较短(-4.6,95%置信区间(CI):-0.3,-8.9; P = 0.037),平均硫酸吗啡总剂量(1.1 mg kg- 1,95%CI:-0.1,2.4; P = 0.069)。出院后苯巴比妥平均持续3.8个月(1到8个月)。结论:苯巴比妥作为辅助治疗与可乐定相比,临床上住院时间短,无临床意义,但总体治疗时间长得多。

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