A randomised controlled trial of morphine versus phenobarbitone for neonatal abstinence syndrome
A randomised controlled trial of morphine versus phenobarbitone for neonatal abstinence syndrome
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DOI：
10.1136/adc.2003.033555
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发表时间：
2004-07-01
影响因子：
4.4
通讯作者：
Skeoch, C
中科院分区：
文献类型：
--
作者：
Jackson, L;Ting, A;Skeoch, C
背景：在过去的十年中，格拉斯哥新生儿禁欲综合征(NAS)的发病率增加了10倍。目的：比较阿片类药物替代疗法(硫酸吗啡)和现行标准疗法(苯巴比妥)治疗NAS的疗效。主要研究终点是药物治疗的持续时间。次级终点是额外药物的要求和SCBU入院的要求。设计：双盲、随机对照临床试验。方法：排除鉴别诊断，两个连续的Lipsitz评分。4定义了需要处理的NAS。婴儿被随机接受硫酸吗啡或苯巴比妥治疗。这些处理在外观、气味和体积上都是相同的。方案包括递增、递减和停止治疗。结果：75名婴儿参与试验。所有母亲均在孕期接受阿片类药物替代治疗(美沙酮)，大多数母亲使用其他药物(n=62，83%)。在治疗组之间，母亲的药物使用模式没有显著差异。阿片类药物替代治疗的中位治疗时间缩短了4天(8vs12天，Mann-Whitney U检验，p=0.02)。接受苯巴比妥治疗的婴儿往往需要二线治疗(47%对35%，x(2)检验，p=0.11)和SCBU入院(62%对30%，x(2)检验，p=0.04)。结论：当母亲普遍使用阿片类药物时，阿片类替代疗法似乎是治疗症状性NAS的更好方法。治疗持续时间较短，对高强度护理的要求较低，可能会产生重大的成本影响。根据当地孕妇的药物使用情况量身定做NAS治疗可能会产生类似的好处。
Background: The incidence of neonatal abstinence syndrome (NAS) has increased 10-fold over the last decade in Glasgow. In the Princess Royal Maternity Hospital, it now accounts for 17% of special care baby unit (SCBU) admissions.Objective: To compare opiate replacement therapy ( morphine sulphate) with the present standard treatment ( phenobarbitone) for management of NAS. The primary study end point was duration of pharmaceutical treatment. Secondary end points were the requirement for additional drugs and the requirement for SCBU admission.Design: Double blind, randomised controlled clinical trial.Methods: Differential diagnoses were excluded, and two consecutive Lipsitz scores. 4 defined NAS requiring treatment. Infants were randomised to receive morphine sulphate or phenobarbitone. Treatments were identical in appearance, odour, and volume. Increments, decrements, and discontinuation of treatments were protocol driven.Results: Seventy five infants participated. All mothers received opiate replacement therapy ( methadone) during pregnancy and most used other drugs ( n = 62, 83%). No significant difference in maternal drug use patterns was observed between treatment groups. Median treatment duration was four days shorter with opiate replacement ( 8 v 12 days, Mann-Whitney U test, p = 0.02). Phenobarbitone treated infants tended to require second line treatment (47% v 35%, chi(2) test, p = 0.11) and SCBU admission (62% v 30%, chi(2) test, p = 0.04) more often.Conclusions: Opiate replacement therapy appears to be superior for management of symptomatic NAS when maternal opiate use is prevalent. The shorter treatment duration and lower requirement for higher intensity nursing may have significant cost implications. Tailoring NAS treatment to local maternal drug use may result in similar benefits.