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催产素鼻喷雾剂用于早产母亲挤母乳的随机双盲试验。

Randomised, double blind trial of oxytocin nasal spray in mothers expressing breast milk for preterm infants.

作者信息

Fewtrell M S, Loh K L, Blake A, Ridout D A, Hawdon J

机构信息

Childhood Nutrition Reserach Centre, Institute of Child Health, 30 Guilford Street, London WC1N 1EH, UK.

出版信息

Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F169-74. doi: 10.1136/adc.2005.081265. Epub 2005 Oct 13.

Abstract

BACKGROUND

Human milk has considerable short and long term benefits for preterm infants, but mothers may experience difficulties in expressing breast milk for infants too immature or sick to breast feed. Oxytocin has been used to assist breast feeding and milk expression, but few data are available to support this intervention in the neonatal unit setting.

AIM

To test the hypothesis that oxytocin nasal spray increases early milk output in mothers expressing milk for preterm infants.

METHODS

A randomised, double blind trial of oxytocin nasal spray (100 microl per dose) versus placebo was conducted in mothers delivering infants <35 weeks gestation. Sprays were used before expression of milk using an electric pump up to day 5.

MAIN OUTCOME

Total weight of milk expressed while using spray (study powered to detect >1SD difference between groups).

SECONDARY OUTCOMES

Pattern of milk production; number of pumping sessions; weight/fat content of milk expressed during a fixed 20 minute period on day 5 ("physiological study"); mother's opinion of expressing and spray assessed by questionnaire.

RESULTS

Fifty one mothers were randomised (27 oxytocin, 24 placebo). Total milk production did not differ between groups. Repeated measures analysis of variance suggested significantly (p = 0.001) different patterns of milk production, with initial faster production in the oxytocin group then convergence between groups. Parity did not influence the response to the intervention. No significant differences were seen in milk weight or fat content in the physiological study nor in mothers' opinions of milk expression and treatment.

CONCLUSIONS

Despite marginal differences in the pattern of early milk production, the use of oxytocin nasal spray did not significantly improve outcome. Most mothers believed they were receiving the active spray, suggesting a significant placebo effect (supported by limited data from historical controls) and benefits from the extra breast feeding support available during the study.

摘要

背景

母乳对早产儿具有显著的短期和长期益处,但对于那些因过于不成熟或患病而无法进行母乳喂养的婴儿,母亲在挤奶时可能会遇到困难。催产素已被用于辅助母乳喂养和挤奶,但在新生儿病房环境中支持这种干预措施的数据很少。

目的

检验催产素鼻喷雾剂能增加为早产儿挤奶的母亲早期奶量的假设。

方法

对孕周小于35周的产妇进行了一项随机双盲试验,比较催产素鼻喷雾剂(每剂100微升)与安慰剂。在使用电动吸奶器挤奶前使用喷雾剂,直至第5天。

主要结局

使用喷雾剂期间挤出的奶的总重量(该研究旨在检测组间>1标准差的差异)。

次要结局

产奶模式;挤奶次数;第5天固定20分钟期间挤出的奶的重量/脂肪含量(“生理学研究”);通过问卷调查评估母亲对挤奶和喷雾剂的看法。

结果

51名母亲被随机分组(27名使用催产素,24名使用安慰剂)。两组间的总产奶量没有差异。重复测量方差分析表明产奶模式存在显著差异(p = 0.001),催产素组最初产奶速度较快,然后两组趋于一致。胎次不影响对干预的反应。在生理学研究中,奶的重量或脂肪含量以及母亲对挤奶和治疗的看法均无显著差异。

结论

尽管早期产奶模式存在微小差异,但使用催产素鼻喷雾剂并未显著改善结局。大多数母亲认为她们使用的是活性喷雾剂,这表明存在显著的安慰剂效应(历史对照的有限数据支持)以及研究期间额外的母乳喂养支持带来的益处。

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