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苯巴比妥治疗 Rh 溶血病新生儿:一项随机、双盲、安慰剂对照试验。

Phenobarbitone in Rh hemolytic disease of the newborn: a randomized double-blinded placebo-controlled trial.

机构信息

Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.

出版信息

J Trop Pediatr. 2013 Oct;59(5):380-6. doi: 10.1093/tropej/fmt032. Epub 2013 Jun 8.

DOI:10.1093/tropej/fmt032
PMID:23748474
Abstract

OBJECTIVE

To evaluate the efficacy of prophylactic oral phenobarbitone (PB) in neonates with Rh hemolytic disease of the newborn.

STUDY DESIGN

In this double-blind randomized trial conducted in a tertiary care unit, we randomly allocated neonates with Rh hemolytic disease of the newborn born at or after 32 weeks' gestation to PB (10 mg/kg/day on day 1 followed by 5 mg/kg/day on days 2-5) (n = 23) or oral glucose (n = 21). The primary outcome was the duration of phototherapy.

RESULTS

Baseline variables were comparable. There was no difference in the median duration of phototherapy [54 (range: 0-180) vs. 35 h (0-127); p = 0.39] and in the incidences of failure of phototherapy or significant rebounds of serum bilirubin. However, the proportion of infants with cholestasis was significantly lower in the PB group (0 vs. 19%; p = 0.04).

CONCLUSIONS

PB does not reduce duration of phototherapy or its episodes. Its potential to reduce cholestasis needs validation in larger studies.

摘要

目的

评估新生儿 Rh 溶血病预防性口服苯巴比妥(PB)的疗效。

研究设计

这是一项在三级医疗中心进行的双盲随机试验,我们将胎龄≥32 周出生的 Rh 溶血病新生儿随机分为 PB 组(第 1 天 10 mg/kg/天,随后第 2-5 天 5 mg/kg/天)(n = 23)或口服葡萄糖组(n = 21)。主要结局是光疗持续时间。

结果

基线变量无差异。光疗持续时间中位数无差异[54(范围:0-180)vs. 35 小时(0-127);p = 0.39],光疗失败或血清胆红素显著反弹的发生率也无差异。然而,PB 组胆汁淤积的婴儿比例显著较低(0 vs. 19%;p = 0.04)。

结论

PB 不能缩短光疗时间或次数。其降低胆汁淤积的潜力需要更大规模的研究来验证。

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