Murki Srinivas, Dutta Sourabh, Narang Anil, Sarkar Urmi, Garewal Gurjeevan
Division of Neonatology, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
J Perinatol. 2005 May;25(5):325-30. doi: 10.1038/sj.jp.7211258.
Decreased conjugation is probably more important than hemolysis for causing jaundice in G6PD-deficient neonates. The role of enzyme inducers, like phenobarbital, in G6PD deficiency is unclear. This randomized controlled trial was performed to evaluate Phenobarbital's role in reducing the need for phototherapy among G6PD-deficient neonates.
This stratified, randomized, triple-blinded, placebo-controlled trial was conducted in a level III NICU. Consecutive babies with gestation >/=34 weeks and birth weight >/=1800 g were screened from cord blood. G6PD-deficient neonates, who were otherwise healthy, were enrolled. Rh isoimmunization, maternal Phenobarbital use and lack of parental consent were exclusion criteria. Subjects were randomly allocated to receive 5 mg/kg day of oral phenobarbital/ placebo for first 3 days. They were monitored daily for total serum bilirubin (TSB) until declining TSB was documented twice. The primary outcome was requirement for phototherapy and secondary outcomes were duration of phototherapy, need for exchange transfusion, peak TSB and adverse effects. Sample size of 56 could detect a decline in phototherapy requirement from 40 to 5% with 80% power and 5% error.
Of 2370 babies screened, 63 were G6PD-deficient. Of them, 56 eligible babies were allocated to phenobarbital (n=27) or placebo (n=29). The mean age of administration of the first dose was 18.55+/-7.3 h. In total, 44% in phenobarbital group and 41% in placebo group required phototherapy (p=1.0). There was no significant difference in exchange transfusion rates (18.5 vs 10%, p=0.46). No baby had adverse reactions.
Prophylactic oral phenobarbital does not decrease the need for phototherapy or exchange transfusions in G6PD-deficient neonates.
对于葡萄糖-6-磷酸脱氢酶（G6PD）缺乏的新生儿，肝脏结合胆红素能力下降可能比溶血在黄疸形成过程中更为重要。酶诱导剂（如苯巴比妥）在G6PD缺乏症中的作用尚不清楚。本随机对照试验旨在评估苯巴比妥在减少G6PD缺乏新生儿光疗需求方面的作用。
本分层、随机、三盲、安慰剂对照试验在一家三级新生儿重症监护病房（NICU）进行。从脐带血中筛选出孕周≥34周且出生体重≥1800g的连续婴儿。纳入其他方面健康的G6PD缺乏新生儿。Rh血型免疫、母亲使用苯巴比妥以及缺乏父母同意为排除标准。受试者在前3天随机分配接受5mg/kg/天的口服苯巴比妥/安慰剂。每天监测总血清胆红素（TSB），直至TSB下降记录两次。主要结局是光疗需求，次要结局是光疗持续时间、换血需求、TSB峰值和不良反应。样本量为56时，可在80%的检验效能和5%的误差下检测到光疗需求从40%降至5%。
在2370名筛查的婴儿中，63名G6PD缺乏。其中，56名符合条件的婴儿被分配到苯巴比妥组（n = 27）或安慰剂组（n = 29）。首剂给药的平均年龄为18.55±7.3小时。总体而言，苯巴比妥组44%、安慰剂组41%需要光疗（p = 1.0）。换血率无显著差异（18.5%对10%，p = 0.46）。无婴儿出现不良反应。
预防性口服苯巴比妥不能降低G6PD缺乏新生儿的光疗需求或换血需求。
