Antenatal phenobarbital therapy and neonatal outcome. I: Effect on intracranial hemorrhage.

Antenatal phenobarbital therapy and neonatal outcome. I: Effect on intracranial hemorrhage.
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产前苯巴比妥治疗和新生儿结局。

DOI：
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发表时间：
1996
期刊：
Pediatrics
影响因子：
8
通讯作者：
M. Bedard
M. Bedard
中科院分区：
医学2区
文献类型：
--
作者：
S. Shankaran;E. Cepeda;Geraldine Muran;Federico G. Mariona;Samuel Johnson;N. Kazzi;Ronald L. Poland;M. Bedard

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目的 探讨产前苯巴比妥（PB）治疗早产儿颅内出血（ICH）的效果。 设计 前瞻性随机对照试验。 设置 单机构研究。 受试者和干预措施 早产妇女（< 35周妊娠）被分配到对照组和治疗组。治疗组静脉注射10 mg/kg（最大1000 mg）PB，随后每日口服100 mg，直至分娩。新生儿出生后未接受PB。在第3、7和14天以及出院时进行头部超声检查。由一名阅片人将出血分为轻度、中度或重度。 观察指标 所有婴儿、体重小于1250 g的婴儿和多胎妊娠婴儿的新生儿ICH发生率。 结果 研究人群包括110名女性，对照组60名，PB组50名。对照组新生儿（n = 74，包括10对双胞胎和2组三胞胎）与治疗组新生儿（n = 62，包括7对双胞胎、1组三胞胎和1组四胞胎）在出生体重、胎龄和其他ICH临床风险因素方面相当。PB组（22% [14/62]）任何级别出血的发生率有低于对照组（35% [26/74]）的趋势。与对照组（9.4% [7/74]）相比，PB组（1.6% [1/62]）的中度和重度脑梗死发生率显著较低。在体重小于1250 g的婴儿中，PB组（23% [6/26]）的总体ICH低于对照组（51% [18/35]）。在多胎妊娠婴儿中，PB组的总体ICH为4.7%（1/21），而对照组为31%（8/26）。 结论 产前PB治疗可显著降低妊娠35周以下出生婴儿的中度和重度ICH。产前PB治疗还导致体重小于1250 g的婴儿和多胎妊娠婴儿中所有级别ICH的发生率降低。
OBJECTIVE To evaluate the effect of antenatal phenobarbital (PB) therapy on neonatal intracranial hemorrhage (ICH) in preterm infants. DESIGN Prospective, randomized, controlled trial. SETTING Single institution study. SUBJECTS AND INTERVENTIONS Women in preterm labor ( < 35 weeks' gestation) were assigned to control and treatment groups. The treatment group received 10 mg/kg (maximum, 1000 mg) PB intravenously, followed by 100 mg orally daily, until delivery. Neonates did not receive PB after birth. Head sonograms were performed on days 3, 7, and 14 and at discharge. Hemorrhage was classified as mild, moderate, or severe by a single reader. OUTCOME MEASURES Incidence of neonatal ICH in all infants, infants weighing less than 1250 g, and infants of multiple gestations. RESULTS The study population comprised 110 women, 60 in the control group and 50 in the PB group. Neonates in the control group (n = 74, including 10 pairs of twins and 2 sets of triplets) were comparable to those in the treatment group (n = 62, including 7 pairs of twins, 1 set of triplets, and 1 set of quadruplets) regarding birth weight, gestational age, and other clinical risk factors for ICH. There was a trend for the incidence of any grade of hemorrhage to be lower in the PB group (22% [14 of 62]) compared with the control group (35% [26 of 74]). Moderate and severe hemorrhages were significantly lower in the PB group (1.6% [1 of 62]) compared with the control group (9.4% [7 of 74]). Among infants weighing less than 1250 g, overall ICH was lower in the PB group (23% [6 of 26]) compared with the control group (51% [18 of 35]). Among multiple-gestation infants, overall ICH was 4.7% (1 of 21) in the PB group, compared with 31% (8 of 26) in the control group. CONCLUSIONS Antenatal PB therapy results in a significant decrease in moderate and severe ICH in infants born at less than 35 weeks' gestation. Antenatal PB therapy also resulted in a decrease in the incidence of all grades of ICH in infants weighing less than 1250 g and infants born of multiple gestations.