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产前倍他米松与地塞米松对比研究(倍他米松编码试验):一项随机对照试验

Antenatal betamethasone compared with dexamethasone (betacode trial): a randomized controlled trial.

作者信息

Elimian Andrew, Garry David, Figueroa Reinaldo, Spitzer Alan, Wiencek Vandy, Quirk J Gerald

机构信息

Department of Obstetrics, Gynecology and Reproductive Medicine, Stony Brook University, Stony Brook, New York, USA.

出版信息

Obstet Gynecol. 2007 Jul;110(1):26-30. doi: 10.1097/01.AOG.0000268281.36788.81.

DOI:10.1097/01.AOG.0000268281.36788.81
PMID:17601892
Abstract

OBJECTIVE

To compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.

METHODS

We enrolled 299 women at risk for preterm delivery in a double-blind, placebo-controlled, randomized trial of antenatal betamethasone compared with dexamethasone at Stony Brook University Hospital from August 2002 through July 2004. We excluded women with clinical chorioamnionitis, fetal structural and chromosomal abnormalities, prior antenatal steroid exposure, and steroid use for other indications. Statistical analysis was performed in accordance of the intention-to-treat principle.

RESULTS

There were no significant differences between the groups with regard to baseline characteristics. The rate of respiratory distress syndrome, need for vasopressor therapy, necrotizing enterocolitis, retinopathy of prematurity, patent ductus arteriosus, neonatal sepsis, and neonatal mortality were not significant different between the groups. However, the rates of intraventricular hemorrhage (6 of 105 [5.7%] compared with 17 of 100 [17.0%], relative risk [RR] 2.97, 95% confidence interval [CI] 1.22-7.24, P=.02) and any brain lesion (7 of 105 [6.7%] compared with 18 of 100 [18.0%], RR 2.7, 95% CI 1.18-6.19, P=.02) were significantly lower in neonates exposed to dexamethasone compared with betamethasone. The absolute risk reduction in the rate of intraventricular hemorrhage was 11.3 % ( 95% CI 2.7-11.9%), and the number needed to treat was 9 (95% CI 5-37) in favor of dexamethasone.

CONCLUSION

Betamethasone and dexamethasone are comparable in reducing the rate of most major neonatal morbidities and mortality in preterm neonates. However, dexamethasone seems to be more effective in reducing the rate of intraventricular hemorrhage compared with betamethasone.

摘要

目的

比较倍他米松和地塞米松在降低早产儿围产期发病率和死亡率方面的有效性。

方法

2002年8月至2004年7月期间,我们在石溪大学医院进行了一项双盲、安慰剂对照、随机试验,将299名有早产风险的妇女纳入其中,比较产前使用倍他米松与地塞米松的效果。我们排除了患有临床绒毛膜羊膜炎、胎儿结构和染色体异常、既往产前使用过类固醇以及因其他指征使用类固醇的妇女。根据意向性治疗原则进行统计分析。

结果

两组在基线特征方面无显著差异。两组在呼吸窘迫综合征、需要血管活性药物治疗、坏死性小肠结肠炎、早产儿视网膜病变、动脉导管未闭、新生儿败血症和新生儿死亡率方面无显著差异。然而,与倍他米松相比,地塞米松治疗的新生儿脑室内出血发生率(105例中有6例[5.7%],而100例中有17例[17.0%],相对危险度[RR]2.97,95%置信区间[CI]1.22 - 7.24,P = 0.02)和任何脑损伤发生率(105例中有7例[6.7%],而100例中有18例[18.0%],RR 2.7,95% CI 1.18 - 6.19,P = 0.02)显著更低。脑室内出血发生率的绝对风险降低为11.3%(95% CI 2.7 - 11.9%),地塞米松治疗所需的治疗人数为9(95% CI 5 - 37)。

结论

倍他米松和地塞米松在降低早产儿大多数主要新生儿发病率和死亡率方面具有可比性。然而,与倍他米松相比,地塞米松在降低脑室内出血发生率方面似乎更有效。

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