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【文摘发布】《Obstetrics and Gynecology》（ 2007年7月
A Randomized Controlled Trial 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领 Antenatal Betamethasone Compared With Dexamethasone (Betacode Trial)
A Randomized Controlled Trial
Andrew Elimian, MD1, David Garry, DO1, Reinaldo Figueroa, MD1, Alan Spitzer, MD2, Vandy Wiencek, RN1 and J. Gerald Quirk, MD, PhD1
From the 1Department of Obstetrics, Gynecology and Reproductive Medicine and 2Department of Pediatrics, Stony Brook University, Stony Brook, New York.
OBJECTIVE: To compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.
目的：比较倍他米松和地塞米松在降低早产儿围生期发病率和死亡率中的作用。
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.
方法：从2002年8月到2004年7月，我们在斯托尼布鲁克大学医院一项双盲，安慰剂随机对照实验招募了299名有早产风险的妇女，对产前应用倍他米松及地塞米松进行比较。
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.
我们排除了患有绒毛膜羊膜炎，胎儿结构和染色体畸形，出生前有类固醇接触及有使用类固醇征候的妇女。统计分析与意向性治疗原则一致。
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.
结果：各组的基线特征都没有显著性差异。各组之间呼吸窘迫综合症，抗利尿素治疗的需要，坏死性小肠结肠炎，早产儿视网膜病，动脉导管未闭，新生儿脓毒症以及新生儿死亡率都没有显著性差异。
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.
然而，使用地塞米松的新生儿脑室内出血(6/105 [5.7%] 相比较17 / 100 [17.0%], 相对危险度 [RR] 2.97, 95% 可信区间 [CI] 1.22–7.24, P=.02)和脑损害(7 /105 [6.7%] 相比较18 /100 [18.0%],相对危险度 2.7, 95% 可信区间 CI 1.18–6.19, P=.02)的患病率都显著低于使用倍他米松的新生儿。
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.
脑室内出血的绝对危险率下降了11.3 % ( 95% 可信区间 2.7–11.9%), 需要治疗的人数是9 (95% 可信区间 5–37) ，这都支持使用地塞米松。
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.
结论：在降低早产儿的主要新生儿发病率和死亡率几率方面，倍他米松和地塞米松具有可比性。可是，在降低脑室内出血几率方面地塞米松比倍他米松更为有效。
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00418353
临床实验注册证:ClinicalTrials.gov, www.clinicaltrials.gov, NCT00418353
LEVEL OF EVIDENCE: I 编译：
产前运用倍他米松和地塞米松的比较(Betacode Trial)
随机对照实验
发表在《产科学与妇科学》杂志2007年的一篇论文表明产前运用地塞米松较
倍他米松更能降低早产儿患新生儿脑室内出血和脑损害的机率。（Obstetrics & Gynecology 2007;110:26-30 ）
为比较产前运用倍他米松和地塞米松对早产儿发病率和死亡率的影响，斯托尼布鲁克大学医院妇产和生殖学科的安德鲁.埃里米及其同事设计了一项双盲，安慰剂随机对照实验。从2002年8月到2004年7月，他们招募了299名有早产风险的妇女，对产前应用倍他米松及地塞米松进行比较。
实验排除了患有绒毛膜羊膜炎，胎儿结构和染色体畸形，出生前有类固醇接触及有使用类固醇征候的妇女。结果显示：两组间呼吸窘迫综合症，抗利尿素治疗的需要，坏死性小肠结肠炎，早产儿视网膜病，动脉导管未闭，新生儿脓毒症以及新生儿死亡率都没有显著性差异。然而，然而，使用地塞米松的新生儿脑室内出血(6/105 [5.7%] 相比较17 / 100 [17.0%], 相对危险度 [RR] 2.97, 95% 可信区间 [CI] 1.22–7.24, P=.02)和脑损害(7 /105 [6.7%] 相比较18 /100 [18.0%],相对危险度 2.7, 95% 可信区间 CI 1.18–6.19, P=.02)的患病率都显著低于使用倍他米松的新生儿。脑室内出血的绝对危险率下降了11.3 % ( 95% 可信区间 2.7–11.9%), 需要治疗的人数是9 (95% 可信区间 5–37) ，这都支持使用地塞米松。在降低早产儿的主要新生儿发病率和死亡率几率方面，倍他米松和地塞米松具有可比性。可是，在降低脑室内出血几率方面地塞米松比倍他米松更为有效。 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-02-17 18:02
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