Instituto de Medicina Integral Professor Fernando Figueira, Recife, Pernambuco, Brazil.
BMJ. 2011 Apr 12;342:d1696. doi: 10.1136/bmj.d1696.
To determine the effectiveness of corticosteroids in reducing respiratory disorders in infants born at 34-36 weeks' gestation. Design Randomised triple blind clinical trial. Setting A large tertiary teaching hospital in northeast of Brazil. Participants Women at 34-36 weeks of pregnancy at risk of imminent premature delivery. Interventions Betamethasone 12 mg or placebo intramuscularly for two consecutive days. Main outcomes measures Primary outcome was the incidence of respiratory disorders (respiratory distress syndrome and transient tachypnoea of the newborn). Secondary outcomes included the need for ventilatory support, neonatal morbidity, and duration of stay in hospital.
320 women were randomised, 163 of whom were assigned to the treatment group and 157 to the controls. Final analysis included 143 and 130 infants, respectively. The rate of respiratory distress syndrome was low (two (1.4%) in the corticosteroid group; one (0.8%) in the placebo group; P = 0.54), while the rate of transient tachypnoea was high in both groups (34 (24%) v 29 (22%); P = 0.77). There was no reduction in the risk of respiratory morbidity with corticosteroid use even after adjustment for subgroups of gestational age (34-34(+6) weeks, 35-35(+6) weeks, and ≥ 36 weeks). The adjusted risk of respiratory morbidity was 1.12 (95% confidence interval 0.74 to 1.70). The need for ventilatory support was around 20% in both groups. There was no difference in neonatal morbidity (88 (62%) v 93 (72%); P = 0.08) or in the duration of stay in hospital between the two groups (5.12 v 5.22 days; P = 0.87). Phototherapy for jaundice was required less often in babies whose mothers received corticosteroids (risk ratio 0.63, 0.44 to 0.91).
Antenatal treatment with corticosteroids at 34-36 weeks of pregnancy does not reduce the incidence of respiratory disorders in newborn infants. Trial registration Clinical Trials NCT00675246.
确定皮质类固醇在减少 34-36 周妊娠早产儿呼吸障碍中的有效性。
随机三盲临床试验。
巴西东北部的一家大型三级教学医院。
有早产风险的 34-36 周妊娠妇女。
倍他米松 12 毫克或安慰剂肌内注射，连续 2 天。
主要结果是呼吸障碍（呼吸窘迫综合征和新生儿短暂性呼吸急促）的发生率。次要结果包括需要通气支持、新生儿发病率和住院时间。
320 名妇女被随机分组，其中 163 名分配到治疗组，157 名分配到对照组。最终分析包括 143 名和 130 名婴儿。呼吸窘迫综合征的发生率较低（皮质类固醇组 2 例（1.4%）；安慰剂组 1 例（0.8%）；P=0.54），而两组的短暂性呼吸急促发生率均较高（34 例（24%）比 29 例（22%）；P=0.77）。即使在校正了胎龄亚组（34-34（+6）周、35-35（+6）周和≥36 周）后，皮质类固醇的使用也不能降低呼吸发病率的风险。调整后的呼吸发病率风险为 1.12（95%置信区间 0.74 至 1.70）。两组需要通气支持的比例约为 20%。两组的新生儿发病率无差异（88 例（62%）比 93 例（72%）；P=0.08）或住院时间无差异（5.12 天比 5.22 天；P=0.87）。接受皮质类固醇治疗的婴儿接受光疗治疗黄疸的需求较少（风险比 0.63，0.44 至 0.91）。
在 34-36 周妊娠时用皮质类固醇进行产前治疗不能降低新生儿呼吸障碍的发生率。
临床试验 NCT00675246。
