Walters Anthony G B, Lin Luling, Crowther Caroline A, Gamble Greg D, Dalziel Stuart R, Harding Jane E
Liggins Institute, University of Auckland, Auckland, New Zealand.
Emergency Department, Starship Children's Hospital, Auckland, New Zealand; Department of Surgery and Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.
J Pediatr. 2023 Apr;255:80-88.e5. doi: 10.1016/j.jpeds.2022.10.028. Epub 2022 Nov 3.
The objective of this study was to use modern analysis and reporting methods to present the full results of the first randomized trial of antenatal corticosteroids, performed 50 years ago.
In this single-center trial, women at risk of preterm birth at 24 to less than 37 weeks of gestation were randomized to receive 2 doses of betamethasone or placebo, 24 hours apart. Women and their caregivers were blinded to treatment allocation. The primary outcome was respiratory distress syndrome. Secondary outcomes included measures of neonatal mortality and morbidity, mode of birth, and maternal infection.
Between 1969 and 1974, 1115 women (1142 pregnancies) were randomized, 560 pregnancies (601 infants) to betamethasone and 582 (617 infants) to placebo. The risk of respiratory distress syndrome was significantly reduced in the betamethasone group compared with placebo (8.8% vs 14.4%, adjusted relative risk 0.62, 95% CI 0.45-0.86, P = .004). Subgroup analyses indicated greater efficacy in male than female infants but no effect of tocolytic therapy or doubling of betamethasone dose. Fetal or neonatal death, neonatal or maternal infection, neonatal hypoglycaemia, cesarean delivery, and lactation status at discharge were not different between the groups.
Antenatal betamethasone administered to women at risk of preterm birth between 24 and less than 37 weeks of gestation reduces the incidence of respiratory distress syndrome, with greater effect in male than in female infants. Doubling the dose of betamethasone does not provide additional benefit.
本研究的目的是运用现代分析和报告方法，呈现50年前进行的首次产前糖皮质激素随机试验的完整结果。
在这项单中心试验中，妊娠24至不足37周有早产风险的女性被随机分为两组，分别接受间隔24小时的2剂倍他米松或安慰剂治疗。女性及其护理人员对治疗分配不知情。主要结局是呼吸窘迫综合征。次要结局包括新生儿死亡率和发病率、分娩方式及母体感染的相关指标。
1969年至1974年期间，1115名女性（1142次妊娠）被随机分组，560次妊娠（601名婴儿）接受倍他米松治疗，582次妊娠（617名婴儿）接受安慰剂治疗。与安慰剂组相比，倍他米松组呼吸窘迫综合征的风险显著降低（8.8%对14.4%，调整后相对风险0.62，95%置信区间0.45 - 0.86，P = 0.004）。亚组分析表明，倍他米松对男婴的疗效优于女婴，但宫缩抑制剂治疗或倍他米松剂量加倍并无效果。两组在胎儿或新生儿死亡、新生儿或母体感染、新生儿低血糖、剖宫产分娩及出院时的泌乳状态方面无差异。
对妊娠24至不足37周有早产风险的女性给予产前倍他米松治疗可降低呼吸窘迫综合征的发生率，对男婴的效果优于女婴。倍他米松剂量加倍并无额外益处。
