Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre, Local Postal Code 791, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
JAMA. 2013 Jan 2;309(1):41-7. doi: 10.1001/jama.2012.153817.
In threatened preterm labor, maintenance tocolysis with nifedipine, after an initial course of tocolysis and corticosteroids for 48 hours, may improve perinatal outcome.
To determine whether maintenance tocolysis with nifedipine will reduce adverse perinatal outcomes due to premature birth.
DESIGN, SETTING, AND PARTICIPANTS: APOSTEL-II (Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labor) is a double-blind, placebo-controlled trial performed in 11 perinatal units including all tertiary centers in The Netherlands. From June 2008 to February 2010, women with threatened preterm labor between 26 weeks (plus 0 days) and 32 weeks (plus 2 days) gestation, who had not delivered after 48 hours of tocolysis and a completed course of corticosteroids, were enrolled. Surviving infants were followed up until 6 months after birth (ended August 2010).
Randomization assigned 406 women to maintenance tocolysis with nifedipine orally (80 mg/d; n = 201) or placebo (n = 205) for 12 days. Assigned treatment was masked from investigators, participants, clinicians, and research nurses.
Primary outcome was a composite of adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage >grade 2, periventricular leukomalacia >grade 1, or necrotizing enterocolitis). Analyses were completed on an intention-to-treat basis.
Mean (SD) gestational age at randomization was 29.2 (1.7) weeks for both groups. Adverse perinatal outcome was not significantly different between groups: 11.9% (24/201; 95% CI, 7.5%-16.4%) for nifedipine vs 13.7% (28/205; 95% CI, 9.0%-18.4%) for placebo (relative risk, 0.87; 95% CI, 0.53-1.45).
In patients with threatened preterm labor, nifedipine-maintained tocolysis did not result in a statistically significant reduction in adverse perinatal outcomes when compared with placebo. Although the lower than anticipated rate of adverse perinatal outcomes in the control group indicates that a benefit of nifedipine cannot completely be excluded, its use for maintenance tocolysis does not appear beneficial at this time.
trialregister.nl Identifier: NTR1336.
在有早产风险的患者中，硝苯地平维持治疗可以改善围产期结局。在初始的保胎和皮质激素治疗 48 小时后，使用硝苯地平维持治疗。
确定硝苯地平维持治疗是否会降低因早产而导致的不良围产期结局。
设计、地点和参与者：APOSTEL-II（早期分娩时持续保胎的围产期结局评估）是一项双盲、安慰剂对照试验，在荷兰的 11 个围产单位进行，包括所有的三级中心。从 2008 年 6 月至 2010 年 2 月，招募了妊娠 26 周（加 0 天）至 32 周（加 2 天）之间、保胎治疗 48 小时后尚未分娩且完成皮质激素治疗的有早产风险的患者。存活的婴儿随访至出生后 6 个月（截至 2010 年 8 月）。
随机分配 406 名患者接受硝苯地平（80mg/d）或安慰剂（n=205）口服维持治疗 12 天。研究人员、参与者、临床医生和研究护士对治疗方案设盲。
主要结局为不良围产期结局的复合指标（围产儿死亡、慢性肺疾病、新生儿败血症、脑室出血>2 级、脑室周围白质软化>1 级或坏死性小肠结肠炎）。分析采用意向治疗原则。
两组随机分组时的平均（SD）孕龄均为 29.2（1.7）周。两组不良围产期结局无显著差异：硝苯地平组为 11.9%（24/201；95%CI，7.5%-16.4%），安慰剂组为 13.7%（28/205；95%CI，9.0%-18.4%）（相对风险，0.87；95%CI，0.53-1.45）。
在有早产风险的患者中，与安慰剂相比，硝苯地平维持治疗并不能显著降低不良围产期结局。尽管对照组不良围产期结局的发生率低于预期，这表明硝苯地平可能没有益处，但目前使用硝苯地平维持治疗似乎没有益处。
trialregister.nl 标识符：NTR1336。
