Maintenance oral nifedipine for preterm labor: A randomized clinical trial
Maintenance oral nifedipine for preterm labor: A randomized clinical trial
复制标题
DOI：
10.1016/s0002-9378(99)70308-x
复制
发表时间：
1999-10-01
影响因子：
9.8
通讯作者：
Spinnato, JA
中科院分区：
文献类型：
--
作者：
Carr, DB;Clark, AL;Spinnato, JA
目的：本研究旨在评估最初接受静脉注射硫酸镁治疗早产的患者维持口服硝苯地平的疗效。研究设计：妊娠 24 至 33.9 周之间诊断为早产的患者被随机分配接受口服硝苯地平维持保胎治疗（每 4-6 小时 20 毫克）或在停止镁保胎后不接受治疗（对照）。评估妊娠和新生儿结局。需要 50 名患者的样本量才能检测平均时间增加的 10 天差异（β = 0.2，α = 0.05）。统计分析基于治疗意图。进行了 t、chi(2) 和 Fisher 精确检验。结果：74 名患者被随机分配接受口服硝苯地平 (n = 37) 或不接受治疗 (n = 37)。各组之间的年龄、种族、产次、早产危险因素、入组胎龄、宫颈检查结果、分娩胎龄、获产时间或新生儿并发症均无统计学差异。随机分配接受硝苯地平治疗的患者的分娩胎龄（平均值 +/- SD）为 35.4 +/- 3.2 周，未接受治疗的患者为 35.3 +/- 3.2 周 (P = .9)。硝苯地平组的妊娠时间延长了 37 +/- 23.9 天，对照组为 32.8 +/- 20.4 天 (P = .4)。结论：对于最初接受静脉硫酸镁治疗的早产患者，口服硝苯地平维持治疗不会显着延长妊娠时间。
OBJECTIVE: This study was undertaken to evaluate the efficacy of maintenance oral nifedipine in patients initially treated with intravenous magnesium sulfate for preterm labor.STUDY DESIGN: Patients with a diagnosis of preterm labor between 24 and 33.9 weeks' gestation were randomly assigned to receive either maintenance tocolytic therapy with oral nifedipine (20 mg every 4-6 hours) or no treatment (control) after discontinuation of magnesium tocolysis. Pregnancy and neonatal outcomes were evaluated. A sample size of 50 patients was required to detect a 10-day difference in mean time gained (beta = .2, alpha = .05). Statistical analyses were based on intent to treat. The t, chi(2), and Fisher exact tests were performed.RESULTS: Seventy-four patients were randomly assigned to receive either oral nifedipine (n = 37) or no treatment (n = 37). There were no statistically significant differences in age, race, parity, preterm delivery risk factors, enrollment gestational age, results of cervical examination, delivery gestational age, time gained, or neonatal complications between the groups. Delivery gestational age (mean +/- SD) was 35.4 +/- 3.2 weeks for patients randomly assigned to receive nifedipine and 35.3 +/- 3.2 weeks for patients who received no treatment (P = .9). Time gained during pregnancy was 37 +/- 23.9 days in the nifedipine group and 32.8 +/- 20.4 days in the control group (P = .4).CONCLUSION: Maintenance therapy with oral nifedipine does not significantly prolong pregnancy in patients initially treated with intravenous magnesium sulfate for preterm labor.