Nassar Anwar H, Abu-Musa Antoine A, Awwad Johnny, Khalil Ali, Tabbara Jad, Usta Ihab M
Department of Obstetrics and Gynecology, American University of Beirut Medical Center, Beirut, Lebanon.
Am J Perinatol. 2009 Sep;26(8):575-81. doi: 10.1055/s-0029-1220780. Epub 2009 Apr 27.
We compared two dose regimens of tocolytic oral nifedipine. Women with singleton pregnancies admitted in preterm labor (24 to 34 weeks) were randomized to high-dose (HD) nifedipine ( N = 49; 20 mg loading dose, repeated in 30 minutes, daily 120 to 160 mg slow-release nifedipine for 48 hours followed by 80 to 120 mg daily until 36 weeks) or low-dose (LD) nifedipine ( N = 53; 10 mg, up to four doses every 15 minutes, daily 60 to 80 mg slow-release nifedipine for 48 hours followed by 60 mg daily until 36 weeks). Uterine quiescence at 48 hours (primary outcome); delivery at 48 hours, 34 and 37 weeks; and recurrent preterm labor were similar. Gestational age at delivery was higher in HD (36.0 +/- 2.8 versus 34.7 +/- 3.7 weeks, P = 0.049). Rescue treatment was needed more in LD (24.5 versus 50.9%, odds ratio = 0.3; 95% confidence interval 0.1 to 0.7). Maternal adverse effects, birth weight, intensive care nursery admission, and composite neonatal morbidity were similar. However, neonatal mechanical ventilation was needed less and nursery stay was shorter in HD. HD nifedipine does not seem to have an advantage over LD in achieving uterine quiescence at 48 hours. Further studies should address the optimal dose and formulation of tocolytic nifedipine.
我们比较了口服硝苯地平用于保胎治疗的两种剂量方案。将单胎妊娠且发生早产（24至34周）的女性随机分为高剂量（HD）硝苯地平组（N = 49；负荷剂量20 mg，30分钟后重复给药，每日给予120至160 mg缓释硝苯地平，持续48小时，随后每日80至120 mg直至孕36周）或低剂量（LD）硝苯地平组（N = 53；10 mg，每15分钟最多给药4次，每日给予60至80 mg缓释硝苯地平，持续48小时，随后每日60 mg直至孕36周）。48小时时的子宫静息状态（主要结局）；48小时、34周和37周时的分娩情况；以及复发性早产情况相似。HD组的分娩孕周更高（36.0±2.8周对34.7±3.7周，P = 0.049）。LD组需要更多的补救治疗（24.5%对50.9%，优势比 = 0.3；95%置信区间0.1至0.7）。母体不良反应、出生体重、新生儿重症监护病房入住率和综合新生儿发病率相似。然而，HD组新生儿机械通气需求较少且住院时间较短。HD硝苯地平在48小时达到子宫静息方面似乎并不比LD有优势。进一步的研究应探讨保胎用硝苯地平的最佳剂量和剂型。
