Fenakel K, Fenakel G, Appelman Z, Lurie S, Katz Z, Shoham Z
Department of Obstetrics and Gynecology, Kaplan Hospital, Rehovot, Israel.
Obstet Gynecol. 1991 Mar;77(3):331-7.
We conducted a randomized clinical trial in which patients with severe preeclampsia between 26-36 weeks of gestation received either nifedipine (10-30 mg sublingually, then 40-120 mg/day orally; N = 24) or hydralazine (6.25-12.5 mg intravenously, then 80-120 mg/day orally; N = 25). Effective control of blood pressure was achieved with nifedipine in 95.8% of subjects and with hydralazine in 68%, a statistically significant difference (P less than .05). Maternal side effects were minor in both groups. Acute fetal distress developed in one nifedipine subject and in 11 treated with hydralazine. Mean prolongation of gestation was 15.5 +/- 10 days with nifedipine and 9.5 +/- 11 days with hydralazine, a difference that did not reach statistical significance (P less than .07). Infants born to women treated with nifedipine were delivered at more advanced gestational ages (34.6 +/- 2.3 versus 33.6 +/- 2.4 weeks; statistically not significant), weighed more (1826 +/- 456 versus 1580 +/- 499 g; statistically not significant), and tended to have fewer, mainly minor, complications. The average number of days spent in the neonatal intensive care unit was significantly lower in the nifedipine group (15.1 versus 32.7 days; P less than .005), leading to an average 31% reduction in total (maternal and neonatal) hospitalization-related charges for each nifedipine-treated pregnancy. We conclude that nifedipine is an effective, convenient, and low-cost treatment for patients with severe preeclampsia, and is not associated with undesirable side effects.
我们进行了一项随机临床试验，纳入妊娠26至36周的重度子痫前期患者，其中24例接受硝苯地平治疗（舌下含服10 - 30 mg，然后口服40 - 120 mg/天），25例接受肼屈嗪治疗（静脉注射6.25 - 12.5 mg，然后口服80 - 120 mg/天）。硝苯地平组95.8%的受试者血压得到有效控制，肼屈嗪组为68%，差异有统计学意义（P小于0.05）。两组的母体副作用均较小。1例接受硝苯地平治疗的受试者及11例接受肼屈嗪治疗的受试者出现急性胎儿窘迫。硝苯地平组妊娠平均延长15.5±10天，肼屈嗪组为9.5±11天，差异无统计学意义（P小于0.07）。接受硝苯地平治疗的女性所分娩的婴儿出生时孕周更大（34.6±2.3周对33.6±2.4周；无统计学意义），体重更重（1826±456 g对1580±499 g；无统计学意义），且并发症往往更少，主要为轻微并发症。硝苯地平组新生儿重症监护病房的平均住院天数显著更低（15.1天对32.7天；P小于0.005），使得每例接受硝苯地平治疗的妊娠（母体和新生儿）相关总住院费用平均降低31%。我们得出结论，硝苯地平是治疗重度子痫前期患者的一种有效、便捷且低成本的治疗方法，且无不良副作用。
