Weiner C P, Renk K, Klugman M
Department of Obstetrics and Gynecology, University of Iowa Medical School, Iowa City.
Am J Obstet Gynecol. 1988 Jul;159(1):216-22. doi: 10.1016/0002-9378(88)90524-8.
We conducted a randomized trial comparing bed rest with tocolysis to determine the therapeutic efficacy, safety, and cost-effectiveness of tocolysis for the treatment of preterm labor after membrane rupture. One hundred nine women participated over a 26-month interval. Treatment groups did not differ significantly in terms of gestational age at membrane rupture, gestational age at delivery, birth weight, maternal or fetal infectious morbidity, respiratory distress syndrome, necrotizing enterocolitis, or perinatal mortality. Prolongation of intrauterine time after the onset of uterine contractions was seen in women receiving tocolysis (105.2 +/- 157 hours versus 62.1 +/- 77 hours, p = 0.06). This prolongation was not associated with a significant reduction in the total cost per surviving infant (tocolysis, $38,593 +/- $40,887 versus bed rest, $43,158 +/- $37,116; p = 0.445). The cost difference was artifactual. The number of very premature infants born (less than 28 weeks' gestation) was unequal in the two groups (12 in the bed rest group and 5 in the tocolysis group) and skewed the results. Before 28 weeks' gestation tocolysis was associated with a significant increase in intrauterine time after the onset of regular contractions (p = 0.05). However, there was no identifiable perinatal benefit garnered from the additional 5 days. After 28 weeks there were no significant differences between treatment groups in terms of intrauterine time after the onset of regular contractions and total cost per surviving infant. Because tocolysis does not improve perinatal outcome and can itself be associated with major maternal morbidity, it should be avoided after 28 weeks' gestation. Before 28 weeks' gestation tocolysis may greatly increase intrauterine time, but the benefit of this prolongation is not clear.
我们进行了一项随机试验，比较卧床休息与宫缩抑制剂，以确定宫缩抑制剂在胎膜破裂后治疗早产的疗效、安全性和成本效益。在26个月的时间里，有109名女性参与。治疗组在胎膜破裂时的孕周、分娩时的孕周、出生体重、母婴感染发病率、呼吸窘迫综合征、坏死性小肠结肠炎或围产期死亡率方面没有显著差异。接受宫缩抑制剂治疗的女性在子宫收缩开始后宫内时间延长（105.2±157小时对62.1±77小时，p = 0.06）。这种延长与每个存活婴儿的总成本显著降低无关（宫缩抑制剂治疗组为38,593±40,887美元，卧床休息组为43,158±37,116美元；p = 0.445）。成本差异是人为造成的。两组中出生的极早产儿（孕周小于28周）数量不相等（卧床休息组12例，宫缩抑制剂治疗组5例），这使结果产生了偏差。在孕周28周之前，宫缩抑制剂与规律宫缩开始后宫内时间的显著增加相关（p = 0.05）。然而，额外的5天并没有带来可识别的围产期益处。在孕周28周之后，治疗组在规律宫缩开始后的宫内时间和每个存活婴儿的总成本方面没有显著差异。由于宫缩抑制剂不能改善围产期结局，且本身可能与主要的母体发病率相关，因此在孕周28周之后应避免使用。在孕周28周之前，宫缩抑制剂可能会大大增加宫内时间，但这种延长的益处尚不清楚。
