Morales W J, Smith S G, Angel J L, O'Brien W F, Knuppel R A
Department of Obstetrics and Gynecology, University of South Florida, Orlando.
Obstet Gynecol. 1989 Oct;74(4):567-72.
One hundred six patients in preterm labor with intact amniotic membranes and gestational age less than or equal to 32 weeks were randomized to receive either ritodrine hydrochloride or a 48-hour course of indomethacin for tocolysis. The relative efficacy, maternal and neonatal safety, and costs were evaluated to determine which may be the more appropriate first-line pharmacologic agent used to manage preterm labor. Fifty-four patients and 52 patients were randomized to receive ritodrine hydrochloride or indomethacin, respectively. Ritodrine hydrochloride and indomethacin were equally effective in inhibiting uterine contractions and delaying delivery. Delivery was delayed for at least 48 hours in 83 and 94%, and for at least 7 days in 70 and 75% of patients receiving ritodrine or indomethacin, respectively. Tocolysis with indomethacin was associated with no maternal side effects, whereas tocolysis with ritodrine hydrochloride was associated with a 24% incidence of serious cardiovascular and metabolic adverse effects prompting discontinuation of the drug. There were no differences in outcome between the infants exposed to indomethacin versus ritodrine hydrochloride when delivered either remote from therapy or during therapy, except for a statistically higher serum glucose in the infants exposed to ritodrine hydrochloride when delivered during tocolytic therapy. There were no cases of premature closure of the ductus arteriosus or pulmonary hypertension. Tocolysis with indomethacin was 17 times less costly than tocolysis with ritodrine hydrochloride. For gestations less than or equal to 32 weeks complicated by preterm labor, indomethacin may be an appropriate alternative as a first-line tocolytic agent.
106例胎膜完整、孕周小于或等于32周的早产患者被随机分为两组，分别接受盐酸利托君或48小时疗程的吲哚美辛进行宫缩抑制治疗。对两者的相对疗效、母婴安全性及成本进行评估，以确定哪种药物可能是更合适的用于治疗早产的一线药物。分别有54例和52例患者被随机分配接受盐酸利托君或吲哚美辛治疗。盐酸利托君和吲哚美辛在抑制子宫收缩和延迟分娩方面同样有效。接受盐酸利托君或吲哚美辛治疗的患者中，分别有83%和94%的患者分娩延迟至少48小时，70%和75%的患者分娩延迟至少7天。使用吲哚美辛进行宫缩抑制未出现母体副作用，而使用盐酸利托君进行宫缩抑制有24%的患者出现严重心血管和代谢不良反应，导致停药。在远离治疗期或治疗期分娩时，暴露于吲哚美辛与暴露于盐酸利托君的婴儿结局无差异，但在宫缩抑制治疗期间分娩的婴儿中，暴露于盐酸利托君的婴儿血清葡萄糖水平在统计学上更高。未出现动脉导管过早关闭或肺动脉高压的病例。使用吲哚美辛进行宫缩抑制的成本比使用盐酸利托君低17倍。对于孕周小于或等于32周并伴有早产的患者，吲哚美辛可能是一种合适的一线宫缩抑制剂替代药物。
