Ricci J M, Hariharan S, Helfgott A, Reed K, O'Sullivan M J
Department of Obstetrics and Gynecology, University of Miami/Jackson Memorial Medical Center.
Am J Obstet Gynecol. 1991 Sep;165(3):603-10. doi: 10.1016/0002-9378(91)90293-z.
A prospective randomized clinical trial was conducted to assess the efficacy and safety of enteric-coated magnesium chloride (SLOW MAG) as an oral tocolytic agent. Seventy-five patients between 24 and 34 weeks' gestation who were treated with intravenous magnesium sulfate for a first episode of preterm labor were enrolled. After a 12-hour contraction-free period on intravenous therapy, patients were randomized by sealed envelope to one of three groups: group 1, SLOW MAG (535 mg every 4 hours); group 2, oral ritodrine (20 mg every 4 hours); or group 3, no therapy (control). Patients receiving oral therapy were treated until delivery or completion of 36 weeks' gestation. No difference was found between groups with respect to time gained with the use of oral therapy or number completing 36 weeks' gestation. Therapy with enteric-coated magnesium chloride was associated with significantly fewer side effects (20%) as compared with ritodrine (48%) (p less than 0.01). Our results suggest that compared with ritodrine, enteric-coated magnesium chloride is as effective in prolonging pregnancy and preventing recurrent preterm labor. However, neither enteric-coated magnesium chloride nor ritodrine appeared to be any more effective in the prevention of preterm delivery than observation alone.
进行了一项前瞻性随机临床试验,以评估肠溶氯化镁(SLOW MAG)作为口服宫缩抑制剂的疗效和安全性。纳入了75例妊娠24至34周、因首次早产接受静脉硫酸镁治疗的患者。在静脉治疗12小时无宫缩期后,患者通过密封信封随机分为三组:第1组,SLOW MAG(每4小时535毫克);第2组,口服利托君(每4小时20毫克);或第3组,不治疗(对照组)。接受口服治疗的患者持续治疗至分娩或妊娠36周结束。在使用口服治疗获得的时间或完成妊娠36周的人数方面,各组之间未发现差异。与利托君(48%)相比,肠溶氯化镁治疗的副作用明显较少(20%)(p小于0.01)。我们的结果表明,与利托君相比,肠溶氯化镁在延长妊娠和预防复发性早产方面同样有效。然而,单独观察时,肠溶氯化镁和利托君在预防早产方面似乎都没有更有效。