Klauser Chad K, Briery Christian M, Martin Rick W, Langston LeDon, Magann Everett F, Morrison John C
Departments of Obstetrics and Gynecology, The Mount Sinai Medical Center , New York City, NY , USA .
J Matern Fetal Neonatal Med. 2014 May;27(8):801-6. doi: 10.3109/14767058.2013.847416. Epub 2013 Oct 11.
To compare the efficacy and maternal side effects of nifedipine (N), magnesium sulfate (M), and indomethacin (I) for acute tocolysis.
In this single center randomized trial, women in preterm labor 24-32 weeks' gestation received intravenous M, oral N, or I suppositories. The primary outcomes of interest were arrest of preterm labor (>48 h, ≥7 days), gestational age at delivery, and maternal side effects.
Over a 38-month period, 301 women were allocated to receive M (90), N (114), or I (90). Gestational age at delivery (p = 0.551) or arrest of labor >48 h, >7 days were similar between the three groups (p = 0.199, 0.654). Hypotension and tachycardia were more common in N patients compared to women receiving M or I (p = 0.003, 0.009). Patients receiving I had more fetal ductal constriction or oligohydramnios compared to M or N (p = 0.001, 0.020) but, I women were tested more often. There was one case of pulmonary edema in the M group and one with plural effusion in the N group.
There were no differences in efficacy or in major maternal safety issues between the three tocolytic agents. Since there is no FDA approved tocolytic to treat preterm labor, clinicians should use the tocolytic that has afforded them the best results with the least maternal/neonatal side effects.
比较硝苯地平(N)、硫酸镁(M)和吲哚美辛(I)用于急性宫缩抑制的疗效及对母体的副作用。
在这项单中心随机试验中,妊娠24 - 32周的早产女性接受静脉注射M、口服N或I栓剂。主要观察指标为早产停止(>48小时,≥7天)、分娩时的孕周以及母体副作用。
在38个月的时间里,301名女性被分配接受M(90名)、N(114名)或I(90名)治疗。三组之间分娩时的孕周(p = 0.551)或>48小时、>7天的宫缩停止情况相似(p = 0.199,0.654)。与接受M或I的女性相比,N组患者低血压和心动过速更为常见(p = 0.003,0.009)。与M或N组相比,接受I治疗的患者胎儿导管狭窄或羊水过少更为常见(p = 0.001,0.020),但接受I治疗的女性接受检查的频率更高。M组有1例肺水肿,N组有1例胸腔积液。
三种宫缩抑制剂在疗效或主要母体安全问题方面没有差异。由于美国食品药品监督管理局(FDA)未批准用于治疗早产的宫缩抑制剂,临床医生应使用对母体/新生儿副作用最小且效果最佳的宫缩抑制剂。