Surbek D V, Boesiger H, Hoesli I, Pavic N, Holzgreve W
Department of Obstetrics and Gynecology, University Hospital, Basel, Switzerland.
Am J Obstet Gynecol. 1997 Nov;177(5):1018-23. doi: 10.1016/s0002-9378(97)70006-1.
Our purpose was to compare the safety and efficacy of intravaginally administered misoprostol versus prostaglandin E2 for labor induction in a double-blind, randomized trial.
One hundred three patients with indications for labor induction (including prelabor rupture of membranes) were randomized and received either misoprostol 50 micrograms or prostaglandin E2 (dinoprostone) 3 mg intravaginally. The dose was repeated 6, 24, and 30 hours after the first dose until active labor was achieved. For proper blinding, the drugs were prepared as identical-looking vaginal tablets.
With use of a random number-generated table 52 patients were allocated to the misoprostol group and 51 to the prostaglandin E2 group. After exclusion of 3 patients, 50 in each group were evaluated. Delivery within 24 hours after administration occurred more often in the misoprostol group (70% vs 46% in the prostaglandin E2 group, p = 0.009), and fewer patients in this group needed more than two doses (12% vs 30%, p = 0.027). No difference in cesarean section rate (12% vs 14%, p = 0.67), fetal heart rate anomalies (33% vs 34%, p = 0.89), tachysystole (8% vs 14%, p = 0.37), hyperstimulation syndrome (0% vs 2%, not significant), meconium passage (28% vs 18%, p = 0.22), and fetal outcome (Apgar score at 1 and 5 minutes, arterial and venous umbilical cord blood pH, transfer to neonatal intensive care unit) was noted between the two groups.
Intravaginal misoprostol is a safe drug for labor induction with superior effectiveness compared with intravaginal prostaglandin E2.
在一项双盲随机试验中，比较阴道内给予米索前列醇与前列腺素E2引产的安全性和有效性。
103例有引产指征（包括胎膜早破）的患者被随机分组，阴道内给予50微克米索前列醇或3毫克前列腺素E2（地诺前列酮）。首剂给药后6、24和30小时重复给药，直至出现规律宫缩。为实现恰当的盲法，将药物制成外观相同的阴道片。
使用随机数字表，52例患者被分配至米索前列醇组，51例被分配至前列腺素E2组。排除3例患者后，每组各50例接受评估。米索前列醇组给药后24小时内分娩的发生率更高（70%，而前列腺素E2组为46%，p = 0.009），且该组需要超过两剂药物的患者更少（12% vs 30%，p = 0.027）。两组间剖宫产率（12% vs 14%，p = 0.67）、胎儿心率异常（33% vs 34%，p = 0.89）、宫缩过速（8% vs 14%，p = 0.37）、过度刺激综合征（0% vs 2%，无显著差异）、胎粪排出（28% vs 18%，p = 0.22）及胎儿结局（1分钟和5分钟阿氏评分、脐动脉和脐静脉血pH值、转入新生儿重症监护病房）均无差异。
阴道内使用米索前列醇引产安全，与阴道内使用前列腺素E2相比有效性更高。
