滴定口服米索前列醇溶液与阴道米索前列醇用于引产的比较
Titrated oral misoprostol solution versus vaginal misoprostol for labor induction.
作者信息
Souza Alex S R, Feitosa Francisco E L, Costa Aurélio A R, Pereira Ana P R, Carvalho Andreza S, Paixão Renata M, Katz Leila, Amorim Melania M R
机构信息
Department of Maternal and Child Health, Instituto de Medicina Integral Prof. Fernando Figueira, Recife, Brazil; Emergency Obstetric Care, Policlínica e Maternidade Prof. Arnaldo Marques, Recife, Brazil; Department of Maternal and Child Health, Universidade Federal de Pernambuco, Recife, Brazil; Research Department, Instituto de Pesquisa Prof. Joaquim Amorim Neto, Campina Grande, Brazil; Emergency Obstetric Care, Hospital Barão de Lucena, Recife, Brazil.
出版信息
Int J Gynaecol Obstet. 2013 Dec;123(3):207-12. doi: 10.1016/j.ijgo.2013.06.028. Epub 2013 Sep 3.
OBJECTIVE
To determine the efficacy and safety of a titrated oral misoprostol solution compared with vaginal misoprostol tablets for labor induction.
METHODS
A randomized, triple-blind, multicenter clinical trial was conducted between March 2010 and June 2011. Women with a single gestation (n=200) were randomized to receive a titrated oral misoprostol solution (initial misoprostol dose 20 μg/hour; dose increased by 20 μg/hour every 6 hours up to 80 μg/hour for a maximum of 48 doses) or vaginal misoprostol tablets (25 μg of misoprostol every 6 hours for a maximum of 8 doses). Risk ratios (RR) and 95% confidence intervals (CIs) were calculated for maternal and perinatal outcomes.
RESULTS
The frequencies of vaginal delivery not achieved within 12 hours (RR 0.87; 95% CI, 0.62-1.22) and within 24 hours (RR 1.11; 95% CI, 0.83-1.49) were similar in the 2 groups. No differences were found in terms of uterine hyperstimulation, unfavorable cervix at 12 and 24 hours, oxytocin augmentation, tachysystole, epidural analgesia, adverse effects, and perinatal outcome. Approximately 70% of the women preferred the oral solution.
CONCLUSION
A titrated oral misoprostol solution was as effective and safe for labor induction as vaginal misoprostol tablets. ClinicalTrial.gov: NCT00 992524.
目的
比较滴定口服米索前列醇溶液与阴道用米索前列醇片用于引产的有效性和安全性。
方法
2010年3月至2011年6月进行了一项随机、三盲、多中心临床试验。单胎妊娠妇女（n = 200）被随机分为接受滴定口服米索前列醇溶液组（初始米索前列醇剂量为20μg/小时；每6小时剂量增加20μg/小时，直至80μg/小时，最大剂量为48剂）或阴道用米索前列醇片组（每6小时25μg米索前列醇，最大剂量为8剂）。计算产妇和围产期结局的风险比（RR）和95%置信区间（CI）。
结果
两组在12小时内（RR 0.87；95%CI，0.62 - 1.22）和24小时内（RR 1.11；95%CI，0.83 - 1.49）未实现阴道分娩的频率相似。在子宫过度刺激、12小时和24小时宫颈条件不佳、催产素增加、子宫收缩过速、硬膜外镇痛、不良反应和围产期结局方面未发现差异。约70%的妇女更喜欢口服溶液。
结论
滴定口服米索前列醇溶液用于引产与阴道用米索前列醇片一样有效和安全。ClinicalTrial.gov：NCT00 992524。
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