米索前列醇用于负压吸宫术前宫颈准备疗效评价

Misoprostol for Cervical Preparation Prior to the Vacuum Aspiration

目的:对不同剂量米索前列醇用于吸宫术前促宫颈软化效果及药物不良反应进行评价。方法:采用多中心随机双盲对照临床试验,比较在术前3小时服用米索前列醇600μg与米索前列醇400μg对宫颈的软化作用及观察两组的药物不良反应情况。结果:米索前列醇600μg组宫颈扩张平均值6.70±1.23mm高于米索前列醇400μg组6.44±1.20mm(P=0.03),两组的初孕妇女宫颈扩张平均值差异明显(6.85±1.58mmvs6.51±1.16mm,P=0.01);同时,未行静脉麻醉的孕妇中米索前列醇600μg初孕组宫颈扩张平均值高于400μg初孕组(P=0.02),米索前列醇600μg的初孕组宫颈扩张平均值也高于有1次人工流产史组(P=0.002);两组服药后主要的药物不良反应为阴道流血、恶心及腹痛等,均无大出血的情况发生,未作特殊处理。结论:负压吸宫术前3小时口服米索前列醇能安全、有效促进宫颈软化,600μg较400μg效果好,尤其对于初孕的妇女。

Objective：To evaluate the effectiveness and adverse drug reaction of different dosage of misoprostol in cervical softening prior to the vacuum aspiration.Methods：A multicenter randomized double-blinded controlled clinical trial was applied to compare the effectiveness and adverse drug reaction of misoprostol （600 μg vs 400 μg） 3 hours prior to the operation.Results：The mean cervical dilatation was superior in the 600 μg misoprostol group（6.70±1.23 mm） than that in the 400 μg misoprostol group （6.44±1.20 mm）（P=0.03）.This tendency was more obvious in the primigravida （6.85±1.58 mm vs 6.51±1.16 mm,P=0.01）.Mean while,as for the primigravida without intravenous anesthesia,the mean cervical dilatation was more preferable in the 600 μg misoprostol group than that in the 400 μg misoprostol group.In the 600 μg misoprostol group,there was significant difference between the primigravida and the women with one abortion history.The main adverse drug reactions of taking misoprostal were vaginal bleeding,nausea,abdominal pain and so on.No severe hemorrhage occurred in either of the two groups and none of the women needed specific treatment.Conclusions：It is safety and efficacy for cervical softening with misoprostol taken by oral 3 hours before the vacuum aspiration and the dosage of 600μg is more effective than that of 400μg,especially for the primigravida.