Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, São Paulo, Brazil.
Menopause. 2018 Jul;25(7):789-794. doi: 10.1097/GME.0000000000001074.
To evaluate pain and determine the efficacy of misoprostol, compared with placebo, for postmenopausal women before diagnostic hysteroscopy.
This randomized, double-blind, placebo-controlled clinical trial included 158 postmenopausal women who received either 200 μg of misoprostol or placebo through the vaginal route before diagnostic hysteroscopy (79 women/group). The primary outcome was pain assessment (presence and intensity) during the four steps of hysteroscopy: cervical grasping with a Pozzi tenaculum forceps immediately before hysteroscopy, during hysteroscopy, during performance of the endometrial biopsy, and postprocedure. The secondary outcomes were duration of the procedure, need for additional cervical dilatation, complications, and adverse effects.
Mean ages of the women were 62 ± 8.2 years and 60 ± 7.3 years in the misoprostol and placebo groups, respectively. Abnormal bleeding (misoprostol group, 45.6%; placebo, 43%) and endometrial thickening (54.4% in the misoprostol group and 57% in the placebo group) were the most common indications for the examination in both groups (P = 0.49). There was no significant difference between groups in the pain intensity of the four steps of the procedure. The duration of hysteroscopy was similar in both groups (misoprostol group, 2.5 ± 2.7 minutes; placebo, 2.1 ± 1.6 minutes; P = 0.43). Additional cervical dilatation was needed in 11 women in the misoprostol group versus 9 in the placebo group (P = 0.63). In both groups, there was no significant difference in terms of complications. Adverse effects were reported by 25.3% of women using misoprostol (vaginal bleeding, 11.3%; cramping, 12.6%; diarrhea, 2.5%; 1 woman reported both vaginal bleeding and cramping). In the placebo group, only 2.5% of women developed adverse effects (P < 0.0001).
Misoprostol does not reduce pain intensity, the duration of the procedure, or need for additional cervical dilatation, and causes more adverse effects when used in postmenopausal women before diagnostic hysteroscopy.
评估米索前列醇在绝经后女性行诊断性宫腔镜检查前的止痛效果，并与安慰剂进行比较。
本随机、双盲、安慰剂对照临床试验纳入了 158 例绝经后女性，她们在诊断性宫腔镜检查前分别经阴道给予 200μg 米索前列醇或安慰剂（每组 79 例）。主要结局是评估宫腔镜检查的四个步骤（宫颈用 Pozzi 宫颈钳夹住后立即进入宫腔镜检查、宫腔镜检查时、进行子宫内膜活检时和检查后）中的疼痛情况（存在和强度）。次要结局是手术持续时间、需要额外的宫颈扩张、并发症和不良反应。
两组女性的平均年龄分别为 62±8.2 岁和 60±7.3 岁。异常出血（米索前列醇组 45.6%，安慰剂组 43%）和子宫内膜增厚（米索前列醇组 54.4%，安慰剂组 57%）是两组最常见的检查指征（P=0.49）。两组患者在手术四个步骤的疼痛强度方面无显著差异。两组宫腔镜检查的持续时间相似（米索前列醇组 2.5±2.7 分钟，安慰剂组 2.1±1.6 分钟；P=0.43）。米索前列醇组需要额外宫颈扩张的有 11 例，安慰剂组有 9 例（P=0.63）。两组的并发症无显著差异。米索前列醇组有 25.3%的女性出现不良反应（阴道出血 11.3%，痉挛 12.6%，腹泻 2.5%，1 例同时出现阴道出血和痉挛），安慰剂组仅有 2.5%的女性出现不良反应（P<0.0001）。
在绝经后女性行诊断性宫腔镜检查前使用米索前列醇不能减轻疼痛强度、手术持续时间或对额外宫颈扩张的需求，反而会增加不良反应。
