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比较芳香化酶抑制剂(来曲唑)+卡麦角林( Dostinex)与单独使用来曲唑对子宫肌瘤消退的影响:一项随机临床试验。

Comparing the effect of aromatase inhibitor (letrozole) + cabergoline (Dostinex) and letrozole alone on uterine myoma regression,a randomized clinical trial.

作者信息

Sayyah-Melli M, Mobasseri M, Gharabaghi P M, Ouladsahebmadarek E, Rahmani V

机构信息

Women's Reproductive Health Research Centre, Tabriz University of Medical Sciences, Tabriz, Iran.

Women's Reproductive Health Research Centre, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:257-264. doi: 10.1016/j.ejogrb.2016.11.001. Epub 2016 Dec 23.

DOI:10.1016/j.ejogrb.2016.11.001
PMID:28076829
Abstract

OBJECTIVE

To evaluate the effect of letrozole in combination with cabergoline and letrozole alone on regression of symptomatic uterine myomas in women of reproductive age.

DESIGN

Randomized controlled clinical trial.

SETTING

University hospital.

PATIENTS

Ninety-one women of reproductive age were enrolled in the study and 88 women were eligible. Eight participants were excluded from the study.

INTERVENTIONS

Eighty women of reproductive age with symptomatic myomas >4cm were evaluated in two groups. Participants in Group 1 received 2.5mg letrozole once daily and cabergoline 0.5mg/week from the first day of the menstrual cycle for 12 weeks, and participants in Group 2 received letrozole alone.

MAIN OUTCOME MEASURES

Changes in uterine size and volume; myoma size, volume and number; and side effects of treatment.

RESULTS

Overall, 76 patients completed the study. Compared with baseline values, mean uterine volume was reduced significantly in both groups (p=0.01), and there was no significant difference between groups (p=0.99). The mean number of dominant myomas was reduced significantly in both groups (p=0.03), with no significant difference between groups (p=0.6). The mean volume of myomas was reduced significantly in both groups (p=0.01), with no significant difference between groups (p=0.45). Although a significant decrease in number and volume of myomas was documented in each group (p<0.05), the intergroup analyses did not reveal significant differences between the two groups in terms of the change in number (p=0.28) and volume (p=0.96) of myomas. Headache was significantly more common in the letrozole+cabergoline group (nine vs two cases, p=0.02), but the two groups were comparable for the remaining minor side effects.

CONCLUSION

This study showed that 12 weeks of treatment with letrozole with and without cabergoline improved the size and volume of the uterus and myomas, led to symptom improvement, and could be used for short-term treatment prior to surgery or fertility programmes.

CONDENSATION

Condensation letrozole in combination with cabergoline in the management of uterine fibroids.

摘要

目的

评估来曲唑联合卡麦角林及单独使用来曲唑对育龄期有症状子宫肌瘤缩小的效果。

设计

随机对照临床试验。

地点

大学医院。

患者

91名育龄期女性参与研究,88名符合条件。8名参与者被排除在研究之外。

干预措施

80名有症状且肌瘤>4cm的育龄期女性被分为两组进行评估。第1组参与者从月经周期第一天起每天服用2.5mg来曲唑,每周服用0.5mg卡麦角林,持续12周;第2组参与者仅服用来曲唑。

主要观察指标

子宫大小和体积的变化;肌瘤大小、体积和数量;以及治疗的副作用。

结果

总体而言,76名患者完成了研究。与基线值相比,两组的平均子宫体积均显著减小(p=0.01),两组之间无显著差异(p=0.99)。两组中优势肌瘤的平均数量均显著减少(p=0.03),两组之间无显著差异(p=0.6)。两组中肌瘤的平均体积均显著减小(p=0.01),两组之间无显著差异(p=0.45)。尽管每组肌瘤的数量和体积均有显著减少(p<0.05),但组间分析显示两组在肌瘤数量(p=0.28)和体积(p=0.96)的变化方面无显著差异。来曲唑+卡麦角林组头痛明显更常见(9例对2例,p=0.02),但两组在其余轻微副作用方面相当。

结论

本研究表明,来曲唑联合或不联合卡麦角林治疗12周可改善子宫和肌瘤的大小及体积,缓解症状,可用于手术或生育计划前的短期治疗。

缩编

来曲唑联合卡麦角林治疗子宫肌瘤。

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