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比较地诺孕素和 OCPS 对子宫内膜异位症女性疼痛和生活质量的影响:一项随机、双盲、安慰剂对照试验。

Comparing the Effect of Dienogest and OCPS on Pain and Quality of Life in Women with Endometriosis: A Randomized, Double-Blind, Placebo-Controlled Trial.

机构信息

Resident of Obstetrics and Gynecology, Iran University of Medical Sciences, Tehran, Iran.

Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran.

出版信息

Arch Iran Med. 2021 Sep 1;24(9):670-677. doi: 10.34172/aim.2021.96.

DOI:10.34172/aim.2021.96
PMID:34816682
Abstract

BACKGROUND

Endometriosis is an estrogen-dependent disease that adversely affects women's quality of life (QOL). We aimed to compare the effect of dienogest and oral contraceptive pills (OCPs) on pain and QOL in women with endometriosis.

METHODS

This randomized double-blind trial was conducted at Rasoul-e-Akram hospital, affiliated to Iran University of Medical Sciences, Tehran, Iran, from March 2018 to March 2020, on women with severe endometriosis confirmed by laparoscopic surgery. Ninety patients were randomly given either dienogest (Vissane 2 mg tablet; n = 30), or OCPs (LD; n = 30), or placebo (n = 30) daily for 12 weeks. The primary objective of this study was to evaluate the patient's pain including dyspareunia, dysuria, dyschezia, and pelvic pain. The secondary outcome was considered as a change in patients' QOL score.

RESULTS

The mean age of population was 32.99 ± 7.1 years. There was no significant difference in the three groups regarding baseline characteristics. Pelvic pain was significantly reduced, while the effect of medication on dysuria and dyschezia was not significant. The overall QOL score between the control and dienogest ( = 0.02) and OCPs groups ( = 0.001) was significantly different; however, the difference was not significant between the two intervention groups.

CONCLUSION

The finding of the present study revealed that there is no difference in the efficacy of dienogest and OCPs in management of pain and the QOL. But there was a significant difference between the placebo and intervention groups.

摘要

背景

子宫内膜异位症是一种雌激素依赖性疾病,会对女性的生活质量(QOL)产生不利影响。我们旨在比较地诺孕素和口服避孕药(OCPs)对子宫内膜异位症患者疼痛和 QOL 的影响。

方法

这项随机双盲试验于 2018 年 3 月至 2020 年 3 月在伊朗德黑兰的拉苏尔·阿克拉姆医院(隶属于伊朗医科大学)进行,纳入了经腹腔镜手术证实患有严重子宫内膜异位症的女性患者。90 名患者被随机分为地诺孕素组(Vissane 2 毫克片剂;n=30)、OCP 组(LD;n=30)或安慰剂组(n=30),每天服用 12 周。本研究的主要目的是评估患者的疼痛,包括性交痛、尿痛、排便困难和盆腔痛。次要结果被认为是患者 QOL 评分的变化。

结果

人群的平均年龄为 32.99±7.1 岁。三组患者的基线特征无显著差异。盆腔疼痛显著减轻,而药物对尿痛和排便困难的影响不显著。对照组和地诺孕素组( = 0.02)和 OCP 组( = 0.001)之间的总体 QOL 评分差异有统计学意义;然而,两组干预组之间的差异无统计学意义。

结论

本研究结果表明,地诺孕素和 OCPs 在管理疼痛和 QOL 方面的疗效无差异。但安慰剂组和干预组之间存在显著差异。

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引用本文的文献

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Dienogest vs. combined oral contraceptive: A systematic review and meta-analysis of efficacy and side effects to inform evidence-based guidelines.地诺孕素与复方口服避孕药:一项关于疗效和副作用的系统评价与荟萃分析,以指导循证指南制定
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