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一项比较地诺孕素与复方口服避孕药治疗子宫内膜异位症女性的随机、双盲、安慰剂对照的初步研究。

A randomized, double-blind, placebo-controlled pilot study of the comparative effects of dienogest and the combined oral contraceptive pill in women with endometriosis.

机构信息

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

School of Medicine, Iran University of Medical Sciences, Tehran, Iran.

出版信息

Int J Gynaecol Obstet. 2022 Jan;156(1):124-132. doi: 10.1002/ijgo.13677. Epub 2021 Apr 2.

DOI:10.1002/ijgo.13677
PMID:33728657
Abstract

OBJECTIVE

To compare the effects of dienogest and a combined oral contraceptive pill (COCP) after laparoscopic surgery on pain and quality of life in women with severe endometriosis.

METHODS

A randomized double-blind pilot study was conducted from March 2018 to March 2020 in women with severe endometriosis confirmed by laparoscopic surgery. A total of 108 patients who had undergone laparoscopic surgery received dienogest, COCP, or placebo daily for 6 months. Primary and secondary outcomes were compared between the three groups.

RESULTS

Treatment with dienogest or COCP was associated with improved self-reported pain after 6 months of treatment, as evidenced by significantly lower scores for pelvic pain and dyspareunia compared with placebo (P < 0.05). Significant differences in overall quality of life score were observed over 6 months in the dienogest, COCP, and placebo groups (mean difference 22.00, 23.45, and 6.45 points, respectively; P < 0.001). Post-hoc analysis revealed a significant difference in overall quality of life score between the placebo group and the dienogest (P < 0.001) and COCP groups (P = 0.004).

CONCLUSION

Postoperative administration of dienogest or COCP reduced endometriosis-associated pain and improved quality of life in women with severe endometriosis.

CLINICAL TRIALS REGISTRATION

https://en.irct.ir/trial/43070.

摘要

目的

比较地诺孕素和复方口服避孕药(COCP)在腹腔镜手术后对重度子宫内膜异位症患者疼痛和生活质量的影响。

方法

本随机双盲试点研究于 2018 年 3 月至 2020 年 3 月在腹腔镜手术确诊的重度子宫内膜异位症患者中进行。共有 108 例接受过腹腔镜手术的患者接受地诺孕素、COCP 或安慰剂,每日 1 次,疗程 6 个月。比较三组之间的主要和次要结局。

结果

地诺孕素或 COCP 治疗与治疗 6 个月后自我报告的疼痛改善相关,与安慰剂相比,盆腔疼痛和性交困难评分显著降低(P < 0.05)。在 6 个月期间,地诺孕素、COCP 和安慰剂组的整体生活质量评分均有显著差异(平均差异分别为 22.00、23.45 和 6.45 分;P < 0.001)。事后分析显示,安慰剂组与地诺孕素组(P < 0.001)和 COCP 组(P = 0.004)之间的整体生活质量评分差异有统计学意义。

结论

术后给予地诺孕素或 COCP 可减轻重度子宫内膜异位症患者与疾病相关的疼痛并改善生活质量。

临床试验注册

https://en.irct.ir/trial/43070。

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Response: A randomized, double-blind, placebo-controlled pilot study of the comparative effects of dienogest and the combined oral contraceptive pill in women with endometriosis.回应:一项关于地诺孕素与复方口服避孕药对子宫内膜异位症女性比较效果的随机、双盲、安慰剂对照的试点研究。
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