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围绝经期和绝经后妇女的性功能激素治疗。

Hormone therapy for sexual function in perimenopausal and postmenopausal women.

机构信息

Department of Obstetrics and Gynecology, Medical School of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.

Faculty of Nursing, Universidad Andres Bello, Santiago de Chile, Chile.

出版信息

Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.

Abstract

BACKGROUND

The perimenopausal and postmenopausal periods are associated with many symptoms, including sexual complaints. This review is an update of a review first published in 2013.

OBJECTIVES

We aimed to assess the effect of hormone therapy on sexual function in perimenopausal and postmenopausal women.

SEARCH METHODS

On 19 December 2022 we searched the Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, ISI Web of Science, two trials registries, and OpenGrey, together with reference checking and contact with experts in the field for any additional studies.

SELECTION CRITERIA

We included randomized controlled trials that compared hormone therapy to either placebo or no intervention (control) using any validated assessment tool to evaluate sexual function. We considered hormone therapy: estrogen alone; estrogen in combination with progestogens; synthetic steroids, for example, tibolone; selective estrogen receptor modulators (SERMs), for example, raloxifene, bazedoxifene; and SERMs in combination with estrogen.

DATA COLLECTION AND ANALYSIS

We used standard methodological procedures recommended by Cochrane. We analyzed data using mean differences (MDs) and standardized mean differences (SMDs). The primary outcome was the sexual function score. Secondary outcomes were the domains of sexual response: desire; arousal; lubrication; orgasm; satisfaction; and pain. We assessed the certainty of the evidence using the GRADE approach.

MAIN RESULTS

We included 36 studies (23,299 women; 12,225 intervention group; 11,074 control group), of which 35 evaluated postmenopausal women; only one study evaluated perimenopausal women. The 'symptomatic or early postmenopausal women' subgroup included 10 studies, which included women experiencing menopausal symptoms (symptoms such as hot flushes, night sweats, sleep disturbance, vaginal atrophy, and dyspareunia) or early postmenopausal women (within five years after menopause). The 'unselected postmenopausal women' subgroup included 26 studies, which included women regardless of menopausal symptoms and women whose last menstrual period was more than five years earlier. No study included only women with sexual dysfunction and only seven studies evaluated sexual function as a primary outcome. We deemed 20 studies at high risk of bias, two studies at low risk, and the other 14 studies at unclear risk of bias. Nineteen studies received commercial funding. Estrogen alone versus control probably slightly improves the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.50, 95% confidence interval (CI) (0.04 to 0.96; I² = 88%; 3 studies, 699 women; moderate-quality evidence), and probably makes little or no difference to the sexual function composite score in unselected postmenopausal women (SMD 0.64, 95% CI -0.12 to 1.41; I² = 94%; 6 studies, 608 women; moderate-quality evidence). The pooled result suggests that estrogen alone versus placebo or no intervention probably slightly improves sexual function composite score (SMD 0.60, 95% CI 0.16 to 1.04; I² = 92%; 9 studies, 1307 women, moderate-quality evidence). We are uncertain of the effect of estrogen combined with progestogens versus placebo or no intervention on the sexual function composite score in unselected postmenopausal women (MD 0.08 95% CI -1.52 to 1.68; 1 study, 104 women; very low-quality evidence). We are uncertain of the effect of synthetic steroids versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 1.32, 95% CI 1.18 to 1.47; 1 study, 883 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 0.46, 95% CI 0.07 to 0.85; 1 study, 105 women; very low-quality evidence). We are uncertain of the effect of SERMs versus control on the sexual function composite score in symptomatic or early postmenopausal women (MD -1.00, 95% CI -2.00 to -0.00; 1 study, 215 women; very low-quality evidence) and of their effect in unselected postmenopausal women (MD 2.24, 95% 1.37 to 3.11 2 studies, 1525 women, I² = 1%, low-quality evidence). We are uncertain of the effect of SERMs combined with estrogen versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.22, 95% CI 0.00 to 0.43; 1 study, 542 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 2.79, 95% CI 2.41 to 3.18; 1 study, 272 women; very low-quality evidence). The observed heterogeneity in many analyses may be caused by variations in the interventions and doses used, and by different tools used for assessment.

AUTHORS' CONCLUSIONS: Hormone therapy treatment with estrogen alone probably slightly improves the sexual function composite score in women with menopausal symptoms or in early postmenopause (within five years of amenorrhoea), and in unselected postmenopausal women, especially in the lubrication, pain, and satisfaction domains. We are uncertain whether estrogen combined with progestogens improves the sexual function composite score in unselected postmenopausal women. Evidence regarding other hormone therapies (synthetic steroids and SERMs) is of very low quality and we are uncertain of their effect on sexual function. The current evidence does not suggest the beneficial effects of synthetic steroids (for example tibolone) or SERMs alone or combined with estrogen on sexual function. More studies that evaluate the effect of estrogen combined with progestogens, synthetic steroids, SERMs, and SERMs combined with estrogen would improve the quality of the evidence for the effect of these treatments on sexual function in perimenopausal and postmenopausal women.

摘要

背景

围绝经期和绝经后与许多症状相关,包括性抱怨。这是一篇首次发表于 2013 年的综述的更新。

目的

我们旨在评估激素治疗对围绝经期和绝经后妇女性功能的影响。

检索方法

于 2022 年 12 月 19 日,我们检索了生殖妇科专业注册组、CENTRAL、MEDLINE、Embase、PsycINFO、CINAHL、LILACS、ISI Web of Science、两个试验注册库和 OpenGrey,同时参考了该领域的专家,以获取任何其他研究。

选择标准

我们纳入了比较激素治疗与安慰剂或无干预(对照)的随机对照试验,使用任何经过验证的评估工具来评估性功能。我们考虑了以下激素治疗方法:雌激素单独使用;雌激素与孕激素联合使用;合成类固醇,如替勃龙;选择性雌激素受体调节剂(SERMs),如雷洛昔芬、巴多昔芬;以及 SERMs 与雌激素联合使用。

数据收集和分析

我们使用 Cochrane 推荐的标准方法学程序。我们使用均数差(MDs)和标准化均数差(SMDs)来分析数据。主要结局是性功能评分。次要结局是性反应的各个领域:欲望;唤起;润滑;高潮;满足;和疼痛。我们使用 GRADE 方法评估证据的确定性。

主要结果

我们纳入了 36 项研究(23299 名女性;12225 名干预组;11074 名对照组),其中 35 项评估了绝经后妇女,仅有 1 项研究评估了围绝经期妇女。“有症状或早期绝经后妇女”亚组包括 10 项研究,这些研究纳入了经历绝经症状(如热潮红、盗汗、睡眠障碍、阴道萎缩和性交困难)或早期绝经后(绝经后五年内)的妇女。“未选择的绝经后妇女”亚组包括 26 项研究,这些研究纳入了无论是否有绝经症状的妇女,以及最后一次月经超过五年前的妇女。没有研究仅纳入有性功能障碍的妇女,仅有 7 项研究将性功能作为主要结局进行评估。我们认为 20 项研究有高偏倚风险,两项研究有低偏倚风险,其余 14 项研究偏倚风险不确定。19 项研究获得了商业资助。雌激素单独治疗可能会轻微改善有症状或早期绝经后妇女的性功能综合评分(SMD 0.50,95%置信区间(CI)0.04 至 0.96;I² = 88%;3 项研究,699 名妇女;中等质量证据),而对未选择的绝经后妇女的性功能综合评分可能没有影响,或只有轻微影响(SMD 0.64,95%CI-0.12 至 1.41;I² = 94%;6 项研究,608 名妇女;中等质量证据)。汇总结果表明,雌激素单独治疗与安慰剂或无干预相比,可能会轻微改善性功能综合评分(SMD 0.60,95%CI 0.16 至 1.04;I² = 92%;9 项研究,1307 名妇女,中等质量证据)。我们不确定雌激素联合孕激素与安慰剂或无干预对未选择的绝经后妇女的性功能综合评分的影响(MD 0.08,95%CI-1.52 至 1.68;1 项研究,104 名妇女;极低质量证据)。我们不确定合成类固醇与对照组对有症状或早期绝经后妇女的性功能综合评分的影响(SMD 1.32,95%CI 1.18 至 1.47;1 项研究,883 名妇女;极低质量证据),也不确定它们对未选择的绝经后妇女的影响(SMD 0.46,95%CI 0.07 至 0.85;1 项研究,105 名妇女;极低质量证据)。我们不确定选择性雌激素受体调节剂与对照组对有症状或早期绝经后妇女的性功能综合评分的影响(MD-1.00,95%CI-2.00 至-0.00;1 项研究,215 名妇女;极低质量证据),也不确定它们对未选择的绝经后妇女的影响(MD 2.24,95%CI 1.37 至 3.11;2 项研究,1525 名妇女;I² = 1%,低质量证据)。我们不确定选择性雌激素受体调节剂联合雌激素与对照组对有症状或早期绝经后妇女的性功能综合评分的影响(SMD 0.22,95%CI 0.00 至 0.43;1 项研究,542 名妇女;极低质量证据),也不确定它们对未选择的绝经后妇女的影响(SMD 2.79,95%CI 2.41 至 3.18;1 项研究,272 名妇女;极低质量证据)。许多分析中的观察到的异质性可能是由于干预措施和剂量的差异以及使用的评估工具不同造成的。

作者结论

对于有绝经症状或绝经后五年内(围绝经期)的妇女以及未选择的绝经后妇女,激素治疗(雌激素单独治疗)可能会轻微改善性功能综合评分,尤其是在润滑、疼痛和满意度方面。我们不确定雌激素联合孕激素是否能改善未选择的绝经后妇女的性功能综合评分。其他激素治疗(合成类固醇和选择性雌激素受体调节剂)的证据质量非常低,我们不确定它们对性功能的影响。目前的证据并不表明合成类固醇(如替勃龙)或选择性雌激素受体调节剂单独或联合雌激素对围绝经期和绝经后妇女的性功能有有益的影响。更多评估雌激素联合孕激素、合成类固醇、选择性雌激素受体调节剂和选择性雌激素受体调节剂联合雌激素对性功能影响的研究将提高这些治疗方法对围绝经期和绝经后妇女性功能影响的证据质量。

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