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基于能量的绝经后泌尿生殖综合征干预措施:随机对照试验和前瞻性观察性研究的系统评价

Energy-based interventions for genitourinary syndrome of menopause: a systematic review of randomized controlled trials and prospective observational studies.

作者信息

Zerzan Nicholas L, Greer Nancy, Ullman Kristen E, Sowerby Catherine, Diem Susan, Ensrud Kristine, Forte Mary L, Anthony Maylen C, Landsteiner Adrienne, Butler Mary, Wilt Timothy J, Danan Elisheva R

机构信息

From the Center for Care Delivery & Outcomes Research, VA Health Care System, Minneapolis, MN.

Division of Health Policy & Management, School of Public Health, University of Minnesota, Minneapolis, MN.

出版信息

Menopause. 2025 Feb 1;32(2):176-183. doi: 10.1097/GME.0000000000002465. Epub 2025 Jan 7.

Abstract

IMPORTANCE

Hormone treatments for genitourinary syndrome of menopause (GSM) symptoms have limitations. There is interest in nonhormone therapies, including energy-based interventions. Benefits and harms of energy-based interventions are not currently well known.

OBJECTIVE

The aim of this study was to assess the benefits and harms of energy-based therapies (eg, CO 2 laser, Er:YAG laser, and radiofrequency) for GSM. Outcomes of interest are the eight "Core Outcomes in Menopause" and include the following: dyspareunia, vulvovaginal dryness, vulvovaginal discomfort/irritation, dysuria, change in most bothersome symptom, quality of life, treatment satisfaction, and treatment adverse effects.

EVIDENCE REVIEW

Eligible studies included English language randomized controlled trials (RCT) or prospective observational studies of energy-based treatments with ≥8 weeks follow-up in postmenopausal women with ≥1 GSM symptom and studies of any design reporting adverse effects ≥12 months postintervention. Ovid/MEDLINE, Embase, and CINAHL were searched from inception to December 11, 2023 using vocabulary and natural language terms, along with free-text words. Two authors extracted data and assessed the quality of included studies.

FINDINGS

We identified 32 unique studies (16 RCT; 1 quasi-RCT; 15 nonrandomized). Ten RCT and the quasi-RCT were rated low to moderate risk of bias (RoB) and underwent data extraction. Included studies evaluated CO 2 laser (k = 7), Er:YAG laser (k = 3), or radiofrequency and CO 2 laser (k = 1). CO 2 laser compared with sham (k = 4) may result in little to no difference in dysuria, dyspareunia, or quality of life (low certainty of evidence [COE]). CO 2 laser compared with vaginal conjugated estrogens cream (k = 2) may result in little to no difference in dyspareunia, dryness, discomfort/irritation, dysuria, or quality of life (low COE). Treatment effects on all other outcomes and effects of Er:YAG laser or radiofrequency on any outcome are very uncertain (very low COE). Studies noted few adverse events and no serious adverse events.

CONCLUSIONS AND RELEVANCE

CO 2 laser resulted in little to no difference in outcomes compared with sham or vaginal estrogen; the evidence is very uncertain on the effect of energy-based interventions versus all other comparators for all other outcomes. Adverse event reporting was limited. There is a need for further evidence assessing energy-based interventions.

摘要

重要性

用于治疗绝经后泌尿生殖综合征(GSM)症状的激素疗法存在局限性。人们对非激素疗法很感兴趣,包括基于能量的干预措施。目前尚不清楚基于能量的干预措施的益处和危害。

目的

本研究的目的是评估基于能量的疗法(如二氧化碳激光、铒:钇铝石榴石激光和射频)治疗GSM的益处和危害。感兴趣的结果是“绝经的八项核心结果”,包括以下内容:性交困难、外阴阴道干燥、外阴阴道不适/刺激、排尿困难、最困扰症状的变化、生活质量、治疗满意度和治疗不良反应。

证据综述

符合条件的研究包括英文随机对照试验(RCT)或对有≥1种GSM症状的绝经后女性进行的≥8周随访的基于能量治疗的前瞻性观察性研究,以及报告干预后≥12个月不良反应的任何设计的研究。从数据库建立到2023年12月11日,使用词汇、自然语言术语以及自由文本词在Ovid/MEDLINE、Embase和CINAHL中进行检索。两位作者提取数据并评估纳入研究的质量。

研究结果

我们确定了32项独特的研究(16项RCT;1项准RCT;15项非随机研究)。10项RCT和准RCT被评为低至中度偏倚风险(RoB),并进行了数据提取。纳入研究评估了二氧化碳激光(k = 7)、铒:钇铝石榴石激光(k = 3)或射频和二氧化碳激光(k = 1)。与假手术(k = 4)相比,二氧化碳激光在排尿困难、性交困难或生活质量方面可能几乎没有差异(证据确定性低[COE])。与阴道结合雌激素乳膏(k = 2)相比,二氧化碳激光在性交困难、干燥、不适/刺激、排尿困难或生活质量方面可能几乎没有差异(COE低)。对所有其他结果的治疗效果以及铒:钇铝石榴石激光或射频对任何结果的影响非常不确定(COE极低)。研究指出不良事件很少,没有严重不良事件。

结论与相关性

与假手术或阴道雌激素相比,二氧化碳激光在结果方面几乎没有差异;关于基于能量的干预措施与所有其他对照在所有其他结果上的效果,证据非常不确定。不良事件报告有限。需要进一步的证据来评估基于能量的干预措施。

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