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当前治疗女性生殖泌尿系统综合征的疗效和安全性:29 项随机试验和 8311 名患者的贝叶斯网络分析。

Efficacy and safety of current therapies for genitourinary syndrome of menopause: A Bayesian network analysis of 29 randomized trials and 8311 patients.

机构信息

Department of Minimally Invasive Gynecologic Center, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100006, China.

Department of Minimally Invasive Gynecologic Center, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100006, China.

出版信息

Pharmacol Res. 2021 Feb;164:105360. doi: 10.1016/j.phrs.2020.105360. Epub 2020 Dec 8.

Abstract

Genitourinary syndrome of menopause (GSM) seriously affects the quality of life of women in this stage and patients with breast cancer, but optimal treatment options as well as risks associated with the complication remain controversial. We aimed at exploring the safest and most effective treatment for genitourinary syndrome of menopause. The study was performed following a pre-established protocol registered on PROSPERO (CRD42020180807). We searched through PubMed, Embase, Scopus, Cochrane Library, Web of Science and ScienceDirect electronic databases, clinicaltrials.gov and OVID for relevant data on Genitourinary syndrome of menopause provided by March 2020. Randomised controlled trials (RCTs) on women presenting with some or all the signs and symptoms for genitourinary syndrome of menopause were extracted and analyzed based on the Bayesian theory. The key variables were additionally evaluated using the network sub-analyses, standard pairwise comparisons, regression analysis and subgroup and sensitivity analyses. The pooled estimates were quantified as odd ratios or mean differences where appropriate, at 95 % confidence intervals. In the end, 29 randomized controlled trials (RCTs) evaluating 5 different treatment regimens for genitourinary syndrome of menopause, involving 8311 patients, were included in the study. Laser therapy had excellent effect on vaginal dryness, dysparunia, urinary incontinence, proportion of parabasal cells, pH and VHI. Vaginal estrogen also had significant effects on these aspects, although its effect was inferior to that of laser therapy. Ospemifene therapy was however superior to laser and vaginal estrogen therapies in ameliorating sexual function, however, it presents a high risk of developing adverse events and endometrial hyperplasia. Moisturizer/lubricant was effective on dysparunia, proportion of parabasal cells and vaginal pH. In regression analysis, age was an essential factor affecting vaginal dryness and pH treatment effect. Compared with other currently available interventional treatments for genitourinary syndrome of menopause, laser therapy, followed by vaginal estrogen, confers superior clinical outcomes for most aspects associated with the disease. In addition, they pose relatively low risks of developing adverse events. Ospemifene and DHEA therapies on their part significantly improve sexual function of women with GSM. A strong relationship between treatment effect and age provides insights for future studies on clinical treatment.

摘要

绝经后泌尿生殖系统综合征(GSM)严重影响了该阶段女性的生活质量和乳腺癌患者的生活质量,但最佳治疗选择以及与并发症相关的风险仍存在争议。我们旨在探索绝经后泌尿生殖系统综合征的最安全、最有效的治疗方法。该研究按照预先制定的方案在 PROSPERO(CRD42020180807)上进行。我们通过检索 PubMed、Embase、Scopus、Cochrane 图书馆、Web of Science 和 ScienceDirect 电子数据库、clinicaltrials.gov 和 OVID 等数据库,收集截至 2020 年 3 月绝经后泌尿生殖系统综合征的相关数据。提取并分析了所有出现部分或全部绝经后泌尿生殖系统综合征症状和体征的女性的随机对照试验(RCT),并基于贝叶斯理论进行分析。使用网络子分析、标准成对比较、回归分析以及亚组和敏感性分析等方法对关键变量进行了额外评估。汇总估计值以比值比或均值差表示,置信区间为 95%。最终,纳入了 29 项评估 5 种不同绝经后泌尿生殖系统综合征治疗方案的 RCT 研究,共 8311 名患者。激光治疗对阴道干燥、性交困难、尿失禁、基底细胞比例、pH 值和 VHI 有极好的疗效。阴道雌激素对这些方面也有显著疗效,但其效果不如激光治疗。奥昔孕诺治疗在改善性功能方面优于激光和阴道雌激素治疗,但发生不良事件和子宫内膜增生的风险较高。保湿剂/润滑剂对性交困难、基底细胞比例和阴道 pH 值有效。回归分析表明,年龄是影响阴道干燥和 pH 值治疗效果的重要因素。与绝经后泌尿生殖系统综合征的其他现有干预治疗方法相比,激光治疗,其次是阴道雌激素治疗,对大多数与疾病相关的方面都有较好的临床效果。此外,它们发生不良事件的风险相对较低。奥昔孕诺和脱氢表雄酮治疗则显著改善了 GSM 女性的性功能。治疗效果与年龄之间的强相关性为未来的临床治疗研究提供了新的思路。

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