一种含有纯化牛初乳（Monurelle Biogel）的医疗器械用于治疗绝经后女性外阴阴道萎缩：对泌尿症状、性功能和生活质量的回顾性分析。
A medical device containing purified bovine colostrum (Monurelle Biogel) in the treatment of vulvovaginal atrophy in postmenopausal women: Retrospective analysis of urinary symptoms, sexual function, and quality of life.
作者信息
Schiavi M C, Di Tucci C, Colagiovanni V, Faiano P, Giannini A, D'Oria O, Prata G, Perniola G, Monti M, Zullo M A, Muzii L, Benedetti Panici P
机构信息
Department of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome "Sapienza", Umberto I Hospital, Rome, Italy.
Department of Surgery-Week Surgery, Campus Biomedico, University of Rome, Rome, Italy.
出版信息
Low Urin Tract Symptoms. 2019 Apr;11(2):O11-O15. doi: 10.1111/luts.12204. Epub 2017 Oct 23.
OBJECTIVE
This study assessed the effectiveness and safety of a medical device containing purified bovine colostrum (Monurelle Biogel; Zambon, Bresso, Italy) in improving vulvovaginal atrophy (VVA), sexual function, urinary symptoms, and quality of life (QoL) in postmenopausal women.
METHODS
In all, 172 postmenopausal women with VVA were included in the study. All women were treated with vaginal Monurelle Biogel daily for 12 weeks. Patients underwent clinical examinations, completed a 3-day voiding diary, and had VVA graded using the Vaginal Health Index (VHI) at baseline and 12 weeks. Patients also completed the Female Sexual Function Index (FSFI), overactive bladder questionnaire (OAB-Q), and the Urogenital Distress Inventory (UDI-6), among others.
RESULTS
After 12 weeks, there were significant increases in mean (± SD) VHI (12.53 ± 3.67 vs. 19.31 ± 3.49; P < .0001), the number of patients engaging in regular sexual activity 102 (59.3%) vs. 144 (83.7%), and in the total FSFI score (21.64 ± 2.99 vs. 28.16 ± 1.93; P < .0001) compared with baseline. In addition, there were significant reductions in the mean number of 24-hour voids (9.57 ± 2.12 vs. 7.13 ± 1.22; P < .0001), urgent micturition episodes per 24 hours (1.75 ± 0.76 vs. 1.14 ± 0.87; P = .001), nocturia episodes (1.58 ± 0.85 vs. 0.97 ± 1.18; P = .0002), and urinary incontinence episodes per 24 hours (0.74 ± 0.59 vs. 0.28 ± 0.52; P = .003). Finally, after 12 weeks treatment, there were significant differences in UDI-6 (7.85 ± 0.81 vs. 5.56 ± 1.40), OAB-Q symptom (53.60 ± 12.57 vs. 22.08 ± 9.63), and OAB-Q health-related QoL (21.75 ± 8.51 vs. 69.34 ± 14.59) scores compared with baseline (P < .0001 for all). The Patient Impression of Global Improvement scale revealed global improvement in 143 women (83.14%).
CONCLUSIONS
Monurelle Biogel is an effective treatment for VVA in postmenopausal women, improving sexual life, urinary symptoms, and QoL.
目的
本研究评估了一种含有纯化牛初乳的医疗器械（莫努雷尔生物凝胶；赞邦公司，意大利布雷索）在改善绝经后女性外阴阴道萎缩（VVA）、性功能、泌尿系统症状及生活质量（QoL）方面的有效性和安全性。
方法
本研究共纳入172例患有VVA的绝经后女性。所有女性均每日阴道使用莫努雷尔生物凝胶，持续12周。患者接受临床检查，完成一份为期3天的排尿日记，并在基线期和12周时使用阴道健康指数（VHI）对VVA进行分级。患者还完成了女性性功能指数（FSFI）、膀胱过度活动症问卷（OAB-Q）以及泌尿生殖系统困扰量表（UDI-6）等。
结果
12周后，与基线相比，平均（±标准差）VHI显著升高（12.53±3.67 vs. 19.31±3.49；P＜0.0001），进行规律性生活的患者数量增加（102例，59.3% vs. 144例，83.7%），FSFI总分显著升高（21.64±2.99 vs. 28.16±1.93；P＜0.0001）。此外，24小时平均排尿次数显著减少（9.57±2.12 vs. 7.13±1.22；P＜0.0001），每24小时尿急发作次数减少（1.75±0.76 vs. 1.14±0.87；P = 0.001），夜尿发作次数减少（1.58±0.85 vs. 0.97±1.18；P = 0.0002），每24小时尿失禁发作次数减少（0.74±0.59 vs. 0.28±0.52；P = 0.003）。最后，治疗12周后，与基线相比，UDI-6（7.85±0.81 vs. 5.56±1.40）、OAB-Q症状（53.60±12.57 vs. 22.08±9.63）以及OAB-Q健康相关生活质量（21.75±8.51 vs. 69.34±14.59）评分均有显著差异（所有P＜0.0001）。患者整体改善印象量表显示143名女性（83.14%）有整体改善。
结论
莫努雷尔生物凝胶是治疗绝经后女性VVA的有效方法，可改善性生活、泌尿系统症状及生活质量。
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