First use of cord blood platelet-rich plasma in the treatment of vulvar lichen sclerosus: a preliminary study towards a randomized controlled trial.

IF 2.4 3区 医学 Q2 HEMATOLOGY
Veronica Boero, Carlotta Caia, Giulia E Cetera, Elisa Pesce, Serena Uccello, Stefania Villa, Tiziana Montemurro, Larysa Mykhailova, Camilla E M Merli, Ermelinda Monti, Flavia Filippi, Paolo Vercellini, Daniele Prati
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引用次数: 0

Abstract

Background: Although topical corticosteroids (TCS) represent first-line treatment for vulvar lichen sclerosus (VLS) and as such should be prescribed to all women at time of diagnosis, approximately 30% of patients do not experience complete symptom resolution following such treatment. TCS may not effectively improve vulvar trophism and elasticity, both of which are crucial for sexual function. Owing to its regenerative and healing properties, cord blood platelet-rich plasma (CB-PRP) may represent an efficacious supplementary therapy, to be administered following first line treatment with TCS. The primary aim of this study was to assess safety and tolerability of CB-PRP in women with VLS.

Materials and methods: This is a pilot study which precedes a randomized controlled trial of CB-PRP vs placebo in women with VLS. Ten consecutive patients with VLS, who had previously undergone standard TCS-treatment, received three vulvar CB-PRP injections monthly. Follow-up was conducted three months after the last injection using vulvoscopy and validated questionnaires to evaluate safety and tolerability, as well as patient satisfaction, symptom improvement, sexual function, psychological well-being, quality of life, frequency of TCS application as a maintenance treatment, vulvar trophism and architectural modifications.

Results: No adverse clinical effects were observed. Five patients (50%) were either satisfied or very satisfied with the procedure, four (40%) were uncertain about their satisfaction with the treatment. One patient (10%) dropped out for personal reasons and was classified as unsatisfied according to an intention-to-treat analysis. At follow-up median numeric rating scale scores were significantly reduced for vulvar burning compared to baseline (p<0.05) there was a trend toward improvement in itching, dyspareunia, and dysuria. A significant improvement in sexual arousal and satisfaction was observed in all treated women (p<0.05).

Discussion: CB-PRP may be a promising treatment for VLS. It appears to be safe and improve symptoms and sexual function.

首次使用富血小板脐带血血浆治疗外阴地衣硬化:一项随机对照试验的初步研究。
背景:虽然外阴硬化苔藓(VLS)的一线治疗方法是外阴皮质类固醇(TCS),因此在诊断时应该给所有女性开处方,但大约30%的患者在这种治疗后症状没有完全缓解。TCS可能不能有效改善外阴营养和弹性,这两者都是性功能的关键。由于其再生和愈合特性,脐带血富血小板血浆(CB-PRP)可能是一种有效的补充疗法,可在TCS一线治疗后使用。本研究的主要目的是评估CB-PRP在VLS女性患者中的安全性和耐受性。材料和方法:这是一项试点研究,在随机对照试验之前,将CB-PRP与安慰剂用于VLS女性。连续10例VLS患者,先前接受标准tcs治疗,每月接受三次外阴CB-PRP注射。最后一次注射后3个月,通过外阴镜随访,并通过验证问卷评估安全性和耐受性,以及患者满意度、症状改善、性功能、心理健康、生活质量、TCS作为维持治疗的应用频率、外阴营养和建筑修改。结果:无临床不良反应。5名患者(50%)对手术满意或非常满意,4名患者(40%)不确定他们对治疗的满意度。1名患者(10%)因个人原因退出,并根据意向治疗分析归类为不满意。在随访中,与基线相比,外阴烧伤的中位数值评定量表得分显著降低(讨论:CB-PRP可能是一种很有希望的VLS治疗方法。它似乎是安全的,可以改善症状和性功能。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Blood Transfusion
Blood Transfusion HEMATOLOGY-
CiteScore
6.10
自引率
2.70%
发文量
91
审稿时长
2 months
期刊介绍: Blood Transfusion welcomes international submissions of Original Articles, Review Articles, Case Reports and Letters on all the fields related to Transfusion Medicine.
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