玫瑰干细胞衍生的外泌体透明质酸治疗复发性萎缩性阴道炎：病例报告

摘要(中文译文)

萎缩性阴道炎（AV）是绝经生殖泌尿综合征（GSM）的一个方面，由雌激素水平低下引起，导致阴道内壁变薄、阴道干涩、阴道刺激和阴道pH值升高。长期使用激素治疗的副作用是寻求非激素治疗选择的主要原因。本病例报告中，一名41岁围绝经期女性表现为反复阴道不适、阴道干涩、瘙痒及偶有异味阴道分泌物，经反复抗菌治疗无效。临床检查显示黏膜苍白变薄，无感染征象，乳酸杆菌水平降低。首次活检显示良性成熟鳞状黏膜伴轻度萎缩、局灶性基底细胞增生、局灶性糖原沉积及纤维性间质。她接受了三次干细胞外泌体-透明质酸治疗，间隔3至4周。干预措施包括玫瑰干细胞来源的外泌体，以冻干粉形式提供，给药前用透明质酸溶液复溶。产品在2.5 mL瓶中含约30亿个外泌体，报告的纳米颗粒粒径范围为50-100 nm，纯度高于90%。制剂储存于2-8 °C，采用电穿孔后局部涂抹的方式阴道内给药。随访活检显示上皮厚度 categorical 增加（约2.5 mm），保留成熟度，轻微残余萎缩，PAS-D未见糖原，无异常纤维血管间质，无异型增生。患者报告症状缓解，随访评估显示部分黏膜结构改变，短期活检未见异型增生或恶变。在可获得的随访期间，未报告短期局部不良事件，如刺激、出血、感染、超敏反应或分泌物加重。然而，这一单例非对照病例无法确定长期安全性或治疗效果。

Abstract

Atrophic vaginitis (AV), which is an aspect of genitourinary syndrome of menopause (GSM), is caused by low levels of estrogen, which leads to weakening of the vaginal lining, vaginal dryness, vaginal irritation, and high vaginal pH. The side effects related to long-term use of hormonal therapies are the primary reason for the search for non-hormonal therapeutic options. In this case report, a 41-year-old perimenopausal female presented with recurrent vaginal discomfort, vaginal dryness, pruritus, and occasional offensive vaginal discharge that had not responded to repeated antimicrobial therapy. The clinical examination revealed that the mucosa was pale and thinned, without signs of infection, and lactobacilli levels were reduced. The first biopsy revealed benign, mature squamous mucosa with mild atrophy, focal basal cell hyperplasia, focal glycogen deposition, and fibrous stroma. She underwent three sessions of stem cell exosomes-hyaluronic acid at 3- to 4-week intervals. The intervention consisted of rose stem cell-derived exosomes supplied as a lyophilized freeze-dried powder, reconstituted with hyaluronic acid solution before administration. The product contained approximately 3 billion exosomes in a 2.5 mL vial, with a reported nanoparticle size range of 50-100 nm and purity above 90%. The preparation was stored at 2-8 °C and administered intravaginally using electroporation followed by topical application. Follow-up biopsy demonstrated a categorical increase in epithelial thickness (approximately 2.5 mm), retained maturation, slight residual atrophy, no glycogen on PAS-D, or abnormal fibrovascular stroma, and no dysplasia. The patient reported symptomatic relief, and follow-up assessment showed partial structural mucosal changes without dysplasia or malignancy on short-term biopsy. No short-term local adverse events, such as irritation, bleeding, infection, hypersensitivity, or worsening discharge, were reported during the available follow-up. However, this single uncontrolled case cannot establish long-term safety or treatment efficacy.

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