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Abstract：
Background and Objectives: Signs and symptoms of vulvovaginitis, especially when recurrent, have a significant impact on a woman\'s quality of life. The aim of this study was to survey gynecologists about their habits regarding the treatments of the pathology and to evaluate the efficacy of a novel vaginal hydrogel composed of wheat extracts and polyhexanide aimed at reducing vulvovaginitis symptomatology. Materials and Methods: A cross-sectional analysis of a national survey using 155 Italian gynecologists and a prospective, open-label, observational study were carried out in 75 outpatient clinics across Italy. Pre- and postmenopausal women with suspicion of vulvovaginitis due to at least four of the following symptoms (leucoxanthorrhea, bad odor from genitalia, vulvovaginal dryness, petechiae, burning, and pruritus) while waiting for microbiological swab analysis were included and treated with one hydrogel application every 3 days for 1 week. Primary endpoint was the complete resolution of symptomatology. Results: The pre-study survey reported that, for most clinicians, local or oral treatment (65.7% and 82.8%, respectively) with antibiotics or antifungals is used very often. Therefore, we proceeded to carry out an observational study. Overall, 615 (362 of fertile age and 253 in postmenopause) women were included in this study. At the 28th follow-up examination, complete resolution of symptomatology was achieved in 578/615 (94.1%; p < 0.001) within 12.72 ± 6.55 and 13.22 ± 6.33 days for those of fertile age and in postmenopause, respectively (p = 0.342). All of the evaluated symptoms were significantly reduced after treatment (p = 0.001) without differences according to the patient\'s menopausal status. A slightly significant reduction in Gardnerella Vaginalis (p = 0.040) and Candida Albicans (p = 0.049) was found after treatment. No patient reported side effects, adverse reactions, or discontinued therapy. Conclusions: This pilot study showed that a hydrogel based on Rigenase® (wheat extract) and polyhexanide could be a promising treatment for the relief of vulvovaginitis symptoms. However, these results are limited by the absence of a control group. Additional comparative and randomized controlled trials between the hydrogel and other non-antibiotic devices as well as local antibiotic therapy should be performed to increase the validity of the findings.
摘要：
背景和目的：外阴阴道炎的体征和症状，尤其是反复发作时，对女性的生活质量有重大影响。这项研究的目的是调查妇科医生对病理学治疗的习惯，并评估由小麦提取物和聚己内酯组成的新型阴道水凝胶的功效，旨在减少外阴阴道炎的症状学。材料和方法：对155名意大利妇科医生进行的一项全国调查的横断面分析，开放标签，观察性研究在意大利的75家门诊诊所进行.由于以下症状中的至少四种而怀疑外阴阴道炎的绝经前和绝经后妇女（白血，生殖器有难闻的气味,外阴阴道干燥,瘀斑,燃烧,和瘙痒），同时等待微生物拭子分析，并每3天使用一次水凝胶处理，持续1周。主要终点是症状学的完全缓解。结果：研究前调查报告，对于大多数临床医生来说，局部或口腔治疗(65.7%和82.8%，分别）经常使用抗生素或抗真菌药。因此,我们进行了一项观察性研究。总的来说,本研究包括615名（362名育龄妇女和253名绝经后妇女）。在第28次随访检查中,对于育龄期和绝经后的患者，在12.72±6.55和13.22±6.33天内，578/615（94.1％；p<0.001）的症状完全缓解，分别(p=0.342)。根据患者的绝经状态，所有评估的症状在治疗后均显着减轻（p=0.001），没有差异。治疗后发现阴道加德纳菌（p=0.040）和白色念珠菌（p=0.049）略有显着减少。没有患者报告副作用，不良反应,或停止治疗。结论：本初步研究表明，基于Rigenase®（小麦提取物）和聚己内酯的水凝胶可能是缓解外阴阴道炎症状的有希望的治疗方法。然而,这些结果受到对照组缺失的限制.应进行水凝胶和其他非抗生素装置以及局部抗生素治疗之间的其他比较和随机对照试验，以增加发现的有效性。
