Gynaecologicum, Kreuzlingen, Switzerland.
DR. AUGUST WOLFF GmbH & CO. KG-ARZNEIMITTEL, Bielefeld, Germany.
PLoS One. 2019 Jan 24;14(1):e0210967. doi: 10.1371/journal.pone.0210967. eCollection 2019.
This open, prospective, multicenter, observational study was performed to investigate the efficacy and safety of a non-hormonal cream in women undergoing breast cancer treatment and experiencing vulvovaginal dryness symptoms. Overall, 128 patients from 22 study centers participated. The cream was applied to the vagina and vulva for 28 days. For the efficacy analysis, changes in subjective symptoms (feeling of dryness, itching, burning, pain independent of sexual intercourse, dyspareunia, urinary incontinence) were evaluated. Additionally, the following objective diagnostic findings were assessed by a physician: thinning of vaginal epithelium, redness, petechiae, and discharge. Safety and tolerability were assessed by evaluating type and frequency of adverse events, including adverse medical device-related effects. The frequency and intensity of all subjective symptoms significantly improved from baseline at 28 days (p<0.0001). Additionally, 21.4% of patients were completely free of symptoms (p<0.0001) and urinary incontinence was improved or eliminated in 30.8% of women. The overall sum score for all four objective findings was significantly improved from baseline at 28 days (p<0.0001). The frequency of petechial bleedings was significantly reduced (p<0.0001). Further, significant decreases in the severity of vaginal epithelium thinning, redness and petechiae were observed (p<0.0001). More than 88% of patients and investigators assessed the efficacy and tolerability as being good or very good. No serious adverse events were documented. This study demonstrates that the investigated cream is an effective and safe non-hormonal, topical option in the treatment of vulvovaginal dryness symptoms in patients undergoing breast cancer treatment for. However, the study duration and follow-up time of 4 weeks as well as the non-randomized trial design are limitations of the study.
这项开放、前瞻性、多中心、观察性研究旨在探讨一种非激素乳膏在接受乳腺癌治疗并出现阴道干燥症状的女性中的疗效和安全性。共有来自 22 个研究中心的 128 名患者参与了该研究。乳膏应用于阴道和外阴，持续 28 天。为了进行疗效分析，评估了主观症状（干燥感、瘙痒、烧灼感、与性交无关的疼痛、性交困难、尿失禁）的变化。此外，医生还评估了以下客观诊断发现：阴道上皮变薄、发红、瘀点和分泌物。通过评估不良事件的类型和频率，包括与医疗器械相关的不良事件，评估安全性和耐受性。所有主观症状的频率和强度在 28 天时均较基线显著改善（p<0.0001）。此外，21.4%的患者完全无症状（p<0.0001），30.8%的女性尿失禁得到改善或消除。所有四项客观发现的总评分在 28 天时较基线显著改善（p<0.0001）。瘀点出血的频率显著降低（p<0.0001）。此外，阴道上皮变薄、发红和瘀点的严重程度也显著降低（p<0.0001）。超过 88%的患者和研究者认为疗效和耐受性良好或非常好。没有记录到严重的不良事件。这项研究表明，所研究的乳膏是一种有效且安全的非激素、局部选择，可用于治疗接受乳腺癌治疗的患者的阴道干燥症状。然而，研究持续时间和随访时间为 4 周以及非随机试验设计是该研究的局限性。
