Jonasson Aino Fianu, Åstrom Mikael
Department of Clinical Sciences, Intervention, and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute, Stockholm, Sweden.
StatCons, Malmö, Sweden.
Med Devices (Auckl). 2021 Jun 25;14:193-200. doi: 10.2147/MDER.S303234. eCollection 2021.
This pilot study assessed the efficacy of 12 weeks of daily treatment with a vaginal gel based on a water-based cellulose gel in reducing the severity of moderate-severe symptoms of vulvovaginal atrophy (VVA) and followed adverse events in female breast cancer patients undergoing treatment with adjuvant aromatase- inhibitor therapy.
In this open, uncontrolled pilot study, the efficacy and safety of the gel during a treatment period of 12 weeks (daily 1×1 mL) were evaluated (n=28). The gel is made of water and hypromellose, a hydropropylmetyl cellulose, which works by coating the vagina, and was developed to treat moderate-severe symptoms of VVA. The primary efficacy variable was the most bothersome symptom (MBS; among vulvovaginal irritation and itching, vaginal dryness, dysuria, or dyspareunia) self-identified at baseline on a four-point scale.
A total of 28 patients fulfilled all entry criteria and had data available after the start of treatment. Treatment with the gel reduced MBS scores from baseline (n=28, mean 2.71) to week 12 (n=27, mean 1.33, mean reduction 1.37; =0), and reduced the overall total scores for VVA symptoms from a mean of 5.39 at baseline to 2.25 at week 12 (p=0). Eleven subjects (39%) reported 19 AEs.
A 12-week treatment with the gel significantly reduced the severity of MBSs and VVA symptoms, improved quality of life, and was safe to use in women with breast cancer undergoing adjuvant aromatase-inhibitor therapy. In view of the beneficial effects of nonhormonal treatments, for cancer patients in particular, the water-based cellulose gel VagiVital is a suitable candidate for first-choice treatment of VVA symptoms in breast cancer patients and in women predisposed to cancer.
本初步研究评估了一种基于水基纤维素凝胶的阴道凝胶每日治疗12周对减轻中重度外阴阴道萎缩（VVA）症状严重程度的疗效，并跟踪了接受辅助芳香化酶抑制剂治疗的女性乳腺癌患者的不良事件。
在这项开放、非对照的初步研究中，评估了该凝胶在12周治疗期（每日1×1 mL）内的疗效和安全性（n = 28）。该凝胶由水和羟丙甲纤维素制成，通过覆盖阴道发挥作用，用于治疗中重度VVA症状。主要疗效变量是在基线时自我认定的最困扰症状（MBS；在外阴阴道刺激和瘙痒、阴道干燥、排尿困难或性交困难中），采用四点量表评分。
共有28名患者符合所有入选标准，且在治疗开始后有可用数据。使用该凝胶治疗使MBS评分从基线时的（n = 28，平均2.71）降至第12周时的（n = 27，平均1.33，平均降低1.37；P = 0），并使VVA症状的总体总分从基线时的平均5.39降至第12周时的2.25（P = 0）。11名受试者（39%）报告了19起不良事件。
使用该凝胶进行12周治疗可显著降低MBS和VVA症状的严重程度，改善生活质量，且对于接受辅助芳香化酶抑制剂治疗的乳腺癌女性患者而言使用安全。鉴于非激素治疗的有益效果，特别是对于癌症患者，水基纤维素凝胶VagiVital是乳腺癌患者和易患癌症女性中VVA症状首选治疗的合适候选药物。
