Section of Gynecology and Obstetrics, Department of Surgical Sciences, University of Rome Tor Vergata, Rome, Italy.
Department of Obstetrics Gynecology and Neurology, University La Sapienza, Rome, Italy.
Adv Ther. 2021 Feb;38(2):1202-1211. doi: 10.1007/s12325-020-01594-6. Epub 2020 Dec 26.
A Coriolus versicolor-based vaginal gel is available for treating women with cervical uterine high-risk human papillomavirus (HPV) infection through re-epithelizing and re-balancing microbiota actions.
A longitudinal retrospective observational study was performed to evaluate efficacy and safety of the gel. Women treated with Coriolus versicolor-based vaginal gel were compared with women not treated with the gel. Both groups were monitored for HPV infection by an HPV DNA test, Pap smear (cytology) and colposcopy at baseline and after 6 months.
Overall, 183 high-risk HPV positive women were enrolled (97 treated and 86 controls). After 6 months, the HPV DNA test became negative in 67.0% versus 37.2% of treated and controls, respectively (p < 0.0001). Furthermore, 76.1% versus 40.8% registered a colposcopy improvement (p = 0.0005) and 60.4% versus 40.8% showed a remission (p = 0.05), for treated versus controls, respectively. Regarding to cytology, 78.5% of treated versus 37.7% of controls registered an improvement, while 70.8% of treated versus 34.8% of controls had a remission (p < 0.0001 for both variables). At multivariate analyses adjusted for age, smoking habit, and use of estroprogestinic pill, compared to controls, women treated with the gel showed a significantly higher likelihood to experience the clearence of HPV DNA (OR 4.81; 95% 2.43-9.53), and remission at colposcopy (OR 2.30; 95% 1.00-5.31), and cytology (OR 5.13; 95% 2.40-10.96) at 6 months. No adverse event was reported during the follow-up.
The use of a Coriolus versicolor-based vaginal gel in high-risk HPV patients is safe and effective based on all examined tests.
基于云芝的阴道凝胶可用于治疗宫颈 HPV 高危型感染的女性，其通过再上皮化和平衡微生物群发挥作用。
进行了一项纵向回顾性观察性研究，以评估该凝胶的疗效和安全性。将使用云芝阴道凝胶的女性与未使用凝胶的女性进行比较。两组均通过 HPV DNA 检测、巴氏涂片（细胞学）和阴道镜在基线和 6 个月时监测 HPV 感染情况。
共纳入 183 例高危 HPV 阳性女性（97 例治疗组和 86 例对照组）。6 个月后，治疗组 HPV DNA 检测转阴率为 67.0%，而对照组为 37.2%（p<0.0001）。此外，治疗组有 76.1%的患者阴道镜改善，而对照组为 40.8%（p=0.0005）；治疗组有 60.4%的患者缓解，而对照组为 40.8%（p=0.05）。在细胞学方面，治疗组有 78.5%的患者改善，而对照组为 37.7%；治疗组有 70.8%的患者缓解，而对照组为 34.8%（两个变量均 p<0.0001）。在调整年龄、吸烟习惯和使用雌激素孕激素避孕药后进行多变量分析，与对照组相比，使用凝胶治疗的女性 HPV DNA 清除的可能性显著更高（OR 4.81；95%CI 2.43-9.53），阴道镜检查（OR 2.30；95%CI 1.00-5.31）和细胞学（OR 5.13；95%CI 2.40-10.96）在 6 个月时的缓解率更高。在随访期间未报告不良反应。
基于所有检查的结果，高危 HPV 患者使用基于云芝的阴道凝胶是安全且有效的。
