Zambon S.p.A. Bresso (Milan), Italy.
Pharma Research Consulting s.r.l Milan, Italy.
Sex Med. 2013 Dec;1(2):35-43. doi: 10.1002/sm2.8.
Vaginal dryness due to vaginal atrophy is a common complaint of postmenopausal women, interfering with sexual function and quality of life. Hormone replacement therapy is the only effective therapy but with known risks that leave unmet medical needs. A new product, ZP-025 vaginal gel, containing purified (dialyzed lyophilized) bovine colostrum, has been developed for the treatment of vaginal dryness secondary to vaginal atrophy.
The study aims to investigate the effects of intravaginal application of ZP-025 on vaginal atrophy using an animal model.
Ovariectomized female Sprague-Dawley rats were used. Three weeks after surgery, rats were divided into four groups and treated for 4 weeks (twice a day) with placebo or ZP-025 at low (0.5%) or high (2.3%) concentrations of colostrum; in the control group, rats did not receive any treatment. Changes in vaginal blood flow due to pelvic nerve stimulation were assessed by laser Doppler flowmetry and vaginal tissue was collected for histological assay.
The main outcome measures were vaginal blood flow before and after pelvic nerve stimulation and histology of vaginal epithelium.
Treatment with ZP-025 to ovariectomized rats induced an increase of vaginal blood flow parameters (vascular capacitance, amplitude and area under the curve of the response) in response to pelvic nerve stimulation compared with control group, statistically significant at 2.3%. Vaginal epithelium showed a physiological estrous cycle aspect in treated animals, with at least five cell layers vs. one or two cell layers in control rats. As expected from a topical formulation, systemic effects on body weights and uterine wet weights were not observed with application of ZP-025.
In this study, the new product ZP-025, containing purified colostrum, was shown to have beneficial effects on vaginal atrophy in ovariectomized rats, improving vaginal hemodynamics and thickness of vaginal epithelium. Vailati S, Melloni E, Riscassi E, Behr Roussel D, and Sardina M. Evaluation of the effects of a new intravaginal gel, containing purified bovine colostrum, on vaginal blood flow and vaginal atrophy in ovariectomized rat. Sex Med 2013;1:35-43.
由于阴道萎缩导致的阴道干燥是绝经后妇女常见的抱怨，会干扰性功能和生活质量。激素替代疗法是唯一有效的治疗方法，但存在已知的风险，无法满足医疗需求。一种新的产品，ZP-025 阴道凝胶，含有纯化（透析冻干）牛初乳，已被开发用于治疗阴道萎缩引起的阴道干燥。
本研究旨在通过动物模型研究阴道内应用 ZP-025 对阴道萎缩的影响。
使用去卵巢雌性 Sprague-Dawley 大鼠。手术后 3 周，将大鼠分为四组，用安慰剂或 ZP-025 低（0.5%）或高（2.3%）浓度的牛初乳处理 4 周（每天两次）；在对照组中，大鼠未接受任何治疗。通过激光多普勒血流仪评估骨盆神经刺激引起的阴道血流变化，并收集阴道组织进行组织学检测。
主要观察指标为骨盆神经刺激前后的阴道血流参数（血管容量、幅度和反应曲线下面积）和阴道上皮组织学。
与对照组相比，ZP-025 治疗去卵巢大鼠诱导阴道血流参数（血管容量、幅度和反应曲线下面积）增加，对骨盆神经刺激有反应，在 2.3%时具有统计学意义。治疗动物的阴道上皮表现出生理发情周期的特征，至少有 5 个细胞层，而对照组大鼠只有 1 或 2 个细胞层。与局部制剂一致，应用 ZP-025 不会对体重和子宫湿重产生全身影响。
在这项研究中，含有纯化牛初乳的新产品 ZP-025 被证明对去卵巢大鼠的阴道萎缩有有益的影响，可改善阴道血液动力学和阴道上皮厚度。
