Abstract：
OBJECTIVE: This TRIPLE study was aimed to evaluate the efficacy of polycarbophil vaginal gel (PCV) in treating symptoms of vaginal atrophy (VA) of peri- and post-menopausal women.
METHODS: Sexually active women in peri- (n = 29) and post-menopause (n = 54) suffering from VA, were progressively enrolled and treated for 30 days with PCV. Those wishing to continue (n = 73) were treated for additional 180 days. PCV was administered as one application twice a week. The vaginal health index (VHI; range 5 to 25) and the visual analogue score (VAS range for 0 to 100 mm for each item) for vaginal dryness, irritation, and pain at intercourse, along with the global symptoms score (GSS; range 1 to 15) and treatment safety, were evaluated at baseline and after 30 days. In those continuing the treatment an evaluation was performed after additional 180 days.
RESULTS: Women in peri and post-menopause were of 48.7 ± 3.3 years and 57.5 ± 5.7 years old., respectively. At baseline all outcomes were significantly worse (p<0.002) in postmenopausal group, except the VHI (p < 0.056). After 30 days VHI increased (p < 0.001) of 4.1 ± 0.5 (mean ± SE), and 5.1 ± 0.4 in peri- and post-menopausal women respectively. VAS of vaginal dryness decreased (p < 0.001) of -24.4 ± 3.6, and -52.7 ± 2.6 (p < 0.001), VAS of irritation decreased (p<0.001) of -18.6 ± 4.4 and -47.8 ± 3.2, VAS of pain decreased (p < 0.001) of -26.2 ± 4.3 and -55.6 ± 3.1 and the GSS decreased (p < 0.001) of -3.9 ± 0.3, and -4.9 ± 0.2, in peri and post-menopausal women, respectively. All the modifications were significantly greater (p < 0.001)(p < 0.032 for GSS) in postmenopausal women, and after 30 days all outcomes were similar in the two groups of women. In comparison to baseline, after 210 days of treatment VHI increased of 7.7 ± 0.3 (p < 0.001), VAS of vaginal dryness decreased of -53.6 ± 1.9 (p < 0.001) VAS of irritation of -42.6 ± 1.4 (p < 0.001) VAS of pain of -46.7 ± 2.3 (p < 0.001) and the GSS of -6.5 ± 0.2 ± 0.2 (p < 0.001). All outcomes improved (p < 0.001) over the values observed after 30 days of treatment (p < 0.001). No side effect was reported.
CONCLUSIONS: In peri- and post-menopausal women PCV administration rapidly improves VA symptoms, and its prolongation up to 6 months further increases its efficacy.
METHODS: Sexually active women in peri- (n = 29) and post-menopause (n = 54) suffering from VA, were progressively enrolled and treated for 30 days with PCV. Those wishing to continue (n = 73) were treated for additional 180 days. PCV was administered as one application twice a week. The vaginal health index (VHI; range 5 to 25) and the visual analogue score (VAS range for 0 to 100 mm for each item) for vaginal dryness, irritation, and pain at intercourse, along with the global symptoms score (GSS; range 1 to 15) and treatment safety, were evaluated at baseline and after 30 days. In those continuing the treatment an evaluation was performed after additional 180 days.
RESULTS: Women in peri and post-menopause were of 48.7 ± 3.3 years and 57.5 ± 5.7 years old., respectively. At baseline all outcomes were significantly worse (p<0.002) in postmenopausal group, except the VHI (p < 0.056). After 30 days VHI increased (p < 0.001) of 4.1 ± 0.5 (mean ± SE), and 5.1 ± 0.4 in peri- and post-menopausal women respectively. VAS of vaginal dryness decreased (p < 0.001) of -24.4 ± 3.6, and -52.7 ± 2.6 (p < 0.001), VAS of irritation decreased (p<0.001) of -18.6 ± 4.4 and -47.8 ± 3.2, VAS of pain decreased (p < 0.001) of -26.2 ± 4.3 and -55.6 ± 3.1 and the GSS decreased (p < 0.001) of -3.9 ± 0.3, and -4.9 ± 0.2, in peri and post-menopausal women, respectively. All the modifications were significantly greater (p < 0.001)(p < 0.032 for GSS) in postmenopausal women, and after 30 days all outcomes were similar in the two groups of women. In comparison to baseline, after 210 days of treatment VHI increased of 7.7 ± 0.3 (p < 0.001), VAS of vaginal dryness decreased of -53.6 ± 1.9 (p < 0.001) VAS of irritation of -42.6 ± 1.4 (p < 0.001) VAS of pain of -46.7 ± 2.3 (p < 0.001) and the GSS of -6.5 ± 0.2 ± 0.2 (p < 0.001). All outcomes improved (p < 0.001) over the values observed after 30 days of treatment (p < 0.001). No side effect was reported.
CONCLUSIONS: In peri- and post-menopausal women PCV administration rapidly improves VA symptoms, and its prolongation up to 6 months further increases its efficacy.
摘要：
目的：本研究旨在评估聚卡波非阴道凝胶（PCV）治疗绝经前后妇女阴道萎缩（VA）症状的疗效。
方法：患有VA的围绝经期（n=29）和绝经后（n=54）的性活跃女性，逐步纳入并接受PCV治疗30天。希望继续治疗的那些(n=73)再治疗180天。PCV作为一次施用施用,每周两次。阴道干燥的阴道健康指数（VHI;范围5至25）和视觉模拟评分（每个项目的VAS范围为0至100mm），刺激,性交时的疼痛，随着整体症状评分（GSS；范围1至15）和治疗安全性，在基线和30天后进行评估。在那些继续治疗的患者中,在另外180天后进行评估。
结果：围绝经期和绝经后妇女分别为48.7±3.3岁和57.5±5.7岁。,分别。在基线时，绝经后组中所有结果均显着恶化（p<0.002），除了VHI(p<0.056)。30天后，VHI增加（p<0.001）4.1±0.5（平均值±SE），围绝经期和绝经后妇女分别为5.1±0.4。阴道干燥的VAS降低（p<0.001），分别为-24.4±3.6和-52.7±2.6（p<0.001），在围绝经期和绝经后妇女中，刺激的VAS降低（p<0.001）为-18.6±4.4和-47.8±3.2，疼痛的VAS降低（p<0.001）为-26.2±4.3和-55.6±3.1，GSS降低（p<0.001）为-3.9±0.3和-4.9±0.2，分别。在绝经后妇女中，所有的修饰都明显更大（p<0.001）（p<0.032对于GSS），30天后,两组女性的所有结局相似.与基线相比，治疗210天后，VHI增加7.7±0.3（p<0.001），阴道干燥的VAS降低了-53.6±1.9（p<0.001）。刺激的VAS为-42.6±1.4（p<0.001）。疼痛的VAS为-46.7±2.3（p<0.001），GSS为-6.5±0.2±0.2（p<0.001）。与治疗30天后观察到的值（p<0.001）相比，所有结果均有所改善（p<0.001）。没有副作用的报道。
结论：在围绝经期和绝经后妇女中，PCV给药迅速改善VA症状，和它的延长长达6个月进一步增加其疗效。
方法：患有VA的围绝经期（n=29）和绝经后（n=54）的性活跃女性，逐步纳入并接受PCV治疗30天。希望继续治疗的那些(n=73)再治疗180天。PCV作为一次施用施用,每周两次。阴道干燥的阴道健康指数（VHI;范围5至25）和视觉模拟评分（每个项目的VAS范围为0至100mm），刺激,性交时的疼痛，随着整体症状评分（GSS；范围1至15）和治疗安全性，在基线和30天后进行评估。在那些继续治疗的患者中,在另外180天后进行评估。
结果：围绝经期和绝经后妇女分别为48.7±3.3岁和57.5±5.7岁。,分别。在基线时，绝经后组中所有结果均显着恶化（p<0.002），除了VHI(p<0.056)。30天后，VHI增加（p<0.001）4.1±0.5（平均值±SE），围绝经期和绝经后妇女分别为5.1±0.4。阴道干燥的VAS降低（p<0.001），分别为-24.4±3.6和-52.7±2.6（p<0.001），在围绝经期和绝经后妇女中，刺激的VAS降低（p<0.001）为-18.6±4.4和-47.8±3.2，疼痛的VAS降低（p<0.001）为-26.2±4.3和-55.6±3.1，GSS降低（p<0.001）为-3.9±0.3和-4.9±0.2，分别。在绝经后妇女中，所有的修饰都明显更大（p<0.001）（p<0.032对于GSS），30天后,两组女性的所有结局相似.与基线相比，治疗210天后，VHI增加7.7±0.3（p<0.001），阴道干燥的VAS降低了-53.6±1.9（p<0.001）。刺激的VAS为-42.6±1.4（p<0.001）。疼痛的VAS为-46.7±2.3（p<0.001），GSS为-6.5±0.2±0.2（p<0.001）。与治疗30天后观察到的值（p<0.001）相比，所有结果均有所改善（p<0.001）。没有副作用的报道。
结论：在围绝经期和绝经后妇女中，PCV给药迅速改善VA症状，和它的延长长达6个月进一步增加其疗效。
