**标题**：阴道用催产素凝胶对绝经后妇女阴道萎缩的影响：一项随机对照试验 **摘要**：目的：评估阴道用催产素凝胶对绝经后妇女阴道萎缩的影响。方法：我们进行了一项随机、双盲、安慰剂对照试验，纳入了 120 名绝经后妇女，将其随机分为催产素凝胶组（每天使用 0.5% 催产素凝胶 1 支，共 12 周）和安慰剂组。主要结局是阴道萎缩的改善，使用阴道萎缩视觉模拟评分量表（VAS）进行评估。次要结局包括阴道 pH 值、阴道菌群、性健康相关生活质量（SF-36）和安全性。结果：基线时，两组患者的年龄、绝经年限、体重指数和 VAS 评分等一般资料无显著差异。治疗后，催产素凝胶组的阴道萎缩 VAS 评分显著低于安慰剂组（P<0.05）。阴道 pH 值、阴道菌群和 SF-36 评分在两组间无显著差异。两组患者均未出现严重不良反应。结论：阴道用催产素凝胶可显著改善绝经后妇女的阴道萎缩，且安全性良好。
The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial.
机构信息
Menopause Andropause Research Center, Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran.
Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
出版信息
BMC Womens Health. 2020 May 19;20(1):108. doi: 10.1186/s12905-020-00935-5.
BACKGROUND
Around 90% of postmenopausal women are suffering from vaginal atrophy. This study aimed to evaluate the effect of oxytocin vaginal gel on vaginal atrophy among postmenopausal women.
METHODS
This was a randomized controlled trial that was conducted on 96 postmenopausal women who suffered from vaginal atrophy. The inclusion criteria were: literate women, age 40-60, at least 1 year passed from their last menstrual period or the level of FSH > 40 IU, monogamous women with the sexual relationship. Women in the intervention group, requested to use one applicator of 400 IU oxytocin gel per night and women in the placebo group used placebo each night. The subjective symptoms of vaginal atrophy, vaginal PH, maturation index were measured before and after the intervention.
RESULTS
The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention. The improvement of the maturation index was more dominant in the oxytocin group (increased from 7.76 ± 4.68 to 52.48 ± 7.54) in comparison to the placebo group (increased from 8.58 ± 4.35 to 13.25 ± 5.06). The PH of the vagina decreased significantly in the oxytocin group in comparison to the placebo group (p = 0.0001). After 8 weeks, 88.6 and 7.1% of women in the oxytocin and placebo groups did not show the severe symptoms of vaginal atrophy (p = 0.001).
CONCLUSION
The results of this study showed that eight- week intervention with oxytocin vaginal gel (400 IU) could significantly improve the vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina. Using this medication in women who have a contraindication for hormone therapy is recommended.
TRIAL REGISTRATION
IRCT20160602028220N2.
背景
大约 90%的绝经后妇女患有阴道萎缩。本研究旨在评估催产素阴道凝胶对绝经后妇女阴道萎缩的影响。
方法
这是一项随机对照试验，共纳入 96 例患有阴道萎缩的绝经后妇女。纳入标准为：有文化的妇女，年龄 40-60 岁，末次月经后至少 1 年或 FSH > 40IU，有单一性伴侣的女性，有性生活。干预组每晚使用 1 支 400IU 催产素凝胶，安慰剂组每晚使用安慰剂。干预前后测量阴道萎缩的主观症状、阴道 pH 值和成熟指数。
结果
与安慰剂组相比，催产素组的表层细胞数量显著增加（38.7 ± 7.18 与 3.69 ± 2.76，p = 0.0001），而在干预后，催产素组的基底细胞数量显著减少。与安慰剂组相比，催产素组的成熟指数改善更为明显（从 7.76 ± 4.68 增加到 52.48 ± 7.54）。与安慰剂组相比（从 8.58 ± 4.35 增加到 13.25 ± 5.06），催产素组阴道 pH 值显著降低（p = 0.0001）。在 8 周后，催产素组和安慰剂组分别有 88.6%和 7.1%的妇女未出现严重的阴道萎缩症状（p = 0.001）。
结论
本研究结果表明，8 周的催产素阴道凝胶（400IU）干预可显著改善阴道成熟指数、阴道萎缩的主观症状和降低阴道 pH 值。对于有激素治疗禁忌的妇女，推荐使用这种药物。
试验注册
IRCT20160602028220N2。
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