Centre Hospitalier de l'Université Laval, Ste-Foy, Quebec.
McMaster Health Sciences Centre, Hamilton, Ontario.
Menopause. 2018 Nov;25(11):1208-1213. doi: 10.1097/GME.0000000000001220.
The efficacy and safety of 25-μg 17β-estradiol vaginal tablets (Vagifem) were assessed and compared with 1.25-mg conjugated equine estrogen vaginal cream (Premarin Vaginal Cream) for the relief of menopausal-derived atrophic vaginitis, resulting from estrogen deficiency.
In a multicenter, open-label, randomized, parallel-group study, 159 menopausal women were treated for 24 weeks with either vaginal tablets or vaginal cream. Efficacy was evaluated by relief of vaginal symptoms and concentrations of serum estradiol and follicle-stimulating hormone. Safety was monitored by the incidence of adverse events, evaluation of endometrial biopsies, and clinical laboratory results. Patients also assessed the acceptability of the study medications.
Composite scores of vaginal symptoms (dryness, soreness, and irritation) demonstrated that both treatments provided equivalent relief of the symptoms of atrophic vaginitis. At weeks 2, 12, and 24, increases in serum estradiol concentrations and suppression of follicle-stimulating hormone were observed in significantly more patients who were using the vaginal cream than in those who were using the vaginal tablets (p < 0.001). Fewer patients who were using the vaginal tablets experienced endometrial proliferation or hyperplasia compared with patients who were using the vaginal cream. Significantly more patients who were using the vaginal tablets rated their medication favorably than did patients who were using the vaginal cream (p ≤ 0.001). Patients who were receiving the vaginal tablets also had a lower incidence of patient withdrawal (10% versus 32%).
Treatment regimens with 25-μg 17β-estradiol vaginal tablets and with 1.25-mg conjugated equine estrogen vaginal cream were equivalent in relieving symptoms of atrophic vaginitis. The vaginal tablets demonstrated a localized effect without appreciable systemic estradiol increases or estrogenic side effects. Vaginal tablet therapy resulted in greater patient acceptance and lower withdrawal rates compared with vaginal cream therapy.
评估和比较 25μg 17β-雌二醇阴道片（Vagifem）与 1.25mg 结合马雌激素阴道乳膏（Premarin Vaginal Cream）治疗因雌激素缺乏导致的绝经后萎缩性阴道炎的疗效。
在一项多中心、开放性、随机、平行组研究中，159 名绝经后妇女接受阴道片或阴道乳膏治疗 24 周。通过缓解阴道症状和血清雌二醇和卵泡刺激素浓度评估疗效。通过不良事件发生率、子宫内膜活检评估和临床实验室结果监测安全性。患者还评估了研究药物的可接受性。
阴道症状（干燥、疼痛和刺激）综合评分表明，两种治疗方法均能有效缓解萎缩性阴道炎的症状。在第 2、12 和 24 周，使用阴道乳膏的患者血清雌二醇浓度升高和卵泡刺激素抑制的比例明显高于使用阴道片的患者（p<0.001）。使用阴道片的患者中，子宫内膜增生或增生的患者明显少于使用阴道乳膏的患者。与使用阴道乳膏的患者相比，使用阴道片的患者对其药物的评价明显更好（p≤0.001）。使用阴道片的患者停药率也较低（10%比 32%）。
使用 25μg 17β-雌二醇阴道片和 1.25mg 结合马雌激素阴道乳膏的治疗方案在缓解萎缩性阴道炎症状方面效果相当。阴道片显示出局部作用，而没有明显的全身雌二醇增加或雌激素副作用。与阴道乳膏治疗相比，阴道片治疗导致患者接受度更高，停药率更低。
