Barentsen R, van de Weijer P H, Schram J H
Department of Obstetrics and Gynecology, Elkerliek Hospital, Helmond, The Netherlands.
Eur J Obstet Gynecol Reprod Biol. 1997 Jan;71(1):73-80. doi: 10.1016/s0301-2115(96)02612-7.
To determine if the efficacy of continuous low dose estradiol released from a vaginal ring is equivalent to estriol vaginal cream regarding improvement of the patient's subjective feeling of vaginal dryness and to determine if there is a preference for either of the two study treatments.
Open-label randomized parallel group trial with active control with a blind evaluation of vaginal cytology and with a cross-over (change-over) phase for preference comparison. One hundred and sixty five postmenopausal women with symptoms of vaginal dryness and signs of vaginal atrophy were randomized to an estradiol ring (Estring) or estriol cream (Synapause). The duration of each treatment period was 12 weeks.
Both study treatments were equally effective regarding the ability to alleviate the symptom feeling of vaginal dryness and the signs of vaginal atrophy. Both treatments were efficient in restoring the vaginal mucosa, recorded as higher maturation values and as decreased vaginal pH. Estring was superior to estriol cream regarding preference of treatment. Both treatments were equivalent for the occurrence of adverse events, including bleeding.
data from this change-over study confirm efficacy and safety of both the vaginal ring and cream in the treatment of postmenopausal women with urogenital atrophy symptoms and signs. The patients had a strong preference for the vaginal ring.
确定阴道环释放的持续低剂量雌二醇在改善患者阴道干燥主观感受方面的疗效是否等同于雌三醇阴道乳膏，并确定患者对两种研究治疗方法是否存在偏好。
开放标签随机平行组试验，采用活性对照，对阴道细胞学进行盲法评估，并设有交叉（转换）阶段用于偏好比较。165名有阴道干燥症状和阴道萎缩体征的绝经后女性被随机分为接受雌二醇环（爱斯妥）或雌三醇乳膏（司诺美孚）治疗。每个治疗期持续12周。
两种研究治疗方法在缓解阴道干燥症状和阴道萎缩体征方面同样有效。两种治疗方法在恢复阴道黏膜方面均有效，表现为成熟值升高和阴道pH值降低。在治疗偏好方面，爱斯妥优于雌三醇乳膏。两种治疗方法在不良事件（包括出血）的发生方面相当。
这项交叉研究的数据证实了阴道环和乳膏在治疗有泌尿生殖萎缩症状和体征的绝经后女性方面的疗效和安全性。患者对阴道环有强烈偏好。
