Continuous low dose estradiol released from a vaginal ring versus estriol vaginal cream for urogenital atrophy
Continuous low dose estradiol released from a vaginal ring versus estriol vaginal cream for urogenital atrophy
复制标题
DOI：
10.1016/s0301-2115(96)02612-7
复制
发表时间：
1997-01-01
影响因子：
2.6
通讯作者：
Schram, JHN
中科院分区：
文献类型：
--
作者：
Barentsen, R;vandeWeijer, PHM;Schram, JHN
目的：确定从阴道环释放的连续低剂量雌二醇的功效是否等于雌激素乳膏，即改善患者的阴道干燥的主观感觉，以确定是否偏爱两种研究治疗方法中的任何一种。方法：具有主动对照的开放标签随机平行组试验，对阴道细胞学的盲目评估，并具有交叉（更改）阶段以进行比较。一百六十五名具有阴道干燥症状和阴道萎缩症状的绝经后妇女被随机分为雌二醇环（Estring（r））或雌二醇乳膏（Synapause（r））。每个治疗期间的持续时间为12周。结果：两种研究治疗方法在减轻阴道干燥症状和阴道萎缩症状的能力方面同样有效。两种治疗方法均有效地恢复阴道粘膜，记录为更高的成熟值和阴道pH值降低。在治疗偏爱方面，ESTRING优于雌激素。两种治疗都在发生不良事件（包括出血）的情况下等效。结论：这项变更研究的数据证实了阴道环和乳霜在治疗绝经后女性患有泌尿生殖萎缩症状和体征的功效。患者对阴道环有很强的偏爱。版权（C）1997 Elsevier Science Ireland Ltd.
Objectives: 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 sind to determine if there is a preference for either of the two study treatments. Methods: 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(R)) or estriol cream (Synapause(R)). The duration of each treatment period was 12 weeks. Results: 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. Conclusion: 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. Copyright (C) 1997 Elsevier Science Ireland Ltd.