超低剂量雌二醇阴道片有效治疗阴道萎缩

Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet.

作者信息

Simon James, Nachtigall Lila, Gut Robert, Lang Eva, Archer David F, Utian Wulf

机构信息

Women's Health & Research Consultants, Washington, DC 20036, USA.

出版信息

Obstet Gynecol. 2008 Nov;112(5):1053-60. doi: 10.1097/AOG.0b013e31818aa7c3.

DOI:10.1097/AOG.0b013e31818aa7c3

PMID:18978105

Abstract

OBJECTIVE

To evaluate the efficacy of ultra-low-dose 10-microgram 17beta-estradiol (E2) vaginal tablets for treatment of vaginal atrophy.

METHODS

Postmenopausal women (N=309) were randomly assigned to 10-microgram E2 or placebo vaginal tablets for 52 weeks in a multicenter, double-blind study. Primary efficacy endpoints included change from baseline to week 12 in vaginal cytology, vaginal pH, and most bothersome urogenital symptoms score. Grading of vaginal health was a secondary efficacy assessment. Safety assessments included endometrial biopsy, physical and gynecologic examinations, and recording adverse events.

RESULTS

At week 12, the change from baseline for 10 micrograms E2 compared with placebo demonstrated significant improvement in vaginal Maturation Index (proportion of parabasal cells: -37% compared with -9%; superficial cells: 13% compared with 4%; intermediate cells: 24% compared with 5%; P<.001 for each), Maturation Value (25.0 compared with 6.5, P<.001), grading of vaginal health (-0.91 compared with -0.51, P<.001), vaginal pH grade (-1.3 compared with -0.4, P<.001), and most bothersome symptoms score (-1.23 compared with -0.87, P=.003). For each component of vaginal Maturation Index, vaginal Maturation Value, grading of vaginal health, and vaginal pH, treatment effects were statistically different from placebo after 2 weeks of treatment. For most bothersome symptoms, treatment effect became apparent after 4 weeks and reached statistical significance at week 8 of therapy. All treatment effects were statistically significant at week 52. There were no major safety findings regarding physical, gynecologic, or laboratory assessments.

CONCLUSION

After 12 weeks of treatment, an ultra-low-dose 10-microgram E2 vaginal tablet, compared with placebo, demonstrated significant improvement for the primary endpoints: vaginal cytology and pH and most bothersome urogenital symptoms score.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, http://clinicaltrials.gov, NCT00108849

LEVEL OF EVIDENCE

摘要

目的

评估超低剂量10微克17β -雌二醇（E2）阴道片治疗阴道萎缩的疗效。

方法

在一项多中心、双盲研究中，将309名绝经后女性随机分配至接受10微克E2阴道片或安慰剂阴道片治疗，为期52周。主要疗效终点包括从基线至第12周阴道细胞学、阴道pH值及最困扰的泌尿生殖系统症状评分的变化。阴道健康分级为次要疗效评估。安全性评估包括子宫内膜活检、体格检查和妇科检查以及记录不良事件。

结果

在第12周时，与安慰剂相比，10微克E2组从基线的变化显示阴道成熟指数（基底旁细胞比例：-37% 对比 -9%；表层细胞：13% 对比4%；中层细胞：24% 对比5%；每项P<0.001）、成熟值（25.0对比6.5，P<0.001）、阴道健康分级（-0.91对比-0.51，P<0.001）、阴道pH分级（-1.3对比-0.4，P<0.001）以及最困扰症状评分（-1.23对比-0.87，P = 0.003）均有显著改善。对于阴道成熟指数的每个组成部分、阴道成熟值、阴道健康分级和阴道pH值，治疗2周后治疗效果与安慰剂相比有统计学差异。对于最困扰症状，治疗效果在4周后显现，并在治疗第8周达到统计学显著水平。所有治疗效果在第52周时均有统计学意义。在体格、妇科或实验室评估方面未发现重大安全性问题。