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一项关于新型阴道环释放的持续低剂量雌二醇与雌三醇阴道栓剂对有泌尿生殖系统萎缩症状和体征的绝经后妇女影响的多中心比较研究。

A comparative multicenter study of the effects of continuous low-dose estradiol released from a new vaginal ring versus estriol vaginal pessaries in postmenopausal women with symptoms and signs of urogenital atrophy.

作者信息

Henriksson L, Stjernquist M, Boquist L, Alander U, Selinus I

机构信息

Department of Obstetrics and Gynecology, University of Lund, Malmö, Sweden.

出版信息

Am J Obstet Gynecol. 1994 Sep;171(3):624-32. doi: 10.1016/0002-9378(94)90074-4.

Abstract

OBJECTIVE

Our purpose was to study the efficacy, safety, and acceptability of a new estradiol-releasing (6.5 to 9.5 micrograms per 24 hours) silicone rubber vaginal ring compared with Ovesterin 0.5 mg estriol vaginal pessaries.

STUDY DESIGN

Gynecologic clinical status, vaginal pH, cytologic characteristics, and occurrence of bacteriuria were determined before starting and after 3 and 12 weeks of treatment in 146 postmenopausal women.

RESULTS

Both treatments alleviated the subjective and objective symptoms of estrogen deficiency excellently, and both were equally effective at restoring the vaginal pH to levels normally seen in fertile women (< 5.5). Vaginal cytologic studies showed a significant difference in maturation value in favor of the estradiol-releasing silicone rubber vaginal ring, as measured by the pathologist's assessment of the proliferation of the vaginal mucosa. A total of 77% of users were classified as responders, compared with 39% in the pessary group. Both treatments were well accepted. The administration of the pessary was associated with a significantly higher (p < 0.001) incidence of discomfort than that of the ring, which was given better (p < 0.001) rating by the patients at the 12-week visit. A strong preference (p < 0.001) for the ring was shown by patients with previous experience with pessaries.

CONCLUSION

Treatment of urogenital symptoms in postmenopausal women with an estradiol-releasing vaginal ring is shown to be an effective and safe method, exhibiting advantages over treatment with estriol vaginal pessaries.

摘要

目的

我们的目的是研究一种新的释放雌二醇(每24小时6.5至9.5微克)的硅橡胶阴道环与0.5毫克雌三醇阴道栓剂(Ovesterin)相比的疗效、安全性和可接受性。

研究设计

对146名绝经后妇女在治疗开始前以及治疗3周和12周后测定妇科临床状况、阴道pH值、细胞学特征和菌尿的发生情况。

结果

两种治疗方法都能很好地缓解雌激素缺乏的主观和客观症状,并且在将阴道pH值恢复到育龄妇女正常水平(<5.5)方面同样有效。阴道细胞学研究显示,通过病理学家对阴道黏膜增殖的评估,成熟值存在显著差异,有利于释放雌二醇的硅橡胶阴道环。共有77%的使用者被归类为有反应者,而栓剂组为39%。两种治疗方法都很容易被接受。使用栓剂时不适的发生率显著高于阴道环(p<0.001),在12周随访时患者对阴道环的评价更好(p<0.001)。有使用栓剂经验的患者对阴道环表现出强烈的偏好(p<0.001)。

结论

使用释放雌二醇的阴道环治疗绝经后妇女的泌尿生殖系统症状是一种有效且安全的方法,比使用雌三醇阴道栓剂治疗具有优势。

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