IR@PKUHSC  > 北京大学第一临床医学院
学科主题临床医学
Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness: A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group, Clinical Trial
Chen, Junya1; Geng, Li1; Song, Xuehong2; Li, Hongxia3; Giordan, Nicola4; Liao, Qinping1
关键词Menopause Hyaluronic Acid Vaginal Gel Estriol Cream Vaginal Dryness
刊名JOURNAL OF SEXUAL MEDICINE
2013-06-01
DOI10.1111/jsm.12125
10期:6页:1575-1584
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Urology & Nephrology
研究领域[WOS]Urology & Nephrology
关键词[WOS]HORMONE-REPLACEMENT THERAPY ; POSTMENOPAUSAL WOMEN ; ATROPHIC VAGINITIS ; UROGENITAL ATROPHY ; ESTROGEN THERAPY ; CREAM ; MANAGEMENT ; ESTRADIOL ; BACTERIAL ; ESTRIOL
英文摘要

Introduction Atrophic vaginitis is a common occurrence, particularly among postmenopausal women; however, few seek or receive treatment. One therapeutic solution is topically applied products. Estrogen-based treatments have been shown to be effective; however, many patients are reluctant to use such formulations due to health concerns, hence the need to assess the efficacy of acceptable alternatives. Aim This multicenter, randomized, controlled, open-label, parallel-group clinical trial set out to evaluate the efficacy and safety of hyaluronic acid vaginal gel to treat vaginal dryness compared with estriol cream in postmenopausal women. Methods One hundred forty-four subjects were randomized, 72 to the test group treated with hyaluronic acid vaginal gel (Hyalofemme) and 72 to the control group treated with estriol cream (Ovestin). Treatment in both groups was applied by means of a device once every 3 days for a total of 10 applications over 30 days. Main Outcome Measures Efficacy was measured by grading vaginal dryness and three other vaginal symptoms on a visual analog scale. Safety assessments included vital signs, laboratory examinations of the vaginal microecosystem, vaginal pH value, vaginal B ultrasound, and incidence of adverse events. Assessments were performed at baseline, by telephone after the third application, and at the final visit. Results Both hyaluronic acid vaginal gel and estriol cream can significantly improve the clinical symptoms of vaginal dryness in postmenopausal women, with improvement rate of 84.44% and 89.42%, respectively, after 10 applications, without statistically significant difference between them. Conclusion Both hyaluronic acid vaginal gel and estriol cream are effective in the treatment of vaginal dryness. Hyaluronic acid vaginal gel may be considered as a valid alternative to estrogen-based treatments in relieving the symptoms of vaginal dryness.

语种英语
WOS记录号WOS:000319877400015
引用统计
被引频次:32[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/50138
专题北京大学第一临床医学院
北京大学第一临床医学院_妇产科
北京大学第三临床医学院_妇产科
作者单位1.Peking Univ, Hosp 1, Dept Obstet & Gynecol, Beijing 100034, Peoples R China
2.Capital Univ Med Sci, Beijing Chao Yang Hosp, Dept Obstet & Gynecol, Beijing, Peoples R China
3.Beijing Shijintan Hosp, Dept Obstet & Gynecol, Beijing, Peoples R China
4.Fidia Farmaceut SpA, Clin Operat, Abano Terme, PD, Italy
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GB/T 7714
Chen, Junya,Geng, Li,Song, Xuehong,et al. Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness: A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group, Clinical Trial[J]. JOURNAL OF SEXUAL MEDICINE,2013,10(6):1575-1584.
APA Chen, Junya,Geng, Li,Song, Xuehong,Li, Hongxia,Giordan, Nicola,&Liao, Qinping.(2013).Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness: A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group, Clinical Trial.JOURNAL OF SEXUAL MEDICINE,10(6),1575-1584.
MLA Chen, Junya,et al."Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness: A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group, Clinical Trial".JOURNAL OF SEXUAL MEDICINE 10.6(2013):1575-1584.
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