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学科主题: 临床医学
题名:
Directed shift of vaginal flora after topical application of sucrose gel in a phase III clinical trial: a novel treatment for bacterial vaginosis
作者: Zeng Zhong-ming2; Liao Qin-pin3; Yao Chen4; Geng Li5; Feng Li-hua6; Shi Hui-rong7; Xin Xiao-yan8; Li Ping9; Wang Hui-lan10; Pang Yi-cun11; Liu Shu-wen12; Jiang Shi-bo1,12
关键词: bacterial vaginosis ; vaginal flora ; sucrose ; metronidazole ; clinical trial
刊名: CHINESE MEDICAL JOURNAL
发表日期: 2010-08-05
DOI: 10.3760/cma.j.issn.0366-6999.2010.15.018
卷: 123, 期:15, 页:2051-2057
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: IMMUNODEFICIENCY-VIRUS TYPE-1 ; WOMEN ; INFECTION ; VAGINITIS ; HIV ; RELIABILITY ; ACQUISITION ; ASSOCIATION ; DISEASE ; RISK
英文摘要:

Background Bacterial vaginosis (BV) is one of the most common infectious diseases among sexually active women and is associated with the increased acquisition of a variety of sexually transmitted diseases. This study aimed to compare the efficacy of a non-antibiotic sucrose gel against an antibiotic metronidazole gel for the treatment of By.

Methods A randomized, double-blinded, multi-center, parallel-group, placebo-controlled phase Ill clinical trial was conducted at eight hospitals in China. A total of 560 subjects with clinically diagnosed BV were randomly assigned into three groups for vaginally receiving sucrose, metronidazole, and placebo gels, respectively, twice daily for five consecutive days. The efficacy of therapeutic cure, defined as an achievement of both microbiologic cure (a Nugent score of 3 or less) and clinical cure (a resolution of the clinical findings from the baseline visit), was evaluated at the 1st and 2nd test-of-cure (TOC) visits at 7-10 and 21-35 days after the start of treatment, respectively.

Results Therapeutic cure rates for sucrose, metronidazole, and placebo gel groups were 83.13%, 71.30% and 0.92%, at the 1st TOC, and 61.04%, 66.67% and 7.34%, at the 2nd TOC, respectively. While there was no significant difference between the sucrose and metronidazole gel groups at the 2nd TOC (P=0.305), and sucrose gel was more effective than metronidazole gel at the 1st TOC (P=0.009).

Conclusion These findings suggest that sucrose gel restores normal vaginal flora more rapidly than metronidazole gel and can be used as a novel treatment for BV. Chin Med J 2010;123(15):2051-2057

语种: 英语
WOS记录号: WOS:000281025400019
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/57693
Appears in Collections:北京大学第一临床医学院_期刊论文

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作者单位: 1.New York Blood Ctr, Lindsley F Kimball Res Inst, Viral Immunol Lab, New York, NY 10065 USA
2.Guangdong Med Coll, Affiliated Nanshan Hosp, Div Infect Dis, Shenzhen 518052, Peoples R China
3.Beijing Univ, Hosp 1, Div Obstet & Gynecol, Beijing 100034, Peoples R China
4.Beijing Univ, Hosp 1, Dept Med Stat, Beijing 100034, Peoples R China
5.Beijing Univ, Hosp 3, Div Obstet & Gynecol, Beijing 100083, Peoples R China
6.Jilin Univ, Affiliated Hosp 1, Div Obstet & Gynecol, Changchun 130021, Jilin, Peoples R China
7.Zhengzhou Univ, Affiliated Hosp 1, Div Obstet & Gynecol, Zhengzhou 450052, Henan, Peoples R China
8.Fourth Mil Med Univ, Affiliated Xijing Hosp, Div Obstet & Gynecol, Xian 710032, Shaanxi, Peoples R China
9.First Hosp Nanjing, Div Obstet & Gynecol, Nanjing 210029, Jiangsu, Peoples R China
10.Hebei Med Univ, Affiliated Hosp 2, Div Obstet & Gynecol, Shijiazhuang 050000, Hebei, Peoples R China
11.Hebei Med Univ, Affiliated Hosp 3, Div Obstet & Gynecol, Shijiazhuang 050051, Hebei, Peoples R China
12.So Med Univ, Sch Pharmaceut Sci, Antiviral Res Ctr, Guangzhou 510515, Guangdong, Peoples R China

Recommended Citation:
Zeng Zhong-ming,Liao Qin-pin,Yao Chen,et al. Directed shift of vaginal flora after topical application of sucrose gel in a phase III clinical trial: a novel treatment for bacterial vaginosis[J]. CHINESE MEDICAL JOURNAL,2010,123(15):2051-2057.
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