中华医学杂志（英文版）2010，Vol.123Issue(15)：2051-2057,7.DOI:10.3760/cma.j.issn.0366-6999.2010.15.018
Directed shift of vaginal flora after topical application of sucrose gel in a phase Ⅲ clinical trial: a novel treatment for bacterial vaginosis
Directed shift of vaginal flora after topical application of sucrose gel in a phase Ⅲ clinical trial: a novel treatment for bacterial vaginosis
ZENG Zhong-ming 1PANG Yi-cun 2LIU Shu-wen 3JIANG Shi-bo 3LIAO Qin-pin 4YAO Chen 5GENG Li 6FENG Li-hua 7SHI Hui-rong 8XIN Xiao-yan 9LI Ping 10WANG Hui-lan11
作者信息
- 1. Division of Infectious Diseases, Affiliated Nanshan Hospital of Guangdong Medical College, Shenzhen 518052, China
- 2. 0.Division of Obstetrics & Gynecology, Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, Hebei 050051, China
- 3. Antiviral Research Center, School of Pharmaceutical Sciences,Southern Medical University, Guangzhou, Guangdong 510515,China
- 4. Viral Immunology Laboratory, Lindsley F.Kimball Research Institute, New York Blood Center, New York, NY 10065, USA
- 5. Division of Obstetrics & Gynecology First Hospital of Beijing University,Beijing 100034, China
- 6. Department of Medical Statistics First Hospital of Beijing University,Beijing 100034, China
- 7. Division of Obstetrics & Gynecology, Third Hospital of Beijing University, Beijing 100083, China
- 8. Division of Obstetrics & Gynecology, First Affiliated Hospital of Jilin University, Changchun, Jilin 130021, China
- 9. Division of Obstetrics & Gynecology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, China
- 10. Division of Obstetrics & Gynecology, Affiliated Xijing Hospital of the Fourth Military Medical University, Xi'an, Shaanxi 710032,China
- 11. Division of Obstetrics & Gynecology, First Hospital of Nanjing,Nanjing, Jiangsu 210029, China
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摘要
Abstract
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 BV.Methods A randomized, double-blinded, multi-center, parallel-group, placebo-controlled phase Ⅲ 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.关键词
bacterial vaginosis/vaginal flora/sucrose/metronidazole/clinical trialKey words
bacterial vaginosis/vaginal flora/sucrose/metronidazole/clinical trial引用本文复制引用
ZENG Zhong-ming,PANG Yi-cun,LIU Shu-wen,JIANG Shi-bo,LIAO Qin-pin,YAO Chen,GENG Li,FENG Li-hua,SHI Hui-rong,XIN Xiao-yan,LI Ping,WANG Hui-lan..Directed shift of vaginal flora after topical application of sucrose gel in a phase Ⅲ clinical trial: a novel treatment for bacterial vaginosis[J].中华医学杂志（英文版）,2010,123(15):2051-2057,7.
