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卷曲乳杆菌阴道栓剂预防女性复发性尿路感染的Ⅰ期试验

Phase I trial of a Lactobacillus crispatus vaginal suppository for prevention of recurrent urinary tract infection in women.

作者信息

Czaja Christopher A, Stapleton Ann E, Yarova-Yarovaya Yuliya, Stamm Walter E

机构信息

Division of Allergy and Infectious Diseases, University of Washington School of Medicine, Seattle, WA 98195, USA.

出版信息

Infect Dis Obstet Gynecol. 2007;2007:35387. doi: 10.1155/2007/35387.

DOI:10.1155/2007/35387
PMID:18288237
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2216064/
Abstract

OBJECTIVES

We performed a phase I trial to assess the safety and tolerance of a Lactobacillus vaginal suppository for prevention of recurrent UTI.

METHODS

Premenopausal women with a history of recurrent UTI were randomized to use L. crispatus CTV-05 or placebo vaginal suppositories daily for five days.

RESULTS

30 women were randomized (15 to L. crispatus CTV-05). No severe adverse events occurred. Mild to moderate vaginal discharge and genital irritation were reported by women in both study arms. Seven women randomized to L. crispatus CTV-05 developed pyuria without associated symptoms. Most women had high concentrations of vaginal H202-producing lactobacilli before randomization. L. crispatus, L. jensenii, and L. gasseri were the most common Lactobacillus species identified, with stable prevalence over time.

CONCLUSIONS

L. crispatus CTV-05 can be given as a vaginal suppository with minimal sideeffects to healthy women with a history of recurrent UTI. Mild inflammation of the urinary tract was noted in some women.

摘要

目的

我们进行了一项I期试验,以评估乳酸杆菌阴道栓剂预防复发性尿路感染的安全性和耐受性。

方法

有复发性尿路感染病史的绝经前女性被随机分组,每天使用卷曲乳杆菌CTV-05或安慰剂阴道栓剂,持续五天。

结果

30名女性被随机分组(15名使用卷曲乳杆菌CTV-05)。未发生严重不良事件。两个研究组的女性均报告有轻度至中度阴道分泌物增多和生殖器刺激症状。7名被随机分配到卷曲乳杆菌CTV-05组的女性出现脓尿但无相关症状。大多数女性在随机分组前阴道中产H2O2的乳酸杆菌浓度较高。卷曲乳杆菌、詹氏乳杆菌和加氏乳杆菌是最常见的鉴定出的乳酸杆菌种类,且随时间流行率稳定。

结论

对于有复发性尿路感染病史的健康女性,卷曲乳杆菌CTV-05可制成阴道栓剂给药,副作用最小。部分女性出现了轻度泌尿系统炎症。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8749/2216064/a67d5c351062/IDOG2007-35387.004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8749/2216064/59e3303209ae/IDOG2007-35387.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8749/2216064/c50109f7c533/IDOG2007-35387.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8749/2216064/d74ab70fa592/IDOG2007-35387.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8749/2216064/a67d5c351062/IDOG2007-35387.004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8749/2216064/59e3303209ae/IDOG2007-35387.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8749/2216064/c50109f7c533/IDOG2007-35387.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8749/2216064/d74ab70fa592/IDOG2007-35387.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8749/2216064/a67d5c351062/IDOG2007-35387.004.jpg

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