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复发性尿路感染阴道黏膜免疫的I期临床试验

Phase I clinical trial of vaginal mucosal immunization for recurrent urinary tract infection.

作者信息

Uehling D T, Hopkins W J, Dahmer L A, Balish E

机构信息

Department of Surgery (Urology), University of Wisconsin Medical School, Madison.

出版信息

J Urol. 1994 Dec;152(6 Pt 2):2308-11. doi: 10.1016/s0022-5347(17)31664-6.

DOI:10.1016/s0022-5347(17)31664-6
PMID:7966729
Abstract

In a phase I clinical trial to test safety and patient acceptance 25 women with a history of recurrent urinary tract infections but no identifiable anatomic abnormality received a multivalent vaccine instilled into the vagina. The vaccine contained 6 heat-killed Escherichia coli strains and 4 nonE. coli uropathogens. Only minimal adverse reactions were observed in the 5-month period following immunization. Total vaginal and urinary IgG and IgA increased significantly (p < 0.01 by repeated measures analysis of variance). Serum antibodies to some of the nonE. coli strains but not to the E. coli strains increased after vaginal immunization. While efficacy is yet to be shown, this study indicates that this vaginally applied urinary tract infection vaccine is well tolerated, and capable of increasing vaginal and urinary antibody.

摘要

在一项测试安全性和患者接受度的I期临床试验中,25名有复发性尿路感染病史但无明显解剖学异常的女性接受了经阴道注入的多价疫苗。该疫苗包含6株热灭活大肠杆菌菌株和4株非大肠杆菌尿路致病菌。免疫后的5个月期间仅观察到轻微不良反应。通过重复测量方差分析,阴道和尿液中的总IgG和IgA显著增加(p<0.01)。阴道免疫后,针对部分非大肠杆菌菌株而非大肠杆菌菌株的血清抗体增加。虽然尚未证明其有效性,但该研究表明这种经阴道应用的尿路感染疫苗耐受性良好,并且能够增加阴道和尿液抗体。

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