재발성 단순방광염 환자에서 유로박솜의 치료 효과 및 안전성: 다기관 공개 임상연구
Efficacy and Safety of Uro-Vaxom Treatment for Patients with Recurrent Cystitis: An Open Multicenter Study
이승주, 조인래, 이상돈, 김민의, 심봉석, 정병하, 장성구, 김형진, 조용현, 김철성, 김수진, 우영남, 김법완, 이정구,
소속 상세정보
이승주 ( Lee Seung-Ju )
다니엘비뇨기과
조인래 ( Cho In-Rae )
인제대학교 의과대학 비뇨기과학교실
이상돈 ( Lee Sang-Don )
부산대학교 의과대학 비뇨기과학교실
김민의 ( Kim Min-Eui )
순천향대학교 의과대학 비뇨기과학교실
심봉석 ( Shim Bong-Suk )
이화여자대학교 의과대학 비뇨기과학교실
정병하 ( Chung Byung-Ha )
연세대학교 의과대학 비뇨기과학교실, 비뇨의과학연구소
장성구 ( Chang Sung-Goo )
경희대학교 의과대학 비뇨기과학교실
김형진 ( Kim Hyung-Jin )
전북대학교 의과대학 비뇨기과학교실
조용현 ( Cho Yong-Hyun )
가톨릭대학교 의과대학 비뇨기과학교실
김철성 ( Kim Chul-Sung )
조선대학교 의과대학 비뇨기과학교실
김수진 ( Kim Su-Jin )
가톨릭대학교 의과대학 비뇨기과학교실
우영남 ( Woo Young-Nam )
한양대학교 의과대학 비뇨기과학교실
김법완 ( Kim Bup-Wan )
경북대학교 의과대학 비뇨기과학교실
이정구 ( Lee Jeong-Gu )
고려대학교 의과대학 비뇨기과학교실
KMID : 0358320070480040428
Abstract
Purpose: We wanted to investigate the efficacy and safety of the immunotherapeutic Uro-Vaxom for treating uncomplicated recurrent cystitis in female patients only.
Materials & Methods: Adult female patients were enrolled in this multicenter, open-label study if they had acute cystitis at the enrollment visit and positive results on urine culture(≥103CFU/ml). The patients were treated for 3 months with one capsule daily of Uro-Vaxom after antibiotic therapy, and they were observed for another 3 months. The primary efficacy criteria were the cystitis recurrence rates over 6 months, the distribution of cystitis and the proportion of patients with cystitis.
Results: A total of 50 patients were evaluated. During the 6-month trial, the number of cystitis recurrences was significantly reduced in comparison with the 6-month pretrial period(on the average 0.64 as compared to 3.0 recurrences, respectively p＜0.001). The incidences of frequency, urgency and dysuria remained low until the end of the trial. Uro-Vaxom was well tolerated: side-effects were mentioned by 8% of the 50 patients, and there was no case leading to treatment withdrawal.
Conclusion: Uro-Vaxom significantly reduced the incidence of cystitis during the 6 months of this study, including the 3 months of treatment. These results demonstrate that Uro-Vaxom is a valuable agent for prophylaxis of recurrent cystitis. (Korean J Urol 2007;48:428-432)
키워드
Female;Cystitis;Escherichia coli;Uro-Vaxom
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