KMID : 0358320070480040428
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Korean Journal of Urology 2007 Volume.48 No. 4 p.428 ~ p.432
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Efficacy and Safety of Uro-Vaxom Treatment for Patients with Recurrent Cystitis: An Open Multicenter Study
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Lee Seung-Ju
Cho In-Rae Lee Sang-Don Kim Min-Eui Shim Bong-Suk Chung Byung-Ha Chang Sung-Goo Kim Hyung-Jin Cho Yong-Hyun Kim Chul-Sung Kim Su-Jin Woo Young-Nam Kim Bup-Wan Lee Jeong-Gu
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Abstract
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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(¡Ã103CFU/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£¼0.001). 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)
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KEYWORD
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Female, Cystitis, Escherichia coli, Uro-Vaxom
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