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KMID : 1234520070020010053
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Korean Journal of Urogenital Tract Infection Inflammation
2007 Volume.2 No. 1 p.53 ~ p.60
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Multicenter Clinical Outcome of Gatifloxacin for Chronic Prostatitis (NIH Category II or IIIa) in Korea
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Lee Sang-Don
Lee Seung-Ju
Hwang Tae-Kon
Yoon Duck-Ki
Lee Kyu-Sung
Sung Luck-Hee
Choo Myung-Soon
Shim Bong-Suk
Cho In-Rae
Kim Min-Eui
Ryu Soo-Bang
Kim Chul-Sung
Kim Young-Gon
Kim Chun-Il
Rhew Hyun-Yul
Cho Yong-Hyun
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Abstract
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Purpose: The objective of this study was to investigate the efficacy and safety of gatifloxacin for patients with chronic prostatitis (NIH category II or IIIa) in Korean urologic practice.
Materials and Methods: A total of 16 outpatient urology clinics at tertiary care medical centers in Korea participated. Gatifloxacin (400 mg/day) treatment (S.D.) of 149 patients (20 patients with category II and 129 patients with category IIIa) with prostatitis (mean age 45.8±13.3 years) was carried out for 41.7 (33.1) days. A 4-glass test according to Meares and Stamey or two glass test was carried out at study entry and one month after the end of treatment. Clinical response, safety and bacteriological response were assessed before treatment (within 48 hours of initiation of the study medication) and at one month after treatment completion.
Results: In a otal of 149 patients, the total NIH-CPSI score was significantly reduced from 20.5 to 10.0 (response rate 86.7%; 95% CI 80.2-93.2%) (p<0.05). Sub-scores of pain, urinary symptoms and impact on the quality of life were also significantly reduced from 8.9 to 3.8 (response rate 83.8%; 95% CI 76.8-90.9%), from 4.2 to 2.0 (response rate 73.3%; 95% CI 64.9-81.8%) and from 7.4 to 4.2 (response rate 79.0%; 95% CI 71.3-86.8%), respectively (p<0.05). In terms of the overall clinical efficacy assessment by investigators, out of 149 patients with prostatitis, 71.2% were assessed to be responders. Bacteriological studies in expressed prostatic secretion (EPS) or post prostate massage urine (VB3) at 1 month after treatment completion demonstrated that the overall eradication rates of pathogens was 85% and the pyuria (≥10 WBC/HPF) rates in the NIH category II and IIIa were 35% and 18.6%, respectively (overall rate 20.8%). There were 16.1% of patients that presented with some adverse events considered by investigators to be related to the drug. The majority of adverse events were considered to be of mild (87.5%) or moderate (8.3%) intensity.
Conclusions: These results suggest that gatifloxacin in Korean urologic practice is well tolerated and improves the clinical outcomes in the patientswith chronic prostatitis (NIH category II or IIIa).
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KEYWORD
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Gatifloxacin, Efficacy, Satety, Prostatitis
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