Levofloxacin versus ciprofloxacin in the treatment of chronic bacterial prostatitis: A randomized double-blind multicenter study
Levofloxacin versus ciprofloxacin in the treatment of chronic bacterial prostatitis: A randomized double-blind multicenter study
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DOI：
10.1016/s0090-4295(03)00565-x
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发表时间：
2003-09-01
期刊：
影响因子：
2.1
通讯作者：
Kahn, JB
中科院分区：
文献类型：
--
作者：
Bundrick, W;Heron, SP;Kahn, JB
目标.比较左氧氟沙星与环丙沙星治疗慢性细菌性肠炎的疗效和安全性。在一项多中心、双盲、活性对照试验中，377名有慢性细菌性前列腺炎病史、当前临床体征和症状以及前列腺炎实验室证据的男性随机接受左氧氟沙星500 mg每日一次或环丙沙星500 mg每日两次治疗28天。主要终点是微生物学可评估人群的微生物学疗效。采用Meares-Stamey“四杯法”获取前列腺分泌物和尿液进行培养。共有377例受试者接受了研究药物。临床成功率，包括治愈加改善的患者，相似（左氧氟沙星为75%，环丙沙星为72.8%;成功率差异的95%置信区间：-13.27至8.87），微生物根除率也是如此。（左氧氟沙星为75%，环丙沙星为76.8%;差异的95%置信区间为-8.98至12.58）。粪肠球菌和大肠埃希菌是最常见的分离株。两种方案的6个月复发率相似。左氧氟沙星和环丙沙星均耐受良好，不良事件发生率相似。左氧氟沙星500 mg，每日1次，连用28 d与环丙沙星500 mg，每日2次，连用28 d治疗慢性细菌性前列腺炎疗效相当。高比例的革兰氏阳性微生物以及革兰氏阴性病原体的分离强调了选择具有广谱活性的抗菌剂的必要性。
Objectives. To compare the safety and efficacy of levofloxacin with that of ciprofloxacin for the treatment of chronic bacterial prostatitis.Methods. In a multicenter, double-blind, active-control trial, 377 men with a history of chronic bacterial prostatitis, current clinical signs and symptoms, and laboratory evidence of prostatitis were randomized to treatment with levofloxacin 500 mg once daily or ciprofloxacin 500 mg twice daily for 28 days. The primary endpoint was microbiologic efficacy in the microbiologically assessable population. The Meares-Stamey "four-glass" procedure was used to obtain prostatic secretions and urine for culture.Results. A total of 377 subjects received the study drug. The clinical success rates, including cured plus improved patients, were similar (75% for levofloxacin and 72.8% for ciprofloxacin; 95% confidence interval for the difference in the success rates: - 13.27 to 8.87), as were the microbiologic eradication rates (75% for levofloxacin and 76.8% for ciprofloxacin; 95% confidence interval for the difference -8.98 to 12.58). Enterococcus faecolis and Escherichia coli were the most common isolates. The 6-month relapse rates were similar for both regimens. Both levofloxacin and ciprofloxacin were well tolerated, with similar rates of adverse events.Conclusions. Levofloxacin 500 mg once daily for 28 days is as effective as ciprofloxacin 500 mg twice daily for 28 days for the treatment of chronic bacterial prostatitis. Isolation of a high proportion of gram-positive organisms, as well as gram-negative pathogens, underscores the necessity of choosing an antimicrobial agent with broad-spectrum activity.