Cox C E
University of Tennessee, Memphis.
Am J Med. 1992 Apr 6;92(4A):82S-86S. doi: 10.1016/0002-9343(92)90315-3.
The efficacy and safety of two fluoroquinolone antimicrobial agents, lomefloxacin and ciprofloxacin, were compared in a randomized, investigator-blinded, multiple-dose study that enrolled 150 adult outpatients with complicated or recurrent urinary tract infections. A total of 75 patients were treated with 400 mg of lomefloxacin once daily for 10-14 days; an equal number of patients received 500 mg of ciprofloxacin every 12 hours for 10-14 days. Both groups of patients were comparable in terms of demographics and distribution of underlying conditions. The most frequently occurring pathogens in both groups were Escherichia coli and Klebsiella pneumoniae. A total of 142 patients met the criteria for efficacy evaluation, 72 in the lomefloxacin group and 70 in the ciprofloxacin group. Eradication of the initial pathogen (post-treatment culture of less than or equal to 10(4) colony-forming units (CFU)/mL) was noted in 97.2% of patients treated with lomefloxacin and in 95.7% of ciprofloxacin-treated patients. Clinical success (disappearance or amelioration of presenting signs and symptoms) occurred in 98.6% of lomefloxacin-treated patients and in 95.7% of patients treated with ciprofloxacin. The differences in outcome between the two treatment groups were not statistically significant. Both drug regimens were well tolerated. There were no clinically significant changes in clinical laboratory values during treatment. In the lomefloxacin group three patients reported nausea, one nervousness, and one pruritus; in the ciprofloxacin group, two patients reported nausea and three pruritus. Two lomefloxacin-treated patients (3%) and four patients treated with ciprofloxacin (5%) withdrew from treatment because of adverse events. A single daily dose of 400 mg lomefloxacin was comparable to 500 mg ciprofloxacin every 12 hours for the treatment of complicated or recurrent urinary tract infections.
在一项随机、研究者设盲、多剂量研究中，对150例患有复杂性或复发性尿路感染的成年门诊患者比较了两种氟喹诺酮类抗菌药物洛美沙星和环丙沙星的疗效与安全性。总共75例患者每日一次服用400mg洛美沙星，疗程10 - 14天；同等数量的患者每12小时服用500mg环丙沙星，疗程10 - 14天。两组患者在人口统计学和基础疾病分布方面具有可比性。两组中最常见的病原体均为大肠埃希菌和肺炎克雷伯菌。共有142例患者符合疗效评估标准，洛美沙星组72例，环丙沙星组70例。接受洛美沙星治疗的患者中97.2%初始病原体被清除（治疗后培养菌落形成单位小于或等于10⁴CFU/mL），接受环丙沙星治疗的患者中这一比例为95.7%。临床成功（现有体征和症状消失或改善）在接受洛美沙星治疗的患者中占98.6%，在接受环丙沙星治疗的患者中占95.7%。两个治疗组的结果差异无统计学意义。两种药物方案耐受性均良好。治疗期间临床实验室值无临床显著变化。洛美沙星组有3例患者报告恶心，1例报告紧张，1例报告瘙痒；环丙沙星组有2例患者报告恶心，3例报告瘙痒。两名接受洛美沙星治疗的患者（3%）和四名接受环丙沙星治疗的患者（5%）因不良事件退出治疗。每日单次服用400mg洛美沙星与每12小时服用500mg环丙沙星治疗复杂性或复发性尿路感染的效果相当。
