Iravani A, Klimberg I, Briefer C, Munera C, Kowalsky S F, Echols R M
Central Florida Medical Research Center, Orlando, USA.
J Antimicrob Chemother. 1999 Mar;43 Suppl A:67-75.
The study was undertaken to compare the safety and efficacy of twice-daily ciprofloxacin for 3 days with standard 7 day therapy with either co-trimoxazole or nitrofurantoin in the treatment of women with acute, uncomplicated urinary tract infections (UTI). This multicentre, prospective, randomized, double-blind trial compared oral ciprofloxacin (100 mg bd) for 3 days with co-trimoxazole (160/800 mg bd) or nitrofurantoin (100 mg bd) for 7 days. Bacteriological and clinical evaluations were performed at study entry, during therapy and 4-10 days and 4-6 weeks after the completion of therapy. The primary efficacy parameter was eradication of the causative organism 4-10 days following treatment. Of 713 women enrolled and evaluable for safety, 521 were evaluable for efficacy (168 ciprofloxacin, 174 co-trimoxazole, 179 nitrofurantoin). Escherichia coli (83%) was the most frequently isolated pathogen in all treatment groups. Bacteriological eradication was reported in 88% of ciprofloxacin patients, 93% of co-trimoxazole patients and 86% of nitrofurantoin patients. At the 4-6 week follow-up, ciprofloxacin had statistically significantly higher eradication rates (91%) than co-trimoxazole (79%; 95% confidence limit (CL) = -20.6%, -3.9%) and nitrofurantoin (82%; 95% CL = -17.1%, -0.9%). Clinical resolution 4-10 days after therapy and at the 4-6 week follow-up was similar among the three treatment groups. The overall incidence of treatment-emergent adverse events was not significantly different (P = 0.093) among the three drug regimens, although co-trimoxazole was associated with a greater number of adverse events than ciprofloxacin (P < or = 0.05). Ciprofloxacin also caused fewer episodes of nausea than either of the other agents (P < or = 0.01).
本研究旨在比较每日两次服用环丙沙星3天与标准的7天复方新诺明或呋喃妥因疗法在治疗急性单纯性尿路感染（UTI）女性患者中的安全性和疗效。这项多中心、前瞻性、随机、双盲试验将口服环丙沙星（100毫克，每日两次）3天与复方新诺明（160/800毫克，每日两次）或呋喃妥因（100毫克，每日两次）7天进行了比较。在研究开始时、治疗期间以及治疗结束后4 - 10天和4 - 6周进行了细菌学和临床评估。主要疗效参数是治疗后4 - 10天致病微生物的根除情况。在纳入并可进行安全性评估的713名女性中，521名可进行疗效评估（168名环丙沙星组、174名复方新诺明组、179名呋喃妥因组）。大肠杆菌（83%）是所有治疗组中最常分离出的病原体。报告显示，环丙沙星组88%的患者细菌学根除，复方新诺明组为93%，呋喃妥因组为86%。在4 - 6周的随访中，环丙沙星的根除率（91%）在统计学上显著高于复方新诺明（79%；95%置信区间（CL）= -20.6%，-3.9%）和呋喃妥因（82%；95% CL = -17.1%，-0.9%）。治疗后4 - 10天以及4 - 6周随访时的临床缓解情况在三个治疗组中相似。三种药物治疗方案中治疗中出现的不良事件总体发生率无显著差异（P = 0.093），尽管复方新诺明比环丙沙星出现的不良事件更多（P≤0.05）。环丙沙星引起的恶心发作次数也比其他两种药物少（P≤0.01）。
