Sandberg T, Englund G, Lincoln K, Nilsson L G
Department of Infectious Diseases, University of Göteborg, Ostra Hospital, Sweden.
Eur J Clin Microbiol Infect Dis. 1990 May;9(5):317-23. doi: 10.1007/BF01973737.
In a coordinated, double-blind multi-centre trial, adults with symptoms of acute pyelonephritis were randomly assigned to receive a two-week course of oral treatment with either 400 mg norfloxacin twice daily or 1 g cefadroxil twice daily. Of 197 patients enrolled in the study, 140 could be evaluated for drug efficacy and 193 for drug safety. Norfloxacin gave a significantly higher bacteriological cure rate than cefadroxil, both at 3 to 10 days (98% versus 65%; p less than 0.0001; 95% confidence interval (CI) for difference in proportions 21-46%) and up to eight weeks (87% versus 48%; p less than 0.0001; 95% CI 25-54%) after cessation of treatment. The differences between the two regimens were most pronounced in men and in patients with complicating factors such as diabetes mellitus and urinary tract abnormalities. The clinical response during treatment did not differ between the two groups, but symptomatic recurrences at follow-up were more common in the cefadroxil group (28% versus 3%; p less than 0.0001; 95% CI 14-36%). Adverse events were more often reported by patients receiving cefadroxil (39% versus 22%; p = 0.011; 95% CI 4-30%) and consisted mainly of gastrointestinal disturbances and vulvo-vaginitis. In terms of bacteriological and clinical efficacy and safety, a two-week course of norfloxacin was superior to a two-week course of cefadroxil for oral treatment of community-acquired acute pyelonephritis.
在一项协调的双盲多中心试验中，有急性肾盂肾炎症状的成年人被随机分配接受为期两周的口服治疗，一组为每日两次服用400毫克诺氟沙星，另一组为每日两次服用1克头孢羟氨苄。在197名参与研究的患者中，140名可评估药物疗效，193名可评估药物安全性。诺氟沙星的细菌学治愈率显著高于头孢羟氨苄，在治疗停止后3至10天（98%对65%；p<0.0001；比例差异的95%置信区间[CI]为21 - 46%）以及长达八周（87%对48%；p<0.0001；95%CI为25 - 54%）时均如此。两种治疗方案之间的差异在男性以及患有糖尿病和尿路异常等复杂因素的患者中最为明显。两组在治疗期间的临床反应无差异，但在随访中，头孢羟氨苄组的症状复发更为常见（28%对3%；p<0.0001；95%CI为14 - 36%）。接受头孢羟氨苄治疗的患者报告的不良事件更多（39%对22%；p = 0.011；95%CI为4 - 30%），主要包括胃肠道不适和外阴阴道炎。就细菌学和临床疗效及安全性而言，为期两周的诺氟沙星疗程在口服治疗社区获得性急性肾盂肾炎方面优于为期两周的头孢羟氨苄疗程。
