Iravani A, Richard G A, Johnson D, Bryant A
Department of Pediatrics, University of Florida College of Medicine, Gainesville 32610.
Am J Med. 1988 Sep 16;85(3A):17-23. doi: 10.1016/0002-9343(88)90459-7.
In this 31-site multicenter trial, 565 adult patients with urinary tract infections were randomly assigned to receive either a 10-day course of cefixime 400 mg once daily (n = 279) or amoxicillin 250 mg three times daily (n = 286). Although all patients were included in the safety analysis, only 93 (33 percent) cefixime-treated and 99 (35 percent) amoxicillin-treated patients were fully evaluable for the efficacy analysis. One week after therapy, the evaluable patients treated with cefixime demonstrated a 90 percent clinical cure rate and a 92 percent eradication rate of the baseline pathogen. This compared with an 83 percent clinical cure rate and an 84 percent bacterial eradication rate in the amoxicillin-treated group. The most frequently isolated pathogen was Escherichia coli (80 percent) followed by Proteus mirabilis (10 percent). One hundred thirty-seven (49 percent) of the 279 cefixime-treated and 126 (44 percent) of the 286 amoxicillin-treated patients reported at least one adverse experience during the study. Adverse reactions associated with cefixime were similar to those reported for other beta-lactam antibiotics. The most frequent adverse experiences reported by cefixime-treated patients were diarrhea (15 percent) and stool changes (12 percent). Headaches (11 percent) and diarrhea (9 percent) were the most frequently reported adverse reactions by the amoxicillin-treated patients. Eleven cefixime-treated patients (3.9 percent) and 10 amoxicillin-treated patients (3.5 percent) discontinued therapy because of adverse experiences. Results of this study demonstrate that a once-daily regimen of cefixime is as safe and effective as a three-times-daily regimen of amoxicillin in the treatment of acute urinary tract infections. Although the incidence of bowel changes was somewhat higher in the cefixime treatment group, these events usually resolved when therapy was discontinued.
在这项有31个研究点的多中心试验中，565例成年尿路感染患者被随机分配，分别接受为期10天的每日一次400毫克头孢克肟治疗（n = 279）或每日三次250毫克阿莫西林治疗（n = 286）。尽管所有患者都纳入了安全性分析，但只有93例（33%）接受头孢克肟治疗的患者和99例（35%）接受阿莫西林治疗的患者可完全用于疗效分析。治疗一周后，接受头孢克肟治疗的可评估患者临床治愈率为90%，基线病原体根除率为92%。相比之下，阿莫西林治疗组的临床治愈率为83%，细菌根除率为84%。最常分离出的病原体是大肠埃希菌（80%），其次是奇异变形杆菌（10%）。279例接受头孢克肟治疗的患者中有137例（49%），286例接受阿莫西林治疗的患者中有126例（44%）在研究期间报告了至少一次不良事件。与头孢克肟相关的不良反应与其他β-内酰胺类抗生素报告的不良反应相似。接受头孢克肟治疗的患者报告的最常见不良事件是腹泻（15%）和大便改变（12%）。接受阿莫西林治疗的患者报告的最常见不良反应是头痛（11%）和腹泻（9%）。11例接受头孢克肟治疗的患者（3.9%）和10例接受阿莫西林治疗的患者（3.5%）因不良事件而停药。本研究结果表明，在治疗急性尿路感染方面，每日一次的头孢克肟治疗方案与每日三次的阿莫西林治疗方案一样安全有效。尽管头孢克肟治疗组肠道改变的发生率略高，但这些事件在停药后通常会缓解。
