Cox C E, McCabe R E, Grad C
Am J Med. 1987 Jun 26;82(6B):59-64. doi: 10.1016/0002-9343(87)90620-6.
In a multiclinic, randomized trial, oral norfloxacin, a fluoroquinolone antibacterial, was compared with several standard parenteral regimens for the treatment of nonbacteremic, hospital-acquired urinary tract infections. Parenteral antibiotic agents included aminoglycosides alone; aminoglycosides in combination with either broad-spectrum penicillins or first-generation cephalosporins; or cefotaxime alone. Ninety-two percent of bacterial isolates were multiresistant gram-negative rods including Pseudomonas aeruginosa (31 percent), Escherichia coli (17 percent), Klebsiella/Enterobacter species (14 percent), and Serratia species (11 percent). In the first evaluable 94 patients, norfloxacin was comparable to the parenteral agents in eliminating infecting bacteria from the urine. Similarly, combined bacterial eradication and clinical cure or improvement occurred in 96 percent (76 percent with cures, 20 percent with improvement) of those treated with norfloxacin and 88 percent (67 percent with cures, 21 percent with improvement) of those treated with parenteral agents. A negative outcome (i.e., failure, superinfection, or reinfection) occurred in two (4 percent) norfloxacin-treated patients versus six (12 percent) parenterally treated patients. Adverse effects were few, infrequently drug related, and rarely serious (one with norfloxacin versus two with parenteral agents). Additionally, drug, preparation, and administration costs were substantially less with oral norfloxacin compared with the parenteral agents. The data suggest, therefore, that oral norfloxacin can be substituted for commonly used parenteral antibiotic regimens, without any compromise in efficacy, in the treatment of nonbacteremic patients with multiresistant, nosocomial urinary tract infections.
在一项多中心随机试验中,将氟喹诺酮类抗菌药口服诺氟沙星与几种标准的胃肠外给药方案进行比较,以治疗非菌血症性医院获得性尿路感染。胃肠外抗生素包括单独使用氨基糖苷类;氨基糖苷类与广谱青霉素或第一代头孢菌素联合使用;或单独使用头孢噻肟。92%的细菌分离株为多重耐药革兰氏阴性杆菌,包括铜绿假单胞菌(31%)、大肠杆菌(17%)、克雷伯菌/肠杆菌属(14%)和沙雷菌属(11%)。在首批可评估的94例患者中,诺氟沙星在清除尿液中感染细菌方面与胃肠外给药相当。同样,接受诺氟沙星治疗的患者中,96%(76%治愈,20%改善)实现了细菌清除并临床治愈或改善,接受胃肠外给药治疗的患者中这一比例为88%(67%治愈,21%改善)。接受诺氟沙星治疗的患者中有2例(4%)出现阴性结果(即治疗失败、二重感染或再感染),而接受胃肠外给药治疗的患者中有6例(12%)。不良反应很少,很少与药物相关,且很少严重(诺氟沙星治疗组1例,胃肠外给药治疗组2例)。此外,与胃肠外给药相比,口服诺氟沙星的药物、制剂和给药成本要低得多。因此,数据表明,在治疗多重耐药的医院获得性非菌血症性尿路感染患者时,口服诺氟沙星可替代常用的胃肠外抗生素方案,且疗效不会有任何降低。