氯碳头孢（LY163892）与头孢克洛及诺氟沙星治疗单纯性肾盂肾炎的比较

Hyslop D L, Bischoff W

Lilly Research Laboratories, Indianapolis, Indiana 46285.

Am J Med. 1992 Jun 22;92(6A):86S-94S. doi: 10.1016/0002-9343(92)90614-h.

Optimal therapy for pyelonephritis requires the immediate administration of an effective broad-spectrum antibiotic. Because conventional oral antibiotics such as the sulfonamides and the aminopenicillins are limited by the development of resistant bacteria associated with this common disease, the therapeutic effectiveness of a new oral carbacephem antibiotic was investigated. Two double-blind, randomized clinical trials of loracarbef (LY163892) were conducted. A total of 245 patients (greater than or equal to 18 years old) with uncomplicated pyelonephritis were enrolled in parallel studies. One study compared loracarbef with cefaclor; the other compared loracarbef with norfloxacin. In the combined patient population, 119 patients were treated with loracarbef (400 mg twice daily), 43 with cefaclor (500 mg three times daily), and 83 with norfloxacin (400 mg twice daily). All treatment regimens continued for greater than or equal to 14 days. A total of 68 patients in the loracarbef group, 25 in the cefaclor group, and 43 in the norfloxacin group qualified for efficacy analysis. Escherichia coli was the causative pathogen in 85.0% of these patients. Successful posttherapy clinical and bacteriologic responses were similar for all three study drugs: 94.1 and 86.8%, 96.0 and 80.0%, 97.7 and 88.4% for loracarbef, cefaclor, and norfloxacin, respectively. Late posttherapy clinical responses were 87.4, 83.3, and 91.7% for the loracarbef, cefaclor, and norfloxacin groups, respectively. Bacteriologic responses for the three groups were 79.6, 60.0, and 88.9%. The most frequent adverse effects (headache, diarrhea, and nausea) were experienced by three patients (2.5%) in the loracarbef group; headaches were noted in two (4.7%) cefaclor patients, diarrhea was noted in three (7.0%) patients in the cefaclor group, and nausea was noted in four (9.3%). Gastrointestinal events were noted in four patients (4.8%) in the norfloxacin group. The data demonstrate that loracarbef is comparable in efficacy and safety to both cefaclor and norfloxacin as oral therapy for uncomplicated pyelonephritis.

肾盂肾炎的最佳治疗方法需要立即使用有效的广谱抗生素。由于传统口服抗生素（如磺胺类和氨基青霉素类）受到与这种常见疾病相关的耐药菌产生的限制，因此对一种新型口服碳头孢烯类抗生素的治疗效果进行了研究。进行了两项关于氯碳头孢（LY163892）的双盲、随机临床试验。共有245例（年龄大于或等于18岁）单纯性肾盂肾炎患者纳入平行研究。一项研究将氯碳头孢与头孢克洛进行比较；另一项将氯碳头孢与诺氟沙星进行比较。在合并的患者群体中，119例患者接受氯碳头孢治疗（每日两次，每次400mg），43例接受头孢克洛治疗（每日三次，每次500mg），83例接受诺氟沙星治疗（每日两次，每次400mg）。所有治疗方案持续时间均大于或等于14天。氯碳头孢组共有68例患者、头孢克洛组25例患者、诺氟沙星组43例患者符合疗效分析标准。这些患者中85.0%的致病病原体为大肠埃希菌。三种研究药物治疗后临床和细菌学反应成功的情况相似：氯碳头孢分别为94.1%和86.8%，头孢克洛分别为96.0%和80.0%，诺氟沙星分别为97.7%和88.4%。氯碳头孢组、头孢克洛组和诺氟沙星组治疗后晚期临床反应分别为87.4%、83.3%和91.7%。三组的细菌学反应分别为79.6%、60.0%和88.9%。氯碳头孢组有3例患者（2.5%）出现最常见的不良反应（头痛、腹泻和恶心）；头孢克洛组有2例患者（4.7%）出现头痛，头孢克洛组有3例患者（7.0%）出现腹泻，4例患者（9.3%）出现恶心。诺氟沙星组有4例患者（4.8%）出现胃肠道事件。数据表明，作为单纯性肾盂肾炎的口服治疗药物，氯碳头孢在疗效和安全性方面与头孢克洛和诺氟沙星相当。