Ohmori H, Kumon H, Kanemasa Y, Hirai Y, Saito T
Department of Urology, School of Medicine, Okayama University.
Jpn J Antibiot. 1990 Dec;43(12):2102-32.
To find the optimum dose of cefetamet pivoxil (CEMT-PI, Ro 15-8075), a new oral cephem, in the treatment of complicated urinary tract infections, we performed a randomized trial using cefaclor (CCL) as the control drug. The subjects were patients with complicated urinary tract infections associated with underlying urinary tract diseases. Patients with indwelling catheter were excluded from the analysis, as were patients with infection due to Pseudomonas aeruginosa. Patients were treated with 250 mg of CEMT-PI (CEMT-PI-L) 2 times a day, 500 mg of CEMT-PI (CEMT-PI-H)2 times a day or 500 mg of CCL 3 times a day for 7 days. The overall clinical efficacy was evaluated on the basis of the criteria proposed by the Japanese UTI Committee. Of the 103 patients evaluated for clinical efficacy, 36 patients received CEMT-PI-L, 37 patients received CEMT-PI-H and 30 patients received CCL. No significant difference in background characteristics was observed among the three treatment groups. The overall clinical efficacies at day 3 judgement were 67.9% in 28 patients treated with CEMT-PI-L, 60.0% in 30 patients treated with CEMT-PI-H and 72.0% in 25 patients treated with CCL, with no statistically significant difference. Those at day 7 judgement was 63.6% in 33 patients treated with CEMT-PI-L, 66.7% in 36 patients treated with CEMT-PI-H and 72.4% in 29 patients treated with CCL, with no statistically significant difference. The bacteriological eradication rates at day 3 judgement were 79.5% of 39 strains in the CEMT-PI-L group, 73.2% of 41 strains in the CEMT-PI-H group and 84.4% of 32 strains in the CCL group, with no statistically significant difference. Those at day 7 judgement was 78.7% of 47 strains in the CEMT-PI-L group, 85.5% of 55 strains in the CEMT-PI-H group and 94.9% of 39 strains in the CCL group, with no statistically significant difference. The overall clinical efficacy and bacteriological eradication rate at day 7 judgement for CEMT-PI-H were higher than those for CEMT-PI-L. Clinical adverse reactions were observed in one patient in each of the 3 groups, but no statistically significant difference was found. We have concluded that the optimum daily dose of CEMT-PI in the treatment of complicated urinary tract infection is 1,000 mg.
为确定新型口服头孢菌素头孢他美酯（CEMT-PI，Ro 15-8075）治疗复杂性尿路感染的最佳剂量，我们进行了一项以头孢克洛（CCL）为对照药物的随机试验。研究对象为患有潜在泌尿系统疾病并发复杂性尿路感染的患者。留置导尿管的患者以及由铜绿假单胞菌引起感染的患者被排除在分析之外。患者分别接受每日2次、每次250 mg的CEMT-PI（CEMT-PI-L）治疗，每日2次、每次500 mg的CEMT-PI（CEMT-PI-H）治疗或每日3次、每次500 mg的CCL治疗，疗程均为7天。根据日本尿路感染委员会提出的标准评估总体临床疗效。在103例接受临床疗效评估的患者中，36例接受CEMT-PI-L治疗，37例接受CEMT-PI-H治疗，30例接受CCL治疗。三个治疗组在背景特征方面未观察到显著差异。在第3天判断时，接受CEMT-PI-L治疗的28例患者总体临床有效率为67.9%，接受CEMT-PI-H治疗的30例患者为60.0%，接受CCL治疗的25例患者为72.0%，差异无统计学意义。在第7天判断时，接受CEMT-PI-L治疗的33例患者为63.6%，接受CEMT-PI-H治疗的36例患者为66.7%，接受CCL治疗的29例患者为72.4%，差异无统计学意义。在第3天判断时，CEMT-PI-L组39株菌株的细菌清除率为79.5%，CEMT-PI-H组41株菌株为73.2%，CCL组32株菌株为84.4%，差异无统计学意义。在第7天判断时，CEMT-PI-L组47株菌株的细菌清除率为78.7%，CEMT-PI-H组55株菌株为85.5%，CCL组39株菌株为94.9%，差异无统计学意义。CEMT-PI-H在第7天判断时的总体临床有效率和细菌清除率高于CEMT-PI-L。三个组各有1例患者出现临床不良反应，但差异无统计学意义。我们得出结论，CEMT-PI治疗复杂性尿路感染的最佳日剂量为1000 mg。
