Naide Y, Aso Y, Oshi M, Kumamoto Y, Hirose T, Machida T, Tsuchida S, Suzuki K, Orikasa S, Kawada Y
Department of Urology, Fujita-Gakuen Health University, School of Medicine.
Hinyokika Kiyo. 1991 Apr;37(4):447-64.
We carried out a randomized multi-center study comparing cefpirome (CPR) 0.5 g b.i.d. (1 g group), 1.0 g b.i.d. (2 g group) and ceftazidime (CAZ) 1.0 g b.i.d. (CAZ group) in the treatment of complicated urinary tract infections. Patients who were over 16 years old and had underlying urinary tract disease, with bacteriuria of more than 10(4) cells ml or more and pyuria of more than 5 WBCs/hpf (x 400) or more were randomly allocated to receive either 0.5 g of CPR, 1.0 g of CPR or 1.0 g of CAZ twice a day for 5 days by intravenous drip infusion. The overall clinical efficacy of the treatment was evaluated by the criteria of the Japanese UTI Committee as excellent, moderate or poor, on the basis of the changes in pyuria and bacteriuria. A total of 530 patients were treated. Of these, 141 patients in the 1 g group, 136 in the 2 g group, and 140 in the CAZ group were evaluable for clinical efficacy. No significant differences in background characteristics were observed among the treatment groups. The overall clinical efficacy rate of the 1 g group, the 2 g group and the CAZ group was 80.1%, 76.5% and 71.4%, respectively. The differences were not statistically significant. The overall bacteriological eradication rate of the 1 g group, the 2 g group and the CAZ group was 81.0%, 88.1% and 83.8%. The differences were not statistically significant either. Against the enterococcus group, however, eradication rates were higher significantly in the 1 g and 2 g groups than in the CAZ group. The incidence of adverse reactions was 2.2% in the 1 g group, 0.6% in the 2 g group and 2.9% in the CAZ group. Abnormal laboratory data after medication were observed in 10.8% of the 1 g group, 12.1% of the 2 g group and 10.2% of the CAZ group, the difference not being statistically significant. There were no serious untoward reactions to medication. From the results obtained in this study, we consider that CPR is at least as useful as CAZ in the treatment of complicated urinary tract infections.
我们开展了一项随机多中心研究，比较头孢匹罗（CPR）0.5克每日两次（1克组）、1.0克每日两次（2克组）和头孢他啶（CAZ）1.0克每日两次（CAZ组）治疗复杂性尿路感染的效果。年龄超过16岁且有潜在泌尿系统疾病、细菌尿超过10⁴个/毫升及脓尿超过5个白细胞/高倍视野（×400）的患者被随机分配，分别接受0.5克CPR、1.0克CPR或1.0克CAZ静脉滴注，每日两次，共5天。根据脓尿和细菌尿的变化，依据日本泌尿道感染委员会的标准评估治疗的总体临床疗效，分为优、中、差。共有530例患者接受治疗。其中，1克组141例、2克组136例、CAZ组140例可评估临床疗效。各治疗组间在背景特征方面未观察到显著差异。1克组、2克组和CAZ组的总体临床有效率分别为80.1%、76.5%和71.4%。差异无统计学意义。1克组、2克组和CAZ组的总体细菌清除率分别为81.0%、88.1%和83.8%。差异也无统计学意义。然而，针对肠球菌属，1克组和2克组的清除率显著高于CAZ组。1克组的不良反应发生率为2.2%，2克组为0.6%，CAZ组为2.9%。用药后实验室数据异常在1克组为10.8%，2克组为12.1%，CAZ组为10.2%，差异无统计学意义。未出现严重的药物不良反应。从本研究获得的结果来看，我们认为CPR在治疗复杂性尿路感染方面至少与CAZ同样有效。
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