Arakawa S, Takagi S, Kamidono S, Kataoka N, Tomioka O, Hazama M, Hirose T, Yamazaki K, Kumamoto Y, Hayashi K
Department of Urology, School of Medicine, Kobe University.
Jpn J Antibiot. 1993 Jan;46(1):75-94.
In this study, cefditoren pivoxil (ME 1207, CDTR-PI), a new oral cephem antibiotic, was given to 72 patients with non-catheterized complicated urinary tract infections (UTI) to evaluate clinical efficacy and safety, and also to investigate the rate of recurrence after completion of treatment. Daily dose of CDTR-PI was 100 mg t.i.d., and CDTR-PI was administered for 14 days. According to the criteria proposed by the Japanese UTI Committee, clinical efficacy of CDTR-PI was evaluated at day 7 and day 14. The rate of recurrence was assessed by bacterial count in urine as the marker. The following results were obtained. 1. Overall clinical efficacy rates were 68.4% on day 7 and 81.6% on day 14. The efficacy rate at day 14 was higher than the rate at day 7. 2. Bacteriologically, eradication rates were 75.5% at day 7 and 79.6% at day 14. 3. As to side effects, abdominal discomfort was observed in 1 case and its incidence was 1.6%. Incidence of abnormalities of laboratory findings was 10.4%, and these abnormalities were slight and transient. 4. Thirty-one patients were assessable to the recurrence of infections, 60% of them were judged as "cured" at 1-2 weeks and 3-7 weeks after completion of treatment. In this study, "relapsed", reappearance of causative organisms, was observed much more frequently than "reinfection". These results suggest that sufficient clinical efficacy and safety of CDTR-PI in non-catheterized complicated UTI were effected by 14 days treatment.
在本研究中,新型口服头孢菌素类抗生素头孢托仑匹酯(ME 1207,CDTR-PI)被给予72例非导尿性复杂性尿路感染(UTI)患者,以评估其临床疗效和安全性,并调查治疗结束后的复发率。CDTR-PI的日剂量为100mg,每日3次,给药14天。根据日本UTI委员会提出的标准,在第7天和第14天评估CDTR-PI的临床疗效。以尿液细菌计数为指标评估复发率。获得了以下结果。1. 第7天的总体临床有效率为68.4%,第14天为81.6%。第14天的有效率高于第7天。2. 从细菌学角度看,第7天的根除率为75.5%,第14天为79.6%。3. 关于副作用,观察到1例出现腹部不适,发生率为1.6%。实验室检查结果异常的发生率为10.4%,这些异常轻微且短暂。4. 31例患者可评估感染复发情况,其中60%在治疗结束后1至2周和3至7周被判定为“治愈”。在本研究中,“复发”(致病微生物再次出现)的观察频率远高于“再感染”。这些结果表明,14天的治疗使CDTR-PI在非导尿性复杂性UTI中具有足够的临床疗效和安全性。