緑膿菌による慢性複雑性尿路感染症に対するCefsulodin (SCE-129) とSulbenicillinの二重盲検法による効果の比較

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  • A COMPARATIVE STUDY OF THE EFFICACY, SAFETY USEFULNESS OF CEFSULODIN (SCE-129) AND SULBENICILLIN ON CHRONIC, COMPLICATED URINARY TRACT INFECTIONS DUE TO <I>PSEUDOMONAS AERUGINOSA</I> BY DOUBLE BLIND METHOD
  • リョクノウキン ニヨル マンセイ フクザツセイ ニョウロ カンセンショウ ニ

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Cefsulodin (SCE-129, CFS), a new cephalosporin antibiotic, was evaluated as to its therapeutic efficacy, safety and clinical usefulness in patients with chronic, complicated urinary-tract infections due to Pseudomonas aeruginosa by a double-blind technique using sulbenicillin (SBPC) as control drug.<BR>1. Of a total of 186 patients who received medication, 29 were excluded because of inadequacy for the study and 1 were drop-outs. All of the remaining 156 patients were included in the analyses. Eighty-one of them received CFS and 75 SBPC.<BR>2. No variance existed in the demographic characteristics and diagnosis of the patients in both treatment groups except for age and sex, in which variance was judged to have no influence to the clinical evaluation.<BR>3. Clinical evaluation was done prior to and after treatment with daily dosages of 1g of CFS and 10g of SBPC for 5 days. Overall clinical efficacy in all the patients was “excellent” in 11% after CFS and in 3% after SBPC. It was “excellent” and “good” in 44% after CFS and in 37% after SBPC, respectively. The difference was not statistically significant. In the patients infected with Pseudomonas aeruginosa, overall clinical efficacy was “excellent” in 15% after CFS and in 5% after SBPC, of which difference was not significant. The “excellen” and “good” responses in these patients, however, were obtained in 81% after CFS and in 56% after SBPC and the difference was significant.<BR>4. Pyuria was cleared in 20% after CFS and in 7% after SBPC. The difference was statistically significant, but there was no significant difference between the two treatment groups when compared as to the cases in which pyuria was cleared and decreased (37% after CFS and 36% after SBPC).<BR>5. No difference was noted between the two treatment groups as to the efficacy on bacteruria (eliminated in 27% after CFS and in 25% after SBPC and eliminated or suppressed in 34% after CFS and 34% after SBPC). New organisms appeared in 36% after CFS treatment and in 16% after SBPC treatment, and the degree of bacteruria remained unchanged in 30% after CFS and in 49% after SBPC, showing a significant superiority of CFS over SBPC.<BR>6. CFS was significantly superior to SBPC in the efficacy on pyocyanic bacteruria (eliminated in 65% after CFS and in 48% after SBPC, and eliminated or suppressed in 81%after CFS and in 56% after SBPC).<BR>7. Stratified analyses of overall clinical efficacy significantly favored CFS over SBPC in the patients with single infections and in those with indwell catheter. Especially when limited to Pseudomonas aeruginosa the results were satisfactory with CFS in more than 60% in every diagnostic subtype of single and mixed infections.<BR>8. Bacteriological responses showed that CFS was significantly superior to SBPC. Pseudomonas aeruginosa was eradicated in 65.4% after CFS and in 48.0% after SBPC. Gram-negative bacilli including Pseudomonas aeruginosa were eliminated in 68.5% after CFS and in 52.0% after SBPC.<BR>9. Global judgements by doctors in charge significantly favored CFS over SBPC, which was seemed to be due to the significant superiority of CFS treatment over SBPC treatment in single infections. Clinical usefulness was also evaluated in favor of CFS over SBPC in single infections with a significant difference.<BR>10. Side effects occurred in 4% of the CFS-treated patients and in 8% of the SBPC-treated patients. The difference was not significant, but suggested a higher safety of CFS treatment.<BR>11. The overall results of this study indicate that CFS is a useful drug for therapy of chronic, complicated urinarytract infections due to Pseudomonas aeruginosa.

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