CHEMOTHERAPY
Online ISSN : 1884-5894
Print ISSN : 0009-3165
ISSN-L : 0009-3165
複雑性尿路感染症に対するPipemidic acidとCarindacillinの二重盲検法による効果の比較
河田 幸道西浦 常雄岡元 健一郎江藤 耕作百瀬 俊郎仁平 寛巳黒川 一男新島 端夫石神 襄次黒田 恭一宮村 隆三弓削 順二島野 栄一郎斎藤 功細井 康男西村 洋司田中 恒男白石 彰
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1978 年 26 巻 3 号 p. 285-310

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In order to evaluate the efficacy, safety and usefulness of pipemidic acid (PPA) in complicated urinary-tract infections, a controlled study using carindacillin (I-CBPC) as a reference standard drug was carried out by a double blind method in collaboration with 48 clinics throughout the country. From the results obtained, the following conclusions were drawn.
1. In total of 586 patients, 55 cases were excluded, 38 cases dropped out and 493 cases which consisted of 249 cases given PPA and 244 cases given I-CBPC.
2. For the background characteristics, there were no statistically significant differences between PPA and I-CBPC, indicating that comparison between these drugs was meaningful.
3. The daily dose for both PPA and I-CBPC was 2g each and medication was continued for 7 days.
As to the overall clinical efficacy, the rate of “excellent” response was found to be 21.3% with PPA and 16.0% with I-CBPC without significant difference between the two groups. The rate of both “excellent” and “good” response was 54.2% with PPA and 35.7% with I-CBPC and the former was significantly higher than the latter.
4. The rate of efficacy on pyuria was found to be 34.1% with PPA and 24.2% with I-CBPC in respect to “cleard” response and 49.8% with PPA and 37.7% with I-CBPC in respect to both “cleared” and “decreased” responses. The rates of PPA were significantly higher than those of I-CBPC.
5. The rate of efficacy on bacteriuria was found to be 43.4% with PPA and 25.4% with I-CBPC in respect to “eliminated” response and 47.0% with PPA and 29.1% with I-CBPC in respect to both “eliminated” and “suppressed” responses. The rates of PPA were also significantly higer than those of I-CBPC.
6. When stratified according to the rate of, infection, it was remarkable that the effective rate of PPA on the prostatic bed infection was significantly higher than that of I-CBPC.
When analyzed according to the type of infection classified by UTI-Committee, the rates of efficacy of PPA on all types of infection except type I and V were more than 50%. In even type I and V, the drop of the rate of efficacy of PPA was less than that of I-CBPC.
The results indicated that PPA was expected to be more or less effective on all types of complicated urinary-tract infections.
7. PPA eliminated more than 40% of causative organisms, suggesting that it might be effective on any organism inducing complicated urinary-tract infections.
It was remarkable that the eradication ratio of PPA for E. coli, indole negative and positive Proteus, and Citrobacter were more than 90%.
No significant difference between PPA and I-CBPC was shown in the rate of disappearance of Pseudomonas.
8. In the global judgement made by attending physicians, the rates of efficacy and usefulness of PPA were significantly higher than those of I-CBPC.
9. Incidence of side effect was 9.4% and 7.6% in PPA and I-CBPC respectively without significant difference between them.
As side effects, symptoms were mainly gastric disturbances with a few allergic responses.
Neither PPA nor I-CBPC showed serious side effect.
From the above results, PPA would be a useful drug for the treatment of complicated urinary-tract infections, which may be applied broadly.

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