二重盲検法によるCefapirinとCephaloridineの腎盂腎炎に対する有効性ならびに安全性の検討

抄録

To study the efficacy and the safety of Cefapirin, we performed a double-blind test in treatment of pyelonephritis, using Cephaloridine as control drug for comparison. In this experiment, we obtained the following results :
1) Total number of patients was 112 cases (consisting of Cefapirin-group 56 cases, and Cephaloridine-group 56 cases). For the background factors, there were no significant differences between Cefapirin-group of 42 cases and Cephaloridine-group of 44 cases, except 26 cases which were omitted out from the statistical treatment.
2) For all the cases, except omitted 26 cases, or totally 86 cases (42 cases of Cafapirin-group and 44 cases of Cephaloridine-group), the clinical results were as mentioned below according to the judge of the responsible doctor :
The excellent result and the good result were obtained, respectively, in 16 cases (38%) and in 17 cases (40%) of Cefapirin-group, while in 16 cases (36%) and in 11 cases (25%) of Cephaloridine-group. As far as the rate of excellent efficacy, as well as that of good efficacy, is concerned, no significant difference was found between both groups. According to the evaluation by the Committee, there was no significant difference between Cefapirin-group and Cephaloridine-group for the results obtained on the day 3 as well as for the results obtained on the day 10. However, in patients with non-complicated pyelonephritis (22 cases in Cefapirin-group and 21 cases in Cephaloridine-group), the evaluation on the day 3 by the Committee showed that the results obtained in Cefapirin-group was significantly superior to that obtained in Cephaloridine-group (P<0.05).
3) For the improvement rate of pyuria in patients with non-complicated pyelonephritis, the findings obtained in Cefapirin-group were significantly better than those obtained in Cephaloridine-group (P< 0.05).
4) The side effects were found in 3 cases of Cefapirin-group and in 8 cases of Cephaloridine-group. The occurrence of side effects was slightly higher in Cephaloridine-group. However, in Cefapirin-group, the cessation of treatment was necessary in 2 patients (because of nausea in one case and of itching in the other).
5) The increase in BUN, caused by drug administration, was found in one patient treated with Cephaloridine, the augmentation of values of S-GOT and S-GPT was observed also in Cephaloridine-group (in 2 cases), while neither increase in BUN nor increase in S-GOT or S-GPT in Cefapirin group.