急性単純性膀胱炎を対象としたS-6436の臨床評価

二重盲検法によるCephalexinとの比較成績

抄録

In order to examine the effectiveness and safety of S-6436 (a new long-acting preparation of cephalexin), a double blind controlled study was carried out in acute simple cystitis on S-6436 and cephalexin (CEX). S-6436 or CEX was administered at the daily dose of 1g for 4 days. The results obtained were as follows:
1. The number of cases evaluated on drug efficacy was 65 for S-6436 and 70 for CEX, and no significant difference was observed in the clinical efficacy between S-6436 500mg b.i.d. group and CEX 250mg q.i.d. group.
Excellent S-6436 52 cases: CEX 53 cases
Good S-6436 11 cases: CEX 16 cases
Poor S-6436 2 cases: CEX 1 case
2. Bacteriological efficacy of the drugs in both groups was satisfactory and no significant difference was found between two groups.
3. Recurrence after completion of the treatment was observed in 13.3% in 30 cases with S-6436 and 15.6% in 32 cases with CEX, the difference being not significant.
4. Adverse effects noted were limited to slight gastrointestinal symptoms. In only one case with CEX, the medication was discontinued due to nausea and palpitation. No significant difference was observed between two groups in the incidence of adverse effects. The ratio of the incidence of side effect was 3.6% in 84 cases with S-6436 and 2.4% in 84 cases with CEX.
These results indicated that S-6436 was equal to CEX in the effectiveness and safety in the therapy of acute simple cystitis. Accordingly it is considered that S-6436 administered twice a day is more acceptable and more convenient for patients than CEX administered four times a day.