CLINICAL EVALUATION OF S-6437 IN PEDIATRIC PATIENTS WITH ACUTE PHARYNGITIS AND TONSILLITIS: COMPARATIVE DOUBLE BLIND STUDIES WITH REGULAR CEPHALEXIN

• Published in: Japanese journal of antibiotics 1977/12/25, Vol.30(12), pp.973-992
• Main Authors: FUJII, RYOCHI, UCHIDA, KOZO, SAKANO, YASUAKI, SHIMIZU, SHIGEO, NISHIDA, TSUTOMU, FUKUDA, MICHIO, MAKINO, IKUNOSUKE
• Format: Article
• Language: Japanese
• Subjects: Anti-Inflammatory Agents, Non-Steroidal; Cephalexin - administration & dosage; Cephalexin - blood; Cephalexin - therapeutic use; Child; Child, Preschool; Clinical Trials as Topic; Delayed-Action Preparations; Double-Blind Method; Drug Combinations; Female; Humans; Male; Pharyngitis - drug therapy; Placebos; Tonsillitis - drug therapy
• ISSN: 0368-2781; 2186-5477
• DOI: 10.11553/antibiotics1968b.30.973

In order to evaluate efficacy and safety of sustained release cephalexin (S-6437), comparative double blind studies with regular cephalexin (CEX) were conducted is pediatric patients with acute pharyngitis and tonsillitis. The patients were given S-6437 or CEX within 24 hours after fever appeared. The daily dose used was 500mg of cephalexirt in both drugs. S-6437 was administered at two divided doses per day and CEX was given at four divided doses per day. The following is the summary of the results of the studies. From the studies, it was judged that S-6437 had usefulness. 1. There were no significant differences between both groups (S-6437 treated, group and CEX treated group) regarding background of the patients. Uniformity of both groups was kept and both groups did not have any background factors having effects on clinical effectiveness of the drugs. 2. Clinical effectiveness of S-6437 and CEX was 91.8% and 86.8% respectively. No significant difference was observed. However, the results of the studies in the patients who visited hospitals within 6 hours after fever appeared and who visited hospitals at night showed that S-6437 was significantly (P