急性陰窩性扁桃炎に対するCS-807の臨床評価

Cafaclorを対照とする二重盲検群間比較試験

抄録

In order to compare the clinical efficacy and safety of CS-807 with Cefaclor (CCL) in acute tonsillitis, a double blind study was carried out using a daily dosage of 100mg×2 of CS-807 and 250mg×3 of CCL. The number of cases evaluated for clinical efficacy were 172 (82 treated with CS-807 and 90 treated with CCL). The effective ratings of CS-807 and CCL were 78.0% and 84.4% as judged by committee, and 89.0% and 86.7% as judged by doctor in charge, respectively. Bacteriological effects were satisfactory to yield the eradication rates of 98.4% in CS-807 and 98.6% in CCL. The number of cases evaluated for safety were 182 (87 treated with CS-807 and 95 treated with CCL). The incidence of side effects was 3.4% (3) in CS-807 and 3.2% (3) in CCL. Most of them were mild gastro-intestinal disorders. The number of cases evaluated for utility were 172 (82 treated with CS-807 and 90 treated with CCL). The usefulness rating were 89.0% in CS-807 and 86.7% in CCL. There was no significant difference between CS-807 and CCL in clinical effect, bacteriological effect, safety and utility. From these results, a daily 200mg dosage of CS-807 was found to be as useful as a daily 750mg dosage of CCL for the treatment of acture tonsillitis.