Clinical evaluation of Cefotiam hexetil in acute tosillitis

A double blind comparative study with cefaclor

Abstract

Cefotiam hexetil (CTM-HE) was evaluated for its efficacy, safety and usefulness in acute tonsillitis, in a double blind manner using cefaclor (CCL) as a control drug. The drug was orally administered after each meal, as a rule, for consecutive 7 days (CTM-HE: 200mg×3/day, CCL: 250mg×3/day). Out of the 231 patients recruited in this trial, 192 (99 on CTM-HE and 93 on CCL) were adopted by the committee for the evaluation of therapeutic efficacy. 1. The clinical responses judged by the attending physicians were positive in 91.9% of the patients on CTM-HE and 88.2% of the patients on CCL (commitee's judgement: 88.9% on CTM-HE, 86.0% on CCL). 2. The bacteriological responses were assessed as “eradicated” in 95.7% of the patients on CTM-HE and 97.6% of the patients on CCL. 3. Adverse events, mainly mild or moderate gastrointestinal tract symptoms, were observed in 7.5% (8/107) of the patients on CTM-HE, and in 4.0% (4/100) of the patients on CCL. No abnormal alterations of laboratory findings were noted in any groups. 4. The usefulness was rated as “very useful” and “fairly useful” in 91.0% of the patients on CTM-HE and 91.4% of the patients on CCL. 5. There was no statistically significant difference between the two treatment groups in any evaluation described above. The above results suggest that CTM-HE is a useful drug for the treatment of acute tonsillitis at the daily dosage of 600mg (t. i. d.).