Abstract
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<0.05) superior to CEX. Also, in patients from whom Staph. aureus was isolated as a causative organism, S-6437 tended to be superior to CEX, though no significant (P<0.10) difference was found.
3. Looking into the results of the studies by visiting time of the patients to hospitals, in the patients visiting hospitals. at night, S-6437 was significantly (P<f0.05) superior to CEX as to antipyretic time, but in the patients visiting at daytime, there was no significant difference between both groups. The difference of the antipyretic time between S-6437 and CEX in the patients visiting hospitals at night was considered to be due to the fact that their administration interval at night in the first treatment day was longer than that in next day.
4. Subjective and objective symptoms (e. g. body temperature, sore throat, pain in swallowing, bad humor, reddened throat, swelling) and amount of intake were examined after the administration of the drugs, and no significant differences were observed between both groups.
5. Slight diarrhea and abdominal pain were observed in only one patient receiving CEX but there were no significant differences in side effects between both groups.
