[Therapeutic evaluation of an ampicillin suppository (KS-R1) used against acute suppurative otitis media in children: a comparison with an oral preparation].
A comparative well-controlled study was performed to evaluate the efficacy and tolerability of KS-R1 (ampicillin rectal suppository, 125 mg X 4/day) administered to the rectum as compared with those of orally administered ampicillin (ABPC) with same dosage. The results obtained were as follows. The clinical effect of the drug was judged in 100 cases (suppository group in 45 cases, oral group in 55 cases) out of 111 cases. The overall efficacy rates evaluated on standard criteria were 93.3% for the suppository group and 89.1% for the oral group. There was no statistically significant difference between 2 groups. Evaluation by stratification according to the dose, disease type and age also revealed a slightly higher efficacy rate on each parameter in the suppository group, but no significant difference between 2 groups. The bacteriological effects evaluated in 84 cases (suppository group in 38 cases, oral group in 46 cases) were 94.7% and 93.5%, respectively. There was no statistically significant difference between 2 groups. Side effects were evaluated in 101 cases (suppository group in 46 cases, oral group in 55 cases), but the incidence rate showed no significant difference between the 2 groups; 3 cases (each 1 of abdominal pain, periproctal redness and periproctal erosion) were observed in suppository group and 2 cases (each 1 of stomach pain + soft stool and diarrhea) in oral group. The results indicate that KS-R1 is equally effective and tolerable against acute suppurative otitis media compared to oral administration of ABPC, and considered to be useful.
D000284:Administration, Oral; D000367:Age Factors; D000667:Ampicillin / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D010035:Otitis Media, Suppurative / Q000188:drug therapy*; D013488:Suppositories
D013488:Suppositories; D000667:Ampicillin