[Pharmacological evaluation of an ampicillin suppository (KS-R1) in acute pneumonia in children--a comparison with a parenteral preparation of ampicillin].
A comparative well-controlled study was performed to evaluate the efficacy and tolerability of KS-R1 (ampicillin (ABPC) rectal suppository) compared with those of intravenous injection of ABPC against acute bacterial pneumonia caused by ABPC-sensitive bacteria, such as Streptococcus pyogenes, Streptococcus pneumoniae and Haemophilus influenzae in pediatric field. KS-R1 at the dose of 250 mg X 4/day of ABPC in potency, or the intravenous injection at the dose of 125 mg X 4/day of ABPC in potency, was given to 68 cases of patients with bacterial pneumonia, aged between 10 months and 8 years and 2 months, for 7 days, as a rule. The clinical efficacy rates evaluated in 61 cases (KS-R1 group in 31 cases, intravenous group in 30 cases) on standard criteria of committee members were 93.5% for the KS-R1 group and 83.3% for the intravenous group, respectively. There was no significant difference between 2 groups. Evaluation by stratification according to the age showed that KS-R1 was significantly superior, the rate being 90.5% among the children from 1 year to 3 years in the KS-R1 group and 61.5% in the intravenous group. The bacteriological effect was evaluated in 16 cases (KS-R1 group in 7 cases, intravenous group in 9 cases), the disappearance rate was 100% for the KS-R1 group and 88.9% for the intravenous group, without significant difference. With regard to side effects, 66 cases (KS-R1 group in 35 cases, intravenous group in 31 cases) were strictly evaluated in relation to subjective and objective symptoms. As a result, no significant difference was noted between 2 groups in the incidence rate which was 17.1% for the KS-R1 group and 9.7% for the intravenous group. The above results indicate that against acute bacterial pneumonia in pediatric field, the KS-R1 at the dose of 250 mg X 4/day of ABPC in potency possesses clinical efficacy and safety similar to the intravenous injection at the dose of 125 mg X 4/day of ABPC in potency, and that it is a useful suppository.
D000208:Acute Disease; 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; D007275:Injections, Intravenous; D008297:Male; D011014:Pneumonia / Q000188:drug therapy*; D013488:Suppositories
D013488:Suppositories; D000667:Ampicillin