[Pharmacological evaluation of an ampicillin suppository (KS-R1) in acute respiratory tract infection in children: a comparison with an oral form of ampicillin].

A comparative well-controlled study was performed to evaluate the efficacy and tolerability of ampicillin rectal suppository (KS-R1) compared with those of oral form of ampicillin (ABPC) against acute respiratory tract infections in pediatric field. KS-R1 at the dose of 125 mg X 4/day of ABPC in potency, or the oral form at the same dosage, was given to 166 cases of patients with acute respiratory tract infection due to Streptococcus pyogenes, Streptococcus pneumoniae or Haemophilus influenzae for 7 days, as a rule. The clinical efficacy rates evaluated in 151 cases (KS-R1 group in 77 cases, oral group in 74 cases) on standard criteria of committee members were 88.3% for the KS-R1 group and 86.5% for the oral group, respectively. There was no significant difference between 2 groups. Evaluation by stratification according to the diagnosis showed that the efficacy rates for the KS-R1 group and for the oral group were 87.5% and 85.0% against pharyngitis, 90.5% and 90.0% against tonsillitis and 84.2% and 78.6% against bronchitis, respectively. None of them showed significant difference between 2 groups. The bacteriological effect was evaluated in 55 cases (KS-R1 group in 33 cases, oral group in 22 cases), and disappearance rate was 93.9% for the KS-R1 group and 95.5% for the oral group, showing no significant difference. Side effect including subjective and objective symptoms were strictly evaluated in 163 cases (KS-R1 group in 83 cases, oral group in 80 cases), but the incidence rate which was 22.9% for the KS-R1 group and 23.8% for the oral group showed no significant difference. The above results indicate that against acute respiratory tract infections in pediatric field, KS-R1 possesses clinical efficacy and safety similar to the oral form of ABPC, and that it is a useful suppository.