Comparative Study of the Effectiveness of Lenampicillin and Bacampicillin on Bacterial Pneumonia by Double Blind Method

Abstract

The clinical efficacy and safety of Lenamicillin (KBT-1585, LAPC) were compared with those of Bacampicillin (BAPC) as the control drug in patients with bacterial pneumonia by double blind study.
Patients over 16 years old with apparent clinical signs and symptoms of pneumonia were administered LAPC (at a daily dose of 1 g) or BAPC (at a daily dose of 1 g) orally for 14 days in principle. Then the clinical and bacteriological efficacy, improvement in symptoms, side effects, abnormal changes in laboratory findings, and utility were assessed.
After excluding the patients which did not fit the protocol from the total 209 patients admitted to the study, clinical efficacy, side effects and abnormal changes in laboratory findings were analyzed statistically in 187 patients, in 199 and in 193 patients respectively.
Basides, clinical efficacy was analyzed in the patients with bacterial pneumonia which were completely adapted to the protocol and also in the total patients including those with non-bacterial pneumonia and other respiratory tract infections.
1) On the basis of committee judgement, the clinical efficacy rate in the patients with bacterial pneumonia was 86.9% for the LAPC group and 86.7% for the BAPC group, respectively. As for the total cases, the rate was 80.2% for the LAPC group and 85.4% for the BAPC group, respectively.
In both analyses, no significant differences were found between the two groups.
2) According to the judgement by doctors in charge, the clinical efficacy rate in the patients with bacterial pneumonia was 90.0% for the LAPC group and 84.0% for the BAPC group, respectively.
As for the total cases, the efficacy rate was 81.6% for the LAPC group and 81.7% for the BAPC group, respectively.
In both analyses, there were no significant differences between the two groups.
3) As for the bacteriological efficacy, there was no significant difference between the two groups.
4) The incidence of side effects was 4.1% in the LAPC group and 7.8% in the BAPC group, respectively. The incidence of the abnormal changes in laboratory findigs was 19.4% for the LAPC group and 22.0% for the BAPC group, respectively. There was no significant difference between the two groups.
5) The utility rate in the patients with bacterial pneumonia judged by the committee was 86.9% for the LAPC group and 80.0% for the BAPC group, respectively. The rate in the total cases was 80.2% for the LAPC group and 79.2% for the BAPC group. No significant differences between the two groups were noted. In the utility rate judged by doctors in charge, no significant difference was found between the two groups, too.
As described above, any significant differences were found between LAPC (at a daily dose of 1 g) and BAPC (at a daily dose of 1 g) neither in the efficacy rates nor in their safety. From these results, LAPC as well as BAPC are considered to be highly useful antibacterial agents for the treatment of respiratory tract infections.