A comparative double blind study of lenampicillin (LAPC, KBT-1585) and talampicillin (TAPC) was carried out in order to objectively evaluate efficacy, safety and utility of LAPC in treatment of 238 patients with oral infections. Cases accepted by the Central Committee for evaluation of efficacy and utility were 218, consisting of 101 of the LAPC group and 117 of the TAPC group; safety were 234, consisting of 110 of LAPC and 124 of TAPC. Clinical effectiveness as rated by attending doctor was 84.2% for the LAPC group and 82.9% for the TAPC group. The clinical utility rating was 82.2% in the LAPC group and 82.1% in the TAPC group, showing no significant difference between the 2 drugs. Adverse reactions were found in 6 cases (5.5%) in the LAPC group and 5 cases (4.0%) in the TAPC group, showing no significant difference between the 2 drugs. Cases accepted by the controllers for evaluation of efficacy and utility were 236, consisting of 111 cases of LAPC and 125 cases of TAPC. Those for safety were 236, consisting of 111 cases of LAPC and 125 of TAPC. The clinical effectiveness rating was 77.5% in the LAPC group and 79.2% in the TAPC group. Clinical utility rating was 75.7% in the LAPC group and 78.4% in the TAPC group. Rate of adverse reactions was 5.4% in the LAPC group and 4.0% in the TAPC group, showing no significant difference between the 2 drugs. Cases evaluated for efficacy according to numerical rating on the 3rd day were 200 cases, consisting of 93 of LAPC and 107 of TAPC. The effectiveness rate was 83.9% in the LAPC group and 95.3 in the TAPC group, showing a significant difference between the 2 drugs. On the other hand, taking into consideration evaluation scores of the 5th day, the effectiveness rate was 88.7% in the LAPC group and 96.1% in the TAPC group, showing no significant difference between the 2 drugs. The effectiveness rate in cases of isolated organisms was 84.9% in the LAPC group and 79.7% in the TAPC group, showing no significant difference between the 2 drugs. Adverse reactions were mostly of gastrointestinal origin. Symptoms were not serious and disappeared soon after administration was discontinued or immediately after administration was completed.(ABSTRACT TRUNCATED AT 400 WORDS)
Adolescent Adult