CLINICAL EVALUATION OF TMS-19-Q, A NEW MACROLIDE ANTIBIOTIC, IN OTORHINOLARYNGOLOGICAL INFECTIONS

Abstract

The clinical study for TMS-19-Q ·O tablet was performed with multicenter trial. The results obtained were as follows;
1. Final grobal improvement rating in 332 cases of otorhinolaryngological infections were excellent in 99, good in 142, fair in 40 and poor in 51 and the effective rate was 72.6%. Those of 266 cases with acute infection were excellent in 93 and good in 121 and the effective rate was 80.5%.
2. Optimum daily doses would be 600mg based on the analysis of 144 cases of the acute infection with sensitive bacteria (MIC: ≤3.13μg/ml).
3. In acute infection, major causative bacteria were Gram-positive cocci (GPC) indicating the frequency of 72.0% in total isolates and 87.5% in singly isolated cases.
In chronic infection, although GPC were also dominant, Gram-negative bacilli were observed in 31.9%.
4. Clinical and bacteriological effective rates of 160 cases of acute infection with single species were 80.6% and 90.3%, and those of 43 cases in chronic infection were 44.2% and 72.7%, respectively.
5. The resistant rates of isolates in acute infection to TMS-19-Q were 13.3% in S. aureus, 7.7% in S. epidermidis, 6.0% in S. pyogenes and 0% in S. pneumoniae. Those in chronic infection were 20.0% in S. aureus and 25.0% in S. epidermidis.
6. Slight adverse reactions, such as skin eruption or gastrointestinal disorders were observed in 14 cases and no severe one was observed.
Slight elevation of GOT, GPT, Al-P, BUN, S-Cr. or eosinophil were observed in 12 cases.
These results suggest that TMS-19-Q would be useful antibiotic for otorhinolaryngological infections.