Clinical Evaluation of TMS-19-Q·GC Tablet in Suppurative Otitis Media

A comparative double blind study with Midecamycin

Abstract

TMS-19-Q is a new semisynthetic macrolide derived from leucomycin A₅. The clinical usefulness of TMS-19-Q·GC tablets (TMS) at a daily dose of 600mg was compared with that of midecamycin (MDM) at a daily dose of 1200mg in 185 patients with suppurative otitis media.
The trial was made by double-blind controled study and the results obtained were as follows:
1. The overall efficacy rates of TMS and MDM in acute suppurative otitis media were 77.8% and 69.4% judged by the doctors and 80.6% and 66.9% judged by the committee members respectively.
The rates of TMS and MDM in acute exacerbation of chronic otitis media were 58.3% and 49.1% judged by the doctors and 55.0% and 47.2% judged by the committee members respectively. However, there was no significant difference between the drugs.
2. On further analysis of the data regarding various background characteristics, TMS was significantly different from MDM in the cases with the infection of susceptible strains (MIC≤3.13), single infection of Staphylococcus aureus and with the severity grades of mild (initial clinical scores:≤2.67) and severe (scores:≥4.00). TMS was also statistically superior to MDM in terms of improvement of otalgia at day 3 in acute suppurative otitis media.
3. The frequency of side effects was 1.8% (2 cases) in TMS and 5.5% (6 cases) in MDM and almost all were slight gastrointestinal effects.
These results suggest that TMS is a useful drug for the treatment of suppurative otitis media at a daily half dose of MDM.