ABSTRACT
Clinical efficacy and safety of TMS-19-Q.GC tablet (TMS), a new macrolide antibiotic preparation, were compared with those of josamycin (JM) in the treatment of acute odontogenic infection under multicentered double-blind controlled study at the daily dosage of 600 mg of TMS or 1,200 mg of JM. The results obtained were as follows: The patients entered into the study were 265 cases and 112 in TMS group and 111 in JM group were adopted to evaluate for the efficacy. The evaluation was made by 2 ways i.e. changes in total clinical scores of the symptom and the doctors assessment. Efficacy rating of TMS and JM were 81.3 and 82.0% judged by the score and 73.2 and 77.5% judged by doctors in charge respectively. In the cases with 15 to 20 of total scores at the initial visit, considered to be suitable for the evaluation of antibiotics, the efficacy rating of both drugs were 86.7% in TMS and 84.6% in JM. Organisms were isolated from 34 cases in TMS and 40 in JM and the clinical effectiveness in those cases were almost the same. Slight adverse reactions were observed in 6 cases (4.6%) of TMS group and 1 (0.8%) of JM. In 3 cases (4 incidences) of TMS group and 1 of JM slightly abnormal laboratory findings were found. On the statistical analysis of the data regarding efficacy, safety and usefulness, both drugs had no significant difference. From these results, TMS was considered as effective as JM in the treatment of acute odontogenic infection at a daily half doses of JM.