CLINICAL STUDIES ON TE-031 (A-56268)
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We studied TE-031 (A-56268), a new macrolide antibiotic, to determine its absorption, excretion and clinical efficacy in respiratory tract infections.<BR>Absorption and Excretion<BR>Serum concentration and urinary excretion of TE-031 and EM were investigated in 6 healthy adult male volunteers after a single administration of TE-031 (200mg) or EM (400mg) in a fasting state by cross-over method.<BR>The peak serum concentration of TE-031 was 1.03μg/ml at 2 hours after administration. The serum half-life (T<SUB>1/2</SUB>) was 3.53 hours and the area under the curve (AUC) 6.87μg·h/ml. The peak serum concentration of EM was 1.56μg/ml at 2 hours, serum half-life was 1.78 hours, and its AUC 6.05μg·h/ml. The serum half-life of TE-031 was significantly longer than that of EM. Moreover, although the dosage of TE-031 was only half that of EM, its AUC was larger. Also, the pharmacokinetics of TE-031 were not altered by concomitant administration of probenecid.<BR>Clinical Results<BR>TE-031 was orally administered to 20 patients with respiratory tract infection in a daily dose of 200-400 mg for 4-14 days.<BR>Evaluation of clinical efficacy was: good 16, fair 1, and poor 3, giving an efficacy rate of 80.0%. Bacteriological efficacy was investigated in 7 strains of 3 species (<I>S. aureus</I> 1, <I>S. pneumoniae</I> 2, and <I>H.influenzae</I> 4), isolated from 7 patients. All but one <I>H. influenzae</I> strain were eradicated.<BR>The only subjective or objective symptom attributable to TE-031 was anorexia in one patient.<BR>As abnormal changes in laboratory test values, transient increase in serum hepatocellular enzymes were detected in 2 patients.
- 公益社団法人 日本化学療法学会の論文
公益社団法人 日本化学療法学会 | 論文
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