[Clinical evaluation of clarithromycin in treatment of acute dental infections. Comparative double-blind study using josamycin as the control].
In order to objectively evaluate the usefulness of clarithromycin (TE-031, A-56268), a new oral macrolide antibiotic, in the treatment of acute dental infections, a double-blind comparative clinical trail was conducted using josamycin (JM) as the control drug. TE-031 was administered at a daily dosage of 400 mg in 2 divided doses, and JM was given at a daily dosage of 1,200 mg in 3 divided doses. The administration period was, as a rule, 7 days. A total of 302 patients were administered with the test substances (TE-031 and JM), and the clinical efficacy was evaluated by investigators for 284 patients and by a committee using a score method for 273 patients. Efficacy rates as evaluated by the investigators were 77.2% (105/136) in the TE-031 group and 69.6% (103/148) in the JM group. Efficacy rates as evaluated by the committee by the score method were 86.0% (111/129) in the TE-031 group and 80.6% (116/144) in the JM group. The differences between the 2 drug groups were not statistically significant. The investigators' evaluation of the clinical efficacy in the treatment of osteitis of the jaw gave an efficacy rate of 83.0% (44/53) in the TE-031 group and 64.7% (33/51) in the JM group. The efficacy rate in the TE-031 group was statistically higher than that in the JM group. Side effects were recorded in 7 patients (4.8%) in the TE-031 group and 3 patients (2.0%) in the JM group, while abnormal laboratory test values were detected in 3 cases each in the TE-031 and JM groups. None of these differences were statistically significant. The usefulness rates ("satisfactory" plus "very satisfactory" cases) were 73.9% in the TE-031 group and 70.3% in the JM group and were thus almost the same for the 2 drug groups. On the basis of the above results, TE-031 was concluded to be a useful drug in the treatment of acute dental infections and is expected to be able to achieve almost identical clinical efficacy as JM at only one-third of the usual dosage of JM.
Sasaki
J
J
Department of Oral Surgery, School of Medicine, Tokai University.
Morishima
T
T
Sakamoto
H
H
Takai
H
H
Ikeshima
K
K
Shiiki
K
K
Uematsu
M
M
Morihana
T
T
Tomita
F
F
Noma
H
H
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D001419:Bacteria / Q000187:drug effects / Q000302:isolation & purification; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D017291:Clarithromycin; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004352:Drug Resistance, Microbial; D004917:Erythromycin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007933:Leucomycins / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D014076:Tooth Diseases / Q000188:drug therapy* / Q000382:microbiology
D007933:Leucomycins; D004917:Erythromycin; D017291:Clarithromycin