Evaluation of efficacy and safety of Cefuroxime axetil (CXM-AX) in the treatment of infections in the dentistry and oral surgery

Abstract

Clinical efficacy and safety, and also the optimal dose of cefuroxime axetil (CXM-AX) in the treatment of infections in the Dentistry and Oral Surgery were evaluated. To the patients with periodontitis (Group I), pericoronitis (Group II) and osteitis of the jaw (Group III), CXM-AX was orally administered in three divided doses after meals, with the daily dose of either 750mg or 1500mg.
1. In 234 cases in which clinical efficacy was assessable, the efficacy rates (rate of ‘Excellent’ or ‘Good’) by physician's assessment and by assessment based on numerical rating on Day 3 were comparable, i.e. 80.3 % and 83.8 %, respectively. When these rates were evaluated for each disease group, the efficacy rate by the physician's assessment was the highest in Group I (86.9%), whereas there was almost no difference in efficacy rates by assessment based on numerical rating on Day 3 among three disease groups (82.7%-84.8%) . In the clinical efficacy assessment based on numerical rating on Day 3 for each dose level, the efficacy rate in the 1500mg group (92.7%) was higher than that in the 750mg group (81.3%), but no significant difference was observed between the two dose level groups.
2. Bacteriological response was assessable in 96 cases. The clinical efficacy rates in these assessable cases were 84.4% by physician's assessment, and 83.3% by assessment based on numerical rating on Day 3. In both assessments, the clinical efficacy rate was higher in monomicrobial infection cases than in polymicrobial infection cases, but there was no significant difference. In the assessment of bacteriological response by the Committee, bacterial elimination was observed in 72.9%.
3. A total of 156 strains of organisms were isolated from 96 patients subjected to bacteriological evaluation. (Streptococci: 87, Peptostreptococci : 27, Bacteroides : 14, Staphylococci : 8, B. catarrhalis and others : 20) The MIC₉₀ of cefuroxime for all the isolates was 0.39μg/ml.
4. Adverse events were observed in 11 (4.6%) out of 239 cases ; gastrointestinal tract disorders in 10 and candidiasis of tongue in 1. Among these 11 cases, 6 cases did not require withdrawal of the test drug. As to the remaining 5 cases, adverse events disappeared within 3 days from onset after withdrawal of the test drug.
5. Abnormal changes in laboratory test values were noted in 10 cases (6.2%, a total of 13 values) out of 161 cases examined. They were elevation of S-GPT (6) and S-GOT (3), increase in eosionophil (2), and elevation of BUN (1), and Al-P (1) .
6. Assessment of usefulness was made based on efficacy and safety. Usefulness was assessed as ‘Satisfactory’ or above in 184 cases (78.3%) out of 235. The usefulness rate was the highest in Group I (84.7%), but there was no significant difference among the three disease groups.
From the above results, CXM-AX was considerd to be useful in the treatment of infections in the Dentistry and Oral Surgery. As for the standard dose, a daily dose of 750mg proved to exert the expected effects.