[Clinical evaluation of cefuroxime axetil in acute dental infections. Double blind comparative study vs. cefaclor]

To evaluate objectively clinical efficacy, safety and usefulness of cefuroxime axetil (CXM-AX) in acute dental infections (periodontitis, pericoronitis and gnathitis), we carried out a comparison study using cefaclor (CCL) as the control. Both drugs were orally given after meals in a dose level of 250 mg (potency) t.i.d. for 3-7 days. 1. Clinical efficacy rates in all the treated cases were 81.6% (102/125) in the CXM-AX group and 82.5% (104/126) in the CCL group according to the assessment by physicians in charge, and 89.6% (112/125) and 83.3% (105/126), respectively, according to the assessment based on scores. No significant difference was found between the 2 treatment groups. In clinical efficacy (assessment by score) classified by background factors, efficacy rate in the CXM-AX group (90.6%, 58/64) was significantly higher (P less than 0.05) than that in the CCL group (75.0%, 48/64) in cases receiving no surgical treatment on the first day of drug administration. Other background factors than the above (no surgical treatment) factor or scores on the first day of drug administration, however, did not appear to influence clinical efficacies of 2 treatment groups. 2. As for the bacteriological response in all the treated cases, elimination rate in the CXM-AX group was 73.7% (28/38) and that in the CCL group, 78.3% (36/46), without significant difference between the 2 groups. 3. Regarding the safety, no significant difference was found between the 2 treatment groups. Adverse reactions were observed in 1 out of 128 cases (0.8%) in the CXM-AX group and 6 out of 132 cases (4.5%) in the CCL group. Abnormal laboratory test values were noted in 8 out of 86 cases (9.3%) in the CXM-AX group and 5 out of 91 cases (5.5%) in the CCL group. None of these differences between 2 treatment groups was statistically significant. 4. Usefulness rates in all the treated cases were 81.6% (102/125) in the CXM-AX group and 81.7% (103/126) in the CCL group, thus significant difference was observed between the 2 groups. From the above results, CXM-AX is considered to be a useful drug like CCL in the treatment of acute dental infections.