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To objectively assess azithromycin (AZM) for its clinical efficacy, safety and usefulness in the treatment of acute odontogenic infections (periodontitis, pericoronitis and osteitis of the jaw), a double-blind, randomized, multi-center trial was conducted in which tosufloxacin tosilate (TFLX) was used as the control drug. AZM was administered to 90 patients at a once-daily 500 mg dose for 3 days, while TFLX was given to 90 patients at a 150 mg t.i.d. dose for 7 days. 1. The clinical efficacy rates calculated according to evaluation at an endpoint set on the 3rd day of treatment by a committee of experts were 85.9% (73/85) in the AZM group and 78.9% (71/90) in the TFLX group. No statistically significant difference between the treatment groups was detected, and clinical equivalence was verified (p = 0.002). 2. The clinical efficacy rates according to evaluations made by investigators at the end-of-tail point was 87.1% (74/85) in the AZM group and 73.3% (66/90) in the TFLX group. The efficacy rate in the AZM group was higher than that in the TFLX group, and the difference was statistically significant (p = 0.006). 3. The bacteriological elimination rate in the AZM group was 97.5% (39/40) and that in the TFLX group was 85.7% (30/35), but the difference was deemed statistically not significant. 4. Adverse reactions were observed in 11 of 88 cases (12.5%) in the AZM group and 5 of 90 cases (5.6%) in the TFLX group. Six of 85 cases (7.1%) in the AZM group and 5 of 85 cases (5.9%) in the TFLX group showed laboratory abnormalities. However, neither adverse reactions nor laboratory abnormalities showed any differences in statistical significance between the treatment groups. 5. The safety rates, expressed as percentages of cases with no adverse events and no laboratory abnormalities, was 84.1% (74/88) in the AZM group and 90.0% (81/90) in the TFLX group. The difference between the two groups was found to be statistically insignificant. 6. The usefulness rates, the ratio of cases rated as either "Very useful" or "Useful", was 83.9% (73/87) in the AZM group, and it was statistically higher (p = 0.025) than 72.2% (65/90) obtained for TFLX group. Judging from the above results, it has been concluded that AZM is as useful as TFLX in the treatment of acute dental infections.

The clinical effectiveness and safety of roxithromycin (RU 28965, RU), a new macrolide antibiotic, were compared with those of josamycin (JM) using a double-blind method in the treatment of orofacial odontogenic infections. The diseases covered in this study were periodontal infections, pericoronal infections and osteitis of jaws. Drugs were administered for 3 to 7 days at daily doses of 300 mg (RU) and 1,200 mg (JM). A total of 270 cases was evaluated in this study. Results obtained are summarized as follows: 1. The clinical efficacy was evaluated through the judgement of doctors in charge of 247 cases (128 in the RU group and 119 in the JM group) and by a committee on the 3rd day of treatment in 243 cases (126 in the RU group and 117 in the JM group). Clinical efficacy rates according to the committee judgement were 78.6% for the RU group and 82.1% for the JM group. As for the evaluation through the doctors' judgement, they were 79.7% for the RU group and 73.1% for the JM group. There was no significant difference in clinical effectiveness between 2 groups according to these 2 methods of judgement. 2. Some side effects were observed in 4 cases (2.9% out of 136) treated with RU and in 3 cases (2.4% out of 126) treated with JM. No severe symptoms were observed. Abnormal changes in laboratory test values were noted among 7.9% in the RU group and 4.0% in the JM group. There were no significant differences in their safety between the 2 groups. 3. In terms of clinical usefulness, there were no significant differences between the 2 groups as well. From these results, it has been concluded that RU (daily dose 300 mg) is as effective as JM (daily dose 1,200 mg) in the treatment of orofacial odontogenic infections.

Clinical efficacies of newly developed synthetic oral ampicillin prodrug lenampicillin (LAPC, KBT-1585) applied to 109 cases of oral infection were studied. There were 7 dropout cases. The results as determined on a point system are as follow: Remarkably effective, 26 cases; effective, 63 cases; and not effective, 13 cases, for an efficacy rate of 87.3%. When rated by the subjective judgement of the doctors in charge, these figures are as follow: remarkably effective, 21 cases, effective, 67 cases; slightly effective, 10 cases; and not effective, 4 cases. The rate of efficacy in this way being 86.3%. In either way, the results obtained were favorable. Among 102 cases in this study, pus was aspirated with sterile needle from obstructed abscesses in 65 cases, with the result that 161 strains of bacteria were isolated and identified. Most of infections were found mixed type by aerobic Gram-positive cocci and anaerobes. Especially, cases caused by alpha-Streptococcus were observed in 48 out of 55 mixed infective cases. LAPC's MIC distribution against the detected bacteria showed strong antibacterial effect as follows: against Gram-positive cocci, less than 0.39 micrograms/ml; against Gram-negative bacteria (excluding some insusceptible strains), less than 3.13 micrograms/ml. Thus, LAPC demonstrated a superiority when compared to CEX by 4 approximately 128-fold, and when compared to AMPC by about 2-fold. Adverse reactions among the 109 cases consisted of 6 cases of gastro-intestinal disorders including 3 cases of diarrhea. Recognized cases of abnormal laboratory findings were 3 cases out of 76 (3.9%), but none were serious.

Clinical studies with long acting amoxicillin (L-AMPC) have been carried out and the following results were obtained. 1. Forty-two patients with acute bacterial infections in the oral region were administrated orally L-AMPC at a daily dose of 1 gram. The clinical results obtained were classified as excellent in 3 cases, good in 28 cases, and the overall efficacy was 75.6%. 2. The antibacterial activity of AMPC was determined for 66 strains isolated from patients with oral infections. Of the strains tested, Gram positive cocci showed high sensitivity with MIC's less than 1.56 mcg/ml, while the sensitivity of PC resistance strains of S. aureus, K. pneumoniae and P. vulgaris was lower. 3. There was 1 case of transaminase elevation in the laboratory finding. 4. Five patients reported the following side effects, eruption 3, diarrhea 2, nausea 1, anorexia 1 and malaise 1. From the results of the present study, it is considered that L-AMPC is a useful antibiotic in the treatment of acute bacterial infections in oral region.