The continuous combination chemotherapy of vincristine, methotrexate, peplomycin and mitomycin c (VMPM therapy) was carried out in 9 patients with squamous cell carcinoma of the oral region. During this VMPM therapy, severe a bone marrow depression was observed, so that its clinical aspect was presented.
Side effects due to VMPM therapy were detected in 7 cases (77.8%), and especially in 4 cases, white blood cells (W BC) and platelets began to decrease rapidly about 4 to 5 days after the begining of VMPM therapy. The number of W BC and platelets in these 4 cases were 500-700/mm³ and 7, 000-34, 000/mm³ at their nadir, respectively. A few antibiotics, together with human immunoglobulin in 1 case, were applied to prevent infection, and there was no evidence of infection. As to the thrombocytopenia, the approximate 19-31 units of platelet rich plasma were infused to each case, which resulted in no episode of bleeding.

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Imipenem/Cilastatin sodium (IPM/CS ; Tienam^®), A combination (1 : 1) of a new carbapenem antibiotic with an inhibitor of renal dipeptidase has a broad spectrum of activity against aerobic and anaerobic bacteria. We measured the tissue and serum concentration of IPM in 23 patients with the disease of oral cavity undergoing surgical resection. Clinical efficacy of IPM/CS used for several infections and postoperative chemoprophylaxis were also evaluated.
1) Mean serum levels of IPM were 23.3μg/ml after one hour of the administration and 14.7μg/ml after two hours, and the tissue concentrations were 4.79μg/ml and 3.35μg/ml, respectively. These results indicate that IPM levels are high enough in situ and effectiveness.
2) IPM/CS was administered in 3 patients with oral surgery infections, and the clinical responses were good in 2 cases, poor in 1 case.
3) IPM/CS is a useful antibiotic for the postoperative chemoprophylaxis in the field of oral surgery.
4) Side effects of vomiting and nausea were recorded in 4 cases, but they were mild and disappeared soon without treatment.

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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.

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Objective : For the evaluation of the usefulness of Cefuroxime axetil (CXM-AX), a new oral Cephem antibiotic, in the field of Oral Surgery, oral tissue levels of CXM were determined and pharmacokinetic analysis was carried out.
Method : CXM-AX in the dose of 30mg/kg was orally given to a total of 18 W istar strain rats (in 6 groups, each consisting of 3) through a gastric tube. Samples were taken at 15mins, 30 mins, lhr, 2hrs, 4hrs, and 6hrs after administration. In addition to the oral tissue samples from gingiva, tongue, mandibular bone, cervical lympho node and submandibular gland, serum, liver, and kidney samples were also taken for comparison. CXM levels were determined by bioassay, and a paper disc method was adopted using Bacillus subtilis ATCC 6633 as a test organism.
Results : In serum, Tmax was 1.0 hr, Cmax, 6.95μg/ml and AUC, 24.93μg/hr/ml. When the tissue levels were compared among organs based on Cmax, the level was the highest in the kidney, and then in the descending order of liver, serum, cervical lymphonode, submandibular gland, tongue, gingiva and mandibular bone. The ratios of the above tissue levels to serum level were 1.62, 1.35, 0.78, 0.62, 0.50, 0.42 and 0.27, respectively.

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In the application of a drug to clinical use, it is essential to define its pharmacokinetics. Usually, a pharmacokinetic study is performed in healthy animals in the stage of in vivo studies. In the case of antibiotics, however, it is desirable to study the transfer of the drug using an infected model. We prepared an experimental infected model in rabbits using the Satoh and Heimdahl method which we had used for several years, and orally administrered to these rabbits cefuroxime axetil : CXM-AX, a new cephalosporin antibiotic, to study tissue transfer of the drug in them with that in healthy rabbits. In this study, transfer especially into soft tissues or the oral and maxillofacial region : tongue, gingiva, submandibular gland, parotid gland and submandibular lymphonodi, and into serum were examined, and use of the drug to tissues with dental infections and subsequent symptoms was discussed.
Results
1) In the infected animal group, peaks of the drug levels in the examined tissues were attained 4-42 minutes later than that of serum level, and the peak levels in tissues were about 43-88% of that in serum. Pus level got to the peak 23 minutes later than serum level, and the peak level in pus was about 31% of that in serum. In the healthy animal group, peaks of the drug levels in various tissues appeared 4-18 minutes after that of serum level, and peak levels in tissues were about 27-71% of that in serum. High concentrations of CXM were noted in the gingiva and the submandibular gland, both in the infected and in the healthy animal group.
2) CXM levels in tissues and serum were obout 1.2-2 times higher in the infected animal group than in the healthy animal group.
3) Comparatively good transfer of CXM into pus was observed in experimental lesion, althogh it was not as good as that into serum, and T1/2 was long. The above results demonstrated in vivo that CXM-AX exerts satisfactory effects at the lesion for inflammatory disorders.

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Fundamental and clinical studies were carried out for evaluating the usefulness of Cefuroxime axetil (CXM-AX) in the treatment of periodonitis, pericoronitis or osteitis of the jaw. The results are summarized below.
1. At 60-120 minutes after oral administration of CXM-AX 250mg, CXM levels in the cyst, the gum and the alveolar bone tissues were 1.64μg/g (mean of 8 samples), 1.24μg/g (1 sample) and 0.24μg/g (1 sample), respectively, and ratio of tissue levels to serum levels were 66.4, 58.2 and 8.6%, respectively. At 90-135 minutes after the administration of CXM-AX 500mg, mean CXM levels in the cyst, the gum and the alveolar bone were 1.07μg/g (3 samples), 1.63μg/g (3 samples) and 0.7μg/g (2 samples), respectively, and ratio of tissue levels to serum levels were 22.2, 26.5 and 29.1%, respectively.
2. In the clinical evaluation, 28 patients receved orally either 250mg or 500mg of CXM-AX three times daily. Both in assessment based on scores and in physician's assessment, the efficacy rate in the total cases was 89.3%. The efficacy rates were 86.4% in 22 cases in the 750mg administration group, and 100%, in 6 cases in the 1500mg administration group.
3. Bacteriological examination was performed in 17 strains isolated from 11 out of 28 patients. CXM, at the concentration of 0.78μg/ml or lower, inhibited the growth of every isolate.
4. As for adverse events, only mild nausea and vomitting were observed in one patient out of the 28 (3.6%) .
From the above, CXM-AX is considered to be highly useful in the treatment of oral surgical infections.

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We used Acyclovir (ACV) in oral herpetic infections (herpetic gingivostomatitis : 12 cases, herpes aoster : 2 cases) .
ACV was intravenously used 5mg/kg, two times per day, for at least five days.
The clinical effectiveness of ACV was clinically and virologically compared to the ACV group and the control group (5 cases without ACV) in the patients of herpetic gingivostomatitis.
There was no difference in the clinical signs between the two groups. However, there was a difference in the frequency of viral isolation between the two groups.
According to viral shedding for five days after the administration, the frequency of viral isolation was 20.6% for ACV group and 47% for control group.
No side effects or abnormal changes in laboratory findings appeared in any of the cases.

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In the case of chronic osteomyelitis of the mandible, systemic treatment may not be effective because of chronic ischemia of the diseased bone. Septopal chain consists of PMMA (polymethylmethacrylate) beads (∅=7mm) containing gentamicin. By the use of the Septopal chain, gentamicin is slowly released from PMMA and a high local concentration of antibiotics is achieved without systemic toxic side effects.
Four patients with chronic osteomyelitis of the mandible were treated using the Septopal chain in our clinic in 1988. Our operative procedure is as follows : 1) Decortication and sequestrectomy : Buccal sclerosing cortical bone and sequester were removed, 2) Temporary implantation of Septopal chain, 3) Reoperation : 2, 3 weeks or 5 months after surgery, Septopal chain was removed or exchanged for a new one. Follow-up periods ranged from 8 to 15 months, and all patients had good results.

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An oral dose of 500mg 8 of Cefuroxime axetil was administered before exodontia in 200 patients a sum total of 218 times. The drug concentration as Cefuroxime in the blood from the exodontia wound was measured.
MIC 90% of the isolates from the odontogenic infection, including Oral Streptococci was 0.39μg/ml.
This antimicrobial agent was valued ≥0.39μg/ml, with 74 with cases out of 81 cases (91%) between 60 minutes and 135 minutes after peroral admiistratiom.

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