This study was conducted to evaluate the prophylactic effect of itraconazole (ITCZ) receiving 30Gy or more dosage of radiation for oral cavity carcinoma. Of the patients receiving itraconazole, 14.3% (1/7) developed candidiasis, while 60.0% (3/5) of the patients receiving placebo developed candidiasis. Efficacy, evaluated in 6 patients, wos found to be 85.7% (6/7) . From three weeks after administration of itraconazole, culture tests revealed no positive cases. One patient receiving itraconazole experienced side effects, such as rises in GOT and GPT. These results demonstrate that itraconazole is highly effective in preventing oral cavity candidiasis, which is often associated with radiation therapy, and it improves quality of life for patients undergoing radiation therapy.

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CDDP, commonly used to treat oral cancer, frequently induces adverse effects, such as severe anorexia, nausea, and emesis associated with chemotherapy. Recently, several 5-HT₃receptor antagonists have developed, and among them, Granisetron hydrochrolide injection has been widely used so far. Tropisetron hydrochrolide, an oral anti-emetic reported to be as effective as parenteral anti-emetics, was launched Japan in 1998. Here, We report a comparison of the effectiveness between Kytril^® infusion and Navoban^® capsules, in terms of the grade of anorexia, nausea and emesis, measurement of Performance Status, and evaluation using a QOL questionnaire. Twenty oral cancer patients that received chemotherapy with CDDP and 5-FU were enrolled in the study. Our study clarified that oral anti-emetics exerted anti-anorectic, and anti-emetics effects as potently as parenteral drugs.

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One hypothesis of the anti-mania reaction mechanism of lithium salts is that they act on Na, K-ATPase, but the datails are not yet clear. We studied the effects of lithium salts on Na, K-ATPase in rat brain. The ATP hydrolysis activity of Na, K-ATPase is accelerated to its maximum in the presence of both Na and K (Na, K-ATPase activity), but only about one-tenth of the activity is observed in the presence of Na alone (Na-ATPase activity) . Addition of K to the Na-ATPase condition increased the ATPase activity, depending on its concentration, and the activity reached the maximum level. Additions of Li-acetate, Li-chloride, and Li-carbonate also increased the activity, to 75%, 57%, and 24%, respectively, of the level obtained with K. However, Li salts failed to increase the ATP hydrolysis activity in the presence of both Na and K. Ten mM K and Li reduced the amount of phosphorylated intermediate (EP) of Na, K-ATPase, to 9 % and 72%, respectively, of the maximum level observed in the presence of 40 mM Na. These findings indicate that the two ions accelerate dephosphorylation of EP, but to different degrees. The results suggest that Li has weak K-like effects and promotes Na-ATPase activity by accelerating dephosphorylation of EP.

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We conducted a questionnaire survey of dentists at 11 national university dental hospitals, to learn the influence of drug indications provided by health insurance for dental therapy.
The return rate of the questionnaires was 66.5% (523/786) . Approximately 42.1% of the dentists (220/523) had changed medical orders because the prescribed medicine was not covered by health insurance.
Specifically, 89.4% (110/123) of the dentists who were, specialized in oral maxillofacial surgery, had experienced such situations.
Therefore, 63.5% (332/523) of the dentists requested that drug indications be recognized, to expand dental therapy.
Reasons given for wanting expansion were selection of drug dosage form, therapeutic management of individuals patient, development of new therapy, and the like.
To promote expansion of drug indications provided by health insurance in dental therapy, it is important for all national university dental hospitals to work to carry out clinical trials positively, in cooperation with pharmaceutical companies, under observance of new GCP.

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For chronic disorders in the dental and oral surgical fields, drug therapy is mainly used. In particular, such disorders accompanied by pain may be associated with psychogenic factors, and therefore, often psychotropic drugs are given to reduce anxiety and achieve sedation. To clarify the present state of the use of psychotropic drugs, we carried out a survey of 17 psychotropic agents, using 54, 364 prescriptions written at our hospital between April 1996 and March 1997.
Of all the prescriptions, 3.4% contained the investigated psychotropic agents. Ethyl loflazepate and alprazolam, as antianxiety drugs, were very frequently prescribed (total for the two drugs, 49.4%) . Many patients (64.7%) were middle-aged or aged (40-69 years) . Each psychotropic drug was predominantly used in females; the number for females was threefold higher, or more, than for males, for each drug. According to the departments, the psychotropic agents were frequently prescribed in the oral surgical department, where treatment of oral mucosal diseases and tooth extraction are mainly performed, and in the anesthesiology department, where pain control is primarily performed (total for the two departments, 97.4%) . According to disorders, atypical facial pain (34.2%) was most frequently observed, followed, in order, by temporomandibular arthrosis and glossalgia (total for the three disorders, slightly less than 80%) . Antidepressants were sometimes prescribed for atypical facial pain. All these disorders are accompanied by pain, suggesting a close association between pain and oral psychosomatic disorders. At present, oral psychosomatic disorders are not indications for psychotropic drugs, and expansion of their indications to the dental field is necessary.

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As drug information service (DI) in a dental hospital, we evaluated the efficacy and safety of three products of the drug delivery system (DDS) (Periocline^®, Elyzole^®, Perio Chip^®) for treatment of periodontitis, using literature of clinical trials.
Nine literature references (4 for Periocline^®, 4 for Elyzole^®, 1 for Perio Chip^®) were obtained from a MEDLINE database search on the Internet.
The clinical trial design of each reference was a randomized control trial, and three were double blind randomized control trials. The treatment period and examination period were different for each reference. Items of clinical examination included pocket depth (PD), bleeding on probing (BOP), attachment level (AL), plaque index (PI) ; of these, PD was used in all trials.
As for the efficacy of products evaluated by improvement of PD, two references for Periocline^®, and one for Periochnp^®, showed statistically significant improvement, but two references for Elyzole^®, indicated superior improvement of PD in the control group rather than the test group. Only five of the references discussed side effects, but they were mild, transit, local effects.

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Since the new Good Clinical Practice (GCP) was announced, clinical trials have been conducted based on a new system in our hospital. Six phase II clinical studies (involving 170 patients) were completed by December 1999. Service of a Clinical Research Coordinator (CRC) was approved by the Institutional Review Board (IRB), prior to a phase II clinical study on an antibiotic, and support service was started to obtain informed consent from 10 patients. The CRC serves to promote activities smoothly, from acceptance until the completion of clinical trials. CRC services are provided by two persons: a pharmacist and a nurse, in addition to their routine duties. Nurses care for patients and confirm the patient's consultation for the trial, while pharmacists are responsible for other work (participation in hearing sessions, support in obtaining informed consent) . Among the work conducted by pharmacists, the contents of assisted explanation for obtaining informed consent, description of medical records and case reports, and confirmation of required documents, are recorded in check sheets. We introduce our check sheets.

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