Objective : The incidence rate is used frequently in drug safety assessment. The incidence rate of adverse events is defined as the number of patients experiencing a certain adverse event divided by the number of patients administered a drug in spite of duration of administration (observation). In post-marketing surveillance, the duration of administration (observation) typically differs by patient and most of the analyses fail to take into account the differences in duration of administration (observation). Therefore, we investigated the usefulness of hazard functions in a drug safety assessment using the interim results from Clinical Experience Investigation of the oral anticancer drug, TS-1.
Methods : About three thousand patients with gastric cancer were enrolled in this Clinical Experience Investigation. TS-1 was administrated orally twice daily. One course consisted of consecutive administration for 28 days and 14 days rest. Administration was repeated in two courses. Hematological measurements, stomatitis, anorexia, nausea/vomiting, diarrhea, malaise were analyzed. Adverse events were evaluated in accordance with the criteria of the Japan Society for Cancer Therapy, which were established based on criteria established by the WHO. Time to occurrence of an adverse event was calculated from the first day of administration until the adverse event was first observed. Hazard functions were estimated by smoothing methods using kernel functions.
Results : The occurrence of adverse events using smoothed hazard functions had one peak around 10 days in the first course and decreased by administration rest. With the resumption of administration, the occurrence increased again. The occurrence in the second course were less than that of the first course.
Conclusion : The occurrence peaks of adverse events were estimated graphically by smoothed hazard functions. We conclude that hazard functions are useful as an analytical tool in drug safety assessment.

Purpose: We conducted a group seminar for lung cancer patients. The purpose of the group seminar was to eliminate the negative notions about opioids and to impart the right knowledge about these drugs. Further, we investigated the notions about opioids and the effectiveness of the group seminar. Methods: A pharmacist conducted a group seminar on opioids for lung cancer inpatients who agreed to participate in the group seminar. Moreover, we performed a questionnaire survey before and after the delivery of the group seminar. Results: Sixty patients answered the questionnaire. After completion of the group seminar, the understanding and knowledge about opioids increased, as indicated by the responses of the patients to all of the questions. Conclusion: Complete elimination of the negative notion about opioids could not be achieved through the group seminar. However, the group seminar was thought to be one of the useful methods of educating patients. If a patient resists treatment with opioids, control of pain may be delayed. This in turn would hamper improvement of the quality of life. Therefore, we consider that it is necessary that a patient has the right knowledge about opioids beforehand. Palliat Care Res 2011; 6(1):109-118

Background: Problems associated with using inhalational anaesthesia are numerous in veterinary anaesthesia practice. Decreasing the amount of used inhalational anaesthetic agents and minimising of cardiorespiratory disorders are the standard goals of anaesthetists. Objective: This experimental study was carried out to investigate the sparing effect of intravenous tramadol, lidocaine, dexmedetomidine and their combinations on the minimum alveolar concentration (MAC) of sevoflurane in healthy Beagle dogs. Methods: This study was conducted on six beagle dogs. Sevoflurane MAC was determined by the tail clamp method on five separate occasions. The dogs received no treatment (control; CONT), tramadol (TRM: 1.5 mg kg -1 intravenously followed by 1.3 mg kg -1 h -1 ), lidocaine (LID: 2 mg kg -1 intravenously followed by 3 mg kg -1 h -1 ), dexmedetomidine (DEX: 2 μg kg -1 intravenously followed by 2 μg kg -1 h -1 ), and their combination (COMB), respectively.Cardiorespiratory variables were recorded every five minutes and immediately before the application of a noxious stimulus. Results: The COMB treatment had the greatest sevoflurane MAC-sparing effect (67.4 ± 13.9%) compared with the other treatments (5.1 ± 25.3, 12.7 ± 14.3, and 40.3 ± 15.1% for TRM, LID, and DEX treatment, respectively). The cardiopulmonary variables remained within the clinically acceptable range following COMB treatment, although the mean arterial pressure was higher and accompanied by bradycardia. Conclusions Tramadol-lidocaine-dexmedetomidine co-infusion produced a remarkable sevoflurane MAC-sparing effect in clinically healthy beagle dogs and could result in the alleviation of cardiorespiratory depression caused by sevoflurane. Cardiorespiratory variables should be monitored carefully to avoid undesirable side effects induced by dexmedetomidine.