As for spontaneous case reports of suspected adverse drug reactions, the following problems are known, a part of phenomenon actually recognized to be side effects in clinical site is reported, moreover, the thing which report bias which fluctuate produces by a factor with the various rates exists, since an appearance ratio is incalculable, it cannot be adapted in the analysis technique for common side-effects data. Therefore, the search algorithm analyzing method of signal detection has been established. Japanese Adverse Drug Event Report database (abbreviation; JADER) is exhibited from Pharmaceuticals and Medical Devices Agency (abbreviation; PMDA) to April 2012, and can use anyone now without restrictions. It is expected that the quality of research of pharmacoepidemiology will improve by practical use of JADER. However, as for the present condition, there are few reports of the practical use example in a pharmaceutical company as a subject which tends to attract attention from “signal detection” as the practical use method, consequently regulatory agency should cope with. Although the pharmacoepidemiology group of the author Japanese Society for Biopharmaceutical Statistics is not comprehensive before public presentation of JADER, the list obtained by “case report line list search with which side effects are suspected” which PMDA offers was collected and put in a database, and practical use in a pharmaceutical company has been tried by referring to the examination method of pharmacoepidemiology. This paper explains the processing method of the JADER data for enabling signal detection. Using this method, application to the subject of much pharmacoepidemiology is performed actively, and it expects to contribute to improvement in the quality of research of pharmacoepidemiology.

The new practical use example of the JADER datasets from Japanese Adverse Drug Event Report database opened by Independent Administrative Agency Pharmaceuticals and Medical Devices Agency in April, 2012 and afterwards will be reported. The purpose of this study is to examine the evaluating method of medicine concomitant use risk by the frequency at which two or more medicines were reported simultaneously, being assumed the possibility of the influence of drug interactions to be the concomitant use risk in an adverse drug event onset. In order to estimate the potential degree of the safety risk at the time of the concomitant use, the methodology was estimated by the following procedures. 1) For considering that two suspicion medicine targeted is one medicine, the statistical signal index which means those of medicines with use in the case where they both are indicated in one report, the index of the concomitant use, is computed. 2) The statistical signal index about two target suspicion medicines is computed individually. 3) The case where the ratio of the index of the concomitant use to the index obtained individually exceeds 2 also in any of two suspicion medicines is judged as there being the concomitant use risk. The Proportional Reporting Ratio (PRR) and the Reporting Odds Ratio (ROR) were used as a statistical signal index. In order to check the validity of this method, Stevens-Jonson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) which are known for the adverse events of critical drug rash reported in JADER were taken up, and the causality of medical supplies limited to the medicine with which they were reported as a suspicion medicine. As for the combination of the suspicion medicine which fulfills the conditions of the concomitant use risk, 10 kinds of candidates out of 159 combinations for SJS and 22 kinds of candidates out of 111 combinations for TEN were detected, respectively. Although this approach for the concomitant use risk was considered to be an effective means in showing the above results, some issues about the ratio of the index of the concomitant use and criteria in the report numbers of the medicine to be chosen, the effective calculation method for combinations in more than 3 medicines, etc. will be required for the further examination.

The purpose of this study was to establish by way of trial reference interval of serum lipids (TC, HDL-C, TG and LDL-C) for old people aged 65 or over based on the document published by America's National Committee for Clinical Laboratory Standards. For this purpose, we used the results of the mass health screening tests run on a total of 14, 738 residents in Shimane Prefecture. We selected reference sample groups by excluding those examinees who had been undergoing medical treatment, those who had taken their meal less than 12 hours before, habitual drinkers and smokers, and those whose systolic blood pressure was more than 160mmHg, diastolic blood pressure upwards of 95mmHg, obesity level downwards -20% or upwards of +20%.
T-C values peaked in the age group of 50s for men, while for women in the age group of 60s. Regarding HDL-C values, women were generally high compared withmen, but mean values for women in their 60s were significantly low (p<0.01) compared with those for women in their 50s. TG values were higher in men than in women. LDLC levels showed the same tendency as T-C levels.
We compared the mean values of adults aged 64 or below and elders aged 65 or above. In the elders, the mean values for T-C, TG and LDL-C were significantly higher (p<0.01) than in the adults, and the mean HDL-C values were significantly lower (p<0.01) than in the adults.
These results indicated that the reference interval of elders of T-C, HDL-C, TG and LDL-C could be from 147 to 289mg/dl, from 37 to 99mg/dl, from 40 to 209mg/dl and from 70 to 200mg/dl, respectively.

We report on the state of postgraduate anesthesiology training (3 months) at Fukui Medical School. This report was based on a questionnaire sent to 144 doctors who had undergone this training. The response rate was 68%.
Participants entered anesthesiology training at a mean of 1.9 ± 1.2 years after graduation. Seventyone trainees (91%) were actively involved in clinical anesthesiology, among which 48 trainees (63%) had experienced between 31 to 60 cases over a 3 month period. Twenty-four trainees (31%) indicated that the training period (3 months) was too short. After such training, 50 doctors (66%) practiced anesthesia, among which 29 encountered difficulties with endotracheal intubation. Sixty-nine trainees (93%) thought the training would be useful for resuscitation. We conclude that anesthesia training is effective at the end of a 2-year postgraduate training course, and recognize the need for improvement in the teaching of anesthesiology.

A case of Budd-Chiari syndrome in which direct surgical intervention was successfully performed is reported. A 43-year-old female who had had a history of hepatic coma was pointed out complete obstruction of inferior vena cava (IVC) between the right atrium and diaphragma, associated with hepatic dysfunction and esophageal varices. At operation, the IVC lesion was visualized directly by thoracotomy through midsternal incision and by laparotomy through right hypochondrial oblique incision, with the liver retracted. Under partial extracorporeal circulation with suction of blood from hepatic vein, the IVC was incised, 3cm in length, and membranous tissue causing obstruction was resected. The defect of the IVC wall was repaired with ringed EPTFE patch. Postoperatively, both central venous and portal pressure were decreased, 21 mmHg to 10mmHg and 26cm H₂O to 21cm H₂O, respectively, with good patency of the IVC on venogram. Now the patient is up and well, 11 months after operation. Thus, complete removal of obstruction under direct vision is thought to be important for surgical treatment of Budd-Chiari syndrome.

A lower abdominal tumor with thrill and bruit was pointed out in a 59-year-old female. Angiography showed a pelvic arteriovenous malformation (AVM) with remarkably dilated vessels resembling an aneurysm. Feeding arteries for this AVM originated from the right internal iliac artery, right lumbar artery and right renal artery, and drainage blood flowed into the inferior vena cava from the dilated vessel via a large vein. At operation the right internal iliac artery and right lumbar artery were ligated and the dilated vessel with AVM, which connected with the right renal artery, was resected. An angiography 16 days after the operation revealed the normal arteries without AVM and the right internaal iliac artery filled through collateral arteries. Recently catheter embolization in frequently the first choice for treatment of AVM. However, in the case of AVM with aneurysmal dilated vessels, surgical resection should be selected.

We report on a rare case of Marfan syndrome with giant dissecting descending thoracic and abdominal aortic aneurysms associated with poor left ventricular function and severe mitral regurgitation. Before the anesthetic induction, a partial extra-corporeal circulation was established to prevent a collapse of the circulation. Descending aortic graft replacement and following abdominal aortic graft replacement were performed safely using the partial extra-corporeal circulation to relief the afterload for the severely deteriorated left ventricle with severe mitral regurgitation. Intra-aortic balloon pumping was also promptly used to assist the poor circulation in the postoperative period. Despite the admission to a specialized institute, he died from irreversible heart failure with a developing renal failure. Even for a difficult patient with Marfan syndrome with severe left ventricular dysfunction and mitral regurgitation, graft replacement was feasible with meticulous perioperative circulatory management using partial extra-corporeal circulation and intra-aortic balloon pumping. However, a prompt registration for heart transplantation and an aortic surgery concomitant with implantation of left ventricular assisted device should have been considered to save the patient.