Although the two regulatory bodies, Pharmaceutical and Medical Devices Agency (PMDA) and Ministry of Health, Labour & Welfare (MHLW) cooperate in pharmacovigilance in Japan, presence of clinicians in the two bodies is surprisingly limited with only about twenty medical doctors compared more than 300 in CDER/CBER. The lack of doctors in PMDA, resulting from several factors including low social status and hard work, make them to review drugs and devices in which they are not expertised at all. For example, a paediatric cardiologist is obliged to review a drug for overactive bladder because no urologist is available for drug review in PMDA. Such a case would make the reviewer guilty of professional negligence. These critical issues make a PMDA reviewer rather dangerous than unexciting job. On the other hand, most Japanese doctors, heavily dependent on PMDA and pharmaceutical companies for drug information, would not commit in the drug review or pharmacovigilance. To make Japanese doctors more committed in pharmacovigilance, there are several measures to be implemented. First, better benefit, i.e. income, working hours, holidays. Second, escape clause for the reviewers. Third, more doctors to the Office of Safety rather than the Offices of New Drug. People outside PMDA can also contribute to pharmacovigilance with better media literacy and better understanding of PMDA.

Effects of sit-up exercise in the healthy adults to the point of exhaustion on the respiratory-circulatory functions and oxygen consumption were studied in thirtyone males and thirtysix females whose age varied between twenty and thirtyf our years old. The subjects were classified into two groups, the superior and the inferior, according to the number of sit-ups to reach the exhaustion point. Collected vallues were compared between the pre-exercise and the post-exercise records. The results were as follows ;
1) No sex differences in the inferior group were found in the degree of increase in systolic pressure, heart rate and respiratory rate.
2) In the superior group, no sex difference was found in the degree of increase in respiration rate, but male subjects were greater than female subjects in the degree of increase in both systolic pressure and heart rate.
3) In males, when the superior subjects were compared with the inferior subjects, the former were greater than the latter in the degree of increase in both systolic pressure and heart rate, but in females no differences were found.
4) In males the more the degree of increase in blood pressure, the more the degree of increase in heart rate. In contrast with males, in females there were no relation between them were observed.
5) It was recognized that relative metabolic rate varied in values from 4.7-13.5 and there was a tendency among the inferior subjects to have a large relative metabolic rate.

In August 1995, a committee was inaugurated in our hospital to improve hospital-patient relationship. Under the auspices of the committee, a series of lecture meetings were held with professional consultants and teachers invited. From September to December in that year, the on-the-job training was started and all the staff and part-time workers participated. The second training was carried out exclusively for people in managerial positions and the committee members from January to February in 1996. From March to June the third training was done for all the staff. The fourth and final training was given to the committee members from July to August in 1996. These on-the-job training and meetings resulted in marked improvements in communication between patients and hospital members. Moreover, the reform image of our hospital has been known widely. From now, we should continue our efforts to improve the hospital-patient relationship through various projects.

This report concerns a 62-year-old woman with Wegener's granulomatosis. She complained cough, macroscopic hematuria and oligulia. She had a consolidation without a cavity in the left upper lung field, massive proteinuria (2.5 g/day) and massive hematuria. The serum creatinine level was 2.5 mg/dl. The C-ANCA was positive. Renal biopsy revealed crescentic glomerulonephritis. She wa treated with prednisone and trimethoprim-sulfamethoxazole. The lung shadow, proteinuria and hematuria disappeared in one month. The C-ANCA titer also decreased. The use of trimethoprimsulfamethoxazole which may eliminate an infection as a cause to promote Wegener's granulomatosis should be actively included in the conventional treatment.

Effects of 20km running uppn taking a low-carbohydrate, high-fat and protein diet on the changes in blood pressure, heart rate, body weight, skinf old thickness, blood components and urinary recordings in five healthy young men were investigated and the changes in these items which occured by taurine inducement were studied by double blind test method. The results were as follows:
1) As to the degree of decrease in body weight in 20km running, the case in taurine administration (T. A.) was more than in placebo administration (P. A.) .
2) As to the degree of increase in systolic pressure upon 20km running, T. A. was less than P. A. 3) The rate of creatine kinase isozyme (CK-MB) against creatine kinase (CK), which increased after 20km running in P. A., was possible to reduce by T. A.
4) T. A. was less than P.A. in the rate of increase in lactate dehydrogenase (LDH) on 20km running.
5) In P. A., triglyceride increased after 20km running, but in T. A., it decreased.
6) T. A, much influenced the rate of individual fatty acid composition on 20km running
7) T. A, was more than P. A. in the secretion of adrenaline on 20km running.
8) No changes were observed in other blood components and urinary kallikrein.

The present study was performed to investigate the effect of long distance walking upon physical functions for healthy male subjects. The first experiment was carried out in 1977, the second, in 1978, and the third, in 1979 in each autum season. At the first experiment, subjects began walking upon having breakfast, then ate and drank noting during first 30km, and took some foods during another 26km. Twelve hours and fifty minutes of time was spent for 56km walking including 15, 60, and 30 minutes rest periods in between. In the second experiment, subjects ate nothing after dinner of the previous evening and 35km walking took 6 hours during which some rest periods were taken for blood sampling. The third was 80km walking for two days. Subjects walked 40km in 8 hours in the first day and on the following day they walked 40km in ten hours and twenty minutes. They took foods and rest freely.
From the view points of the changes in blood and urinary recordings obtained from those three experiments, the influences of long distance walking on the body indicate as follows ;
1) In case of long distance walking while nothing to eat and drink, the rate of serum saturated fatty acids composition decreased and unsaturated fatty acids increased.
2) In a fasting state, blood glucose gradually decreased, LDH activity increased and blood lactate, GOT and GPT activity presented no significant changes on long distance walking.
3) It was shown that the longer distance to walk, the lesser tendency in blood triglyceride even though subjects take a carbohydrate rich diet while walking.
4) In fasting state, less than 35km walking without foods, the stress to the body seemed not to be critical.
5) More than 40km walking in a day, even though taking meals, would result a significantly severe stress for body.
6) As long as usual meals are taken, 80km walking for two days continuously, 40km in each day, would not result in such a physical stress over the following days.

OBJECTIVEExposure to polychlorinated biphenyls (PCBs) is considered to have culminated between 1950 and 1970 in Japan, and exposure through diet, the major exposure route, has decreased significantly over the last 10 years. The primary goal of the present study was to investigate the long-term trends and congener profiles of serum and dietary levels of PCBs using historical samples.

METHODSUsing banked samples collected in 1980, 1995, and 2003 surveys, we determined the daily intakes and serum concentrations of 13 PCB congeners (#74, #99, #118, #138, #146, #153, #156, #163, #164, #170, #180, #182, and #187) in women.

RESULTSThe total daily PCB intake [ng/day, geometric mean (geometric standard deviation)] decreased significantly from 523 (2.5) in 1980 to 63 (3.2) in 2003. The serum total PCB level (ng/g lipid) in women <40 years of age decreased significantly from 185 (1.8) in 1980 to 68 (1.8) in 2003. In contrast, the level in women >50 years of age increased significantly from 125 (1.7) in 1980 to 242 (1.7) in 2003. Specifically, the serum concentrations of hexa (#138, #146, #153, #156, #163, and #164) and hepta (#170, #180, #182, and #187) congeners increased significantly. A comparison of the serum PCB levels of women born from 1940 to 1953 revealed that their serum total PCB level was significantly higher in the 2003 survey [242 (1.7), n = 9] than in the 1995 [128 (2.0), n = 17] surveys. This increase in the total PCB level was attributable to increases in the hepta congener groups.

CONCLUSIONPresent results suggest a decreased rate of elimination of hepta congeners with aging in females, rather than a birth-generation phenomenon.