In Japan, large scale health databases were constructed in a few years, such as National health insurance claim and health checkup database(NDB) and Japanese Sentinel project. But the there are some legal issues for making adequate balance between privacy and public benefit by using such databases. NDB is carried based on the act for elderly person's health care but in this act, nothing is mentioned for using this database for general public benefit. Therefore researchers who use this database are forced to pay much concern about anonimization and information security that may disturb the research work itself. Japanese Sentinel project is a National project to detecting drug adverse reaction using large scale distributed clinical databases of large hospitals. Although patients give the future consent for general such purpose for public good, it is still under discussion using insufficiently anonymized data. Generally speaking, researchers of study for public benefit will not infringe patient's privacy, but vague and complex requirements of legislation about personal data protection may disturb the researches. Medical science does not progress without using clinical information, therefore the adequate legislation that is simple and clear for both researchers and patient is strongly required. In Japan, fortunately, the specific act for balancing privacy and public benefit is planned to lay before Diet, but is still under discussion. The author recommended the researchers including the field of pharmacoepidemiology should pay attention to, participate in the discussion of, and make suggestion to this act. (Jpn J Pharmacoepidemiol 2012; 17(2): 101-107)

Objective : To examine the association between the combination therapy of calcium antagonists with angiotensin converting enzyme (ACE) inhibitors and underlying diseases for hypertensive patients.
Design : Cross-sectional survey of the drug utilization.
Methods : This survey included 603 hypertensive patients who had visited Toyama Medical and Pharmaceutical University Hospital, Toyama, Japan more than twice from January to June in 1996 and received the prescriptions of calcium antagonists and/or ACE inhibitors. Main outcome measure was the combined medication of calcium antagonists with ACE inhibitors. Underlying diseases under consideration were diabetes mellitus (DM), hyperlipidemia (LIPID), ischemic heart disease (IHD), chronic heart failure (CHF), and ischemic stroke (STROKE).
Results : Out of 603 hypertensive patients, 57.5% received only calcium antagonists, 23.7% received only ACE inhibitors, and 18.7% received both of them. Patients with either IHD or CHF tended to receive the combination therapy as compared to DM or LIPID. Although men tended to receive the combination therapy, a gender effect might be a confounder for the association. Logistic regression showed a 33% increase (P=0.265) in frequency of the combination therapy in patients with IHD after adjusting for age and gender.
Conclusion : Some underlying diseases were associated with more frequent prescriptions of the combination therapy for hypertensive patients, especially with ischemic heart diseases. This result should be regarded as an exploratory stage although the pattern of antihypertensive drug use could be reasonably explained from the pharmacological sense.

Perivalvular leakage (PVL) is one of the serious complications of mitral valve replacement. Between 1991 and 2006, 9 patients with mitral PVL underwent reoperation. All of them had severe hemolytic anemia before surgery. The serum lactate dehydrogenase (LDH) level decreased from 2,366±780 IU/l to 599±426 IU/l after surgery. The site of PVL was accurately defined in 7 patients by echocardiography. PVL occurred around the posterior annulus in 3 patients, anterior annulus in 2, anterolateral commissure in 1, and posteromedial commissure in 1. The most frequent cause of PVL was annular calcification in 5 patients. Infection was only noted in 1 patient. In 4 patients, the prosthesis was replaced, while the leak was repaired in 5 patients. There was one operative death, due to multiple organ failure, and 4 late deaths. The cause of late death was cerebral infarction in 1 patient, subarachnoid hemorrhage in 1, sudden death in 1, and congestive heart failure (due to persistent PVL) in 1. Reoperation for PVL due to extensive annular calcification is associated with a high mortality rate and high recurrence rate, making this procedure both challenging and frustrating for surgeons.

Effects of 5 km running upon taking a low-carbohydrate, high-fat and protein diet on the body, in fourteen healthy young males and three healthy young females, all being affected by taurine inducement, were investigated by double blind test method. The results obtained were as follows ;
1) As to the degree of in heart rate upon 5 km running, in males, there were no differences between taurine administration group (M-group) and placebo administration group (P-group) . But in females, recordings in P-group were much larger than those of M-group.
2) As to the degree of increase in systolic blood pressure upon 5 km running, in males, no differences between both groups were observed, but in females, recordings in P-group were larger than those of M-group.
3) Both serum creatine kinase (CK) and creatine kinase isoenzyme (CK-MB) activities did not recover to pre-exercise levels during 3 days after 5 km running in both groups of both sexes.
4) In the rate of CK-MB against CK, not only P-group of females had extraordinary high levels immediately after 5 km running, but also P-group of both sexes had higher levels on 3rd and 5th day after 5 km runnning than M-group.
5) In both sexes P-group was larger than M-group in the degree of increase in blood lactate and serum triglyceride levels.
6) As to the changes in serum total protein levels, in males, no differences between both groups were observed, but in females, P-group had extraordinary low levels on 1st day after 5 km running and maintained low levels during 5 days recovery.
7) As to the changes in both serum total fatty acids levels and the rate of unsaturated fatty acids against total fatty acids, no differences were observed between both groups of both sexes.
8) As to the degree of increase in plasma noradrenalin and adrenalin levels, in males, no differences between both groups were observed, but in females, recordings in M-group were larger than those of P-group.

Background/Aims: The aim of this study was to evaluate the safety and efficacy of partially covered self-expandable metallic stents (PCSEMS) in patients undergoing neoadjuvant chemo (radio) therapy (NAC) for pancreatic cancer (PC). Methods: This was a prospective multicenter study to evaluate the safety and efficacy of PCSEMS in patients receiving NAC for resectable and borderline resectable PC. The primary endpoint was the rate of recurrent biliary obstruction (RBO). Results: Twenty-six patients with PC (three with resectable PC and 23 with borderline resectable PC) who underwent NAC at seven Japanese centers were included in the analysis. Both the technical and functional success rates of PCSEMS placement were 100%. Early stent-related complications were observed in three patients (11.5%): mild pancreatitis (n=2) and mild liver abscess (n=1). The median time to surgery or palliation was 4.0 months. Surgical resection was eventually performed in 73.1% of patients, and stent removal during surgery was successful in all patients. RBO was observed in nine patients (34.6%): seven with stent occlusion, one with kinking and one with migration. The RBO rates in resected cases and nonresected cases were 36.8% and 28.6%, respectively. Conclusions Biliary drainage by PCSEMS was safe and feasible in patients undergoing NAC for resectable and borderline resectable PC.

BACKGROUND/AIMS: Upper gastrointestinal symptoms are more frequent and severe in female than in male outpatients in Japan. This study compared the upper gastrointestinal symptoms between healthy male and female young adult volunteers using a questionnaire. METHODS: In total, 581 third-grade medical students at Saga Medical School aged 22 to 30 years underwent upper gastrointestinal endoscopy and completed a questionnaire (frequency scale for symptoms of gastroesophageal reflux disease) from 2007 to 2013. Of these 581 students, 298 who were negative for Helicobacter pylori infection and had no particular lesions on endoscopic examination were enrolled in the present evaluation. A symptom was defined as positive when the subject evaluated the frequency of the symptom as sometimes, often, or always. RESULTS: The subjects comprised of 163 males (average age, 23.7 years) and 135 females (average age, 23.1 years). Upper gastrointestinal symptoms were more frequent in the females (75 of 135, 55.6%) than males (69 of 163, 42.3%; P < 0.05), with a high score for 4 symptoms (bloated stomach, heavy feeling in the stomach after meals, subconscious rubbing of the chest with the hand, and feeling of fullness while eating meals). Of the 144 subjects (69 males and 75 females) who complained of these symptoms, the females complained of dysmotility symptoms more often than did the males, but this was not true for reflux symptoms. CONCLUSIONS: This study suggests that females develop upper gastrointestinal symptoms more frequently than do males among the young healthy Japanese population.
Asian Continental Ancestry Group* ; Dyspepsia ; Eating ; Endoscopy ; Endoscopy, Gastrointestinal ; Esophagitis ; Female* ; Gastroesophageal Reflux ; Gastrointestinal Motility ; Hand ; Helicobacter pylori ; Humans ; Japan ; Male* ; Meals ; Outpatients ; Schools, Medical ; Stomach ; Students, Medical ; Thorax ; Unconscious (Psychology) ; Volunteers* ; Young Adult