Application of a Japanese insurance claims database to pharmacovigilance activities in pharmaceutical industry was discussed. Using a commercially available insurance claims database, incidences of several cancers, the number of patients who were administered anticancer agents, and possible adverse effects were studied. Cancer incidences obtained from the database were virtually equivalent to those from a traditional survey program. The number of cancer patients included in the database with one million beneficiaries, were a few thousands a year. Disorders in epithelial-derived tissue were observed more frequently in lung cancer patients after the initiation of EGF tyrosine kinase inhibitor therapy than after platinum-based therapy, suggesting possible candidates of adverse effects of the EGF tyrosine kinase. We concluded that an estimation of disease incidence and selecting candidates of adverse events with the claims database is theoretically possible. And the database is also applicable to pharmacovigilance fields. (Jpn J Pharmacoepidemiol 2012; 17(2): 145-153)

Since the Infection Control Team (ICT) was organized in 1999, our hospital has been engaged in evidence-based operations against nosocomial infections. The ICT's major activities included guidance in preventive measures against infections, surveillance involving continuous environmental monitoring, proposition as regards prescription of antibacterial medicines, and consultation with clinicians about prophylaxis. The team comprising physicians, nurses, pharmacists and clinical laboratory technicians has made expert propositions to clinicians. To be concrete, the team members, with the liaison clerk playing a central role, met with physicians in charge or with other staff members of the hospital, studied the infection cases in question, and presented the study findings to the clinicians. Fundamentally, therefore, it is not that the ICT intervenes in the affairs of the clinical department by way of directions but that it presents clinicians with the ideas gained through discussion between ICT members and physicians and other hospital staffers. While cementing a relationship of mutual trust between hospital employees, the ICT is expected to engage in nosocomial infection prevention activities by joining forces transdeoartmentally.
Clinical ; Hospitals ; Infection Control ; seconds ; Prophylactic

BACKGROUND/AIMS: To determine the nutritional markers important for assessing the degree of pancreatic insufficiency due to chronic pancreatitis in routine clinical practice. METHODS: A total of 137 patients with chronic pancreatitis were followed up for more than 1 year. They were divided into two groups: a pancreatic diabetes mellitus (DM) group, consisting of 47 patients undergoing medical treatment for DM of pancreatic origin, and a nonpancreatic DM group, consisting of 90 other patients (including 86 patients without DM). Serum albumin, prealbumin, total cholesterol, cholinesterase, magnesium, and hemoglobin were compared between the two groups. RESULTS: The total cholesterol was significantly lower in the pancreatic than the nonpancreatic DM group (164 mg/dL vs 183 mg/dL, respectively; p=0.0028). Cholinesterase was significantly lower in the former group (263 U/L vs 291 U/L, respectively; p=0.016). Among the 37 patients with nonalcoholic pancreatitis, there was no difference in the cholinesterase levels between the pancreatic and nonpancreatic (296 U/L vs 304 U/L, respectively; p=0.752) DM groups, although cholesterol levels remained lower in the former (165 mg/dL vs 187 mg/dL, respectively; p=0.052). CONCLUSIONS: Cholinesterase levels are possibly affected by concomitant alcoholic liver injury. The total cholesterol level should be considered when assessing pancreatic insufficiency due to chronic pancreatitis.
Adult ; Aged ; Aged, 80 and over ; Cholesterol/*blood ; Cholinesterases/blood ; Diabetes Mellitus, Type 2/complications ; Exocrine Pancreatic Insufficiency/*blood/etiology ; Female ; Follow-Up Studies ; Humans ; Liver Cirrhosis, Alcoholic/blood ; Male ; Middle Aged ; Nutritional Status ; Pancreas/enzymology ; Pancreatitis, Alcoholic/blood/complications ; Pancreatitis, Chronic/blood/*complications ; Serum Albumin/analysis

BACKGROUND/AIMS: Stent migration occurs frequently, but the prevention of complications resulting from covered self-expandable metal stents (C-SEMSs) remains unresolved. We prospectively assessed a newly developed C-SEMS, a modified covered Zeo stent (m-CZS), in terms of its antimigration effect. METHODS: Between February 2010 and January 2011, an m-CZS was inserted into 42 patients (31 initial drainage cases and 11 reintervention cases) at a tertiary referral center and three affiliated hospitals. The laser-cut stent was flared for 1.5 cm at both ends, with a 1 cm raised bank located 1 cm in from each flared end. The main outcome of this study was the rate of stent migration, and secondary outcomes were the rate of recurrent biliary obstruction (RBO), the time to RBO, the frequencies of complications, and overall survival. RESULTS: Of the 31 patients with initial drainage, stent migration occurred in four (12.9%, 95% confidence interval, 5.1% to 29.0%), with a mean time of 131 days. RBO occurred in 18 (58%), with a median time to RBO of 107 days. Following previous C-SEMS migration, seven of 10 patients (70%) did not experience m-CZS migration until death. CONCLUSIONS: m-CZSs with antimigration properties effectively, although not completely, prevented stent migration after stent insertion.
Aged ; Aged, 80 and over ; Alloys ; Carcinoma/*complications ; Cholestasis/etiology/*therapy ; Digestive System Neoplasms/*complications ; Drainage ; Equipment Design ; Feasibility Studies ; Female ; Humans ; Kaplan-Meier Estimate ; Lymphatic Metastasis ; Male ; Middle Aged ; *Prosthesis Failure ; Recurrence ; Reoperation ; *Stents/adverse effects ; Time Factors

PURPOSE: The purpose of this study was to evaluate the reproducibility and validity of a short food frequency questionnaire (FFQ) for food group intake in Japan, the reproducibility and partial validity of which were previously confirmed for nutrients. METHODS: A total of 288 middle-aged healthy volunteers from 11 different areas of Japan provided nonconsecutive 3-day weighed dietary records (DRs) at 3-month intervals over four seasons. We evaluated reproducibility based on the first (FFQ1) and second (FFQ2) questionnaires and their validity against the DRs by comparing the intake of 20 food groups. Spearman's rank correlation coefficients (SRs) were calculated between energy-adjusted intake from the FFQs and that from the DRs. RESULTS: The intake of 20 food groups estimated from the two FFQs was mostly equivalent. The median energy-adjusted SRs between the FFQ1 and FFQ2 were 0.61 (range 0.38-0.86) for men and 0.66 (0.45-0.84) for women. For validity, the median de-attenuated SRs between DRs and the FFQ1 were 0.51 (0.17-0.76) for men and 0.47 (0.23-0.77) for women. Compared with the DRs, the proportion of cross-classification into exact plus adjacent quintiles with the FFQ1 ranged from 58 to 86% in men and from 57 to 86% in women. According to the robust Z scores and the Bland-Altman plot graphs, the underestimation errors in the FFQ1 tended to be greater in individuals with high mean levels of consumption for meat for men and for other vegetables for both men and women. CONCLUSION The FFQ demonstrated high reproducibility and reasonable validity for food group intake. This questionnaire is short and remains appropriate for identifying associations between diet and health/disease among adults in Japan.
Adult ; Aged ; Diet/statistics & numerical data* ; Diet Surveys ; Energy Intake ; Female ; Food/statistics & numerical data* ; Healthy Volunteers ; Humans ; Japan ; Male ; Middle Aged ; Reproducibility of Results