Objective : To detect signals of potential drug adverse events (DAEs) through data mining of health insurance claims.
Design and Data : Retrospective observational study. The data used were the database of health insurance claims collected and maintained by the Japan Medical Data Center consisting of 312, 797 medical and pharmaceutical claims in one year (August 2003 through July 2004) linked uniquely for 35, 410 patients using an encryption technique to ensure privacy.
Methods : We counted all combinations (cross product or Cartesian product) of drugs and diagnoses appearing in the same claims and counted the number of times a given drug was prescribed preceding the suspected diagnosis in all combinations of the drug and the diagnosis appearing in a claim, i.e., the prescription date precedes the diagnosing date (the preceding number). We calculated the expected preceding number from the overall prevalence of drugs and diagnoses, and then calculated the observed and expected ratio, which was used as the signal indices. We calculated the signal indices on the health insurance claims data to detect DAEs of psychiatric drugs.
Results : Amoxapine and trazodone HCL showed high signal indices with paralytic ileus and convulsion (epilepsy) as documented in their package inserts. However, paroxetine HCL and etizolam showed high signal indices with these potential adverse events although no such DAEs are documented in their package inserts.
Conclusions : The undocumented high signal indices observed between the drugs and diagnoses indicate the potential DAEs and warrant in-depth pharmacovigilance. Given the strength of health insurance claims with a well-defined source population and accurate drug exposure, the proposed signal index will likely prove to be an effective data mining technique when combined with nested case-control analysis and counter-matching.

A 62-year-old woman was admitted to our hospital because of dextrocardia on her chest X-ray film. She had been in good health though the X-ray abnormality had been pointed out from her childhood. Echocardiogram, magnetic resonance imaging, and cardiac catheterization revealed situs inversus, congenitally corrected transposition of the great arteries, and severe tricuspid valve (systemic atrioventricular valve) regurgitation with mild systemic ventricular dysfunction. The surgeon stood on the patient's left side during the operation. On cardiopulmonary bypass, the tricuspid valve, facing almost dorsally, was exposed through a superior transseptal approach. Tricuspid valve replacement with a mechanical valve was performed with leaflet preservation. Systemic ventricular function is preserved at one year after operation.

Introduction: The importance of estimating the prognosis of advanced cancer patients is well known, but clinicians do not estimate survival time accurately. Since there is a need for an objective index to estimate survival time, the utility of the Prognostic Nutritional Index (PNI), which depends only on objective factors, was evaluated. Methods: The PNI was calculated using the following formula, PNI=10×serum albumin value (g/dL)+0.005×lymphocyte count in peripheral blood, at 3 months, 2 months, 1 month, 3 weeks, 2 weeks, 1 week, and within 3 days before death in 278 cancer patients (166 men, 112 women; age range, 33-99 years; mean age, 69.8 years) who died in a hospital surgical unit. Results: Sites of primary diseases included lung, breast, esophagus, stomach, colorectum, liver, biliary tract, and pancreas. The PNI values showed a gradual decrease over time. Changes in the PNI values were lower in non-gastrointestinal cancer patients than in gastrointestinal cancer patients. The mean PNI value was significantly higher in patients who lived >3 weeks (38.8) than in those who died within 3 weeks (32.4). When the PNI cut-off point was set at 35, and it was assumed that the life expectancy was within 3 weeks in cases with PNI <35, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 74.8%, 62.2%, 68.1%, and 69.6%, respectively. Discussion: The PNI appears to be a useful and simple parameter to predict clinical outcomes of patients with terminal stage cancer. Particularly, the PNI is considered feasible for gastrointestinal cancer patients.

A 36-year-old man underwent direct closure of an atrial septal defect through median sternotomy at the age of 14. He also underwent a mitral valve replacement with tricuspid annuloplasty using the same approach at the age of 18. The patient also presented with pretibial edema and congestive liver disease at the age of 27 and the pretibial edema progressed at the age of 35. Hypoalbuminemia (TP ; 3.6 g/dl, Alb ; 1.6 g/dl) was also observed. Further examinations were performed, which revealed that the right ventricular pressure curve presented a dip and plateau pattern by cardiac catheterization. Computed tomography of the chest additionally revealed thickened and calcified pericardium in the left ventricle. Abdominal scintigraphy showed tracer accumulation in the transverse colon hepatic flexure 4 h after intravenous administration of technetium-99m-labelled human serum albumin. The patient was diagnosed with a protein-losing gastroenteropathy caused by constrictive pericarditis. He underwent pericardiectomy via left anterior thoracotomy without cardiopulmonary bypass. No complications were present after the surgery, and he was discharged after 46 postoperative days. Following his discharge from the hospital, the pretibial edema disappeared, and serum albumin levels gradually increased and normalized within 3 months after the surgery (TP 7.1 g/dl, Alb 4.2 g/dl).

As a screening tool for detecting latent pre-locomotive syndrome (latent pre-LS) in women over the age of 40, measuring handgrip strength with a cut-off value of 26 kg was proposed in a previous report. However, this screening method missed 22% of latent pre-LS. It would be beneficial to screen almost persons with latent pre-LS in community pharmacies. In this study, it was investigated whether screening using the combination of measuring handgrip strength and the questionnaire, “Loco-check,” which was proposed by the Japanese Orthopaedic Association, improved the detection of latent pre-LS in the same group mentioned above. Combining only one of the “Loco-check” questions, “I cannot put on a pair of socks while standing on one leg,” with the measurement of handgrip strength with the cut-off value of 26 kg, the detection of latent pre-LS was increased to 90.2%. The odds ratio was 9.72 in logistic regression analysis. Using the combination of the measurement of handgrip strength and the response to one question is both rapid and convenient. Therefore, in this study, this screening combination is proposed to be a useful tool in community pharmacies for detecting early latent pre-LS.