Postmarketing Benefit-Risk Assessment for Erythropoiesis-Stimulating Agents Using a Health Care Database.

Background: While benefit-risk (B-R) assessment in the real-world setting is an important challenge for pharmacovigilance, few studies have explored this approach. To investigate the utility and limitations of B-R assessment using a health care database by applying the Benefit Risk Action Team (BRAT) framework, we have conducted a case study with erythropoietin agents.

Methods: Postmarketing data from the Medical Data Vision health care database were used in a B-R comparison between methoxy polyethylene glycol-epoetin beta (continuous erythropoietin receptor activator; C.

Aerobic exercise improves insulin resistance and decreases body fat and serum levels of leptin in patients with hepatitis C virus.

Aim:   Hepatitis C virus infection often complicates glucose intolerance, which can be caused by insulin resistance. Aerobic exercise can improve insulin resistance and decrease body fat in patients with diabetes. The aim of the present study is to clarify whether aerobic exercise improves insulin resistance and decreases body fat in patients with chronic hepatitis C (CH-C).

Sustained virological response of patients with hepatitis C virus genotype 2 depends on pegylated interferon compliance.

Aim:   Patients infected with hepatitis C virus (HCV) genotype 2 are more sensitive to interferon (IFN) therapy than those infected with genotype 1, but 10-20% of patients do not achieve a sustained viral response (SVR) to combination therapy with pegylated (PEG) IFN and ribavirin (RBV). This study examines the prognostic factors associated with SVR in patients infected with HCV genotype 2 treated with PEG IFN and RBV.

Methods:   We treated 149 patients with chronic hepatitis C caused by HCV genotype 2.

Biochemical response to ursodeoxycholic acid predicts long-term outcome in Japanese patients with primary biliary cirrhosis.

Aim:   There is an ongoing need for predictors of long-term outcomes for patients with primary biliary cirrhosis (PBC). Biochemical response to ursodeoxycholic acid (UDCA) has been introduced to predict development of symptoms by our group (Ehime criteria) and to predict long-term outcomes in Western countries (Paris, Barcelona and Rotterdam criteria). The aim of this study was to evaluate whether these criteria are also useful to predict long-term outcomes in Japanese patients with PBC.

Prospective study of chronic hepatitis C treated with reduced initial ribavirin dose.

Background/aims: We prospectively examined the effects of a reduced initial dose of ribavirin (RBV) combined with pegylated interferon (Peg-IFN) to prevent RBV discontinuation due to adverse events in patients with chronic hepatitis C (CH-C) infection aged > 60y or with low hemoglobin values.

Methodology: We enrolled 42 patients with hepatitis C virus (HCV) serotype 1. Twenty-one of them with hemoglobin values < 14g/dl or who were aged > 60y comprised group A.

Liver fibrosis in patients with chronic hepatitis C: noninvasive diagnosis by means of real-time tissue elastography--establishment of the method for measurement.

Purpose: To prospectively measure liver stiffness with real-time tissue elastography in patients with chronic hepatitis C and to compare the results with those of clinical assessment of fibrosis by using histologic stage as the reference standard.

Materials And Methods: All subjects gave informed consent, and the study was approved by the institutional ethics committee. Seventy hospitalized patients (46 men, 24 women; mean age, 65.

Diabetes pattern on the 75 g oral glucose tolerance test is a risk factor for hepatocellular carcinoma in patients with hepatitis C virus.

Background: Patients with hepatitis C virus (HCV) frequently show glucose intolerance. Diabetes mellitus (DM) has been proposed to be a risk factor for hepatocellular carcinoma (HCC).

Aims: The aim of this study is to clarify the influence of glucose intolerance as evaluated by the 75 g oral glucose tolerance test (OGTT) on hepatocarcinogenesis in patients with HCV.

Neuropsychiatric dysfunction in patients with chronic hepatitis and liver cirrhosis.

Aim: The aim of this study is to clarify the cerebral functions in patients with chronic hepatitis (CH) as well as those with liver cirrhosis (LC).

Methods: We studied 58 patients with CH (20 in fibrosis stage F1, 20 in F2, 18 in F3), 77 with LC (46 rated as Child-Pugh class A, 24 as B, 7 as C), and 20 healthy volunteers (HV). Computer-aided quantitative neuropsychiatric function test systems, including eight neuropsychiatric tests were performed.

Hepatitis C virus replication is inhibited by 22beta-methoxyolean-12-ene-3beta, 24(4beta)-diol (ME3738) through enhancing interferon-beta.

Unlabelled: A derivative of soyasapogenol, 22beta-methoxyolean-12-ene-3beta, 24(4beta)-diol (ME3738), ameliorates liver injury induced by Concanavalin A in mice. We examined whether ME3738 has independent antiviral effects against hepatitis C virus (HCV) using an established HCV replication model that expresses the full-length genotype 1a HCV complementary DNA plasmid (pT7-flHCV-Rz) under the control of a replication-defective adenoviral vector expressing T7 polymerase. Hepatocellular carcinoma (HepG2) cells, human hepatoma (Huh7) cells, or monkey kidney (CV-1) cells were transfected with pT7-flHCV-Rz, and infected with adenoviral vector expressing T7 polymerase.

Wilms' tumour 1 gene expression is increased in hepatocellular carcinoma and associated with poor prognosis.

Background/aims: Wilms' tumour 1 gene (WT1) was originally isolated as a tumour-suppressor gene. We investigated the expression of WT1 in hepatocellular carcinoma (HCC; T) and in non-cancerous hepatic tissues (non-tumour: NT) from patients with chronic liver diseases, and then examined the role of WT1 in the carcinogenesis or prognosis of HCC.

Methods: The expression of WT1 in T and NT from 50 patients with HCC was investigated using Western blotting, immunohistochemistry and real-time reverse transcriptase-polymerase chain reaction (RT-PCR).

Budd-Chiari syndrome associated with hypereosinophilic syndrome; a case report.

A 27-year-old man was admitted due to abdominal fullness. He had ascites and subcutaneous nodules on his head, with liver dysfunction and eosinophilia. Abdominal imaging revealed obstruction of the hepatic veins and stenosis of the inferior vena cava.

[Treatment of respiratory and urinary tract infections in elderly inmates at a nursing home by selective antimicrobial agents based on the sensitivity of the isolated bacteria].

Objectives: Elderly patients living in nursing homes can easily find themselves unable to carry out their daily activities, once they become ill, even with infectious diseases of a slight to mild degree, and rapid treatment is required to cure them of their malaise. However, treatment is often difficult due to the presence of drug-resistant bacteria. This study was designed to evaluate the efficacy of the selective use of antimicrobial agents based on a sensitivity test of isolated bacteria.

[Drug-resistant bacteria isolated from pharyngeal swab cultures and urine in acutely or chronically febrile elderly nursing home inmates].

Aim: Patients in nursing homes are becoming more and more elderly and also prone to infectious diseases. It is important to select proper antimicrobial agents in treating such patients because of the increase in drug-resistant bacteria in recent years.

Methods: Pathogenic aerobic bacteria were isolated from cultures of the pharyngeal swab obtained from patients with acute febrile episodes and those with chronic febrile conditions with a repetition of fever or continuing low-grade fever.

Characteristics of lamivudine-resistant hepatitis B virus (HBV) strains with and without breakthrough hepatitis in patients with chronic hepatitis B evaluated by serial HBV full-genome sequences.

Lamivudine therapy often causes breakthrough of hepatitis B virus (HBV) DNA and breakthrough hepatitis. The aim of this study was to determine the viral factors that relate to HBV-DNA breakthrough with and without breakthrough hepatitis. Among 82 patients with chronic hepatitis B (CHB) who received lamivudine at a dose of 100 mg daily for more than 24 months, 23 patients had HBV-DNA breakthrough induced by a lamivudine-resistant mutant.

Diabetes mellitus reduces the therapeutic effectiveness of interferon-alpha2b plus ribavirin therapy in patients with chronic hepatitis C.

Aim: Patients with chronic hepatitis C (CHC) often have diabetes mellitus (DM). However, it is unknown whether DM affects patient response to interferon (IFN) plus ribavirin therapy. Therefore, the aim of this study was to examine the influence of DM on the outcome of IFN-alpha2b plus ribavirin therapy.

Anti-HBs-positive liver failure due to hepatitis B virus reactivation induced by rituximab.

A 59-year-old man developed acute hepatitis with reactivated hepatitis B virus (HBV) following administration of rituximab (anti-CD20 monoclonal antibody). The patient was diagnosed with malignant lymphoma in 1998, and virus marker testing indicated HBV surface antigen (HBsAg)-negative and anti-HBs antibody (anti-HBs)-positive results when chemotherapy including rituximab was started. Levels of aminotransferases were elevated, and HBsAg results turned positive.

Pleomorphic carcinoma of the lung associated with loss of heterozygosity of p53 gene.

We report a case with pleomorphic carcinoma of the lung in a 70-year-old man. Pleomorphic carcinoma is characterized by a heterogenous composition that includes epithelial and mesechymal malignancies. In the present case, the tumor was composed of a mixture of unequivocal squamous cell carcinoma and spindle cell components resembling sarcomatous overgrowth.

Long-term survivors after resection of carcinoma of the head of the pancreas: significance of histologically curative resection.

Background/purpose: The prognosis of patients with pancreatic cancer is said to have not been improved markedly by any procedures in the past 20 years. Since 1973, we have gradually extended the area of dissection when performing curative resection for pancreatic cancer to improve the resection rate and prognosis. Nineteen patients have survived for 3 years or more, and the 5-year survival rates of patients with cancer of the head of the pancreas were 23.

Comparison of eight- versus 16-slice multidetector-row computed tomography for visibility and image quality of coronary segments.

Ten patients who underwent conventional coronary angiography (CA) were examined with both 8- and 16-slice multidetector-row computed tomography (MDCT) angiography within 6 months, and visibility and image quality of 16-slice MDCT-CA were compared with those of 8-slice MDCT-CA directly. In 136 segments determined by conventional CA, 101 (74.3%) and 126 (92.

Renal transplant recipient with chronic hepatitis C who obtained sustained viral response after interferon-beta therapy.

A 44-year-old Japanese woman with a history of living-related renal transplantation was treated with interferon-beta (IFN-beta) for chronic infection with sero-group 2 hepatitis C virus (HCV). Serum HCV-RNA titer was 160 kilo-international units/ml. Treatment with intravenous IFN-beta daily was given for 6 weeks.

Gianotti-Crosti syndrome caused by acute hepatitis B virus genotype D infection.

A 12-year-old girl with Gianotti-Crosti syndrome caused by hepatitis B virus (HBV) infection was admitted due to eruption on her extremities. Laboratory findings revealed elevation of transaminase, positivity for HB surface antigen (HBsAg), and an IgM type anti-HB core. The eruption and level of transaminase improved, and HBsAg became negative within 2 months of onset.

Expression of dihydropyrimidine dehydrogenase in cancer cells but not in stromal cells predicts the efficacy of fluorouracil treatment in patients with gastric carcinoma.

Background: It is not known whether immunohistochemical quantification of dihydropyrimidine dehydrogenase (DPD) in cancer cells, stromal mononuclear cells and normal glands predicts the efficacy of fluorouracil (FU) derivatives inpatients with T3 gastric adenocarcinoma.

Materials And Methods: The levels of DPD in cancer cells, stromal cells and normal glands were measured immunohistochemically in 111 patients with T3 gastric carcinoma. Adjuvant chemotherapy with oral UFT (uracil/tegafur[4:1]) was administered to 95 patients for more than 1 year after surgery.

CCR5 promoter polymorphism influences the interferon response of patients with chronic hepatitis C in Japan.

Objective: Chemokines and chemokine receptors play important roles in the pathogenesis of chronic hepatitis C. Here, we explore the influence of genetic polymorphisms of chemokine and chemokine receptors such as regulated upon activation and T cell secreted (RANTES), CC chemokine receptor 5 (CCR5) and CCR2 on the outcome of interferon (IFN) monotherapy.

Methods: In a cohort of 105 patients with chronic hepatitis C as well as in 50 sustained responders and 55 nonresponders the presence of polymorphisms such as CCR5-Delta32, CCR5 59029G/A, CCR2 V64I and RANTES -403G/C was determined.

Comparison of visibility and diagnostic capability of noninvasive coronary angiography by eight-slice multidetector-row computed tomography versus conventional coronary angiography.

The usefulness of multidetector-row computed tomography (MDCT) for visualization of coronary arteries has been reported; however, little is known about the diagnostic capability of noninvasive coronary angiography (CA) using 8-detector row CT. We investigated the visualization and diagnostic values of 8-slice MDCT-CA. Twenty-five consecutive patients who underwent conventional CA were investigated.

Longitudinal optical imaging study for locomotor recovery after stroke.

Background And Purpose: We sought to investigate cerebral mechanisms underlying locomotor recovery after stroke.

Methods: We measured cortical activities during hemiparetic gait on the treadmill before and after 2 months of inpatient rehabilitation in 8 patients with initial stroke (5 men, 3 women; 4 with right and 4 with left hemiparesis; aged 57 years; 3 months after stroke on average), using an optical imaging system.

Results: On the initial evaluation, hemiparetic gait was associated with increased oxygenated hemoglobin levels in the medial primary sensorimotor cortex (SMC) that were greater in the unaffected hemisphere than in the affected hemisphere as well as in the premotor cortex (PMC) and supplementary motor area.