Effect of beraprost sodium on arterial stiffness in patients with type 2 diabetic nephropathy

Trial registration : ClinicalTrials.gov number NCT01796418Background : Diabetic nephropathy is the leading cause of end-stage renal disease (ESRD). Cardiovascular (CV) complications are the most common cause of death among ESRD patients. Beraprost sodium (BPS) is a prostacyclin analog with vasodilatory and antiplatelet effects. Methods : This is a multicenter prospective, randomized, double-blind, placebo-controlled trial to determine whether treatment with BPS improves arterial stiffness in patients with type 2 diabetic nephropathy. A total of 102 participants with type 2 diabetic nephropathy will be screened, enrolled, and randomly assigned to receive either 80 μg BPS or placebo daily for 12 weeks. The primary outcome is the change in brachial-ankle pulse wave velocity between baseline and after 12 weeks of medication use. The secondary outcomes will include changes in the ankle-brachial index, the urine albumin to creatinine ratio, the estimated glomerular filtration rate, lipid profiles, and blood pressure from baseline to after treatment. Discussion : This clinical trial is the first to investigate the effects of BPS on changes in CV biomarkers, albuminuria, renal function, and lipid profiles in patients with diabetic nephropathy.Peer Reviewe

Force-sensitive resistors to measure the distribution of weight in the pads of sound dogs in static standing position

The purpose of this study was to measure how weight is distributed in the pads of each of the 4 limbs of dogs and evaluate the intra-investigator reproducibility and inter-investigator reliability of the measurement method. Eight dogs were examined 3 times a day by 3 investigators at 1 week intervals for 3 weeks to determine the weight distribution to each of the pads. The force-sensitive resistor was used for measurement and specific software (PetLAB2) was used to calculate the weight applied to each pad. The intra-investigator reproducibility showed moderate to good reliability (ICC range, 0.575-0.873) and the inter-investigator reliability was moderate (ICC range, 0.525-0.746). Based on this study, it can be observed whether the weight distributed to each pad approaches the normal value after treatment in patients with orthopaedic and neurologic diseases. It is expected that this experimental method will be one of the objective indicators to evaluate the degree of recovery in patients with orthopaedic and neurologic diseases

Factors affecting the long-term outcomes of idiopathic membranous nephropathy

Abstract Background We attempted to describe the clinical features and determine the factors associated with renal survival in idiopathic membranous nephropathy (iMN) patients with nephrotic syndrome (NS) and to determine the factors associated with spontaneous complete remission (sCR) and progression to NS in iMN patients with subnephrotic proteinuria. Methods This retrospective study involved 166 iMN patients with NS and 65 patients with subnephrotic proteinuria. The primary end point was a doubling of serum creatinine or initiation of dialysis. In patients with subnephrotic proteinuria, we determined the factors associated with sCR and factors associated with progression to NS. Results Remission of NS was achieved in 125 out of 166 patients (75.3%). Of those who reached remission, 26 patients (20.8%) experienced relapse that was followed by second remission. The relapse or persistence of proteinuria was associated with the primary end points (hazard ratio [HR] = 12.40, P = 0.037, HR = 173, P < 0.001, respectively). In patients with subnephrotic proteinuria, sCR occurred in 35.4% of the patients. The patients with sCR had lower proteinuria and serum creatinine levels and higher serum albumin concentrations at baseline. The serum albumin level at diagnosis was a prognostic factor for progression to NS (Odds ratio [OR] = 0.015, P < 0.001). Conclusions The occurrence of relapse or persistence of proteinuria had negative effects on renal survival in iMN patients with NS, and low serum albumin levels at baseline were associated with non-achievement of sCR and progression to NS

Estimating the Biases of the Korean National Cholesterol Proficiency Test

It is recommended that clinical laboratories keep the bias of serum total cholesterol analysis at <= 3.0% compared to a reference method. In Korea, national cholesterol proficiency testing has long been available, but there has been little information about the magnitude of analytical bias. The authors calculated the bias of the peer group mean for Korea`s national cholesterol proficiency test through an indirect approach that overcomes the potential matrix effect of proficiency test materials. One laboratory was selected among the proficiency test participants to represent Korean laboratories. Total cholesterol levels of six fresh serums spanning a wide range of concentrations were measured by the representative laboratory and three reference laboratories. The relationship between the proficiency test mean and the reference method mean was established by linear regression analysis. The peer group mean of the proficiency test was calculated to have a bias of +2.4 to +2.5% at the medical decision levels. When grouped by instrument and reagent, 29 to 66% of the laboratories showed biases < 3.0%. Thus it was determined that the peer group mean of the Korean cholesterol proficiency test has an acceptable level of positive bias. The indirect approach used in this study provides a practical model for estimating cholesterol analytical bias for proficiency testing.Ross JW, 1998, ARCH PATHOL LAB MED, V122, P587MYERS GL, 2000, CLIN CHEM, V46, P762Cleeman JI, 2001, JAMA-J AM MED ASSOC, V285, P2486, DOI 10.1001/jama.285.19.2486BROTONS C, 2003, EUR J GEN PRACT, V9, P124SHIN HH, 2003, KOR J LIPIDOL, V12, P226MIN WK, 2006, J LAB MED QUAL ASSUR, V28, P1MIN WK, 2007, J LAB MED QUAL ASSUR, V29, P1Teramoto T, 2007, J ATHEROSCLER THROMB, V14, P45MIN WK, 2008, J LAB MED QUAL ASSUR, V30, P1Stockl D, 1996, CLIN CHEM, V42, P469ROSS JW, 1993, ARCH PATHOL LAB MED, V117, P393*NIH, 1993, NIH PUBL*BUR INT POIDS MES, 2009, DAT HIGH ORD REF MAT*CDCP DIV LAB SCI, 2009, CHOL REF METH LAB NEELLERBE P, 1990, CLIN CHEM, V36, P370

Isolated Double-Chambered Right Ventricle in a Young Adult

Double-chambered right ventricle (DCRV) is a rare congenital heart disorder in which the right ventricle is divided by an anomalous muscle bundle into a high pressure inlet portion and a low pressure outlet portion. We report a case of isolated DCRV without symptoms in adulthood, diagnosed through echocardiography, cardiac catheterization and cardiac magnetic resonance imaging

Dose selection method for pharmacokinetic study in hemodialysis patients using a subpharmacological dose: oseltamivir as a model drug

BACKGROUND: Dose selection is an important step in pharmacokinetic (PK) studies of hemodialysis patients. We propose a simulation-based dose-selection method for PK studies of hemodialysis patients using a subpharmacological dose of oseltamivir as a model drug. METHODS: The concentrations of oseltamivir and its active metabolite, oseltamivir carboxylate (OC), were measured by liquid chromatography-tandem mass spectrometry. To determine a low oseltamivir dose exhibiting PK linearity, a pilot low dose determination investigation (n = 4) was performed using a single administration dose-escalation study. After the dose was determined, a low dose study (n = 10) was performed, and the optimal dose required to reach the hypothetical target OC exposure (area under the concentration-time curve [AUC] of 60,000 ng · hr/mL) was simulated using a nonparametric superposition method. Finally, observed PKs at the optimal dose were compared to the simulated PKs to verify PK predictability. RESULTS: In the pilot low dose determination study, 2.5 mg of oseltamivir was determined to be the low dose. Subsequently, we performed a single-dose PK study with the low oseltamivir dose in an additional group of 10 hemodialysis patients. The predicted AUC(last) of OC following continuous oseltamivir doses was simulated, and 35 mg of oseltamivir corresponded to the hypothetical target AUC(last) of OC. The observed PK profiles of OC at a 35-mg oseltamivir dose and the simulated data based on the low dose study were in close alignment. CONCLUSION: The results indicate that the proposed method provides a rational approach to determine the proper PK dose in hemodialysis patients