Uremic pruritus is a very common and frustrating condition for both patients and clinicians because no treatment has been demonstrated to be effective in relieving the itch. In this report, nalfurafine, a new -opioid receptor agonist, was used to treat uremic pruritus in patients who were undergoing routine hemodialysis. Two multicenter, randomized, double-blind, placebocontrolled studies enrolled 144 patients with uremic pruritus to postdialysis intravenous treatment with either nalfurafine or placebo for 2 to 4 wk. A meta-analysis approach was used to assess the efficacy of nalfurafine. Statistically significant reductions in worst itching (P ؍ 0.0212), itching intensity (P ؍ 0.0410), and sleep disturbances (P ؍ 0.0003) were noted in the nalfurafine group as compared with placebo. Improvements in itching (P ؍ 0.0025) and excoriations (P ؍ 0.0060) were noted for the nalfurafine-treated patients. Nalfurafine showed similar types and incidences of drug-related adverse events as did placebo. Nalfurafine was shown to be an effective and safe compound for use in this severely ill patient population. U remic pruritus has a major impact on the quality of life in patients who already have a compromised lifestyle (1-5). It is, of itself, not a life-threatening condition; however, it is known to contribute to an increase in morbidity (6) and mortality (7) of uremic patients. The only current definitive treatment for uremic pruritus is successful renal transplantation (8). Increasing the dialysis dose as well as implementing other therapeutic measures to lessen the symptoms, some as extraordinary as acupressure, (9) have provided only limited effectiveness in dialysis patients.Stimulation of the -opioid receptor in the brain and/or peripheral nerve endings by its agonists, such as morphine, can result in itching (10 -12). -Opioid receptor antagonists can inhibit itching induced by substance P (13). -Opioid stimulation inhibits -receptor effects both centrally and peripherally (11). Nalfurafine, a new -opioid receptor agonist, was effective in reducing the scratching behavior induced by an injection of substance P in the mouse model (13,14). From these findings, it was hypothesized that uremic pruritus could be triggered and sustained by the release of substance P (15). This led to the studies in the treatment of uremic pruritus using nalfurafine. Materials and Methods Study Design and TreatmentsTwo multicenter, randomized, double-blind, placebo-controlled clinical studies were performed with the common objective of assessing the efficacy and the safety of nalfurafine, as compared with placebo, in the treatment of uremic pruritus. The inclusion and exclusion criteria and the evaluations, methods of evaluations, and times of evaluations were the same in both studies.Patients were males and females who were at least 18 yr of age and undergoing routine hemodialysis secondary to ESRD and had severe, uncontrolled pruritus caused only by ESRD. Female patients were not of childbearing potential or were using an acceptab...
Routine biomarker results from hospital laboratory information systems, covering hospitals and general practitioners, in Denmark are available to researchers through access to the regional Clinical Laboratory Information System Research Database at Aarhus University and the nationwide Register of Laboratory Results for Research. This review describes these two data sources. The laboratory databases have different geographical and temporal coverage. They both include individual-level biomarker results that are electronically transferred from laboratory information systems. The biomarker results can be linked to all other Danish registries at the individual level, using the unique identifier, the CPR number. The databases include variables such as the CPR number, date and time (hour and minute) of sampling, NPU code, and name of the biomarker, identification code for the laboratory and the requisitioner, the test result with the corresponding unit, and the lower and upper reference limits. Access to the two databases differs since they are hosted by two different institutions. Data cannot be transferred outside Denmark, and direct access is provided only to Danish institutions. It is concluded that access to data on routine biomarkers expands the detailed biological and clinical information available on patients in the Danish healthcare system. The full potential is enabled through linkage to other Danish healthcare registries.
PI and RI correlated to the severity of the renal disease, as reflected by the rate of decline in reciprocal serum creatinine during antihypertensive treatment. The median RI or PI value could separate the patients into groups one of slow and another of fast progression.
We present the complete maps of five Mycoplasma hominis genomes, including a detailed restriction map and the locations of a number of genetic loci. The restriction fragments were resolved by field inversion gel electrophoresis or by the contour-clamped homogeneous-electric-field system of pulsed-field gel electrophoresis. All
Antibodies to hepatitis C virus (anti-HCV) were determined in an unselected group of 340 patients with chronic renal failure treated with maintenance dialysis. A second generation hepatitis C virus (HCV) enzyme-linked immunosorbent assay (ELISA) was used and confirmation made by a second generation recombinant immunoblot assay (RIBA). Sixteen patients (4.7%) were anti-HCV positive and 8 (2.4%) were anti-HCV indeterminate. All anti-HCV positive and anti-HCV indeterminate patients had received blood transfusions. No statistically significant differences were found between anti-HCV positive and indeterminate patients considering blood transfusions, dialysis and liver disease. The combined group of anti-HCV positive and indeterminate patients had had more blood transfusions (P < 0.005) and had been on dialysis for a longer period (P < 0.01) compared with anti-HCV negative patients. Further, significant correlation with elevation of transaminases and anti-HCV was observed (P < 0.001). Thirty patients (8.8%) had elevated transaminase levels and 13 (43%) of these were anti-HCV positive or indeterminate. In conclusion, HCV infection accounts for a substantial proportion of liver disease in dialysis patients, probably most often transmitted by blood transfusions but other routes of transmission could not be excluded.
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