This Phase III, randomized, double-blind, placebo-controlled, parallel-group, prospective study based on VAS evaluations clearly showed that orally taken nalfurafine hydrochloride effectively reduced itches that were otherwise refractory to currently available treatments in maintenance haemodialysis patients, with few significant ADRs. This novel drug was officially approved for clinical use in January 2009 by the Ministry of Health, Labour and Welfare of Japan.
A nationwide statistical survey of 4098 dialysis facilities was conducted at the end of 2007, and 4052 facilities (98.88%) participated. The number of patients undergoing dialysis at the end of 2007 was determined to be 275 242, an increase of 10 769 patients (4.1%) compared with that at the end of 2006.The number of dialysis patients per million at the end of 2007 was 2154. The crude death rate of dialysis patients at the end of 2007 from the end of 2006 was 9.4%. The mean age of new patients begun on dialysis was 66.8 years and the mean age of the entire dialysis patient population was 64.9 years. For the primary diseases of new patients begun on dialysis, the percentages of patients with diabetic nephropathy and chronic glomerulonephritis were 43.4% and 23.8%, respectively. The percentages of facilities that achieved the control standard of endotoxin concentration in the dialysate solution of<0.05 EU/mL and those that achieved a bacterial count of <100 cfu/mL in the dialysate solution, as specified by the Japanese Society for Dialysis Therapy, were 93.6% and 97.4%, respectively. The percentage of patients positive for the hepatitis C virus antibody among the entire dialysis population significantly decreased from 15.95% at the end of 1999 to 9.83% at the end of 2007. The mean hemoglobin concentration in all the dialysis patients at the end of 2007 was 10.27 (+/-1.32, SD) g/dL, which has scarcely changed over the last three years. The numbers of male and female patients with a history of hip fracture were 142.9 and 339.0 per 10 000 dialysis patients, respectively, showing an extremely high prevalence among female patients. A history of hip fracture correlates with a low body mass index, serum albumin concentration, and a history of diabetes. The serum creatinine level of patients upon introduction to dialysis was 8.34 (+/-3.55) mg/dL, and the estimated glomerular filtration rate was 5.43 (+/-3.43) mL/min/1.73 m(2) for the patients who were newly begun on dialysis in 2007.
A nationwide statistical survey of 4255 dialysis facilities was conducted at the end of 2011. Responses were submitted by 4213 facilities (99.0%). The number of new patients started on dialysis was 38,613 in 2011. Although the number of new patients decreased in 2009 and 2010, it increased in 2011. The number of patients who died each year has been increasing; it was 30,743 in 2011, which exceeded 30,000 for the first time. The number of patients undergoing dialysis has also been increasing every year; it was 304,856 at the end of 2011, which exceeded 300,000 for the first time. The number of dialysis patients per million at the end of 2011 was 2385.4. The crude death rate of dialysis patients in 2011 was 10.2%, which exceeded 10% for the first time in the last 20 years. The mean age of new dialysis patients was 67.84 years and the mean age of the entire dialysis patient population was 66.55 years. The most common primary cause of renal failure among new dialysis patients was diabetic nephropathy (44.3%). Diabetic nephropathy was also the most common primary disease among the entire dialysis patient population (36.7%), exceeding chronic glomerulonephritis (34.8%) which had been the highest until last year. The survey included questions related to the Great East Japan Earthquake, which occurred on 11 March 2011. The results on items associated with the Great East Japan Earthquake were reported separately from this report. The mean uric acid levels of the male and female patients were 7.30 and 7.19 mg/dL, respectively. Certain drugs for hyperuricemia were prescribed for approximately 17% of patients. From the results of the facility survey, the number of patients who underwent peritoneal dialysis (PD) was 9642 and the number of patients who did not undergo PD despite having a peritoneal dialysis catheter was 369. A basic summary of the results on the survey items associated with PD is included in this report and the details were reported separately.
Encapsulating peritoneal sclerosis (EPS) is recognized as a serious complication of continuous peritoneal dialysis. A preliminary diagnosis of EPS is usually based on clinical signs and symptoms, which commonly include abdominal pain, nausea, vomiting, anorexia, abdominal fullness, an abdominal mass, bowel obstruction, and radiologic findings, including abdominal roentgenogram, contrast studies, ultrasound studies, and computed tomography. The diagnosis is confirmed by laparoscopy or laparotomy showing the characteristic gross thickening of the peritoneum enclosing some or all of the small intestine in a cocoon of opaque tissue. A variety of therapeutic approaches to EPS have been reported. This review discusses medical treatment of EPS and includes an overview of the clinical features and diagnostic aspects of the condition.
Background: Our previous placebo-controlled, prospective, double-blind study demonstrated that a new opioid ĸ-receptor agonist, nalfurafine hydrochloride, effectively reduced treatment-resistant pruritus in 337 hemodialysis patients. Thus, we designed this study to evaluate prospectively the efficacy, safety, addiction liability, and pharmacokinetics of nalfurafine given orally for 1 year. Methods: This open-label study examined the effects and adverse drug reactions (ADRs) of 52-week oral administration of nalfurafine hydrochloride (5 µg/day) in 211 hemodialysis patients with a treatment-resistant itch. Results: Of 211 patients, 145 completed the study as scheduled. The mean pruritus value assessed by the visual analogue scale was 75.2 mm during the pre-observation period, which decreased significantly to 50.9 and 30.9 mm in week 2 and 52, respectively, indicating a long-lasting efficacy. ADRs occurred in 103 patients (48.8%). Frequent ADRs were insomnia (sleep disturbance, 19.4%), constipation (7.1%) and increased blood prolactin (3.3%), similar to previous reports. Regarding addiction liability, it appeared unlikely that nalfurafine hydrochloride was abused. After the start of treatment, plasma drug levels reached a steady state in week 2 with no apparent tendency of systemic accumulation. Conclusions: Nalfurafine hydrochloride, orally administered at 5 µg/day for 52 weeks to hemodialysis patients, produced a long-term suppression of pruritus without significant safety problems.
This comprehensive update on the management of encapsulating peritoneal sclerosis incorporates insights gained from recently published findings and the accumulated experience of the authors. Aspects covered include diagnosis, risk factors and predictive markers, treatment, and prevention, including criteria for withdrawal from peritoneal dialysis.
Abstract:A nationwide statistical survey of 4124 dialysis facilities was conducted at the end of 2008 and 4081 facilities (99.0%) responded. The number of patients undergoing dialysis at the end of 2008 was determined to be 283 421, an increase of 8179 patients (3.0%) compared with that at the end of 2007. The number of dialysis patients per million at the end of 2008 was 2220. The crude death rate of dialysis patients from the end of 2007 to the end of 2008 was 9.8%. The mean age of the new patients begun on dialysis was 67.2 years and the mean age of the entire dialysis patient population was 65.3 years. For the primary diseases of the new patients begun on dialysis, the percentages of patients with diabetic nephropathy and chronic glomerulonephritis were 43.3% and 22.8%, respectively. Among the facilities that measured bacterial count in the dialysate solution in 2008, 52.0% of facilities ensured that a minimum dialysate solution volume of 10 mL was sampled.Among the patients treated by facility dialysis, 95.4% of patients were treated three times a week, and the average time required for one treatment was 3.92 Ϯ 0.53 (SD) h. The average amounts of blood flow and dialysate solution flow were 197 Ϯ 31 and 487 Ϯ 33 mL/min, respectively. The number of patients using a polysulfone membrane dialyzer was the largest (50.7%) and the average membrane area was 1.63 Ϯ 0.35 m 2 . According to the classification of dialyzers by function, the number of patients using a type IV dialyzer was the largest (80.3%).The average concentrations of each electrolyte before treatment in patients treated with blood purification by extracorporeal circulation were 138.8 Ϯ 3.3 mEq/L for serum sodium, 4.96 Ϯ 0.81 mEq/L for serum potassium, 102.1 Ϯ 3.1 mEq/L for serum chloride, and 20.7 Ϯ 3.0 mEq/L for HCO 3 -; the average serum pH was 7.35 Ϯ 0.05. Regarding the type of vascular access in patients treated by facility dialysis, in 89.7% of patients an arteriovenous fistula was used and in 7.1% an arteriovenous graft was used. The percentage of hepatitis C virus (HCV)-positive patients who were HCV-negative in 2007 was 1.04%; the percentage is particularly high in patients with a period of dialysis of 20 years or longer.The risk of becoming HCV-positive was high in patients with low serum creatinine, serum albumin, and serum total cholesterol levels, and/or a low body mass index before beginning dialysis. Key Words: Dialysis, Patient population, Endotoxin concentration, Hepatitis C virus antibody positivity rate, Survey, Survival rate, Vascular access.The Japanese Society for Dialysis Therapy has been conducting a statistical survey of dialysis facilities across the country annually since 1968. To improve the efficiency of analyzing survey data accumulated thus far, in 2008 the Society concluded an agreement with The Institute of Japanese Union of Scientists and Engineers to entrust them with the business of data analysis, with the aim of establishing a new analytical system. Some of the analytical results obtained under this agreement were ...
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