Long-term effects of magnesium carbonate on coronary artery calcification and bone mineral density in hemodialysis patients: A pilot study

Observational data suggest that elevated magnesium levels in dialysis patients may prevent vascular calcification and in vitro magnesium can prevent hydroxyapatite crystal growth. However, the effects of magnesium on vascular calcification and bone mineral density have not been studied prospectively. Seven chronic hemodialysis patients participated in this open label, prospective pilot study to evaluate the effects of a magnesium-based phosphate binder on coronary artery calcification (CAC) scores and vertebral bone mineral density (V-BMD) in patients with baseline CAC scores >30. Magnesium carbonate/calcium carbonate (elemental Mg: 86 mg/elemental Ca 100 mg) was administered as the principal phosphate binder for a period of 18 months and changes in CAC and V-BMD were measured at baseline, 6, 12, and 18 months. Serum magnesium levels averaged 2.2±0.4 mEq/L (range: 1.3–3.9 mEq/L). Phosphorus levels (4.5±0.6 mg/dL) were well controlled throughout the 18 months study. Electron beam computed tomography results demonstrated a small not statically significant increase in absolute CAC scores, no significant change in median percent change, and a small none significant change in V-BMD. Magnesium may have a favorable effect on CAC. The long-term effect on bone mineral density remains unclear. Larger studies are needed to confirm these findings.     

Impact of coronary artery calcification in hemodialysis patients: Risk factors and associations with prognosis

The risk factors of coronary artery calcification (CAC) and the impact of CAC on cardiovascular events, cardiovascular deaths, and all‐cause deaths in hemodialysis (HD) patients have not been fully elucidated. We examined the CAC score (CACS) in 74 HD patients using electron‐beam computed tomography. Fifty‐six patients underwent a second electron‐beam computed tomography after a 15‐month interval to evaluate CAC progression. We evaluated (1) the risk factors for CAC and its progression and (2) the impact of CAC on the prognosis. In the cross‐sectional study, HD vintage and high‐sensitive C‐reactive protein (hsCRP) were the independent risk factors for CAC. In the prospective cohort study, delta CACS (progression of CAC) was significantly correlated with hsCRP, fibrinogen, and serum calcium level in the univariate analysis. Stepwise multiple regression analysis revealed that only hsCRP was the independent risk factor for CAC progression in HD patients. Kaplan‐Meier survival analysis revealed that cardiovascular events (P<0.0001), cardiovascular deaths (P=0.039), and all‐cause deaths (P=0.026) were significantly associated with CACS. In conclusion, CAC had significantly progressed in HD patients during the 15‐month observation period. Microinflammation was the only independent risk factor for CAC progression in HD patients. The advanced CAC was a significant prognostic factor in HD patients, i.e., which was strongly associated with future cardiovascular events, cardiovascular deaths, and all‐cause deaths.     

Intracranial arterial calcification is highly prevalent in hemodialysis patients but does not associate with acute ischemic stroke

Intracranial arterial calcification (IAC) is associated with ischemic stroke in the general population but this relationship has not been examined in hemodialysis patients. We examined the factors associated with IAC and its relationship with acute ischemic stroke in this population. We retrospectively studied 490 head computed tomographic scans from 2225 hemodialysis patients presenting with neurological symptoms at our center (October 2005-May 2009). Intracranial arterial calcification was graded using a validated scoring system. Multivariate regression was used to examine the factors associated with the presence of IAC, its severity, and its ability to predict acute ischemic stroke. Weibull's survival models analyzed the relationship between IAC severity and survival. Ninety-five percent of patients with ischemic stroke had IAC vs. 83% in the nonstroke group (P=0.02). Intracranial arterial calcification severity increased with age (P<0.001), hemodialysis vintage (P<0.001), serum phosphate (P<0.05), and major comorbidities. In patients with multiple computed tomographic scans during the study period, increased IAC severity at baseline was predictive of acute ischemic stroke (P=0.05) on logistic regression analysis. High-grade and not low-grade IAC was associated with worse survival (P=0.008). Intracranial arterial calcification is highly prevalent in hemodialysis patients, especially in those with acute ischemic stroke. Its severity is prognostically significant and associated with risk factors for vascular calcification and may confer a greater risk of acute ischemic stroke. The mechanisms underlying the high incidence of ischemic stroke in this patient group require further comprehensive study.     

Effect of sevelamer on aortic pulse wave velocity in patients on hemodialysis: a prospective observational study

Aortic stiffening and aortic calcification are risk factors for cardiovascular events in hemodialysis (HD) patients, and these 2 risk factors are interrelated. Sevelamer decreases aortic calcification but its effect on aortic stiffness has not been investigated previously. Thirteen HD patients commencing sevelamer treatment and 13 matched controls were followed for 11 months. Aortic pulse wave velocity (PWV), augmentation index (AIx), and levels of inhibitors of vascular calcification (fetuin-A, matrix-GLA-protein, osteoprotegerin/RANKL) were measured at baseline and at the end of follow-up, and the differences between the groups were compared. Determinants of the changes in PWV during follow-up were assessed by multivariate linear regression. At baseline, PWV was 9.93 (2.10) m/s in sevelamer-treated patients and 9.20 (2.84) m/s in control patients (p=0.464). By the end of follow-up, PWV decreased by 0.83 (2.3) m/s in sevelamer-treated patients while it increased by 0.93 (1.88) m/s in controls (p=0.042). The direction of changes in AIx were similar, but not statistically significant. There were no significant differences in the levels of inhibitors of calcification either at baseline or during follow-up. In multivariate linear regression sevelamer treatment, diabetes, heart rate, and C-reactive protein were related to the change in PWV. These data suggest that sevelamer treatment is associated with an improvement in aortic stiffness in HD patients, but it does not seem to affect serum levels of inhibitors of vascular calcification.     

Outcome among patients with acute renal failure needing continuous renal replacement therapy: A single center study

Outcome of acute renal failure (ARF) and use of continuous renal replacement therapy (CRRT) have shown a consistently high mortality. (1) Evaluate the short-term patient survival. (2) Evaluate dialysis-free survival. (3) Evaluate risk factors associated with overall survival and the continued need for intermittent dialysis. We identified adults (≥18 years) needing CRRT, treated in the critical care units of Froedtert Medical and Lutheran Hospital from January 1, 2003 till December 31, 2005. Patients were divided into two major groups needing CRRT, end stage renal disease (ESRD) (chronic dialysis) and non-ESRD with ARF. Continuous renal replacement therapy was performed with an average of 2 L replacement fluid exchanges/h. Sigma stat software was used for analysis. Comparison was done for noncontinuous variables by chi-square and t test for categorical and continuous variables, respectively. A total of 110 (ESRD 24/non-ESRD 86) patients received CRRT during study period. Over all in-hospital mortality among non-ESRD patients was 63% vs. 46% for ESRD. Among non-ESRD patients who survived, 47% needed intermittent hemodialysis on intensive care unit discharge and 28% continued to need hemodialysis at last follow-up. Among non-ESRD patients alive at discharge, those who were dialysis dependent on last follow-up were older (64.5) than those who did not require dialysis on last follow-up (58.4) P=0.347. Non-ESRD patients who died were in the hospital for an average of 17.5 days compared with 29 days for those who were discharged from the hospital. Patients with ARF needing CRRT have high in-hospital mortality. A significant percentage of patients remained dialysis dependant on last follow-up.     

Paraoxonase‐1 (PON1) activity as a risk factor for atherosclerosis in chronic renal failure patients

Paraoxonase is a high‐density lipoprotein‐associated enzyme and has been shown to reduce the susceptibility to low‐density lipoprotein peroxidation. This study aimed to investigate the activity of serum paraoxonase in uremic patients on hemodialysis (HD) and in the predialysis period, and to evaluate the correlations of vascular disease with paraoxonase activity. Thirty patients with chronic renal failure (CRF) undergoing HD (group 1), 30 patients with CRF under conservative treatment (group 2), and 30 healthy controls (group 3) were included. Basal, salt‐stimulated, and arylesterase activity were tested by UV spectrophotometry. Serum lipid parameters were determined. B‐Mode Doppler ultrasound was used to assess common carotid intima‐media thickness (IMT). Basal paraoxonase, salt‐stimulated, and arylesterase activity showed no significant difference between group 1 and group 2. However, it was significantly lower in group 1 and in group 2 than controls. Carotid IMT was significantly higher in group 1 than group 2 and both were significantly higher than controls. Basal paraoxonase‐1 (PON1), salt‐stimulated PON1, and arylesterase activity correlate with BUN, but only basal PON1 and salt‐stimulated PON1 correlate with serum albumin. Linear regression showed that the most significant determinant of carotid IMT was PON1 arylesterase activity in group 1 and arylesterase activity and basal PON1 activity in group 2. Patients with CRF, whether under HD or conservative treatment, have reduced basal and stimulated paraoxonase activities, and this could be an important factor causing increased vascular disease in those patients. Modifying this factor can be of great value to protect against this common complication.     

End-stage renal disease patients on hemodialysis: a study from a tertiary care center in a developing country

The exact number of patients with chronic renal failure requiring renal replacement therapy in developing world is not known. Unlike the developed world, most developing countries lack renal registries. This study was initiated to know demographic and clinical data of end-stage renal disease (ESRD) patients presenting to maintenance hemodialysis (MHD) at a government funded tertiary care centre in a developing country. A prospective analysis of all new ESRD patients attending to hemodialysis at our centre from 2004 to 2007 had been done. There were 237 new hemodialysis patients during a three-year period. Males were 153 and females were 84, with the mean age 44.92 years. Diabetes mellitus (31.22%) was the most common cause of ESRD. Only 29.95% of patients had education on renal replacement therapy. 65.40% patients had emergency hemodialysis. Internal jugular catheter was the most common form of vascular access at initiation of hemodialysis. Arteriovenous fistula was secured in 29.95% of patients at presentation. Catheter-related infection appeared in 13.55% of patients on catheter. The most common infection in dialysis patients was urinary tract infection (37.14%). Renal transplantation was opted by 9.7% patients and continuous ambulatory peritoneal dialysis in 20.25% and 103 (43.45%) were lost to follow up. The rest (8.86%) continued on MHD. There were 42 (17.72%) deaths over a three-year period. The present study provided the information of the practice of hemodialysis, its population characteristics and outcomes from a developing country.     

Quality of life of end-stage renal disease patients and study on the implementation of nocturnal home hemodialysis in Greece

The aim of this study was to measure the overall health-related quality of life of patients receiving hemodialysis in Greece and to assess willingness, motivation, and concerns about participating in a nocturnal home hemodialysis program. This review measured successfully the quality of life of 146 end-stage renal disease (ESRD) patients undergoing hemodialysis in 10 hemodialysis centers all over Greece and studied the factors that affect their choice to adopt a specific treatment. Physical and mental health status and health-related quality of life, measured by the Kidney Disease Quality of Life Short Form accompanied by the demographic data gathered, provide information that can help to improve ESRD patient care in Greece. A comparison with the Greek general population identifies lower physical functioning scores for the ESRD patients, while the mental functioning scores are comparable with those of the Greek general population. Moreover, it is important to notice the willingness expressed by half of the patients to participate in a potential program of nocturnal home hemodialysis.     

Sudden unexpected death in patients with epilepsy receiving renal replacement therapy with dialysis: a 17-year experience at a single institution

Epilepsy is the most common acquired chronic neurological disorder; each year about 1 in a 1000 patients with chronic epilepsy die suddenly, unexpectedly, and without explanation, even with postmortem examination (SUDEP). Seizure incidence is approximately 10% in patients with chronic renal failure and hemodialysis-associated seizure has been considered to be a common complication of people on hemodialysis treatment. Considering this, we evaluated the incidence of seizures in 189 patients under dialytic treatment.     

Screening for depression in chronic hemodialysis patients: comparison of the Beck Depression Inventory, primary nurse, and nephrology team

Depression in patients with end-state renal disease (ESRD) is both underdiagnosed and treated, which may contribute to an increase in morbidity and mortality. Efforts aimed at screening, diagnosing, and treating depression could potentially modify outcomes in this population. The purpose of this study was to compare the prevalence of depression, as measured by the Beck Depression Inventory (BDI-II), the primary nurse, and nephrology team, among a cohort of patients receiving chronic hemodialysis (HD). A secondary objective was to identify patient variables associated with depression. Patients were screened for depression at the same time point, using the BDI-II, the primary nurse and the nephrology team. Depression was defined as a BDI-II score > or =14. Agreement between the BDI-II score, nurse, and nephrology team assessment of depression was compared using a kappa score and receiver-operating characteristic (ROC) curves were generated. One hundred and twenty-four of an eligible 154 patients completed the study. Depression as measured by a BDI-II> or =14, the nurse and the team was diagnosed in 38.7%, 41.9%, and 24.2% of patients, respectively. With the BDI-II as the gold standard, the nurses' diagnosis of depression had an agreement of 74.6% vs. only 24.2% agreement with the nephrology team. A previous history of malignancy was the only variable associated with the diagnosis of depression. Depression is common among patients on HD, supporting the need for a routine depression-screening program. The primary dialysis nurse is in a key position to identify patients with depression and should be considered as an integral part of the nephrology team.     

Mini mental status examination (MMSE) in stable chronic renal failure patients on hemodialysis: The effects of hemodialysis on the MMSE score. A prospective study

Cognitive impairment is common in hemodialysis (HD) patients. The mini mental status examination is a simple screening test for dementia. The objectives of this study were to (1) study and compare the predialysis and postdialysis mini mental status examination score and 2 subscores and compare them with those of a control group and (2) determine the factors affecting these scores. This was a prospective study of 54 HD patients, which involved calculation of their predialysis (PrHDSc) and (2–4 weeks later) postdialysis (PoHDSc) scores and comparison of these with the control scores (CoSc). The mean scores for PreHDSc and PoHDSc were 26.5±2.7 and 26.4±3.3, respectively. Both were significantly lower than CoSc, 28.4±1.6 (95% CI for score difference 0.99–2.97, P<0.001). The subscores for orientation, registration, and recall (ORR) and attention (ATT) before and after HD were 14.2±1.3, 14.3±1.8, and 3.5±1.7, 3.2±1.8, respectively. Both were significantly lower than the CoSc, 15.2±1.2 and 4.2±1.1 (P=0.001 and 0.004, respectively). There were no significant differences between the PrHDSc and PoHDSc (P values of 0.87, 0.63, and 0.45, respectively). Patients' PrHDSc correlated positively with PoHDSc and dialysis efficiency measured by the urea reduction ratio and Kt/V (r=0.58, 0.4, and 0.34, respectively). Education level correlated positively with PrHDSc r=0.41 but not PoHDSc. Hemodialysis duration correlated negatively with PrHDSc r=−0.3. There was no correlation among age, chronic renal failure duration, HD frequency, weight loss, systolic or diastolic blood pressure drop, and PrHDSc or PoHDSc. Hemodialysis patients scored significantly less than the control patients. Their score was not affected by HD. This may reflect the stable cognitive function/dysfunction or the mild sensitivity of the test.     

Effect of acetate-free biofiltration with a potassium-profiled dialysate on the control of cardiac arrhythmias in patients at risk: a pilot study

Cardiac arrhythmias are a frequent event in chronic hemodialysis patients. The aim of this study was to evaluate the efficacy and safety of acetate-free hemofiltration with potassium-profiled dialysate (AFB-K) dialysis compared with constant potassium acetate-free biofiltration (AFB). Twelve patients (mean age 79 years) affected by cardiac arrhythmias or at a high risk for arrhythmia (advanced age, hypertension, left ventricular hypertrophy, heart valve disease, coronary artery disease, diabetes, paroxysmal atrial fibrillation) participated in a single-center, sequential cohort study. All were treated with hemodialysis 3 times per week, using constant potassium AFB for the first 3 weeks, followed by an AFB-K dialysate for the subsequent 3 weeks. The hemofilter, duration of dialysis, and electrolyte concentration were the same in both treatments. Both AFB-K and constant potassium AFB dialytic techniques were safe and well tolerated. The results of biochemical tests were similar, except for serum potassium levels after 2 hr of dialysis, which were significantly higher in the AFB-K group (4.0 mmol/L) than in the constant potassium AFB group (3.6 mmol/L) (p<0.001). All cardiac variables improved during AFB-K dialysis. There was a significant reduction of postdialysis QT intervals corrected for heart rate in the AFB-K group (448.8 ms) compared with the constant potassium AFB group (456.8 ms) (p=0.039). The severity and mean number of ventricular extasystoles also decreased (163.5 vs. 444.5/24 hr). Potassium profiling during hemodialysis treatment may be beneficial for patients with arrhythmias or at those risk of arrhythmias, particularly those with predialysis hyperkalemia.     

Cephalic arch stenosis in patients with fistula access for hemodialysis: relationship to diabetes and thrombosis

Numerous studies have identified the fistula as the best access for hemodialysis with fewest complications. The radiocephalic fistula (RCF) is the first access of choice, but often results in poor maturation. Therefore, an increased number of brachiocephalic fistulas (BCF) have been placed. Cephalic arch stenosis (CAS) can occur in patients with fistula access. The current study was done to determine the incidence and associated comorbidities in patients with BCF or RCF who have CAS. A retrospective review of 450 hemodialysis patients in 3 outpatient hemodialysis units between July 1, 2000 and July 1, 2005 (60 months) was preformed. We reviewed demographics, medications, and indications for venograms. Interventional Radiologists reviewed the venograms for evidence of CAS. Radiology reports were screened to determine incidence of thrombosis, treatment with either angioplasty or stent placement and if a complication such as venous rupture occurred. One hundred and twenty-seven patients had fistula access with at least 1 venogram. Of these, 30 were RCF and 97 were BCF. Cephalic arch stenosis occurred in 77% of patients with BCF and in 20% of patients with RCF. Those with diabetes had a lower rate of occurrence than those without (p<0.01). Cephalic arch stenosis led to a high rate of thrombosis (p<0.01). The probability of having multiple radiology procedures was higher with CAS than without (p<0.01). Cephalic arch stenosis is an important problem in hemodialysis patients who have fistula access, and contributes to thrombosis. Diabetes was found to have a negative association with CAS for undefined reasons. Attempts to understand this relationship are important.     

Clinical epidemiology of parathyroidectomy in hemodialysis patients: the USRDS waves 1, 3, and 4 study

Despite advances in the medical management of secondary hyperparathyroidism, parathyroidectomy remains necessary in some end-stage renal disease patients. Observational studies may help with the design of intervention trials. We linked the retrospective Waves 1, 3, and 4 Dialysis Morbidity and Mortality Study datasets to Medicare claims data to identify incident parathyroidectomy in 10,588 Medicare patients receiving hemodialysis in the United States on December 31, 1993. The mean age was 60.0 years, and the mean follow-up 3.6 years. De novo parathyroidectomy incidence was 14.2/1000 patient-years. Considered as quintiles (Q), higher levels of standard bone metabolism variables were associated (p<0.0001) with parathyroidectomy stepwise, such that adjusted hazards ratios (AHR) for Q5 (vs. Q1) were, for calcium (>10.3 mg/dL), 5.09 (3.64-7.10); for phosphorus (>7.5 mg/dL), 2.92 (2.06-4.15); for calcium-phosphorus product (>71 mg2/dL2), 3.32 (2.27-4.85); and for parathyroid hormone (PTH; >480 pg/mL), 13.81 (7.47-25.55). Other antecedent associations included younger age, lower hemoglobin, and longer dialysis vintage, while transplantation, as a time-dependent covariate, was associated with lower hazards ratios. Using interval Poisson analysis, parathyroidectomy was associated with higher mortality risk ratios in the first year, and progressively lower risk ratios subsequently. Demographic variables may modify the risk of parathyroidectomy. Younger patients on long-term hemodialysis may be at a special risk. Parathyroidectomy risk increases stepwise with alterations in bone metabolism variables, suggesting that a single-threshold management approach may not be ideal.     

新型纳米基因载体(PEI/Mn0.5Zn0.5Fe2O4)的制备、表征及体外实验

采用改良的化学共沉淀法制备锰锌铁氧体磁性纳米粒子,聚乙烯亚胺(PEI)对其进行表面修饰.利用XRD、EDS、TEM、SEM、FTIR、XPS、UV-vis、Zeta电位仪、电泳仪、荧光显微镜等手段对其形貌、物象、成份、表面包覆功能团、元素组成、表面电位、磁响应性、DNA结合保护、体外释放及转染能力进行表征.体外加热实验验证其升温恒温能力.XRD及EDS确认已成功制备锰锌铁氧体磁性纳米粒子.修饰后的磁性纳米粒子具有良好的分散性、磁响应性及升温恒温能力.红外光谱及XPS分析验证了PEI在磁性纳米粒子表面的吸附.修饰后磁性纳米粒子的等电点由pH=7.0移至pH=11.0.具有良好的DNA结合保护转染能力.有利于其在生物医学领域的应用.     

Association of mineral metabolism factors with all-cause and cardiovascular mortality in hemodialysis patients: the Japan dialysis outcomes and practice patterns study

Abnormalities in mineral metabolism have been linked to mortality in hemodialysis (HD) patients. We postulated that these abnormalities would have a particularly large deleterious impact on deaths due to cardiovascular causes in Japan. This study describes the recent status of abnormal mineral metabolism, significant predictors, and potential consequences in the Dialysis Outcomes and Practice Patterns Study (DOPPS), Phases 1 and 2, in Japan. Major predictor variables were patient demographics, comorbidities, and laboratory markers of mineral metabolism such as albumin-adjusted serum calcium (calciumAlb), phosphorus, and intact PTH (iPTH). In a cross section of 3973 Japanese HD patients in DOPPS I and II, a large faction had laboratory values outside of the recommended Kidney Disease Outcomes Quality Initiative (K/DOQI) guideline range for serum concentrations of phosphorus (51% of patients above upper target range), calciumAlb (43.7% above), calcium-phosphorus (Ca x P) product (41.1% above), and iPTH (18.6% above). All-cause mortality was significantly and independently associated with calciumAlb (relative risk [RR]=1.22 per 1 mg/dL, p=0.0005) and iPTH (RR=1.04 per 100 pg/mL, p=0.04). Cardiovascular mortality was significantly associated with calciumAlb (RR=1.28, p=0.02), phosphorus (RR=1.13 per 1 mg/dL, p=0.008), Ca x P product (RR=1.07 per 2 mg(2)/dL(2), p=0.002), and PTH (RR=1.08, p=0.0001). This study expands our understanding of the relationship between altered mineral metabolism and mortality outcomes, showing slightly stronger associations with cardiovascular causes than observed for all-cause mortality. These findings have important therapeutic implications for Japanese HD patients.     

Effect of long‐term increase in the frequency and/or prolongation of dialysis duration on certain clinical manifestations and results of laboratory investigations in patients with chronic renal failure

The effects of dialysis frequency increase by one weekly and prolongation of dialysis duration by a mean of 17.5% on certain clinical manifestation and results of laboratory investigations were studied in a group of 14 patients treated with haemodialyses because of chronic renal failure caused by isolated renal diseases. Haemodialyses were carried out using a RSP Travenol artificial kidney and Ultra Flo 145 dialysers. The blood flow was always 200 ml/min and the flow of dialysing fluid was 500 ml/min. One dialyser was used repeatedly during 3 weeks in the same patients. After increasing the frequency or duration of dialyses the patients were not given transfusions of blood donors. The mean length of observation after increasing the frequency of dialyses was 6.4 months and after increasing their duration this length was 6.9 months. The change in the mode of dialysis had no significant effect on the concentration of urea and creatinine before as well as after dialysis. The increase in the frequency of dialyses caused a significant rise in the value of haematocrit by nearly 4%, a rise in the serum albumin concentration by a mean of 0.45 g/100 ml; a mean rise in the velocity of nerve conduction by over 6% of the lower normal range, and a mean rise in dry body weight by nearly 3.5 kg. Prolongation of dialysis time caused a significant mean rise in the haematorcrit value by over 1% before dialysis and in the serum albumin level by a mean of 0.30 g/100 ml. Both, the increase in the frequency and in the duration of dialyses caused a fall in the arterial blood pressure in hypertensive patients. The very favourable effects of increased frequency of dialyses on the clinical state of patients and on important laboratory parameters suggests that in near future the basic form of treatment of chronic renal failure may be daily short‐lasting haemodialysis.     

C.E.R.A. once every 4 weeks in patients with chronic kidney disease not on dialysis: The ARCTOS extension study

C.E.R.A., a continuous erythropoietin receptor activator is approved for the treatment of anemia in patients with chronic kidney disease (CKD). The ARCTOS (administration of C.E.R.A. in CKD patients to treat anemia with a twice‐monthly schedule) phase 3 study demonstrated the efficacy and safety of C.E.R.A. in correcting anemia when administered once every 2 weeks (Q2W) subcutaneously in patients with CKD not on dialysis. We assessed the feasibility and long‐term safety of converting patients who responded to treatment with C.E.R.A. Q2W to C.E.R.A. once every 4 weeks (Q4W) during a 24‐week extension period. After the core ARCTOS study period (28 weeks), 296 patients entered the 24‐week extension period. At week 29, patients who responded to C.E.R.A. Q2W during the core period were rerandomized to receive subcutaneous C.E.R.A. Q2W or Q4W. Patients in the comparator arm could receive darbepoetin alfa once weekly or Q2W. Dosage was adjusted to maintain hemoglobin (Hb) between 11 and 13 g/dL. Mean Hb levels remained stable in all groups, and were comparable at the end of the extension period (mean [standard deviation], C.E.R.A. Q2W, 11.92 [0.90] g/dL; C.E.R.A. Q4W, 11.70 [0.86] g/dL; darbepoetin alfa, 11.89 [0.98] g/dL). Mean within‐patient standard deviation values for Hb were also comparable in all groups (0.66, 0.62, and 0.65 g/dL for C.E.R.A. Q2W, C.E.R.A. Q4W and darbepoetin alfa, respectively). All treatments were well tolerated. Subcutaneous C.E.R.A. Q4W is safe and effective in maintaining stable Hb levels in patients with CKD not on dialysis following correction with subcutaneous C.E.R.A. Q2W.     

Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized,self- and placebo-controlled,double-blind,single centre,pilot study

This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m⁻¹ gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated.