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Background: Immunoglobulin light chains are classified as middle molecule uremic toxins able to interact with B lymphocyte membranes leading to the activation of transmembrane signaling. The ensuing impairment of neutrophil function can contribute to the chronic inflammation state of uremic patients, and the increased risk of bacterial infections or vascular calcifications. The aim of this crossover observational study was to assess the difference in free light chain removal by three different hemodialysis filters in patients not affected by multiple myeloma.
Methods: Free light chain removal was compared in the polymethylmethacrylate (PMMA) membrane Filtryzer BK-F, the polyphenylene HFR17 filter and the conventional polysulfone filter F7HPS. Twenty chronic hemodialysis patients were enrolled: mean age was 67.7 ± 17.0 years, M/F = 14/6, dialysis vintage (months) 25.5 ± 32.0. The patients were randomized into two groups of treatment lasting 6 weeks each. The dialysis sessions checked were the midweek sessions and the blood was drawn at times 0, 120' and 240'. Kappa (k) and lambda (λ) light chain levels, β2microglobulin (β2M), C reactive protein (CRP) and albumin were checked.
The study consisted of 4 visits: screening, randomization, treatment crossover, and end-of-study. Subjects treated up to 2 attacks within 4 weeks. At the screening visit, subjects provided a detailed medical and headache/migraine history, a physical examination was performed, laboratory assessment samples (ie, hematology, serum chemistry, urine analysis, serology, urine drug screen) were obtained, inclusion/exclusion criteria were verified, and a 12-lead electrocardiogram (ECG) was completed. Eligible subjects returned to the site with 14 days of the screening visit and were trained in the appropriate use of the autoinjector device and given printed instructions to take home that reinforced correct DFN-11 administration.
Subjects were divided into 1 block and randomized (1:1) to receive 3 mg SC sumatriptan (using DFN-11 and matching placebo autoinjectors consecutively) or 6 mg SC sumatriptan (using 2 DFN-11 autoinjectors consecutively) in a crossover design and were dispensed the first treatment in the sequence. The randomization scheme was generated by study personnel with no subject interaction or other monitoring roles using an online tool ( ); it was provided to the drug packing company, which used it to prepare and pre-label the kits with sequential numbers. The research coordinator was instructed to dispense the lowest kit number available.
Immunoglobulin light chains are classified as middle molecule uremic toxins able to interact with B lymphocyte membranes leading to the activation of transmembrane signaling. The ensuing impairment of neutrophil function can contribute to the chronic inflammation state of uremic patients, and the increased risk of bacterial infections or vascular calcifications. The aim of this crossover observational study was to assess the difference in free light chain removal by three different hemodialysis filters in patients not affected by multiple myeloma.
The aim of this crossover observational study was to compare free light chain removal by three different hemodialysis filters in a cohort of chronic dialysis patients not affected by multiple myeloma.
The main weaknesses of this study are the small cohort of patients enrolled, the low levels of λ light chains considered suitable for the study at dialysis start and the limited number of biomarkers considered. Conversely, one of the strengths of the study is its crossover study design, which allows each patient to be his/ her control, strongly reducing the variability among patients. Other strengths are the randomization of the patients into two groups and the washout periods between the experimental phases with each filter tested, reducing the carryover effect of the previous filter / hemodialysis technique used.
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Design, Setting, and Participants Twenty-five patients with TRD from 2 hospitals in the Netherlands were enrolled between March 22, 2010, and May 8, 2014. Patients first entered a 52-week open-label trial during which they received bilateral implants of 4 contact electrodes followed by optimization of DBS until a stable response was achieved. A randomized, double-blind, 12-week crossover phase was then conducted with patients receiving active treatment followed by sham or vice versa. Response and nonresponse to treatment were determined using intention-to-treat analyses.
Conclusions and Relevance Deep brain stimulation of the vALIC resulted in a significant decrease of depressive symptoms in 10 of 25 patients and was tolerated well. The randomized crossover design corroborates that vALIC DBS causes symptom reduction rather than sham.
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