Long‐Term Clinical Evaluation of an Adsorbent Column (BM–01) of Direct Hemoperfusion Type for (β₂–Microglobulin on the Treatment of Dialysis‐Related Amyloidosis

Abstract

The clinical efficacy and safety of a beta 2-microglobulin (beta 2M) adsorbent column, BM-01, on the treatment of dialysis-related amyloidosis were investigated in 7 hemodialysis patients for more than 6 months. The percent reduction of serum beta 2M was more than 60-70%, and the level at the end of each session was less than 10 mg/L in almost all patients. The amount of beta 2M removed was calculated as more than 200-300 mg/session. The results demonstrated that BM-01 performed very well for removing beta 2M, was capable of maintaining less than 25 mg/L of time average concentration (TAC) for beta 2M, and improved the clinical symptoms. Clinically severe side effects were not observed. We recommend that BM-01 should undergo further evaluation for its usefulness in the long-term treatment of dialysis-related amyloidosis, though treatment with the column may not be successful in preventing the onset of the disease.

The elevation of plasma levels of myeloperoxidase and polymorphonuclear leukocyte elastase as an index of bioincompatibility of the column during hemodialysis using with a β 2 -microglobulin-selective adsorbent column

“…Many groups have reported the clinical use of this column for long-term hemodialysis patients, and its usefulness and efficacy have been demonstrated. [19][20][21][22][23] However, there have been few reports on the bioincompatibility of this column, because it has been in clinical use with hemodialysis treatment for only a few years.…”

“…Extracorporeal circulation was maintained for 4 h by connecting the BM-01 for direct hemoperfusion (DHP) in series to the arterial side before the dialyzer, as described elsewhere. [19][20][21][22][23][24] Production of monoclonal antibody against MPO Plasma levels of MPO were measured by an enzyme immunoassay (EIA) established in our laboratory. MPO purified from human peripheral blood leukocytes was used to immunize mice.…”

“…It has been reported that the plasma 2 -MG is eliminated efficiently and that the use of this column is an extremely effective therapeutic method, with no serious adverse effects. [19][20][21][22][23][24] However, because the whole blood is directly circulated though this column, any biocompatibility of this column could be a critical problem with long-term use.…”

Clinical and pathogenic factors in dialysis-related amyloidosis: Current research findings

“…One report found that the ineidence of dialysis-related amyloidosis had decreased signifieantly since the introduction of high-flux membrane dialyzers; however, no consensus has yet been reaehed. Nevertheless, for [24]. An adsorbent column of the direct hemoperfusion type that was developed for the elimination of ß2-m appeared to be clinically useful [24].…”

“…Nevertheless, for [24]. An adsorbent column of the direct hemoperfusion type that was developed for the elimination of ß2-m appeared to be clinically useful [24]. van Ypersele et al [25] compared the accumulation of ß2-m in the serum of patients treated with dialyzers using a high-flux membrane (AN-69) versus those treated with dialyzers using a cuprophane membrane.…”