Effect of beta(2)-microglobulin adsorption column on dialysis-related amyloidosis.

BACKGROUND: beta2-microglobulin (beta2-m) is considered a major pathogenic factor in dialysis-related amyloidosis (DRA), often seen in long-term dialysis patients. No effective therapy for this severely debilitating disease is currently available. Lixelle, an adsorption column, has been developed for the elimination of beta2-m; the efficacy of this column has been evaluated in this study. METHODS: Seventeen hemodialysis patients with DRA were first treated with high-flux dialysis for a minimum of 1 year. This was followed by 1-year treatment with Lixelle column connected in series to the high-flux dialyzer. Treatments were used three times a week for both phases of this study. During the study period, beta2-m, pinch strength, motor terminal latency, and activities of daily living were evaluated. RESULTS: After 1-year treatment with high-flux dialysis the beta2-m level remained unchanged; however, after 1-year treatment with the addition of the Lixelle column, beta2-m level decreased significantly from 34.5 +/- 8.4 mg/L to 28.8 +/- 7.3 mg/L (P < 0.05). After 1 year of Lixelle column use, the pinch strength increased from 6.8 +/- 4.7 pounds to 9.1 +/- 5.5 pounds (P < 0.01), and the median motor terminal latency was significantly reduced from 5.1 +/- 1.0 mseconds to 4.5 +/- 1.1 mseconds. A significant improvement was also observed in the activities of daily living score of the upper extremities. CONCLUSION: These results suggest that the addition of Lixelle to the high-flux dialyzer is associated with a significant clinical improvement in DRA patients.

Beta2-microglobulin-selective adsorbent column (Lixelle) for the treatment of dialysis-related amyloidosis.

Lixelle is a direct hemoperfusion-type adsorbent column developed for selective elimination of beta2-microglobulin (beta2-m) from the circulating blood of patients with dialysis-related amyloidosis (DRA). Lixelle S-35, that has a column volume of 350 mL, efficiently eliminates beta2-m and improves symptoms of DRA such as joint pain and nocturnal awakening. The performance of Lixelle S-15, that has a column volume of 150 mL, is dependent on the dialysis membrane used in combination with the adsorbent column in a hemodialysis circuit. The combination of S-15 and a dialysis membrane with a high beta2-m clearance eliminates an amount of beta2-m that is nearly equal to the amount removed by using S-35. Treatment with S-15 for 6 months improved joint pain with an efficacy similar to that observed when using S-35. The major adverse effects were hypotension and decrease in hematocrit, and these incidences were much less in S-15 compared to S-35.