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用于治疗透析相关性淀粉样变性的直接血液灌流型β2微球蛋白吸附柱(BM-01)的长期临床评估

Long-term clinical evaluation of an adsorbent column (BM-01) of direct hemoperfusion type for beta 2-microglobulin on the treatment of dialysis-related amyloidosis.

作者信息

Gejyo F, Teramura T, Ei I, Arakawa M, Nakazawa R, Azuma N, Suzuki M, Furuyoshi S, Nankou T, Takata S

机构信息

Department of Clinical and Laboratory Science, Fukui Medical School, Matsuoka, Japan.

出版信息

Artif Organs. 1995 Dec;19(12):1222-6. doi: 10.1111/j.1525-1594.1995.tb02289.x.

DOI:10.1111/j.1525-1594.1995.tb02289.x
PMID:8967878
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.

摘要

在7例血液透析患者中对一种β2-微球蛋白(β2M)吸附柱BM-01治疗透析相关性淀粉样变的临床疗效和安全性进行了6个月以上的研究。几乎所有患者的血清β2M降低百分比超过60%-70%,且每次治疗结束时水平低于10mg/L。计算得出每次治疗清除的β2M量超过200-300mg。结果表明,BM-01在清除β2M方面表现良好,能够将β2M的时间平均浓度(TAC)维持在25mg/L以下,并改善了临床症状。未观察到临床严重副作用。我们建议,尽管使用该吸附柱治疗可能无法成功预防疾病的发生,但BM-01在透析相关性淀粉样变的长期治疗中的有效性应接受进一步评估。

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