Development of Adsorbent for Anti-Phospholipid Antibodies and These Clinical Trials

建立了抗心磷脂抗体（anti-CL）的ELISA检测方法和狼疮抗凝剂（LAC）的1/5高岭土部分凝血酶活时间（1/5KPTT）检测方法。使用上述方法检测到的抗cl和/或LAC与血栓形成显著相关。SLE患者胎儿丢失、血小板减少和STS。特别是IgG类抗cl与以上临床表现有较强的相关性，所有SLE合并LAC患者均有IgG类抗cl。在吸附柱方面，研究了各种磷脂、氨基酸和带有重复负电荷单元的分子对抗磷脂抗体的亲和力或吸附能力。结果表明，用葡聚糖硫酸盐纤维素球填充的吸附柱不仅能有效吸附抗磷脂抗体，而且能有效吸附抗dna抗体，具有临床应用价值。6例SLE患者采用葡聚糖硫酸盐柱吸附血浆置换对抗dna和/或抗cl的影响4次血浆置换治疗后2 ~ 4周内抗dna （RI）、IgG抗dsdna （ELISA）、IgG和/或IgM抗ssdna （ELISA）、IgG抗cl （ELISA）滴度均显著降低或恢复正常。同时，皮疹和关节痛消失。此外，我们有一个系统性红斑狼疮患者反复流产和抗cl /LAC谁是成功地治疗吸附血浆置换。我们期望利用葡聚糖硫酸盐柱进行吸附血浆置换，不仅对有抗磷脂抗体的SLE患者，而且对有抗磷脂抗体综合征的患者都是有影响的治疗方法。

ELISA assay for anti-cardiolipin antibodies (anti-CL) and 1/5 Kaolin partial thromboplastin time (1/5KPTT) assay for lupus anticoagulant (LAC) were established. Anti-CL and/or LAC which were detected using above assays were significantly associated with thrombosis. fetal loss, thrombocytopenia and STS in SLE. Especially, IgG class anti-CL and above clinical findings had a strong association and all of SLE patients with LAC had IgG class anti-CL.Concerning adsorbent columns, affinity or adsorbtion capacities of anti-phospholipid antiboodies using various phospholipids, aminoacids and molecules bearing repeating negatively charged units were studied. It was found that an adsorbent column, in which dextran sulphate cellulose beads were packed, adsorbed not only anti-phospholipid antibodies but also anti-DNA antibodies effectively, and was able to be utilized as clinical use.The effect of adsorbent plasmapheresis using dextran sulphate columns on anti-DNA and/or anti-CL in 6 SLE patients. The titers of anti-DNA (RI assay), IgG anti-dsDNA (ELISA), IgG and/or IgM anti-ssDNA (ELISA), and IgG anti-CL (ELISA) significantly decreased or normalized after four treatments of plasmapheresis during a 2 to 4 week period. At the same time, rash and arthralgia disappeared. Additionally, we had an SLE patient with recurrent abortion and anti-CL/LAC who was successfully treated by adsorbent plasmapheresis. It was expected that adsorbent plasmapheresis using dextran sulphate columns would an influential treatment for patients with not only SLE having anti-phospholipid antibodies but anti-phospholipid antibodies syndrome.