A CONTROLLED TRIAL OF PLASMAPHERESIS THERAPY IN SEVERE LUPUS NEPHRITIS
A CONTROLLED TRIAL OF PLASMAPHERESIS THERAPY IN SEVERE LUPUS NEPHRITIS
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DOI：
10.1056/nejm199205213262101
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发表时间：
1992-05-21
影响因子：
158.5
通讯作者：
LACHIN, JM
中科院分区：
文献类型：
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作者：
LEWIS, EJ;HUNSICKER, LG;LACHIN, JM
背景系统性红斑狼疮合并肾小球肾炎的患者，即使接受免疫抑制治疗，预后也很差。血浆置换疗法已被使用，但其疗效的对照临床观察很少。我们在14个医学中心的86例重症狼疮肾炎患者中进行了一项随机对照试验，比较了泼尼松和环磷酰胺的标准治疗方案（标准治疗）与标准治疗加血浆置换的方案。患者接受血浆置换术，每周三次，持续四周。药物治疗是标准化的，严格遵守9个详细的医疗管理协议。46例患者接受标准治疗，40例患者接受标准治疗加血浆置换。平均随访时间为136周。标准治疗组有6名患者（13%）死亡，血浆置换组有8名患者（20%）死亡。标准治疗组中有8例患者（17%）发生肾衰竭，而血浆置换组有10例（25%）。30名患者（35%）达到停止点-标准治疗组14名（30%），血浆置换组16名（40%）。两组中有相似数量的患者血清肌酐浓度和尿蛋白排泄均下降至接近正常值。血浆置换治疗的患者血清中抗双链DNA抗体和cryopulins抗体浓度的下降速度更快。与单用标准方案相比，血浆置换联合泼尼松和环磷酰胺标准方案治疗不能改善系统性红斑狼疮和重症肾炎患者的临床结局。
Background. The prognosis of patients with systemic lupus erythematosus who have glomerulonephritis is poor, despite treatment with immunosuppressive therapy. Plasmapheresis therapy has been used, but there have been few controlled clinical observations of its efficacy.Methods. We carried out a randomized, controlled trial comparing a standard-therapy regimen of prednisone and cyclophosphamide (standard therapy) with a regimen of standard therapy plus plasmapheresis in 86 patients with severe lupus nephritis in 14 medical centers. The patients underwent plasmapheresis three times weekly for four weeks. Drug therapy was standardized, with strict adherence to nine detailed medical-management protocols.Results. Forty-six patients received standard therapy, and 40 patients received standard therapy plus plasmapheresis. The mean follow-up was 136 weeks. Six patients (13 percent) in the standard-therapy group and eight patients (20 percent) in the plasmapheresis group died. Renal failure developed in 8 patients (17 percent) in the standard-therapy group, as compared with 10 (25 percent) in the plasmapheresis group. Thirty patients (35 percent) reached stopping points - 14 (30 percent) in the standard-therapy group and 16 (40 percent) in the plasmapheresis group. A similar number of patients in each group had a decrease in both the serum creatinine concentration and urinary protein excretion to approximately normal values. Patients treated with plasmapheresis had a significantly more rapid reduction of serum concentrations of antibodies against double-stranded DNA and cryoglobulins.Conclusions. Treatment with plasmapheresis plus a standard regimen of prednisone and cyclophosphamide therapy does not improve the clinical outcome in patients with systemic lupus erythematosus and severe nephritis, as compared with the standard regimen alone.