Randomized trial of plasma exchange or high-dosage Methylprednisolone as adjunctive therapy for severe renal vasculitis
Randomized trial of plasma exchange or high-dosage Methylprednisolone as adjunctive therapy for severe renal vasculitis
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DOI：
10.1681/asn.2007010090
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发表时间：
2007-07-01
影响因子：
13.6
通讯作者：
Pusey, Charles D.
中科院分区：
文献类型：
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作者：
Jayne, David R. W.;Gaskin, Gill;Pusey, Charles D.
与中性粒细胞胞浆抗原（ANCA）自身抗体相关的系统性血管炎是快速进展性肾小球肾炎的最常见原因。尽管进行了免疫抑制治疗，但出现肾功能衰竭时终末期肾病和死亡的风险增加。本研究调查了在血清肌酐> 500 μ mol/L（5.8 mg/dl）的患者中，血浆置换是否比静脉注射甲基强的松龙更有效地实现肾脏恢复。共有137例新诊断为ANCA相关系统性血管炎的患者经肾活检证实，血清肌酐> 500 μ mol/L（5.8 mg/dl），随机分配接受7次血浆置换（n = 70）或3000 mg静脉注射甲泼尼龙（n = 67）。两组均口服环磷酰胺和泼尼松龙。主要终点是3个月时的透析独立性。次要终点包括肾脏和患者1年生存率和严重不良事件发生率。在3个月时，静脉注射甲泼尼龙后67例患者中有33例（49%）存活，而血浆置换后为48例（69%）或70例（95%置信区间差异为18%至35%; P = 0.02）。与静脉注射甲基强的松龙相比，血浆置换与12个月时进展为ESRD的风险降低24%（95%置信区间6.1 - 41%），从43%降至19%相关。静脉注射甲泼尼龙组和血浆置换组患者1年生存率和严重不良事件发生率分别为51/67（76%）和32/67（48%），51/70（73%）和35/70（50%）。与静脉注射甲基强的松龙相比，血浆置换可增加ANCA相关系统性血管炎伴肾功能衰竭患者的肾功能恢复率。两组患者的生存率和严重不良事件发生率相似。
Systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic antigens (ANCA) is the most frequent cause of rapidly progressive glomerulonephritis. Renal failure at presentation carries an increased risk for ESRD and death despite immunosuppressive therapy. This study investigated whether the addition of plasma exchange was more effective than intravenous methylprednisolone in the achievement of renal recovery in those who presented with a serum creatinine > 500 mu mol/L (5.8 mg/dl). A total of 137 patients with a new diagnosis of ANCA-associated systemic vasculitis confirmed by renal biopsy and serum creatinine > 500 mu mol/L (5.8 mg/dl) were randomly assigned to receive seven plasma exchanges (n = 70) or 3000 mg of intravenous methylprednisolone (n = 67). Both groups received oral cyclophosphamide and oral prednisolone. The primary end point was dialysis independence at 3 mo. Secondary end points included renal and patient survival at 1 yr and severe adverse event rates. At 3 mo, 33 (49%) of 67 after intravenous methylprednisolone compared with 48 (69%) or 70 after plasma exchange were alive and independent of dialysis (95% confidence interval for the difference 18 to 35%; P = 0.02). As compared with intravenous methylprednisolone, plasma exchange was associated with a reduction in risk for progression to ESRD of 24% (95% confidence interval 6.1 to 41%), from 43 to 19%, at 12 mo. Patient survival and severe adverse event rates at 1 yr were 51 (76%) of 67 and 32 of 67 (48%) in the intravenous methylprednisolone group and 51 (73%) of 70 and 35 of (50%) 70 in the plasma exchange group, respectively. Plasma exchange increased the rate of renal recovery in ANCA-associated systemic vasculitis that presented with renal failure when compared with intravenous methylprednisolone. Patient survival and severe adverse event rates were similar in both groups.