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【文摘发布】随机试验：血浆置换或大剂量甲基
Published ahead of print on June 20, 2007
Journal of the American Society of Nephrology
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 μmol/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 μmol/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. Randomized Trial of Plasma Exchange or High-Dosage Methylprednisolone as Adjunctive Therapy for Severe Renal Vasculitis
关于血浆置换或者大剂量甲基强的松龙辅助治疗重症肾血管炎的随机临床试验。
Published ahead of print on June 20, 2007
Journal of the American Society of Nephrology
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.
中性粒细胞胞浆抗原自身抗体相关性系统性血管炎是急进性肾小球肾炎最常见的病因。即使接受免疫抑制治疗，发病时出现肾衰也会增加发生ESRD的风险。
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 μmol/L (5.8 mg/dl).
该研究观察联合血浆置换是否比静脉使用甲基强的松龙更容易使血肌酐>500 μmol/L (5.8 mg/dl)的血管炎患者肾脏得以恢复
A total of 137 patients with a new diagnosis of ANCA-associated systemic vasculitis confirmed by renal biopsy and serum creatinine >500 μmol/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.
137例通过肾活检新诊断的ANCA相关性系统性血管炎患者（血肌酐>500 μmol/L，5.8 mg/dl）被随机分配到血浆置换组（7次，70例）或者3000mg静脉输注甲基强的松龙组（67例）。两组患者都接受口服环磷酰胺和强的松龙。
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.
初级终点为3个月时脱离透析。次级终点包括一年时肾脏和患者生存率以及严重的不良事件。
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).
3个月时，静脉应用甲基强的松龙组和血浆置换组分别有49%（33/ 67）和69%（48 / 70）的患者存活并脱离透析（差异的95%可信区间为18%~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.
与甲基强的松龙组相比，12个月时血浆置换组发展为ESRD的风险下降24%（从43%下降到19%，95%可信区间6.1%~ 41%）。
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.
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作者:admin@医学,生命科学 2011-02-19 17:11
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