Department of Endocrinology, Diabetology and Rheumatology and the Department of Nephrology, Heinrich-Heine University, Duesseldorf, Germany.
J Rheumatol. 2012 Nov;39(11):2111-7. doi: 10.3899/jrheum.120537. Epub 2012 Sep 15.
Intravenous cyclophosphamide (IV CYC) in combination with high doses of corticosteroids is considered the "gold standard" of therapy for lupus nephritis (LN). However, the optimal dose of corticosteroids needed has not been defined. We evaluated the efficacy of a monotherapy with IV CYC in patients with a first episode of LN (duration ≤ 6 months).
Forty patients with LN received IV CYC (12 pulses). Prednisone alone was administered and dose-adjusted to control extrarenal manifestations. Response after 24 months was defined as normalization of creatinine level, inactive urinary sediment, and proteinuria ≤ 0.2 g/day [complete response (CR)] or ≤ 0.5 g/day [partial response (PR)].
CR was achieved in 25 (62.5%) and PR in 8 (20%) patients. Mean starting dose of prednisone was 23.9 ± 23.8 mg/day. In a posthoc analysis, we separately analyzed patients initially treated with prednisone doses ≥ 20 mg/day (Group A, n = 19) or < 20 mg/day (Group B, n = 21). CR was achieved in 52.6% (Group A) versus 71.4% (Group B; p = 0.37); and PR in 26.3% versus 14.3%, respectively (p = 0.58). During longterm followup (10.4 ± 3.1 yrs), 37.8% experienced a renal flare. Thirty patients (81%) still have normal renal function. Renal outcome was irrespective of initial prednisone doses (p = 0.46, Pearson chi-square test of independence).
Our rates of CR and PR and longterm outcomes were comparable with rates after treatment with a combination of IV CYC with high doses of corticosteroids. These data warrant randomized controlled trials evaluating different doses of corticosteroids in LN.
静脉注射环磷酰胺（IV CYC）联合大剂量皮质类固醇被认为是狼疮肾炎（LN）治疗的“金标准”。然而，所需的皮质类固醇最佳剂量尚未确定。我们评估了 IV CYC 单药治疗首次发作的 LN（病程≤6 个月）患者的疗效。
40 例 LN 患者接受 IV CYC（12 个脉冲）治疗。单独给予泼尼松龙，并调整剂量以控制肾外表现。24 个月后的反应定义为肌酐水平、非活动性尿沉渣和蛋白尿≤0.2 g/天（完全缓解[CR]）或≤0.5 g/天（部分缓解[PR]）恢复正常。
25 例（62.5%）患者达到 CR，8 例（20%）患者达到 PR。泼尼松龙的起始平均剂量为 23.9±23.8mg/天。在事后分析中，我们分别分析了初始泼尼松龙剂量≥20mg/天（A 组，n=19）或<20mg/天（B 组，n=21）的患者。A 组 CR 率为 52.6%（n=10），B 组为 71.4%（n=15）（p=0.37）；PR 率分别为 26.3%和 14.3%（p=0.58）。在长期随访（10.4±3.1 年）中，37.8%的患者出现肾脏复发。30 例（81%）患者仍有正常肾功能。肾脏结局与初始泼尼松龙剂量无关（p=0.46，Pearson 卡方检验独立性）。
我们的 CR 和 PR 率以及长期结局与 IV CYC 联合大剂量皮质类固醇治疗后的比率相当。这些数据需要随机对照试验来评估 LN 中不同剂量的皮质类固醇。
