Methylprednisolone and cyclophosphamide, alone or in combination, in patients with lupus nephritis - A randomized, controlled trial
Methylprednisolone and cyclophosphamide, alone or in combination, in patients with lupus nephritis - A randomized, controlled trial
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DOI：
10.7326/0003-4819-125-7-199610010-00003
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发表时间：
1996-10-01
影响因子：
39.2
通讯作者：
Steinberg, AD
中科院分区：
文献类型：
--
作者：
Gourley, MF;Austin, HA;Steinberg, AD
背景：甲基强的松龙推注疗法或甲基强的松龙与环磷酰胺联合治疗狼疮性肾炎的疗效和毒性存在不确定性。目的：确定 1) 甲基强的松龙强化推注疗法是否足以替代环磷酰胺推注疗法，2) 甲泼尼龙和环磷酰胺优于单用甲泼尼龙或环磷酰胺的推注疗法。设计：随机对照试验，随访至少 5 年。地点：政府转诊研究医院。患者：82 名狼疮性肾炎患者，每个高倍视野有 10 个或更多红细胞、细胞管型、蛋白尿（> 1 g 干预措施：用甲基强的松龙（1 g/m(2) 体表面积）推注治疗，每月给予至少 1 年；环磷酰胺推注疗法（0.5至1.0 g/m(2)体表面积），每月一次，持续6个月，然后每季度一次；或同时使用甲泼尼龙和环磷酰胺进行推注治疗。测量：1) 肾脏缓解（定义为
Background: Uncertainty exists about the efficacy and toxicity of bolus therapy with methylprednisolone or of the combination of methylprednisolone and cyclophosphamide in the treatment of lupus nephritis.Objective: To determine 1) whether intensive bolus therapy with methylprednisolone is an adequate substitute for bolus therapy with cyclophosphamide and 2) whether the combination of methylprednisolone and cyclophosphamide is superior to bolus therapy with methylprednisolone or cyclophosphamide alone.Design: Randomized, controlled trial with at least 5 years of follow-up.Setting: Government referral-based research hospital.Patients: 82 patients with lupus nephritis who had 10 or more erythrocytes per high-power field, cellular casts, proteinuria (>1 g of protein per day), and a renal biopsy specimen that showed proliferative nephritis.Interventions: Bolus therapy with methylprednisolone (1 g/m(2) body surface area), given monthly for at least 1 year; bolus therapy with cyclophosphamide (0.5 to 1.0 g/m(2) body surface area), given monthly for 6 months and then quarterly; or bolus therapy with both methylprednisolone and cyclophosphamide.Measurements: 1) Renal remission (defined as