IMMUNOSUPPRESSIVE DRUG THERAPY IN LUPUS GLOMERULONEPHRITIS

狼疮性肾小球肾炎的免疫抑制药物治疗

• 批准号: 4689969
• 负责人: J E BALOW
• 金额: --
• 依托单位: NAT INST OF ARTHRITIS, DIABETES, DIGESTIVE & KIDNEY DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/4689969
• 关键词: autoimmune disorder; cyclophosphamide; dosage; drug adverse effect; glomerulonephritis; human subject; human therapy evaluation; immunopathology chemotherapy; immunosuppressive; kidney disorder chemotherapy; kidney function; methylprednisolone; prednisone

The efficacy of intensive, intermittent immunosuppressive drug therapy will be evaluated in patients with active lupus glomerulonephritis over a 30 month study period. Patients with renal biopsy documented active glomerulonephritis with or without renal function deterioration will be treated with low dose corticosteroids and randomized to receive (a) intravenous pulse methylprednisolone monthly for 6 months or (b) intravenous pulse cyclophosphamide monthly for 6 months or (c) intravenous pulse cyclophosphamide monthly for 6 months and then every 3 months for the remaining 24 months of the study. During the final 24 months of the study, all patients will receive low dose prednisone. Active disease, as manifested by renal functional deterioration, increased proteinuria or worsened urinary sediment, will be treated by increased prednisone. Comparison will be made of the number of favorable outcomes of renal function, glomerular pathology and drug related toxicities achieved by each treatment group at the end of the 6th and 30th study months. Between April 1981 and July 1985 there have been more than 50 patients entered into this protocol.

强化的间歇性免疫抑制药物治疗的疗效将 在活动性狼疮性肾小球肾炎患者中进行评估 一个月的学习时间。接受肾活检的患者记录为活跃 伴或不伴肾功能恶化的肾小球肾炎 接受小剂量皮质类固醇治疗并随机接受(A) 每月静脉注射甲基强的松龙6个月或(B) 每月静脉注射环磷酰胺6个月或(C)静脉注射 每月冲击环磷酰胺6个月，然后每3个月治疗一次 研究的剩余24个月。在研究的最后24个月里， 所有患者都将接受小剂量强的松治疗。活动性疾病，如 表现为肾功能恶化、蛋白尿增加或 尿沉渣恶化，将通过增加泼尼松来治疗。 将比较肾移植的有利结果的数量。 各自的功能、肾小球病理和药物相关毒性 治疗组在研究第6个月和第30个月末。4月之间 1981年和1985年7月，已有50多名患者参加了这项活动 协议。