Austin H A, Klippel J H, Balow J E, le Riche N G, Steinberg A D, Plotz P H, Decker J L
N Engl J Med. 1986 Mar 6;314(10):614-9. doi: 10.1056/NEJM198603063141004.
We evaluated renal function in 107 patients with active lupus nephritis who participated in long-term randomized therapeutic trials (median follow-up, seven years). For patients taking oral prednisone alone, the probability of renal failure began to increase substantially after five years of observation. Renal function was better preserved in patients who received various cytotoxic-drug therapies, but the difference was statistically significant only for intravenous cyclophosphamide plus low-dose prednisone as compared with high-dose prednisone alone (P = 0.027). The advantage of treatment with intravenous cyclophosphamide over oral prednisone alone was particularly apparent in the high-risk subgroup of patients who had chronic histologic changes on renal biopsy at study entry. Patients treated with intravenous cyclophosphamide have not experienced hemorrhagic cystitis, cancer, or a disproportionate number of major infections. We conclude that, as compared with high-dose oral prednisone alone, treatment of lupus glomerulonephritis with intravenous cyclophosphamide reduces the risk of end-stage renal failure with few serious complications.
我们评估了107例活动性狼疮性肾炎患者的肾功能，这些患者参与了长期随机治疗试验（中位随访时间为7年）。对于仅口服泼尼松的患者，观察5年后肾衰竭的可能性开始大幅增加。接受各种细胞毒性药物治疗的患者肾功能得到更好的保留，但与单独使用高剂量泼尼松相比，只有静脉注射环磷酰胺加低剂量泼尼松的差异具有统计学意义（P = 0.027）。在研究入组时肾活检有慢性组织学改变的高风险亚组患者中，静脉注射环磷酰胺治疗相对于单独口服泼尼松的优势尤为明显。接受静脉注射环磷酰胺治疗的患者未出现出血性膀胱炎、癌症或大量严重感染。我们得出结论，与单独使用高剂量口服泼尼松相比，静脉注射环磷酰胺治疗狼疮性肾小球肾炎可降低终末期肾衰竭的风险，且严重并发症较少。
