Dinant H J, Decker J L, Klippel J H, Balow J E, Plotz P H, Steinberg A D
Ann Intern Med. 1982 Jun;96(6 Pt 1):728-36. doi: 10.7326/0003-4819-96-6-728.
Forty-one patients with systemic lupus erythematosus and glomerulonephritis were studied in a randomized drug trial. Thirteen patients received prednisone only (Group 1), 16 received oral cyclophosphamide and oral azathioprine (1 mg/kg body weight . d of each initially) (Group 2), and 12 were given boluses of intravenous cyclophosphamide (0.5 to 1.0 g/m2 body surface area every 3 months) (Group 3). The mean observation period was 42 months (range 1 to 6.5 years). Renal function deteriorated in four of 12 patients in Group 1 and three of 27 patients in Groups 2 and 3 (p = 0.114). By life-table analysis, 86% of the entire group survived 5 years after entry to the study. Marked hypertension, fluctuating changes in serum creatinine, erratic changes in levels of antibody to DNA, reduced C3 levels, increasing proteinuria or sustained hematuria, and flares of extrarenal disease activity occurred more commonly in Group 1. Infectious complications were not commoner in Groups 2 and 3. We conclude that any marginal benefits produced by the programs tested cannot be shown in this class of patients without markedly increasing the sample size. Our current studies involve more vigorous treatment of patients with more acute disease and less treatment during prolonged periods of relatively good health.
在一项随机药物试验中，对41例系统性红斑狼疮合并肾小球肾炎患者进行了研究。13例患者仅接受泼尼松治疗（第1组），16例接受口服环磷酰胺和口服硫唑嘌呤（初始剂量均为1mg/kg体重·天）（第2组），12例接受大剂量静脉注射环磷酰胺（每3个月0.5至1.0g/m²体表面积）（第3组）。平均观察期为42个月（范围1至6.5年）。第1组12例患者中有4例肾功能恶化，第2组和第3组27例患者中有3例肾功能恶化（p = 0.114）。通过生命表分析，整个组中86%的患者在进入研究后存活了5年。明显的高血压、血清肌酐的波动变化、抗DNA抗体水平的不稳定变化、C3水平降低、蛋白尿增加或持续性血尿以及肾外疾病活动的发作在第1组中更为常见。第2组和第3组的感染并发症并不更常见。我们得出结论，在不显著增加样本量的情况下，此类患者无法显示所测试方案产生的任何边际效益。我们目前的研究包括对病情更急性的患者进行更积极的治疗，以及在相对健康的较长时期内减少治疗。
