Chan T M, Li F K, Tang C S, Wong R W, Fang G X, Ji Y L, Lau C S, Wong A K, Tong M K, Chan K W, Lai K N
Department of Medicine, University of Hong Kong and Queen Mary Hospital, Hong Kong, China.
N Engl J Med. 2000 Oct 19;343(16):1156-62. doi: 10.1056/NEJM200010193431604.
The combination of cyclophosphamide and prednisolone is effective for the treatment of severe lupus nephritis but has serious adverse effects. Whether mycophenolate mofetil can be substituted for cyclophosphamide is not known.
In 42 patients with diffuse proliferative lupus nephritis we compared the efficacy and side effects of a regimen of prednisolone and mycophenolate mofetil given for 12 months with those of a regimen of prednisolone and cyclophosphamide given for 6 months, followed by prednisolone and azathioprine for 6 months. Complete remission was defined as a value for urinary protein excretion that was less than 0.3 g per 24 hours, with normal urinary sediment, a normal serum albumin concentration, and values for serum creatinine and creatinine clearance that were no more than 15 percent above the base-line values. Partial remission was defined as a value for urinary protein excretion that was between 0.3 and 2.9 g per 24 hours, with a serum albumin concentration of at least 30 g per liter.
Eighty-one percent of the 21 patients treated with mycophenolate mofetil and prednisolone (group 1) had a complete remission, and 14 percent had a partial remission, as compared with 76 percent and 14 percent, respectively, of the 21 patients treated with cyclophosphamide and prednisolone followed by azathioprine and prednisolone (group 2). The improvements in the degree of proteinuria and the serum albumin and creatinine concentrations were similar in the two groups. One patient in each group discontinued treatment because of side effects. Infections were noted in 19 percent of the patients in group 1 and in 33 percent of those in group 2 (P = 0.29). Other adverse effects occurred only in group 2; they included amenorrhea (in 23 percent of the patients), hair loss (19 percent), leukopenia (10 percent), and death (10 percent). The rates of relapse were 15 percent and 11 percent, respectively.
For the treatment of diffuse proliferative lupus nephritis, the combination of mycophenolate mofetil and prednisolone is as effective as a regimen of cyclophosphamide and prednisolone followed by azathioprine and prednisolone but is less toxic.
环磷酰胺与泼尼松龙联合用药对重症狼疮性肾炎有效，但有严重不良反应。霉酚酸酯是否可替代环磷酰胺尚不清楚。
我们将42例弥漫性增殖性狼疮性肾炎患者分为两组，一组接受泼尼松龙与霉酚酸酯联合治疗12个月，另一组接受泼尼松龙与环磷酰胺联合治疗6个月，随后接受泼尼松龙与硫唑嘌呤联合治疗6个月，比较两组的疗效和副作用。完全缓解定义为24小时尿蛋白排泄量小于0.3 g，尿沉渣正常，血清白蛋白浓度正常，血清肌酐和肌酐清除率不超过基线值的15%。部分缓解定义为24小时尿蛋白排泄量在0.3至2.9 g之间，血清白蛋白浓度至少为30 g/L。
接受霉酚酸酯与泼尼松龙治疗的21例患者（第1组）中，81%达到完全缓解，14%达到部分缓解；相比之下，接受环磷酰胺与泼尼松龙治疗，随后接受硫唑嘌呤与泼尼松龙治疗的21例患者（第2组）中，完全缓解和部分缓解的比例分别为76%和14%。两组蛋白尿程度、血清白蛋白和肌酐浓度的改善情况相似。每组各有1例患者因副作用停药。第1组19%的患者和第2组33%的患者出现感染（P = 0.29）。其他不良反应仅出现在第2组；包括闭经（23%的患者）、脱发（19%）、白细胞减少（10%）和死亡（10%）。复发率分别为15%和11%。
对于弥漫性增殖性狼疮性肾炎的治疗，霉酚酸酯与泼尼松龙联合用药与环磷酰胺与泼尼松龙，随后硫唑嘌呤与泼尼松龙联合用药的疗效相当，但毒性较小。
