Division of Nephrology, Department of Internal Medicine, Tanta University Hospitals, Tanta University, Tanta, Egypt.
Clin Exp Nephrol. 2010 Jun;14(3):214-21. doi: 10.1007/s10157-010-0270-7. Epub 2010 Feb 19.
Recent studies have suggested that mycophenolate mofetil (MMF) may offer advantages over intravenous cyclophosphamide (IVC) for the treatment of lupus nephritis. The aim of this study was to evaluate the efficacy of MMF compared with IVC in the induction therapy of proliferative lupus nephritis.
We randomly assigned 47 patients with newly diagnosed active proliferative lupus nephritis class III or IV to open-label oral MMF 2 g/day for 6 months or intravenous cyclophosphamide 0.5-1 g/m(2) monthly for 6 months in addition to corticosteroids.
In the intention-to-treat analysis, 14 of the 24 patients (58.33%) receiving MMF and 12 of the 23 patients receiving cyclophosphamide (52.17%) had remission (P = 0.48); complete remission occurred in 6 of the 24 patients (25%) and 5 of the 23 patients (21.74%), respectively (P = 0.53). Improvements in packed cell volume, the erythrocyte sedimentation rate, anti-double-stranded DNA antibodies titer (anti-dsDNA), serum complement, proteinuria, urinary activity, renal function, serum soluble interleukin-2 receptor alpha concentration and the systemic lupus activity measure score were similar in both groups. Two patients assigned to MMF and another patient assigned to IVC developed end-stage renal failure with commencement of dialysis. Adverse events were similar. Major infections occurred in two patients in each group. There was no difference in gastrointestinal side effects, but more diarrhea occurred in those receiving MMF.
In this 24-week trial, MMF or IVC combined with corticosteroids demonstrated equal efficacy in inducing remission of proliferative lupus nephritis.
最近的研究表明，霉酚酸酯（MMF）可能优于静脉注射环磷酰胺（IVC）用于治疗狼疮肾炎。本研究的目的是评估 MMF 与 IVC 在增生性狼疮肾炎诱导治疗中的疗效。
我们将 47 例新诊断的活动期增生性狼疮肾炎 III 或 IV 类患者随机分为口服 MMF 组（2g/天，持续 6 个月）和 IVC 组（0.5-1g/m²/月，持续 6 个月），两组均联合皮质激素治疗。
意向治疗分析中，24 例 MMF 组患者中有 14 例（58.33%）和 23 例 IVC 组患者中有 12 例（52.17%）达到缓解（P=0.48）；完全缓解分别发生在 6 例 MMF 组患者（25%）和 5 例 IVC 组患者（21.74%）（P=0.53）。两组患者的红细胞压积、红细胞沉降率、抗双链 DNA 抗体滴度（抗 dsDNA）、血清补体、蛋白尿、尿活性、肾功能、血清可溶性白细胞介素-2 受体 α 浓度和系统性红斑狼疮活动度评分均有改善。两组均有 2 例患者接受 MMF 治疗和 1 例患者接受 IVC 治疗后进展为终末期肾衰竭，开始透析。不良反应相似。两组各有 2 例患者发生严重感染。胃肠道副作用无差异，但 MMF 组腹泻发生率更高。
在这项 24 周的试验中，MMF 或 IVC 联合皮质激素在诱导增生性狼疮肾炎缓解方面疗效相当。
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