Department of Nephrology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Department of Nephrology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Kidney Int. 2016 Jan;89(1):235-42. doi: 10.1038/ki.2015.318. Epub 2016 Jan 4.
No previous study has compared mycophenolate mofetil (MMF) with low-dose cyclophosphamide (CYC) in the treatment of lupus nephritis (LN). To do so, we recruited patients with LN (class III, IV, or V) and randomized them to receive either low-dose CYC or oral MMF. Those with crescentic LN, a serum creatinine over 265 μmol/l, and neurological or pulmonary lupus were excluded. MMF was prescribed at daily doses of 1.5-3 g for 24 weeks, while CYC was administered as six fortnightly infusions of 500 mg each. All patients received three methylprednisolone injections, followed by oral corticosteroids. Maintenance therapy with azathioprine and low-dose corticosteroid was started at end of induction therapy. The primary end point was treatment response at 24 weeks, while secondary end points were complete remission, Systemic Lupus Erythematosus Disease Activity Index and adverse events. Of the 173 patients recruited, 100 were equally randomized to receive either CYC or MMF. Baseline characteristics were similar, except for higher 24 h proteinuria in the CYC group. At 24 weeks, 37 patients in each group achieved the primary end point. The complete remission rate was 50% in CYC and 54% in MMF group. Gastrointestinal symptoms were significantly more frequent in patients receiving MMF (52 vs. 4%). However, other adverse events were similar. Thus, low-dose intravenous CYC is comparable in safety and efficacy to oral MMF in the induction treatment of less severe LN.
此前尚无研究比较霉酚酸酯（MMF）与低剂量环磷酰胺（CYC）在狼疮肾炎（LN）治疗中的效果。为了进行比较，我们招募了 LN（III、IV 或 V 类）患者，并将他们随机分为接受低剂量 CYC 或口服 MMF 治疗的两组。排除新月体性 LN、血清肌酐>265μmol/l、神经或肺部狼疮患者。MMF 治疗剂量为每日 1.5-3g，疗程 24 周；CYC 治疗方案为每两周静脉滴注 500mg，共 6 次。所有患者接受 3 次甲泼尼龙冲击治疗，随后给予口服皮质激素。诱导治疗结束时开始给予硫唑嘌呤和低剂量皮质激素维持治疗。主要终点为 24 周时的治疗反应，次要终点为完全缓解、系统性红斑狼疮疾病活动指数和不良事件。173 例入组患者中，100 例被随机分为 CYC 组或 MMF 组，两组患者的基线特征相似，除 CYC 组的 24 小时蛋白尿更高外。24 周时，每组各有 37 例患者达到主要终点。CYC 组完全缓解率为 50%，MMF 组为 54%。接受 MMF 治疗的患者胃肠道症状明显更常见（52% vs. 4%）。然而，其他不良反应相似。因此，在诱导治疗较轻的 LN 时，低剂量静脉 CYC 的安全性和疗效与口服 MMF 相当。
