Department of Nephrology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Front Med. 2022 Oct;16(5):799-807. doi: 10.1007/s11684-021-0849-2. Epub 2022 Mar 18.
This study aimed to evaluate the efficacy and safety of mycophenolate mofetil (MMF) or tacrolimus (TAC) compared with azathioprine (AZA) as maintenance therapy for active lupus nephritis (ALN). Patients with ALN who responded to 24 weeks of induction treatment were enrolled. Patients who received MMF or TAC as induction therapy continued MMF or TAC treatment during the maintenance period, whereas those who received intravenous cyclophosphamide were subjected to AZA treatment. The primary endpoint was the incidence of renal relapse. Secondary endpoints included extrarenal flares and composite endpoints (deaths, end-stage renal disease, or doubling of serum creatinine levels). A total of 123 ALN patients (47 in the MMF group, 37 in the TAC group, and 39 in the AZA group) were enrolled. The median follow-up time was 60 months. Ten MMF-treated patients, ten TAC-treated patients, and eight AZA-treated patients experienced renal relapses (P = 0.844). The cumulative renal relapse rates in the MMF group (P = 0.934) and TAC group (P = 0.673) were similar to the renal relapse rate in the AZA group. No significant difference in the incidence of severe adverse event was observed among the groups. Long-term maintenance therapies with MMF or TAC might have similarly low rates of renal relapse and similar safety profiles compared with AZA.
本研究旨在评估霉酚酸酯（MMF）或他克莫司（TAC）与硫唑嘌呤（AZA）作为活动性狼疮肾炎（ALN）维持治疗的疗效和安全性。纳入对 24 周诱导治疗有反应的 ALN 患者。接受 MMF 或 TAC 作为诱导治疗的患者在维持期继续接受 MMF 或 TAC 治疗，而接受静脉环磷酰胺的患者则接受 AZA 治疗。主要终点是肾脏复发的发生率。次要终点包括肾外发作和复合终点（死亡、终末期肾病或血清肌酐水平翻倍）。共纳入 123 例 ALN 患者（MMF 组 47 例，TAC 组 37 例，AZA 组 39 例）。中位随访时间为 60 个月。10 例 MMF 治疗患者、10 例 TAC 治疗患者和 8 例 AZA 治疗患者发生肾脏复发（P = 0.844）。MMF 组（P = 0.934）和 TAC 组（P = 0.673）的累积肾脏复发率与 AZA 组相似。各组严重不良事件发生率无显著差异。与 AZA 相比，长期使用 MMF 或 TAC 的维持治疗可能具有相似的低肾脏复发率和相似的安全性。
