Zou Pei-Mei, Li Hang, Cai Jian-Fang, Chen Zhen-Jie, Li Chao, Li Xue-Wang
Department of Nephrology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China.
Chin Med Sci J. 2018 Mar 30;33(1):9-19. doi: 10.24920/21803.
Objective To investigate the efficacy and safety of rituximab (RTX) in the treatment of idiopathic membranous nephropathy (IMN) with nephrotic syndrome with a systematic review and meta-analysis. Methods PubMed, Embase, Cochrane Library and Clinical Trials (December 2016) were searched to identify researches investigating the treatment of RTX in adult patients with biopsy-proven IMN. Complete remission (CR) or partial remission was regarded as effective therapy, and the cumulated remission rate was calculated. Result Seven studies involved 120 patients (73% were men) were included in our systematic review and meta-analysis. All were prospective observation cohort studies or matched-cohort studies, mainly came from two medical centers, and one study was multi-centric (four nephrology units in northern Italy). The creatinine clearance was more than 20 ml/(min·1.73 m) and persistent proteinuria higher than 3.5 g/d for at least 6 months. All patients received treatment previously [44 (36.7%) had immunosuppressive treatment]. In 12- and 24-month, 56% (95%CI, 0.47-0.65) and 68% (95%CI, 0.41-0.87) patients could reach remission, while 15% (95%CI, 0.09-0.23) and 20% (95%CI, 0.12-0.32) patients could reach CR. The reduction in proteinuria was gradual and obvious, paralleled with upward trend of serum albumin level and decreasing serum cholesterol level. Renal functions were stable. Relapses happened in 24 months were around 8%. RTX related adverse events were mild and were mostly infusion-related reactions. Conclusions RTX treatment in IMN was efficient, well tolerated and safe. More than 60% patients can reach partial remission or CR in 24 months, and relapse is rare. Adverse events of RTX are mostly infusion-related reactions and generally mild.
目的 通过系统评价和荟萃分析，探讨利妥昔单抗（RTX）治疗特发性膜性肾病（IMN）合并肾病综合征的疗效和安全性。方法 检索PubMed、Embase、Cochrane图书馆和临床试验数据库（截至2016年12月），以确定关于RTX治疗经活检证实的成年IMN患者的研究。完全缓解（CR）或部分缓解被视为有效治疗，并计算累积缓解率。结果 7项研究共纳入120例患者（73%为男性），纳入我们的系统评价和荟萃分析。所有研究均为前瞻性观察队列研究或匹配队列研究，主要来自两个医学中心，1项研究为多中心研究（意大利北部的4个肾病科）。肌酐清除率大于20 ml/（min·1.73 m²），持续性蛋白尿高于3.5 g/d至少6个月。所有患者之前均接受过治疗[44例（36.7%）接受过免疫抑制治疗]。在12个月和24个月时，分别有56%（95%CI，0.47 - 0.65）和68%（95%CI，0.41 - 0.87）的患者达到缓解，而分别有15%（95%CI，0.09 - 0.23）和20%（95%CI，0.12 - 0.32）的患者达到CR。蛋白尿逐渐明显减少，同时血清白蛋白水平呈上升趋势，血清胆固醇水平下降。肾功能稳定。24个月内复发率约为8%。RTX相关不良事件轻微，主要为输液相关反应。结论 RTX治疗IMN有效、耐受性良好且安全。超过60%的患者在24个月内可达到部分缓解或CR，且复发率低。RTX不良事件主要为输液相关反应，一般较轻。
