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利妥昔单抗治疗膜性肾病的疗效与安全性:一项系统评价和荟萃分析。

Efficacy and safety of rituximab in the treatment of membranous nephropathy: A systematic review and meta-analysis.

作者信息

Lu WanJun, Gong ShuHao, Li Juan, Luo HongWen, Wang Ying

机构信息

Department of Nephrology, The First Affiliated Hospital of Nanchang University, Dong Hu District, Nan Chang City, Jiang Xi Province, China.

出版信息

Medicine (Baltimore). 2020 Apr;99(16):e19804. doi: 10.1097/MD.0000000000019804.

DOI:10.1097/MD.0000000000019804
PMID:32311997
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7440335/
Abstract

BACKGROUND AND OBJECTIVES

Rituximab (RTX) is considered to be a promising drug for curing membranous nephropathy. However, the efficacy and safety of RTX in treating membranous nephropathy remain uncertain. This meta-analysis aimed to investigate the efficacy and safety of RTX in patients with membranous nephropathy.

METHODS

A literature search was performed using Pubmed, Embase, OVID, and Cochrane Library and randomized controlled trials (RCTs) case-controls and cohort studies published till 30 July 2019 were assessed. The studies assessing the efficacy and safety of RTX in patients with membranous nephropathy were included.

RESULTS

Eight relevant trials involving 542 patients were included in the meta-analysis. It was found that RTX did not significantly improve serum albumin levels and e-GFR when compared with the control group (including cyclosporine and cyclophosphamide, chlorambucil, prednisone, non-immunosuppressive anti-proteinuria treatment), serum albumin levels (OR = 0.31, 95%CI-0.12-0.74, P = .15), e-GFR (OR = -1.49, 95%CI-17.14-14.17, P = .85). However, RTX did reduce the serum creatinine (OR = -0.01, 95%CI-0.36-0.34, P = .95) and urinary protein (OR = -2.39, 95%CI -7.30 -2.53, P = .34) levels. Also, in comparison to the control group, RTX did improve the total remission rate (OR = 1.63, 95%CI 0.48-5.54, P = .43), achieve a higher rate of complete remission (OR = 2.54, 95%CI 1.65-3.90, P < .01) and also reduced the amount of M-type phospholipase A2 receptor-Antibody depletion in patients (OR = 5.59, 95%CI 1.81-17.2, P = .003). RTX-related adverse events were mostly mild (most infusion-related reactions) in nature and serious adverse events were rare.

CONCLUSION

RTX proved to be efficient, well-tolerated and a safe drug in the treatment of membranous nephropathy. Most patients reach complete remission during the follow-up period, and relapse is rare. RTX may turn out to be promising in membranous nephropathy patients.

摘要

背景与目的

利妥昔单抗(RTX)被认为是治疗膜性肾病的一种有前景的药物。然而,RTX治疗膜性肾病的疗效和安全性仍不确定。本荟萃分析旨在研究RTX治疗膜性肾病患者的疗效和安全性。

方法

使用PubMed、Embase、OVID和Cochrane图书馆进行文献检索,并评估截至2019年7月30日发表的随机对照试验(RCT)、病例对照研究和队列研究。纳入评估RTX治疗膜性肾病患者疗效和安全性的研究。

结果

荟萃分析纳入了8项涉及542例患者的相关试验。发现与对照组(包括环孢素、环磷酰胺、苯丁酸氮芥、泼尼松、非免疫抑制性抗蛋白尿治疗)相比,RTX并未显著提高血清白蛋白水平和估算肾小球滤过率(e-GFR),血清白蛋白水平(OR = 0.31,95%CI -0.12 - 0.74,P = 0.15),e-GFR(OR = -1.49,95%CI -17.14 - 14.17,P = 0.85)。然而,RTX确实降低了血清肌酐(OR = -0.01,95%CI -0.36 - 0.34,P = 0.95)和尿蛋白(OR = -2.39,95%CI -7.30 - 2.53,P = 0.34)水平。此外,与对照组相比,RTX确实提高了总缓解率(OR = 1.63,95%CI 0.48 - 5.54,P = 0.43),达到了更高的完全缓解率(OR = 2.54,95%CI 1.65 - 3.90,P < 0.01),并且还降低了患者体内M型磷脂酶A2受体抗体的消耗水平(OR = 5.59,95%CI 1.81 - 17.2,P = 0.003)。RTX相关不良事件大多性质轻微(大多数为输液相关反应),严重不良事件罕见。

结论

RTX被证明在治疗膜性肾病方面有效、耐受性良好且安全。大多数患者在随访期间达到完全缓解,复发罕见。RTX在膜性肾病患者中可能很有前景。

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