Department of Nephrology, People's Liberation Army Strategic Support Force Medical Center, Beijing, China.
Department of Nephrology, Beijing Jishuitan Hospital, Beijing, China.
BMJ Open. 2023 Jan 18;13(1):e064220. doi: 10.1136/bmjopen-2022-064220.
Primary membranous nephropathy (PMN) is a major cause of nephrotic syndrome in adults. Rituximab has been recommended in the treatment of PMN by the updated Kidney Disease Improved Outcome guideline. However, the optimal dosing regimen of rituximab for the initial treatment of patients with PMN is unclear.
A comprehensive screening will be performed by searching PubMed, Embase and the CENTRAL (Cochrane Central Register of Controlled Trials) without language restriction. Studies evaluating the efficacy of rituximab monotherapy using the following types of dosing regimens will be included: high-dose regimen; standard regimen and low-dose regimen. Studies with less than 10 participants will be excluded. The primary outcome is the remission rate at 12 months. The secondary outcomes are remission rate at 6 and 24 months, complete remission rate at 6, 12 and 24 months, relapse at 6, 12 and 24 months, and side effects. Risk of Bias In Non-randomised Studies of Interventions tool will be used to assess the risk of bias for non-randomised studies and the Cochrane risk of bias assessment tool will be used for randomised controlled trials. The pooled remission rate, complete remission rate, relapse rate and side effects will be estimated using the metaprop command. All analyses will be calculated using Stata software (V.15.0; StataCorp).
Ethics approval is not required. The results of our study will be submitted to a peer-review journal.
CRD42022319401.
原发性膜性肾病（PMN）是成人肾病综合征的主要病因。更新的肾脏病改善预后指南推荐利妥昔单抗治疗PMN。然而，PMN 患者初始治疗中利妥昔单抗的最佳剂量方案仍不清楚。
将通过检索 PubMed、Embase 和 CENTRAL（Cochrane 对照试验中心注册库），不限制语言，进行全面筛选。将纳入使用以下剂量方案的利妥昔单抗单药治疗疗效评估的研究：高剂量方案；标准剂量方案和低剂量方案。将排除参与者少于 10 人的研究。主要结局是 12 个月时的缓解率。次要结局是 6 个月和 24 个月时的缓解率、6、12 和 24 个月时的完全缓解率、6、12 和 24 个月时的复发率以及副作用。将使用非随机干预研究偏倚风险工具评估非随机研究的偏倚风险，并使用 Cochrane 偏倚风险评估工具评估随机对照试验。将使用 metaprop 命令估计缓解率、完全缓解率、复发率和副作用的汇总率。所有分析将使用 Stata 软件（V.15.0；StataCorp）进行计算。
不需要伦理批准。我们的研究结果将提交给同行评议期刊。
PROSPERO 注册号：CRD42022319401。
