在誘導治療中加入莫須瘤治療狼瘡腎炎患者的效益：系統性文獻回顧、統合分析與臨床試驗計畫書

The benefit of Rituximab adding on induction therapy for lupus nephritis: a systematic review, meta-analysis and clinical trial protocol

陳玟霖(Wen-Lin Chen)

指導教授 ： 王治元

國立臺灣大學/醫學院/臨床醫學研究所/碩士(2021年)

https://doi.org/10.6342/NTU202102202

摘要

目的
在難治型狼瘡腎炎的患者，根據臨床治療指南建議可以使用莫須瘤 (Rituximab, RTX)治療，但在大型隨機雙盲臨床試驗和觀察性研究結果未能得出明確的結論。因此，我們將進行統合分析，以進一步了解 RTX在狼瘡腎炎患者中的效用。
研究方法
我們透過網路電子搜尋平台PubMed Embase和 Medline進行文獻搜索。搜尋範圍從2000-2020 年間，條件是比較狼瘡腎炎患者使用RTX與標準治療的差異。以收集總腎反應率 Total renal response, TR)進行分析，統計結果以 勝算比（ Odds ratio, OR 與比例 (Proportion) 表 示。所有統計分析使用 Cochrane Review Manager version 5.4 (Cochrane Library, UK) 和 MedCalc Software version 19.4 (Ostend, Belgium)。
結果
符合搜尋條件的共有135 篇。最終，符合納入排除條件的有四篇比較性研究與九篇單臂研究，共納入 663 接受或未接受RTX治療的狼瘡腎炎患者。結果顯示，免疫抑制劑加上RTX與免疫調節劑單用相比 有較高的 TR Odds ratio=1.76, 95CI, 1.11-2.81 。進一步分析，RTX加上目前的標準治療藥物 cyclophosphamide (CYC) 或 mycophenolate mofetil ( RTX使用於 CYC的加乘效應 (TR Odds ratio=2.78, 95 CI, 1.17-6.59) 優於 RTX用於 MMF (TR Odds ratio=1.86, 95 CI, 1.03-3.38)。
結論
我們的研究結果顯示，在誘導治療中將RTX加入狼瘡性腎炎的治療可能會達到臨床上顯著的腎臟反應率，特別是與單獨使用 CYC的情況相比。

關鍵字

狼瘡腎炎 ； 莫須瘤 ； 誘導治療 ； 系統性文獻回顧 ； 統合分析

並列摘要

Objectives
Rituximab (RTX) is recommended for the treatment of refractory patients with lupus nephritis in clinical guidelines, but the results of randomized double-blind clinical trials and observational studies failed to reach a solid conclusion. Therefore, we aim to perform a meta-analysis to provide a further insight for the role of rituximab in lupus nephritis
Methods
Pubmed, Medline, and Embase were used to search for rituximab and lupus nephritis to identify eligible studies and assessed immunosuppressant with adding on RTX total renal response (TR), this evaluation includes comparing the additive effects of different immunosuppressive drugs.
Results
We identified four comparative studies and nine single-arm studies with a total of 663 lupus nephritis patients treated with or without rituximab. The results showed that immunosuppressant with adding on RTX result in a significant higher total renal response ( OR of 1.76, 95% CI, 1.11-2.81). When compared with the standard treatment drugs cyclophosphamide (CYC) and mycophenolate mofetil (MMF), CYC adding on RTX compared with CYC alone (OR was 2.78, 95% CI, 1.17-6.59) was better than MMF adding on RTX compared with MMF (OR was 1.86, 95% CI, 1.03-3.38).
Conclusion
Our study showed that adding on RTX to the treatment of lupus nephritis patients in induction therapy might achieve a clinically significant renal response rate, especially when compared with cyclophosphamide alone.

並列關鍵字

lupus nephritis ； rituximab ； induction therapy ； systematic review ； meta-analysis

參考文獻

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