Department of Nephrology, Jiaxing Hospital of Traditional Chinese Medicine, Jiaxing, Zhejiang, China.
Department of Clinical Medical School, Taizhou University, Taizhou, Zhejiang, China.
Front Immunol. 2023 Jan 4;13:926517. doi: 10.3389/fimmu.2022.926517. eCollection 2022.
Immunoglobulin A (IgA) nephropathy is a common autoimmune kidney disease. Accumulating studies showed that IgA nephropathy may be partially correlated with mucosal immune system dysfunction. Systemic corticosteroid treatment exerts an essential protective effect against renal deterioration in IgA nephropathy. However, long-term use of corticosteroids may cause systemic side effects. The novel targeted-release formulation (TRF) of budesonide has been shown to deliver the drug to the distal ileum with the aim of minimizing adverse events for patients with IgA nephropathy. In this review, we have summarized all the current evidence of the effects of TRF-budesonide protecting against IgA nephropathy. Three randomized controlled trials (RCTs), one cohort, two case reports, and an ongoing Phase 3 trial (Part B, NCT03643965), were under comprehensive review. These included studies demonstrated that TRF-budesonide could remarkably reduce proteinuria, hematuria, and creatinine, as well as preserve renal function. The local immunosuppressive effects exhibited by TRF-budesonide may represent a novel and promising approach to treating IgA nephropathy. However, the current evidence was only derived from limited trials. Therefore, more well-designed RCTs are still warranted to validate the curable profile of TRF-budesonide in treating IgA nephropathy.
免疫球蛋白 A(IgA)肾病是一种常见的自身免疫性肾脏疾病。越来越多的研究表明,IgA 肾病可能与黏膜免疫系统功能障碍部分相关。全身皮质类固醇治疗对 IgA 肾病的肾脏恶化具有重要的保护作用。然而,长期使用皮质类固醇可能会引起全身副作用。布地奈德新型靶向释放制剂(TRF)已被证明可将药物递送到回肠末端,旨在最大程度地减少 IgA 肾病患者的不良事件。在这篇综述中,我们总结了 TRF-布地奈德预防 IgA 肾病的所有现有证据。三项随机对照试验(RCT)、一项队列研究、两项病例报告和一项正在进行的 3 期试验(第 B 部分,NCT03643965)都进行了全面回顾。这些研究表明,TRF-布地奈德可显著减少蛋白尿、血尿和肌酐,并保护肾功能。TRF-布地奈德的局部免疫抑制作用可能代表治疗 IgA 肾病的一种新颖且有前途的方法。然而,目前的证据仅来自有限的试验。因此,仍需要更多设计良好的 RCT 来验证 TRF-布地奈德治疗 IgA 肾病的可治愈特征。