Schena Francesco Paolo, Pasculli Emanuela
Department of Emergency and Organ Transplantation, University of Bari "Aldo Moro", Bari, Italy.
Schena Foundation, Bari, Italy.
Clin Kidney J. 2025 Jul 11;18(8):sfaf214. doi: 10.1093/ckj/sfaf214. eCollection 2025 Aug.
In this narrative review, we summarize the current knowledge on RNA-based therapies used in rare and ultrarare disorders and congenital diseases in which the kidneys may be involved. In these therapies, RNA molecules are packaged into delivery vehicles to reach the desired target. We describe only drugs that have been approved or are under review for approval by the US Food and Drug Administration and/or the European Medicines Agency. We describe the potential therapeutic role of microRNA (miRNA) in Alport syndrome, polycystic kidney disease and renal cell carcinoma. Notably, large randomized clinical studies are required before these drugs can be introduced into clinical practice. The therapeutic effects of short interfering RNA molecules have been tested and evaluated in patients with various congenital or acquired diseases, such as primary hyperoxaluria, hereditary transthyretin amyloidosis, acute kidney injury after cardiovascular intervention or kidney transplantation (i.e. delayed graft function), and in individuals affected by hypercholesterolemia. In addition, synthetic antisense oligonucleotides have proven effective in patients with moderate or severe hypercholesterolemia who developed statin side effects, such as myalgia or rhabdomyolysis, and in individuals with amyloidosis. These new therapeutic approaches need to be validated through global clinical trials in which large patient samples can be enrolled. Nonetheless, some of these promising new approaches are currently undergoing evaluation for the treatment of common diseases, such as hypertension and diabetes, which are the main causes of chronic kidney disease.
在这篇叙述性综述中,我们总结了目前关于用于罕见和超罕见疾病以及可能累及肾脏的先天性疾病的基于RNA的疗法的知识。在这些疗法中,RNA分子被包装进递送载体以到达预期靶点。我们仅描述已获美国食品药品监督管理局和/或欧洲药品管理局批准或正在审批的药物。我们描述了微小RNA(miRNA)在阿尔波特综合征、多囊肾病和肾细胞癌中的潜在治疗作用。值得注意的是,在这些药物能够引入临床实践之前,需要开展大规模随机临床研究。短干扰RNA分子的治疗效果已在患有各种先天性或后天性疾病的患者中进行了测试和评估,这些疾病包括原发性高草酸尿症、遗传性转甲状腺素蛋白淀粉样变性、心血管介入或肾移植后的急性肾损伤(即移植肾功能延迟),以及受高胆固醇血症影响的个体。此外,合成反义寡核苷酸已被证明对出现他汀类药物副作用(如肌痛或横纹肌溶解)的中度或重度高胆固醇血症患者以及患有淀粉样变性的个体有效。这些新的治疗方法需要通过能够纳入大量患者样本的全球临床试验来验证。尽管如此,目前其中一些有前景的新方法正在接受用于治疗常见疾病(如高血压和糖尿病,它们是慢性肾脏病的主要病因)的评估。