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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-03087-3

摘要内容如下：

供体来源的无细胞DNA（DD-cfDNA）是一种新兴的非侵入性生物标志物，具有检测同种异体移植物损伤的潜力。供体来源的无细胞DNA检测肾移植排斥反应的能力及其在标准护理患者监测之外的附加临床价值尚不清楚。在一项基于人群的观察性研究中，我们从欧洲和美国的14个移植中心招募了2，882名肾移植受者。主要分析包括1，134名患者。供体来源的无细胞DNA水平与同种异体移植排斥反应密切相关，包括抗体介导的排斥反应（P<0.0001）、T细胞介导的排斥反应（P<0.0001）和混合排斥反应（P<0.0001）。在多变量分析中，循环DD-cfDNA与同种异体移植排斥反应显著相关（OR:2.275；置信区间:1.902-2.739；p<0.0001）独立于标准护理患者监测参数。将DD-cfDNA纳入标准护理预测模型显示出改善的区分度（0.777[95%CI:0.741-0.811]至0.821[95%CI:0.784-0.852]；P=0.0011）和校准。这些结果在外部验证队列（n=1，748）中得到证实，包括非洲裔美国患者队列（n=439）。最后，DD-cfDNA对检测稳定患者的亚临床排斥反应具有较高的预测价值。我们的研究提供了关于评估DD-cfDNA的潜在价值的见解，除了标准的护理监测，以改善同种异体移植排斥反应的检测。ClinicalTrials.gov注册：NCT05995379。

英文原文如下：

Abstracts

Donor-derived cell-free DNA (dd-cfDNA) is an emerging non-invasive biomarker that has the potential to detect allograft injury. The capacity of donor-derived cell-free DNA to detect kidney allograft rejection and its added clinical value beyond standard of care patient monitoring is unclear. We enrolled 2,882 kidney allograft recipients from 14 transplantation centers in Europe and the US in an observational population-based study. The primary analysis included 1,134 patients. Donor-derived cell-free DNA levels strongly correlated with allograft rejection including antibody-mediated rejection (p < 0.0001), T-Cell mediated rejection (p < 0.0001) and mixed rejection (p < 0.0001). In multivariable analysis, circulating dd-cfDNA was significantly associated with allograft rejection (OR: 2.275; CI:1.902-2.739; p < 0.0001) independently of standard of care patient monitoring parameters. The inclusion of dd-cfDNA to a standard of care prediction model showed improved discrimination (0.777 [95% CI: 0.741-0.811] to 0.821 [95% CI: 0.784-0.852]; p = 0.0011) and calibration. These results were confirmed in the external validation cohorts (n = 1,748) including a cohort of African American patients (n = 439). Finally, dd-cfDNA showed high predictive value to detect subclinical rejection in stable patients. Our study provides insights on the potential value of assessing dd-cfDNA, in addition to standard of care monitoring, to improve the detection of allograft rejection. ClinicalTrials.gov registration: NCT05995379.

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