编者按：慢性肾脏病（CKD）进展隐匿，高风险及晚期患者常合并心血管损伤，长期存在干预滞后、指南推荐药物落地不足、1型糖尿病肾病缺乏有效护肾药物三大临床痛点。第63届欧洲肾脏协会大会（ERA 2026）上，加拿大多伦多大学内科学系David Cherney副教授围绕慢性肾脏病干预时机、指南导向药物治疗（GDMT）、1型糖尿病肾病非奈利酮FINE-ONE研究三大核心议题开展了三项专题报告。其后，Cherney副教授接受肾医线专访，就这三方面内容进行了深入阐述。



一、“时间就是肾脏”，早期干预是延缓肾病进展的核心抓手

提到为何“启动治疗时机”已成为CKD管理中至关重要的一环，David Cherney副教授指出，“启动治疗时机”的重要性体现在两方面。

第一，从临床实践的角度，日常诊疗中，患者常规复诊间隔多为6至12个月，难以做到更高频随访。如果等到下次就诊才启动新治疗方案，患者获得降低心血管风险、肾脏风险或二者兼有的药物之前，可能会经历漫长的延迟期。这是治疗时机至关重要的原因之一——尽早启用药物治疗，以降低风险。

我们已知部分药物，例如钠 - 葡萄糖协同转运蛋白2抑制剂（SGLT2 抑制剂），开始用药后短期内就能降低心力衰竭发生风险，部分患者仅1个月便能显现获益，足见尽早启动治疗意义重大。

第二，我们清楚，等待时间越长，若患者已出现肾功能进行性下降，治疗的绝对获益将相应减少。当治疗始于疾病最早阶段时，患者获得的获益更大。ERA 2026上的一些预测模型研究结果提示：对于肾功能保留但存在白蛋白尿（这是肾脏病进展的危险因素）的患者，早期治疗可将需要透析或移植的时间推迟25年甚至更长。

总而言之，治疗启动越早越好，“时间就是肾脏（Time is kidney）”。当然，即便患者肾功能已经较低、延迟启动治疗仍能收获一定疗效，但早期干预所能带来的获益最为可观。

Nephrology On-line: At ERA 2026, your presentations focus on the importance of timely intervention and guideline-directed medical therapy in patients with high-risk and advanced CKD. From your perspective, why is “time” becoming such a critical factor in CKD management, and what are the clinical consequences of delayed intervention?

Prof. Cherney: Time is important in a couple of ways. Time is crucial because, from a clinical perspective, we often do not see patients regularly in practice more frequently than every 6 to 12 months. If we wait until the next visit before starting a new therapy, there can be a long delay before patients receive medications that reduce cardiovascular risk, kidney risk, or both. That is one reason why time is so important—getting therapies on board early to reduce risk.

We know that some medications, for example, SGLT2 inhibitors, reduce the risk of heart failure very soon after initiation, sometimes within a month. Therefore, starting treatment early is important.

The other issue is that we know the longer we wait, if patients experience kidney function decline, the benefit of therapy is reduced. Patients derive the greatest benefit when therapies are started at the earliest stages of disease.

During today's session, we reviewed models suggesting that if patients have preserved kidney function but albuminuria, which is a risk factor for progressive kidney disease, early treatment may delay the need for dialysis or transplantation by 25 years or more.

So, the earlier you start, the better. Time indeed is kidney.

There is still benefit if therapy is initiated later, when kidney function is lower, but earlier intervention provides the greatest benefit.

二、现实困境：晚期CKD指南导向药物治疗落地不足，多重壁垒亟待破解

专题会议探讨了晚期肾脏病的指南推荐药物，尽管相关循证证据持续积累，但GDMT在真实世界的规范使用情况仍不理想。David Cherney副教授指出，这背后存在多重阻碍：

第一，筛查不足。我们需要确保有风险的患者能够定期检测肾功能和尿白蛋白。例如，糖尿病患者应每年接受肾脏评估，但实际上只有一小部分患者接受了规范的筛查。对于高血压患者而言，情况甚至更差。因此，筛查不足是一个主要障碍。

第二，围绕这些治疗的教育和认知问题。 目前肾脏科医师和心脏科医师的数量远远不足以管理所有心肾疾病患者。我们必须确保基层医师能够从容地处方这些药物，理解支持其使用的循证依据，掌握安全处方的要点，并知道如何对患者进行恰当监测。遗憾的是，基层医师在使用这些药物方面的教育和信心水平仍不理想，有待提高。

第三，医疗体系政策层面的限制。药物的可及性、报销和支付政策等都会影响患者能否接受这些治疗。即便在某些国家，医保已全面覆盖相关药物且处方流程简便，这些药物的实际使用率仍然偏低。

因此，目前GDMT在CKD患者中的使用不理想，并非是单一的意识问题，也非单纯的成本问题或医师问题，而是多个层面障碍的叠加。其中最重要的，一是通过筛查识别高危患者，二是确保临床医师了解应使用哪些药物及其正确用法。幸运的是，这些药物的处方和监测通常较为简便，希望随着时间推移，这一状况会逐步改善。

Nephrology On-line: During today's session we discussed guideline-directed therapies in advanced kidney disease, and despite growing evidence, implementation in the real world remains limited. What are the major barriers?

Prof. Cherney: There are many barriers.

One of the barriers unfortunately remains inadequate screening. We need to ensure that patients who are at risk have their kidney function and urine albumin measured at regular intervals.

For example, people with diabetes should have their kidneys assessed annually, yet only a small proportion of patients actually receive appropriate screening. For people with hypertension, the situation is even worse. So inadequate screening is a major barrier.

A second barrier is education and awareness regarding these therapies. There are simply not enough nephrologists or cardiologists to manage all patients with kidney and heart disease. We need to ensure that primary care physicians are comfortable prescribing these medications, understand the evidence supporting their use, know how to prescribe them safely, and know how to monitor patients appropriately. Unfortunately, education and confidence in using these medications remain suboptimal and need to improve.

There are also broader healthcare-system issues, including access to medications, reimbursement, and coverage policies that affect whether patients receive these therapies.

Even in countries where these medications are readily covered and easy to prescribe, utilization remains very low.

So it is not just an awareness issue, not just a cost issue, and not just a physician issue. There are multiple layers of barriers that need to be addressed.

Among the most important are identifying at-risk patients through screening and ensuring clinicians understand which therapies to use and how to use them. Fortunately, these medications are generally very easy to prescribe and manage, and hopefully this situation will improve over time.

三、重磅临床研究：FINE-ONE试验填补1型糖尿病肾病护肾治疗空白

本次大会上Cherney副教授发布了FINE-ONE试验预设分析结果，该研究旨在评估非奈利酮对合并慢性肾脏病的1型糖尿病患者估算肾小球滤过率（eGFR）早期波动的影响。采访中，Cherney副教授重点介绍了FINE-ONE试验的核心价值与突破性意义。

Cherney副教授指出，FINE-ONE试验的重要性在于，它评估了一种我们在2型糖尿病患者中已常规使用的药物——非奈利酮。然而，该试验的受试人群是1型糖尿病患者。此前的大多数评估SGLT2抑制剂、非奈利酮、GLP-1受体激动剂的大型临床试验，均将1型糖尿病患者排除在外，而FINE-ONE试验正是为了回答“非奈利酮能否降低1型糖尿病患者的尿白蛋白水平”这一关键问题而专门设计的。其主要终点结果已公布并发表于《新英格兰医学杂志》（New England Journal of Medicine），结果显示，在治疗6个月时尿白蛋白水平降低约20%。这些发现提示，非奈利酮在1型糖尿病患者中可能具有与在2型糖尿病患者中相似的肾脏获益。

随着时间推移，我们将从FINE-ONE试验中获得越来越多的重要数据。这项研究之所以特别重要，是因为它是当前首个在1型糖尿病合并肾脏病患者中证实肾脏保护性治疗有效性的临床试验。

因此，这是一个令人振奋的时期——针对1型糖尿病的安全有效疗法正在重新获得研发关注，而FINE-ONE正是这一新时代首批具有里程碑意义的研究之一。

Nephrology On-line: You are also presenting a prespecified analysis from the FINE-ONE trial evaluating the impact of finerenone on acute eGFR changes in patients with type 1 diabetes and CKD. why is understanding these changes important in clinical practice?

Prof. Cherney: What I can say generally is that there will be discussions in various talks about the FINE-ONE trial. The FINE-ONE trial is important because it evaluated a medicine called finerenone, which we use routinely in people with type 2 diabetes.

However, this trial was conducted in people with type 1 diabetes. Patients with type 1 diabetes were unfortunately excluded from most previous trials evaluating SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists.

The FINE-ONE trial was specifically designed to determine whether finerenone lowers albuminuria in people with type 1 diabetes. The primary results have already been presented and published in The New England Journal of Medicine and showed approximately a 20% reduction in urinary albumin levels at six months. These findings suggest potential kidney benefits in people with type 1 diabetes, similar to those observed in people with type 2 diabetes.

As time goes on, we will obtain more and more data from the FINE-ONE trial. What makes the study particularly important is that it is the first contemporary trial of a kidney-protective therapy demonstrating efficacy in people with type 1 diabetes and kidney disease.

It is therefore a very exciting time, because there is renewed interest in developing safe and effective therapies for people with type 1 diabetes, and FINE-ONE is one of the first major studies in this new era.