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慢性肾脏病临床试验中未满足的需求:我们尚未回答的问题以及我们未曾质疑过的答案。

Unmet needs in clinical trials in CKD: questions we have not answered and answers we have not questioned.

作者信息

Levin Adeera, Borkum Megan

机构信息

Division of Nephrology, University of British Columbia, Vancouver, BC,Canada.

出版信息

Clin Kidney J. 2022 Oct 15;16(3):437-441. doi: 10.1093/ckj/sfac226. eCollection 2023 Mar.

DOI:10.1093/ckj/sfac226
PMID:36865013
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9972821/
Abstract

Many advances have been made in the field of nephrology over the last decade. These include an increasing focus on patient-centred involvement in trials, exploration of innovative trial designs and methodology, the growth of personalized medicine and, most importantly, novel therapeutic agents that are disease-modifying for large groups of patients with and without diabetes and chronic kidney disease. Despite this progress, many questions remain unanswered and we have not critically evaluated some of our assumptions, practices and guidelines despite emerging evidence to challenge current paradigms and discrepant patient-preferred outcomes. How best to implement best practices, diagnose various conditions, examine better diagnostic tools, treat laboratory values versus patients and understand prediction equations in the clinical context remain unanswered. As we enter a new era in nephrology, there are extraordinary opportunities to change the culture and care. Rigorous research paradigms enabling both the generation and the use of new information should be explored. We identify here some key areas of interest and suggest renewed efforts to describe and address these gaps so that we can develop, design and execute trials of importance to all.

摘要

在过去十年里,肾脏病学领域取得了许多进展。这些进展包括越来越注重以患者为中心参与试验、探索创新的试验设计和方法、个性化医疗的发展,以及最重要的是,出现了对大量患有和未患有糖尿病及慢性肾脏病的患者具有疾病改善作用的新型治疗药物。尽管取得了这些进展,但许多问题仍未得到解答,而且尽管有新证据挑战当前范式和患者偏好的不同结果,我们仍未对一些假设、做法和指南进行批判性评估。如何最好地实施最佳实践、诊断各种病症、研究更好的诊断工具、根据实验室检查结果还是患者情况进行治疗,以及在临床背景下理解预测方程,这些问题仍未得到解答。随着我们进入肾脏病学的新时代,有绝佳机会改变文化和医疗方式。应该探索能够产生和利用新信息的严格研究范式。我们在此确定了一些关键的关注领域,并建议重新努力描述和填补这些差距,以便我们能够开展、设计和执行对所有人都重要的试验。

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本文引用的文献

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SGLT2 Inhibitors: A Broad Impact Therapeutic Option for the Nephrologist.钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂:肾脏病学家的一种具有广泛影响的治疗选择。
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Protein Restriction for CKD: Time to Move On.慢性肾脏病的蛋白质限制:是时候向前迈进了。
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Kidney Int. 2022 Dec;102(6):1222-1227. doi: 10.1016/j.kint.2022.07.006. Epub 2022 Aug 1.
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Optimizing the Design and Analysis of Future AKI Trials.优化未来 AKI 试验的设计和分析。
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Uses of GFR and Albuminuria Level in Acute and Chronic Kidney Disease.肾小球滤过率和蛋白尿水平在急性和慢性肾脏病中的应用
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Real-Life Prescribing of SGLT2 Inhibitors: How to Handle the Other Medications, Including Glucose-Lowering Drugs and Diuretics.钠-葡萄糖协同转运蛋白2抑制剂的实际处方:如何处理其他药物,包括降糖药和利尿剂。
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