Early change in proteinuria as a surrogate outcome in kidney disease progression: a systematic review of previous analyses and creation of a patient-level pooled dataset.
Early change in proteinuria as a surrogate outcome in kidney disease progression: a systematic review of previous analyses and creation of a patient-level pooled dataset.
复制标题
蛋白尿的早期变化作为肾脏疾病进展的替代结果：对先前分析的系统回顾和患者水平汇总数据集的创建。
DOI：
10.1093/ndt/gfq525
复制
发表时间：
2011
期刊：
影响因子：
--
通讯作者：
Stevens,LesleyA
中科院分区：
文献类型：
--
作者：
Stoycheff,Nicholas;Pandya,Kruti;Okparavero,Aghogho;Schiff,Abigail;Levey,AndrewS;Greene,Tom;Stevens,LesleyA
背景：蛋白尿是慢性肾脏疾病(CKD)随机对照试验(RCT)的候选替代终点。这一假说有合理的生物学基础，但目前只有初步的实证证据。方法：系统回顾和创建患者水平的CKD随机对照试验(RCT)数据集，报告蛋白尿的变化，并根据透析、移植、死亡或GFR或肌酐的变化评估肾脏疾病的进展。结果：系统综述。70个RCT符合资格标准；17个合格的RCT包含蛋白尿作为预后预测因素的分析；15个RCT得出结论，较多的蛋白尿与不良结果相关。大多数是关于糖尿病或高血压肾脏疾病的研究，并测试了肾素-血管紧张素系统阻断。预测变量和结果变量的定义太过多变，无法对群体数据进行荟萃分析。创建数据库需要超过4年的时间才能创建患者级别的数据集。最终的数据集包括34项研究和9,000名慢性肾脏病患者的 ，这些患者有不同的慢性肾脏病类型和干预措施。结论：有相对较少的随机对照试验被设计来严格测试肾脏疾病进展的治疗方法。目前对蛋白尿变化作为CKD进展预测指标的分析是异质性和不完整的，这表明有必要在汇集的个体患者水平数据库中进行进一步评估，以促进该领域的知识。
Background.Proteinuria is a candidate surrogate end point for randomized controlled trials (RCTs) in chronic kidney disease (CKD). There is a reasonably sound biological basis for this hypothesis, but only preliminary empirical evidence currently exists.Methods.A systematic review and creation of a patient-level dataset of randomized controlled trials (RCTs) in CKD that reported changes in proteinuria and assessed progression of kidney disease as defined by dialysis, transplantation, death, or changes in GFR or creatinine were performed.Results.Systematic review.Seventy RCTs met the eligibility criteria; 17 eligible RCTs contained analyses of proteinuria as a predictor of outcomes; 15 RCTs concluded that greater proteinuria was associated with adverse outcomes. A majority were studies of diabetic or hypertensive kidney disease and tested renin–angiotensin system blockade. Definitions of predictor and outcome variables were too variable to conduct a meta-analysis of group data.Database creation.Over 4 years was required to create the patient-level dataset. The final dataset included 34 studies and > 9000 patients with a variety of CKD types and interventions.Conclusions.There are a relatively small number of RCTs designed to rigorously test therapies for kidney disease progression. Current analyses of change in proteinuria as a predictor of CKD progression are heterogeneous and incomplete, indicating further evaluation in a pooled individual patient-level database is necessary to advance knowledge in this field.