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治疗 12 个月后蛋白尿截断值为 0.7g/天可最佳预测狼疮肾炎的长期肾脏结局:来自 MAINTAIN 肾炎试验的数据。

A proteinuria cut-off level of 0.7 g/day after 12 months of treatment best predicts long-term renal outcome in lupus nephritis: data from the MAINTAIN Nephritis Trial.

机构信息

Rheumatology Department , Cliniques Universitaires Saint-Luc, Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Université catholique de Louvain , Bruxelles , Belgium.

Division of Rheumatology , Russell/Engelman Research Center, University of California, San Francisco , San Francisco, California , USA.

出版信息

Lupus Sci Med. 2015 Nov 12;2(1):e000123. doi: 10.1136/lupus-2015-000123. eCollection 2015.

DOI:10.1136/lupus-2015-000123
PMID:26629352
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4654096/
Abstract

BACKGROUND

Although an early decrease in proteinuria has been correlated with good long-term renal outcome in lupus nephritis (LN), studies aimed at defining a cut-off proteinuria value are missing, except a recent analysis performed on patients randomised in the Euro-Lupus Nephritis Trial, demonstrating that a target value of 0.8 g/day at month 12 optimised sensitivity and specificity for the prediction of good renal outcome. The objective of the current work is to validate this target in another LN study, namely the MAINTAIN Nephritis Trial (MNT).

METHODS

Long-term (at least 7 years) renal function data were available for 90 patients randomised in the MNT. Receiver operating characteristic curves were built to test the performance of proteinuria measured within the 1st year as short-term predictor of long-term renal outcome. We calculated the positive and negative predictive values (PPV, NPV).

RESULTS

After 12 months of treatment, achievement of a proteinuria <0.7 g/day best predicted good renal outcome, with a sensitivity and a specificity of 71% and 75%, respectively. The PPV was high (94%) but the NPV low (29%). Addition of the requirement of urine red blood cells ≤5/hpf as response criteria at month 12 reduced sensitivity from 71% to 41%.

CONCLUSIONS

In this cohort of mainly Caucasian patients suffering from a first episode of LN in most cases, achievement of a proteinuria <0.7 g/day at month 12 best predicts good outcome at 7 years and inclusion of haematuria in the set of criteria at month 12 undermines the sensitivity of early proteinuria decrease for the prediction of good outcome. The robustness of these conclusions stems from the very similar results obtained in two distinct LN cohorts.

TRIAL REGISTRATION NUMBER

NCT00204022.

摘要

背景

尽管蛋白尿早期减少与狼疮肾炎 (LN) 的长期肾脏预后良好相关,但目前缺乏旨在定义蛋白尿截断值的研究,除了最近在 Euro-Lupus Nephritis Trial 中随机分组的患者进行的一项分析表明,在第 12 个月时将蛋白尿目标值设定为 0.8g/天可优化对良好肾脏结局的预测的敏感性和特异性。目前这项工作的目的是在另一个 LN 研究,即 MAINTAIN Nephritis Trial (MNT) 中验证这一目标。

方法

MNT 中随机分组的 90 例患者有长期(至少 7 年)肾功能数据。构建受试者工作特征曲线以测试第 1 年内测量的蛋白尿作为长期肾脏结局的短期预测指标的性能。我们计算了阳性和阴性预测值(PPV、NPV)。

结果

治疗 12 个月后,蛋白尿<0.7g/天的患者达到最佳肾脏结局,其敏感性和特异性分别为 71%和 75%。PPV 较高(94%),但 NPV 较低(29%)。在第 12 个月时将尿红细胞<5/hpf 作为反应标准纳入,会使敏感性从 71%降至 41%。

结论

在这组主要为高加索人种患者中,大多数患者为首次发作 LN,在第 12 个月时蛋白尿<0.7g/天可最好地预测 7 年后的良好结局,在第 12 个月时将血尿纳入标准会降低早期蛋白尿减少对预测良好结局的敏感性。这些结论的可靠性源于在两个不同的 LN 队列中获得的非常相似的结果。

临床试验注册号

NCT00204022。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b3b/4654096/cebf196b44f7/lupus2015000123f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b3b/4654096/cebf196b44f7/lupus2015000123f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b3b/4654096/cebf196b44f7/lupus2015000123f01.jpg

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