Importance of glomerular filtration rate change as surrogate endpoint for the future incidence of end-stage renal disease in general Japanese population: community-based cohort study.
Importance of glomerular filtration rate change as surrogate endpoint for the future incidence of end-stage renal disease in general Japanese population: community-based cohort study.
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DOI：
10.1007/s10157-017-1463-0
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发表时间：
2018-04
影响因子：
2.3
通讯作者：
Nangaku M
中科院分区：
文献类型：
--
作者：
Kanda E;Usui T;Kashihara N;Iseki C;Iseki K;Nangaku M
由于事件发生前需要较长的时间和较大的费用，因此替代终点对于实施改善慢性肾脏疾病（CKD）患者预后的临床研究是必不可少的。在日本冲绳，以社区为基础的前瞻性队列研究纳入了基线期超过1-3年血清肌酐水平的受试者（n = 69,238），并随访了15年。终点是终末期肾病（ESRD）。估计肾小球滤过率（%eGFR）变化的百分比是在基线期的基础上计算的。受试者平均±SD年龄55.59±14.69岁；eGFR: 80.15±21.15 ml/min/1.73 m2。在所招募的受试者中，15.81%的受试者eGFR较低（<60 ml/min/1.73 m2）， 36.1/10万人年发生ESRD。根据基线特征调整的Cox比例风险模型显示，在高eGFR组和低eGFR组中，2年或3年内eGFR变化的下降率较高，ESRD的风险也较高。在高eGFR组和低eGFR组中，基于2年或3年eGFR变化小于- 30%的临界值的ESRD的特异性和阳性预测值较高。eGFR变化往往与ESRD的风险相关。在日本普通人群中，2 - 3年内eGFR变化小于- 30%可作为ESRD的候选替代终点。
Because of the necessity for extended period and large costs until the event occurs, surrogate endpoints are indispensable for implementation of clinical studies to improve chronic kidney disease (CKD) patients’ prognosis. Subjects with serum creatinine level for a baseline period over 1–3 years were enrolled (n = 69,238) in this community-based prospective cohort study in Okinawa, Japan, and followed up for 15 years. The endpoint was end-stage renal disease (ESRD). The percent of estimated glomerular filtration rate (%eGFR) change was calculated on the basis of the baseline period. Subjects had a mean ± SD age, 55.59 ± 14.69 years; eGFR, 80.15 ± 21.15 ml/min/1.73 m2. Among the subjects recruited, 15.81% had a low eGFR (<60 ml/min/1.73 m2) and 36.1/100,000 person years developed ESRD. Cox proportional hazards models adjusted for baseline characteristics showed that the risk of ESRD tended to be high with high rates of decrease in %eGFR changes over 2 or 3 years in the high- and low-eGFR groups. The specificities and positive predictive values for ESRD based on a cutoff value of %eGFR change of less than −30% over 2 or 3 years were high in the high- and low-eGFR groups. %eGFR change tends to be associated with the risk of ESRD. %eGFR change of less than −30% over 2 or 3 years can be a candidate surrogate endpoint for ESRD in the general Japanese population.
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DOI：
10.1053/j.ajkd.2009.12.016
发表时间：
2010-04
期刊：
American journal of kidney diseases : the official journal of the National Kidney Foundation
影响因子：
--
作者：
Matsushita K;Selvin E;Bash LD;Astor BC;Coresh J
通讯作者：
Coresh J
影响因子：
13.2
作者：
Heerspink, Hiddo J. Lambers;Tighiouart, Hocine;Inker, Lesley A.
通讯作者：
Inker, Lesley A.
影响因子：
13.2
作者：
Inker, Lesley A.;Heerspink, Hiddo J. Lambers;Levey, Andrew S.
通讯作者：
Levey, Andrew S.
影响因子：
2.3
作者：
Imai, Enyu;Horio, Masaru;Matsuo, Seiichi
通讯作者：
Matsuo, Seiichi
影响因子：
13.2
作者：
Iseki, K;Kinjo, K;Takishita, S
通讯作者：
Takishita, S