慢性肾脏病临床试验的替代终点与中医药研究

慢性肾脏病(chronic kidney disease,CKD)随着时间的迁延而不断进展,临床治疗的评价主要是观察肾功能减退速度和终末期肾衰竭的发生。为了使试验得以进行,需要引出“替代终点”,即：以流行病学、病理生理学、药物治疗以及其他科学证据为基础,用于代替临床终点（结局）的生物学标志,以预测有无临床效益或损害。本文旨在说明替代终点的定义,讨论慢性肾脏病可能使用的替代终点:如蛋白尿、肾小球滤过率（glomerular filtration rate,GFR）下降、斜率以及结局发生时间分析。通过分析中医治疗慢性肾脏病临床研究中存在的问题,提出中医药在治疗慢性肾脏病的疗效观察方法需要改进,主要是引入替代终点进行评价。

Surrogate End Points for Clinical Trials on Chronic Kidney Disease and Research of Chinese Medicine

Chronic kidney disease is a kind of disease with the condition always worsening over time passing through a sequence of stages, and the evaluation on its clinical treatment is mainly by observing the speed of renal function deteriorating and the time of terminal renal failure occurrence. In order to conduct the trial go on wheels, the authors proposed that the "surrogate end points (SEP)" should be introduced. It is the biologic mark for substitute the clinical terminal point (event), formed depending upon the scientific evidences of epidemiology, pathophysiology, drug-therapy and other scientific evidence, which could be used for predicting the efficacy or damage of a certain measure, present or absent. This article aimed to explain the definition of SEP and to discuss the usable SEP for clinical trial on chronic kidney disease, such as proteinuria, declination of glomerular filtration rate and its slope coefficient as well as the time of terminal occurrence. Moreover, through analyzing the existent problems in clinical researches concerning TCM treatment of chronic kidney disease, the authors suggested that some improvements, chiefly the utilization of SEP for efficacy evaluation, are necessary in the clinical observation methodologies for chronic kidney disease.