血液透析类产品临床试验设计要点

血液净化疗法是指应用物理、化学或免疫学等方法清除体内过多的水分及血中代谢废物、毒物、自身抗体、免疫复合物等致病物质,以维持体内水、电解质和酸碱平衡的治疗方法。血液透析作为血液净化疗法的一种,是针对慢性肾衰竭的主要治疗手段之一。近年来随着透析治疗技术的发展,国产透析机、透析器等器械的注册申报数量也越来越多,文章拟对血液透析治疗中几类主要医疗器械的临床试验设计展开探讨,以供同行参考交流。

Key Points of Clinical Trial Design for Hemodialysis Products

Blood purification therapy refers to the application of physical,chemical or immunological methods to remove excess water in the body and pathogenic substances such as metabolic wastes,poisons,autoantibodies,and immune complexes in the blood to maintain the body’s water,electrolytes,and acids Balanced treatment.Hemodialysis(HD),as a type of blood purification therapy,is one of the main treatments for chronic renal failure.In recent years,with the development of dialysis treatment technology,the number of registration applications for domestic dialysis machines,dialyzers and other devices has also increased.This article intends to discuss the clinical trial design of several major medical devices in hemodialysis treatment for peers.Reference exchange.