聚醚砜膜空心纤维透析器Enttex^TM-16LF治疗急、慢性肾功能衰竭的疗效  

Efficacy of enttex^TM-16LF with polyethersulfone membrane hollow fiber dialyser on acute and chronic renal failure treatment

作　　者：陈宇[1] 陈刚毅[2] 刘洪萍[3] 欧阳梓华[4] 李强 余宗超[1] 宋慧锋[2] 李云逸[1] 管保章[1] 董向楠[1] 刘欢欢[1] 张泽宇 范丽静 何永成[3] 尹良红[1] 汤水福[2] 梁文学[1] 胡波[1] CHEN Yu;CHEN Gangyi;LIU Hongping;OUYANG Zihua;LI Qiang;YU Zongchao;SONG Huifeng;LI Yunyi;GUAN Baozhang;DONG Xiangnan;LIU Huanhuan;ZHANG Zeyu;FAN Lijing;HE Yongcheng;YIN Lianghong;TANG Shuifu;LIANG Wenxue;HU Bo(Department of Nephrology,the First Affiliated Hospital,Jinan University,Guangzhou 510630,China;Department of Nephrology,the First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China;Department of Nephrology,the Second People′s Hospital of Shenzhen,Shenzhen 518000,China;Department of Nephrology,Jinghu Hospital of Macao,Macao 820002,China;Department of Nephrology,Dongguan Hospital of Traditionl Chinese Medicine,Dongguan 523000,China)

机构地区：[1]暨南大学附属第一医院肾内科,广东广州510630 [2]广州中医药大学第一附属医院肾内科,广东广州510405 [3]深圳市第二人民医院肾内科,广东深圳518000 [4]澳门镜湖医院肾内科,澳门820002 [5]东莞市中医院肾内科,广东东莞523000

出　　处：《暨南大学学报（自然科学与医学版）》2020年第1期79-85,共7页Journal of Jinan University(Natural Science & Medicine Edition)

基　　金：广东省产学研合作院士工作站基金项目(2013B090400004);广东省工程技术研究中心基金项目(507204531040)。

摘　　要：目的:评价聚醚砜膜空心纤维透析器Enttex^TM-16LF(E60)用于多种因素导致的急性或慢性肾功能衰竭患者的血液透析治疗的安全性和有效性.方法:纳入维持性血液透析患者76例,试验组使用Enttex TM-16LF透析器,对照组使用B-16P透析器,采用随机、开放、二阶段交叉阳性对照、非劣性验证设计.以透析器的肌酐清除率和尿素清除率为主要有效性指标;次要有效性评价指标为整体透析肌酐、尿素清除率、尿素下降率(URR)、透析器对尿素的清除量与体积的比值(Kt/V)、体质量、超滤率、电解质、C-反应蛋白(CRP)、血气分析指标等变化;同时进行安全性和生物相容性评价,观察试验器械的临床疗效和安全性.结果:主要评价指标肌酐清除率和尿素清除率在全数据集(MITTP)及符合方案数据集(PPP)中分析,试验组与对照组比较,均无统计学差异(P>0.05);PPP数据分析证明试验器械非劣于对照器械;一定透析时间内Kt/V、整体透析肌酐、尿素清除率和URR、电解质、血常规、肝功能的改变,试验器械与对照器械比较无统计学差异.结论:临床试验证实聚醚砜膜空心纤维透析器用于血液透析治疗是安全的和有效的.Objective:To evaluate the safety and efficacy of Enttex^TM-16LF(E60)polyethersulfone membrane hollow fiber dialyzer for hemodialysis in patients with acute or chronic renal failure caused by various factors.Methods:The test group used entextm-16lf dialyzer while the control group used b-16p dialyzer.Seventy-six patients with maintenance hemodialysis were selected and tested by randomized,open,two-stage cross positive control and non-inferior validation experimental designs.Creatinine clearance rate of dialyzer and urea clearance rate of dialyzer were the two main effective indexes.The secondary effectiveness evaluation indexs were changes of creatinine,urea nitrogen clearance,URR,kt/V value,body weight,ultrafiltration rate,electrolyte,C-reactive protein(CRP),blood gas analysis index,etc.At the same time,the safety and biocompatibility were evaluated,and the clinical efficacy and safety were observed.Results:There was no significant difference in creatinine clearance rate and urea clearance rate between the test instrument and the control instrument in MITP and PPP(P>0.05);PPP data analysis showed that the test instrument was not inferior to the control instrument.There was no significant difference in Kt/V,creatinine,urea clearance rate,URR(urea decline rate),electrolyte,and blood routine and liver function between the test and control instruments.Conclusion:This clinical trial verified the safety and effectiveness of Enttex^TM-16LF(E60)hollow fiber dialyzer for hemodialysis treatment.

关 键 词：血液透析 聚醚砜膜 透析器 肾功能衰竭 

分 类 号：R318.16[医药卫生—生物医学工程] R197.39[医药卫生—基础医学]