目的:以费森尤斯空心纤维透析器(F60S)为对照,验证国产高通量“HF12、HF16聚砜膜空心纤维透析器”对慢性肾衰竭维持性血液透析(MHD)患者的临床疗效和安全性. 方法:采用随机平行对照试验设计,将2011年3月至6月在南京军区南京总医院全军肾脏病研究所血液净化中心行MHD治疗的135例患者分为HF12试验组、HF16试验组和F60S对照组,每组45例,使用相应透析器行血液透析治疗一次(4h/次),计算患者尿素氮、肌酐、磷酸盐、β2微球蛋白(β2-MG)的清除率和下降率,并检测试验前后外周血红蛋白、白细胞、血小板、血清白蛋白、补体C3等实验室指标变化,观察并记录不良反应和不良事件. 结果:(1)135例患者均完成试验,无一例失访.其中男性85例,女性50例,年龄19～ 62岁,平均年龄(39±11)岁.(2)试验组患者的尿素氮、肌酐、磷酸盐及β2-MG清除率和下降率与对照组相比均无统计学差异.HF12、HF16试验组患者的尿素氮清除率略低于对照组,分别为(184.0±62.8)ml/min、(196.0±37.9)ml/min和(200.6±23.2) ml/min,三者间无统计学差异.试验组和对照组患者的尿素氮下降率均＞60％(P＞0.05).HF12试验组患者的β2-MG下降率略低于对照组[(41.3±15.6)％ vs(44.0±16.8)％,P＞0.05],HF16试验组患者的β2-MG下降率略高于对照组[(47.0±15.0)％ vs(44.0±16.8)％,P＞0.05].(3)试验组和对照组患者在试验前后外周血红蛋白、白细胞、血小板、血清白蛋白、补体C3均无明显变化.(4)试验组和对照组均未发生不良反应及不良事件. 结论:国产高通量HF12、HF16聚砜膜透析器与进口F60S透析器具有相同的小分子毒素和中分子物质清除作用,生物相容性较好,未发生不良反应和不良事件.%Objective;To evaluate the clinical safety and efficacy of domestically produced high-flux HF12 and HF16 polysulfon dialyzer in maintenance hemodialysis patients' treatments of chronic renal failure, which contrast with F60S polysulfon dialyzer of Fresenius. Methodology: One hundred and thirty-five patients with maintenance hemodialysis were admitted to the center of blood purification of Nanjing Institution of Nephrology. By random parallel controlled trial design, they were divided into three groups,the experiment group of HF12 (n =45) ,the experiment group of HF16 (n =45) and the control group of F60S (n = 45) , and each of them worked 4 hours. Through test the decrease rate and the clearance of patients with urea nitrogen,serum creatinine,phosphate, β2-micro globulin,and test hemoglobin,white blood cells,platelets, serum albumin,C3 which form peripheral blood before and after experiment, d the efficacy and safety of the experiment group on the basis of laboratory parameters. Observed and recorded the opposite events and opposite reactions. Results; (1 )They were 85 males and 50 females with an average age of (39 ± 11 ) years old ranged form 19 to 62. All of patients were completed the clinical trial, no case was lost to follow-up. (2) There were no significant differences in the decrease rate and the clearance of serum creatinine, urea nitrogen, phosphate, β2-,micro globulin. The urea nitrogen clearance of HF12 group and HF16 group were lower than that of control group [ (184. 0 ± 62. 8 ) ml/min, (196. 0 ± 37. 9) ml/min vs ( 200. 6 ±23. 2)ml/min] , there were no statistically significant differences among them (P > 0. 05 ). The decrease rate of urea nitrogen in the experiment group and the control group were above 60% , among the three groups there were no statistical difference (P > 0. 05). β2 -microglobulin decrease rate of HF12 group was lower than those of the control group [(41.3 ± 15. 6)% vs (44. 0 ± 16. 8)% ] ,β2-microglobulin decrease rate of HF16 group was higher than those in the control group [ (47. 0 ± 15. 0) % vs (44. 0 ± 16. 8) % ] , there were no statistically significant differences among them (P > 0. 05 ). ( 3) Before and after, there were no sharp changes in those three groups with hemoglobin, white blood cells, platelets, serum albumin,and C3 of peripheral blood. (4)Those three groups hadnt occurred opposite events,also with no opposite reaction. Conclusion: Domestically produced high-flux HF12,HF16 polysulfon dialyzer could eliminate small molecules toxins effectively as imported F60S dialyzer, and also could have good effects for middle-molecular elimination, without obvious adverse events.
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