W-T6008S型血液透析滤过机治疗终末期肾脏病的临床疗效和安全性观察

Observation on clinical efficacy and safety of domestic W-T6008S hemodiafiltration machine in treating end stage renal disease

目的:验证国产W-T6008S型血液透析滤过机在治疗终末期肾脏病方面的有效性和安全性,并与已上市的同类进口产品进行比较。方法:采用随机、交叉、对照、非劣效性及非盲性试验,选择成都中医药大学附属医院行维持性血液透析的16例患者,试验设备为国产W-T6008S型血液透析滤过机,对照机型为B.Braun Avitum AG 7102072型Dialog+血液透析滤过机。比较试验设备与对照设备的超滤相对误差,单室尿素清除指数(spKt/V)值,血清肌酐、尿素下降率,透析治疗前后透析置换液内毒素、血清及透析液电解质水平,设备工作情况及患者的安全性等情况。结果:试验设备与对照设备的超滤相对误差(%)之差的95%置信区间上限(-1.33%)小于非劣效界值4%,可认为试验设备非劣于对照设备;试验设备和对照设备两者spKt/V值分别为1.37±0.24和1.33±0.21,两者比较差异有统计学意义(F=5.07,P<0.05);两者血清肌酐、尿素下降率的比较,差异无统计学意义;试验设备透析前后的置换液内毒素与透析液电解质浓度均在正常范围内;透析过程中,受试者生命体征平稳,无严重不良事件发生,试验设备与对照设备均工作稳定,操作满意度高。结论:W-T6008S型血液透析滤过机治疗终末期肾脏病患者安全有效。

Objective:To verify the effectiveness and safety of the domestic W-T6008S hemodiafiltration machine in treating end stage renal disease(ESRD),and compare it with similar imported products that have been on the market.Methods:This research adopted randomized,crossover,controlled,non-inferiority,non-blind trials,and 16 patients who underwent maintainable hemodialysis in the affiliated hospital of Chengdu University of Traditional Chinese Medicine were selected.The tested equipment was domestic W-T6008S hemodiafiltration machine and the controlled equipment was B.Braun Avitum AG 7102072 Dialog+hemodiafiltration machine.The relative errors of ultrafiltration,spKt/V value,the decline rate of serum creatinine and urea,and the level of endotoxin,the levels of electrolyte in serum and dialysate of displacement liquid of dialysis pre and post treatment between tested equipment and controlled equipment were compared.And the operation situation of equipment and safety of patients between two kinds of equipment were compared.Results:The upper limit(-1.33%)of the 95%confidence interval of the difference of the relative error(%)of ultrafiltration between the tested equipment and the controlled equipment was less than that of the non-inferiority threshold value which was set to 4%,and it could be considered that the tested equipment was not inferior to the controlled equipment.The spKt/V values of the tested equipment and the controlled equipment were 1.37±0.24 and 1.33±0.21,respectively,and the difference of that between the two groups was statistically significant(F=5.07,P<0.05).And there were no statistically significant difference in the decline rates of serum creatinine and urea between two groups.And the concentration of endotoxin in displacement liquid and electrolyte of dialysate of the tested equipment both before and after the dialysis were within the normal range.During the dialysis process,the vital signs of the subjects were stable,and there was no serious adverse events,and both tested and controlled equipments worked stably,and the operation satisfaction both of them were high.Conclusion:The W-T6008S hemodiafiltration machine is safe and effective in treating patients with renal disease at terminal stage.