国产SWS-4000型血透机与进口金宝AK-200型血透机的临床对比研究

Clinic study on domestic SWS-4000 dialysis machine compared with imported AK-200 dialysis machine

目的研究国产SWS-4000型血透机的治疗效果、安全性、稳定性。方法采用前瞻、开放、随机对照研究方法研究国产SWS-4000型血透机,以进口金宝AK-200型血透机为对照;以住院慢性肾功能衰竭新入透析患者为研究对象,在为期2年的观察期内,SWS-4000型血透机纳入507例(8 094人次),AK-200血透机纳入593例(8 150人次);观察近期、长期透析效果、透析并发症、机器配液等指标。结果治疗过程中不同血透机型患者低血压、高血压、胸闷、心悸、恶心、肌肉痉挛等发生率差异无统计学意义(P>0.05);SWS-4000型血透机误超的离散度较大,水路报警较多,透析液钠离子浓度较高(P<0.05),但可通过下调机器的电导设定值来纠正;采用SWS-4000型血透机单次透析后KT/V、尿素下降率(URR)、血钙、血磷、血钾、总CO2、血β2微球蛋白等指标的改善程度与AK-200型血透机差异无统计学意义(P>0.05);采用SWS-4000型血透机维持性血透3个月时,患者的血红蛋白、清蛋白、甲状旁腺激素(PTH)、铁蛋白、转铁蛋白饱和度等指标,与AK-200型血透机差异无统计学意义(P>0.05)。结论SWS-4000型透析机能满足日常血液透析工作需要,能安全有效地治疗尿毒症患者。

Objective To evaluate the treatment effect,security and stability of SWS-4000 dialysis machine made in China.Meth-ods Prospective,open and randomized controlled method was used,the study was controlled for imported AK-200 dialysis ma-chine;the object of study were inpatients with chronic kidney failure treated with renal dialysis technology,there were 507 cases （8 094 times dialysis）in group of SWS-4000 dialysis machine and 593 cases（8 150 times dialysis）in group of AK-200 dialysis ma-chine;the recent and long-term dialysis effect,dialysis complication,dialysate made by machine and so on were observed.Results Occurrence rate of hypotension,hypertension,choking sensation in chest,palpitation,nausea,spasticity and so on was not significant difference between both two groups（P〉0.05）.The error dispersion of SWS-4000 dialysis machine was larger than that of AK-200 dialysis machine,waterway alarm times of SWS-4000 dialysis machine was more than that of AK-200 dialysis machine,sodium con-centration of dialysate made by SWS-4000 dialysis machine was higher than that by AK-200 dialysis machine（P〈0.05）,but it could be corrected by down-regulate the electric conductance of the machine.after one time treatment by SWS-4000 dialysis ma-chine,the KT/V,urea descend rate（URR）,blood calcium,phosphorus,kalium,total CO2 ,β2microglobulin of SWS-4000 group were similar to the AK-200 group（P〉0.05）.After 3 months dialysis by SWS-4000 dialysis machine,there were no significant difference of hemoglobin,albumin,parathormone（PTH）,ferritin,transferin saturation between two groups（P〉0.05）.Conclusion The SWS-4000 dialysis machine can effectively and safely treat renal failure patients.