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目的验证OBERS-3000型多功能血液透析机用于尿毒症患者治疗的安全性和有效性。方法采用随机、开放、二阶段交叉、阳性对照设计,观察两家医院共72例患者,对照机为德国费森尤斯Fresenius 4008系列血液透析装置,比较试验机与对照机血常规、血电解质、肝肾功能、血气分析、CRP等指标,记录透析前后体重、超滤量,计算尿素清除指数、整体尿素下降率等指标。同时监测透析液的各项指标实测值与理论值的误差,详细记录透析过程中的不良事件。结果试验机和对照机一样,均能有效清除肌酐和尿素氮等尿毒症毒素,均能连续供给透析器合格的透析液,精确控制患者的脱水量。临床并发症发生率与进口设备相同。结论 OBERS-3000型多功能血液透析机用于血液透析治疗与进口机一样是安全和有效的。
Objective To verify the safety and efficacy of the OBERS-3000 multi-functional hemodialysis machine in the treatment of patients with uremia. Methods A randomized, open, two-phase crossover and positive control design was used to observe 72 patients in two hospitals. The control device was Fresenius 4008 series hemodialysis apparatus in Fresenius, Germany. The blood routine, blood electrolytes, Liver and kidney function, blood gas analysis, CRP and other indicators, before and after dialysis records body weight, ultrafiltration volume, calculate the urea clearance index, the overall rate of decline in urea and other indicators. At the same time monitoring the dialysate indicators of the measured value and the theoretical error, a detailed record of the adverse events in the dialysis process. The results of the test machine and the same as the control machine, can effectively remove creatinine and urea nitrogen and other uremic toxins, can continue to dialyzer qualified dialysate, precise control of patients with dehydration. The incidence of clinical complications and imported equipment the same. Conclusion The OBERS-3000 multi-function hemodialysis machine is as safe and effective as an import machine for hemodialysis.