国产OBERS血液透析机治疗尿毒症的安全性与临床疗效观察  

Observation on Safety and Effect of Domestic Hemodialysis Machine OBERS in the Treatment of Patients with Uremia

作　　者：尹良红[1] 云琛 李佛兰[1] 黄莹[3] 管保章[1] 余霞[3] 胡波[1] 肖龙[3] 罗丽花[1] 古英明[3] 

机构地区：[1]暨南大学附属第一医院,广东广州510630 [2]广州奥柏仕医疗器械有限公司,广东广州510000 [3]广州医科大学附属第二医院,广东广州510260

出　　处：《临床医学工程》2016年第5期549-551,共3页Clinical Medicine & Engineering

基　　金：广东高校工程技术研究(开发)中心计划项目(GCZXA1104);广东省教育部产学研结合项目(2011B090400570);广东省高新区发展引导专项计划项目(2012B010900039)

摘　　要：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 effectiveness of multifunction hemodialysis machine OBERS-3000 for patients with uremia hemodialysis. Methods A random, open, two state gross-over design, positive contrast method was adopted to observe 72 patients with uremia in two hospitals. The contrast machine was German Fresenius 4008, and the testing machine was domestic OBERS-3000. The changes of blood count indicators, serum electrolytes, liver and kidney function, blood gas analysis, body weight, ultrafiltration volume, urea clearance index and overall urea reduction rate before and after dialysis were compared between two machines. The errors of the measure values to the theoretical values about every indicator of dialysate were monitored. The adverse events during the dialysis process were recorded. Results The testing machine had the same effect as the contrast machine. It had the capacity to effectively clear creatinine, urea nitrogen and other uremic toxins, constantly supply the hemodialysis machine with qualified dialysate and precisely control the dehydrating amount of patients, with the same clinical complication incidence as the imported equipment. Conclusions OBERS-3000 multifunction dialysis machine has the same safety and effect as the imported dialysis equipment.

关 键 词：尿毒症 血液透析 血液透析设备 

分 类 号：R459.5[医药卫生—治疗学]