Clinical Efficacy Observation Of Domestically Produced OBERS-3000 Hemodialysis Machine For End-stage Renal Disease

Objective: To evaluate the clinical safety and efficacy of domestically produced OBERS- 3000 hemodialysis machine in hemodialysis patients with end-stage renal disease, which contrast with the German Fresenius 4008 series hemodialysis machine.Methods: This study used randomized, open, two-stage cross positive control, non-inferiority design verification method. 36 cases of maintenance hemodialysis patients were enrolled from the First Affiliated Hospital of Jinan University, according to the proportion of 1:1 were randomly divided into test group I and test group II. Test group I first received the test machine(OBERS-3000 hemodialysis machine) treatment, and then accept the control machine(German Fresenius 4008 series hemodialysis device) treatment. In contrast, the test group II first received the control machine treatment, and then accept the test machine treatment. The pre-post-treatment laboratory indexes of blood electrolyte, blood routine, blood gas analysis,serum creatinine(Scr), blood urea nitrogen(BUN), alanine aminotransferase(ALT), aspartate aminotransferase(AST), albumin(ALB), globulin(GLB), C- reactive protein(CRP) and so on were collected. Calculating Kt/V, the clearance of urea nitrogen and serum creatinine, overall urea reduction rate(URR), overall creatinine reduction rate(CRR). Meanwhile, the measured value of the electrolyte and PH value of the dialysis solution was monitored, and the error between the measured value and the theoretical value was calculated. Observed and recorded the patient’s vital signs and complications of dialysis. Monitoring the operation of all parts of dialysis machine and evaluating the operation performance and stability of the monitoring system.Result: In this study, the distribution of baseline data of test group I and test group II of patients was balanced. There were no significant differences of Kt/V, URR,CRR, the clearance of nitrogen and creatinine between test and control machine(P>0.05). The indexes of serum K +,Mg2 +, PO43-, BUN and Scr, systolic and diastolic blood pressure decreased significantly(P<0.05) both test machine and control machine dialysis after hemodialysis, compared the two kinds of machines, the decline of the index difference was not statistically significant(P> 0.05).The indexes of RBC, HB, Na +, Ca2 +, total CO2, PH, AST, ALB, GLB after dialysis were significantly increased(P <0.05), which showed no significant difference in change between the test machine and control machine(P> 0.05). Before and after, there were no sharp changes with WBC, PLT, Cl-, ALT, CRP and other vital signs(temperature, pulse, respiration). There was no significant difference between the measured value and the theoretical value of the dialysis solution electrolyte in two groups(P>0.05), and the measured value of the PH was in the range of theoretical value. No serious complications occurred in this experiment, acute complication has13 people, a total of 19 cases, test machine and control machine complication rate was 26.47%(9/34) and 28.57%(10/35). Comparing OBERS-3000 hemodialysis machine with imported machine, there was no significant difference between the two groups in the rate of complication.Throughout the process of dialysis, two kinds of machine operated normally and flowed stability.Conclusion:1. Compared with the imported hemodialysis machine,OBERS-3000 hemodialysis machine can also accurately prepared dialysis solution and effective removal of uremic toxins, correct the disorder of electrolyte and acid-base and maintain a relatively stable internal environment in the body. Treatment effect is remarkable.2. Domestically produced OBERS-3000 hemodialysis machine operating normally,ultrafiltration and the vital signs of patients are relatively stable. There is no rise in the acute complication. The treatment is safe and steady.