国产透析器LST140与进口透析器F7HPS对维持血液透析患者疗效和安全性的交叉对比分析

目的 评价国产一次性使用空心纤维血液透析器LST140与进口一次性使用空心纤维血液透析器F7HPS是否具有同样的安全性和有效性.方法 本试验采用开放性交叉对比设计.选择满足入选/排除标准并自愿参加本试验的维持血液透析患者57例,采用国产透析器LST140组（试验组）与进口透析器F7HPS组（对照组）目标值法进行对照,观察对患者透析前后血尿素、肌酐下降率的影响以及不良反应.结果 试验组与对照组透析后血尿素、肌酐均明显下降,两组间透析前后血尿素、肌酐下降值比较差异无统计学意义（P＞0.05）.试验组与对照组透析前后肌酐下降率比较差异无统计学意义（P＞0.05）.患者血液透析期间至下次透析自我感觉良好,无低血压、热原反应、过敏反应、透析器凝血、心律失常、恶心、呕吐等不良事件发生.结论 国产透析器LST140与进口透析器F7HPS对血液透析患者具有相当的疗效和安全性.

Cross-over study of efficiency and safety of domestic disposable hollow fiber polysulfone dialyzer LST140 and import disposable hollow fiber polysulfone dialyzer F7HPS in maintenance hemodialysis patients

Objective To evaluate whether domestic disposable hollow fiber polysulfone dialyzer LST140 have the same efficiency and safety compared with import disposable hollow fiber polysulfone dia- lyzer FTHPS in maintenance hemodialysis（MHD） patients. Methods A total of 57 MHD patients who met inclusion/exclusion criteria and volunteered were enrolled in this open cross-over study. We adopt the target value method to compare the two types of dialyzer and observe blood urea and creatinine reduction rate before and after dialysis. Adverse event and adverse reaction were recorded. Results Serum urea and creatinine level decreased significantly after hemodialysis compared with before hemodialysis in both group. There was no significant difference in decline value of serum urea and creatinine in both group. there was no significant difference of serum creatinine reduction rate between the experimental group and the control group. All patients felt good during hemodialysis treatment and the interdialytic period. There was no hypotension, pyrogen reaction, allergic reaction, dialyzer clotting, arrhythmia, nausea and vomiting, and other adverse event. Conclusion There are the same efficiency and safety between domestic dialyzer LST140 and imported dialyzer FTHPS in bemodialysis patients.