四种不同膜材料透析器生物相容性的临床研究

Clinical study on biocompatibility of four dialyzers with different membranes

目的观察4种不同膜材料透析器临床应用过程中的生物相容性。方法60例维持性血液透析（MHD）患者入选，进行前瞻、随机、对照、队列研究。在基线水平所有患者均应用聚砜（PS）膜透析器透析至少3个月，随后患者按随机数字法分配入3个不同膜材质透析器组：聚醚砜膜（PES）组、三醋酸纤维素膜（CTA）组和聚甲基丙烯酸甲酯膜（PMMA）组，观察6个月。透析器无复用，在不同的时间点测定生物相容性指标进行比较：结果血超敏C反应蛋白（hsCRP）、白细胞介素（IL）1B、IL-13、红细胞计数、血小板计数在不同组之间及分组前（0）、3、6个月透析前后进行比较，差异均无统计学意义。透析过程中，血补体C3a、C5a水平均先升后降。PMMA组在0个月时透析0min、15min、240min补体C3a为（117．92±35．99）、（183．09±57．02）、（135．20±43．08）μg／L；在3个月时分别为（96．11±30．84）、（141．48±50．70）、（115．38±37．49）μg／L；在6个月时分别为（85．05±17．28）、（146．31±41．07）、（116．69±32．95）Ixg／L，0个月分别与3个月、6个月间C3a水平差异有统计学意义（均P〈0．05）。3个月时PMMA组透析0min、15min、240minC5a为（60．59±19．07）、（85．30±23．50）、（72．74±28．97）μg／L，PES组透析0min、15min、240minC5a为（74．70±18．70）、（98．85±27．78）、（83．96±27．87）μg／L，两组间差异有统计学意义（P〈0．05）。白细胞计数（WBC，×10^9／L）在透析过程中先降后升。PMMA组WBC0个月、3个月、6个月的透析0min为（5．60±1．42）、（6．02±1．36）、（6．45±1．29）（均P〈0．05）；15min为（4．44±0．98）、（2．32±1．11）、（2．20±1．42）（均P〈0．01）：0个月、6个月的透析30min为（5．64±1．22）、（4．74±1．35）（P=0．026）；60min为（5．97±0．82）、（6．82±1．58）（P=0．39）；240min为（7．41±1．87）、（8．44±1．61）（P=0．001）；3个月、6个月的透析240min为（7．53±2．31）、（8．44±1．61）（P=0．004）。差异均有统计学意义。结论4种膜材料透析器生物相容性存在一定的差异。

Objective To elucidate the bioeompatibility differences of 4 dialyzers with different membranes in maintenance hemodialysis （MHD） patients. Methods A total of 60 MHD patients were enrolled in the prospective, randomized, control, cohort study. In baseline, synthetic polysulfone （PS） membrane dialyzer was used in all the patients for at least 3 months. Then the patients were randomly divided into three groups： ployethersulfone （PES） membrane group, cellulose triacetate （CTA） membrane group, and synthetic polymethyhnethaerylate （PMMA） membrane group. Study duration was 6 months. No dialyzer was reused. The bioeompatibility markers were detected repeatedly at different time points and compared with each other in different dialyzer groups. Results The blood levels of high sensitive C reactive protein, interleukin-1β, and interleukin-13 were not significantly different among different groups on every time point. However, the blood complements levels and WBC count were significantly different among four kinds of dialyzer. When the dialyzers changed from PS to PMMA membrane, C3a levels and WBC count changed significantly （P〈0.05）. Moreover, the change of CSa level was significantly different between PES group and PMMA group on month 3 （P〈0.05）. Conclusion There are some differences of biocompatibiliy among different dialyzer membranes.