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目的初步观察选择性粒细胞吸附装置(selective cytopheretic device,SCD)联合连续性静静脉血液滤过(continuous veno-venous hemofiltration,CVVH)治疗重症急性肾损伤(acute kidney injury,AKI)患者的疗效,并观察不良事件的发生情况。方法本研究重症AKI的定义为临床诊断为缺血性或肾毒性急性肾小管坏死,同时至少有1个肾外器官衰竭或存在脓毒血症。入选者除给予标准的重症监护治疗外,还同时接受SCD联合CVVH治疗。历史对照组为改善急性肾脏疾病照护计划(the program to improve care in acute renal disease,PICARD)研究中年龄和序贯器官衰竭评分(sequential organ failure assessment,SOFA)评分匹配的患者。主要终点事件为院内全因死亡。其他观察指标包括尿量变化及不良反应情况。使用Cox回归模型校正混杂因素,分析SCD联合CVVH治疗模式的疗效是否优于常规CVVH治疗。结果共入选9例重症AKI患者。SCD联合CVVH治疗组院内全因死亡率为22.2%,显著低于历史对照组(77.8%)(x2=5.247,P=0.027)。在校正年龄、SOFA评分、平均尿量变化等混杂因素后,Cox回归模型显示,SCD联合CVVH的疗效优于常规CVVH治疗(T=-2.596,P=0.0222)。治疗7d后,SCD治疗组平均尿量从基线值约500ml/d升高至2000ml/d以上。研究过程中,患者仅有数例轻度不良反应,无严重不良事件发生。结论 SCD可通过灭活激活的白细胞而调控机体免疫反应,最终降低重症AKI患者的死亡率。SCD安全性良好。
Objective To observe the curative effect of selective cytophatic device (SCD) and continuous veno-venous hemofiltration (CVVH) on patients with acute kidney injury (AKI) Observe the occurrence of adverse events. Methods In this study, severe AKI was defined as a clinically diagnosed acute tubular necrosis of either ischemic or nephrotoxicity with at least one extra-renal organ failure or the presence of sepsis. Participants in addition to the standard intensive care treatment, but also to accept SCD combined with CVVH treatment. The historical control group was matched for age and sequential organ failure assessment (SOFA) scores in the program to improve care in acute renal disease (PICARD). The main end point was all-cause death in the hospital. Other observations include changes in urine output and adverse reactions. Cox regression models were used to correct for confounding factors to determine whether the efficacy of SCD in combination with CVVH therapy was superior to that of conventional CVVH. Results Nine patients with severe AKI were enrolled. In-hospital all-cause mortality was 22.2% in the SCD combined with CVVH treatment group, which was significantly lower than the historical control group (77.8%) (x2 = 5.247, P = 0.027). Cox regression model showed that SCD combined with CVVH was more effective than conventional CVVH in treatment (P = 0.0222, P = 0.0222) after adjusting for age, SOFA score and changes in average urine volume. After 7 days of treatment, the average urine volume of SCD treatment group increased from baseline value of about 500ml / d to over 2000ml / d. During the study, there were only a few mild adverse reactions in the patient, with no serious adverse events. Conclusions SCD can regulate the immune response by inactivating activated leukocytes and ultimately reduce the mortality of critically ill patients with AKI. SCD is safe.