选择性粒细胞吸附装置治疗重症急性肾损伤的研究

The effects of the selective cytopheretic device on outcome of severe acute kidney injury:a pilot study

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。

Objectives To evaluate the effect of the selective cytopheretic device （SCD） on outcome of severe acute kidney injury （AKI） requiring renal replacement therapy, and to observe the occurrence of adverse events from application of the device. Methods In this study, acute kidney injury was defined as ischemic or nephrotoxic acute tubular necrosis by clinic diagnosis, with at least one nonrenal organ failure or presence of sepsis at the same time. All subjects received standard intensive care treatment with continuous veno-venous hemofiltration （CVVH） in addition to the SCD treatment. Patients enrolled in the trial were compared with the historical casematched controls from PICARD study with respect to age and Sequential Organ Failure Assessment （SOFA） score. The primary endpoint was in-hospital all cause mortality. Other observation index included urine output change and the occurrence of adverse events. After adjusting for confounders, the Cox model was used to analyze whether SCD combined with CVVH treatment was better than routine CVVH. Results A total of 9 patients were enrolled. In-hospital all cause mortality of SCD combined with CVVH treatment group was 22.2%, significantly lower than historical case-matched control group （77.8%） （x2=5.247,P=0.027）. Multiple regression analysis identified treatment with SCD as the only significant variable affecting mortality among age, SOFA score, and average change in urine output （SCD vs. CVVH historical cohort,（T=-2.596,P=0.0222）. Mean total urine output in the 9 subjects receiving SCD treatment increased from a baseline of approximately 500 ml/d to more than 2,000 ml/d by day 7 of treatment. In this study, only a few mild adverse events occurred, and no serious adverse events were reported.Conclusion SCD can regulate the immune response by deactivating leukocytes, and therefore improve in-hospital mortality of patients with AKI. The safety of SCD is favorable.