一种有效清除蛋白结合类毒素的新型血液灌流器的临床应用研究

Clinical study of novel hemoperfusion apparatus of effectively removal protein-bound toxins

目的研究新型血液灌流器MG350对蛋白结合类毒素晚期糖基化终产物(AGE)和硫酸吲哚酚(IS)的清除效果。方法分别选择上海长征医院和佛山市第一人民医院长期血液透析(HD)患者共36例,其中男性28例,女性8例;年龄29~74岁,平均年龄54.28岁;体质量65.00~100.60 kg,平均体质量73.70 kg。随机分为2组,每组18例。采用灌流器MG350、聚砜膜透析器F 6,使用二阶段交叉试验对照研究方法,比较血液灌流(HP)+HD和单纯HD治疗前后血清AGE、IS、β_2-微球蛋白(β_2-MG)和炎性因子的水平,评价MG350组织相容性。结果两组临床资料比较,差异无统计学意义(P>0.05)。两组治疗后AGE和IS浓度均明显降低,差异有统计学意义(P<0.05)。HP+HD和单纯HD治疗2 h后AGE下降率分别为47.5%、-29.1%,差异有显著统计学意义(F=36.012,P<0.001);IS下降率分别为62.3%、4.4%,差异有显著统计学意义(F=150.032,P<0.001);β_2-MG下降率分别为41.1%、-8.7%,差异有显著统计学意义(F=180.764,P<0.001)。2例轻度不良事件发生。血常规、凝血功能、补体、肝功能等治疗前后差异无统计学意义。白细胞介素6(IL-6)、肿瘤坏死因子-α(TNF-α)在MG350治疗后均明显降低,TNF-α降低程度差异有显著统计学意义(P<0.001)。结论新型血液灌流器MG350能够有效清除蛋白结合类毒素,疗效安全、可靠,值得临床推广应用。

Objective To study the effect of the novel hemoperfusion apparatus on removing protein-bound toxins, such as advanced glycation end products（AGE） and indoxyl sulfate（IS）. Methods A total of 36 patients undergoing maintenance hemodialysis（HD） were enrolled, which included 28 males and 8 females, aged 29 - 74 year old with mean age of 54.28 years old; body weight 65.00 - 100.60 kg with mean of 73.70 kg. All of them were randomly divided into 2 groups（n = 18）, HD group performed HD treatment and hemoperfusion（HP） ＋ HD group performed both MG350 apparatus treatment and Polysulfone membrane dialyzer F 6 used in two-stage crossover control study method. The serum AGE, IS, β2-macroglobulin（β2-MG） and inflammatory eytokines were detected, and histoeompatibility of the MG350 apparatus were observed. Results There was no significant difference in clinical data between 2 groups（P 〉 0.05）. After treatment, concentrations of AGE and IS significantly decreased in 2 groups, and the difference was statistically signifieant（P 〈 0.05）. The reduction rates of AGE in HP ＋ HD group and HD group after treatment 2-hour were 47.5 % and - 29.1%, respectively, which showed statistically significant（F = 36.012, P 〈 0.001）; The reduction rates of IS were 62.3 % and 4.4 %, respectively, which showed statistically significant（F = 150.032, P 〈 0.001）; The reduction rates of β2-MG were 41.1% and - 8.7 %, respectively, which showed statistically significant（F = 150.032, P 〈 0.001）. The slight adverse events occurred in 2 cases. There was no significant difference of blood, coagulation, complement, liver function in before and after treatment. The intedeukin 6（IL-6） and tumor necrosis factor α（TNF- α） significantly decreased after MG350 treatment, and TNF-α showed statistically significant（P 〈 0.001）. Conclusion The novel hemoperfusion apparatus MG350 combination with HD could effectively remove the protein-bound uremic toxins and inflammatory cytokines, which is safe and reliable and worthy of application in clinic.