护肠清毒微丸结肠靶向给药阻断瘀毒内蕴证乙型肝炎相关慢加急性肝衰竭肠源性内毒素血症临床观察

Effect of Colon-targeted Huchang Qingdu Pellets in Blocking Intestinal Endotoxemia in Patients with HBV-related Acute on Chronic Liver Failure with Syndrome of Interior Stasis Toxin

目的:观察护肠清毒微丸结肠靶向给药治疗瘀毒内蕴证乙型肝炎(HBV)相关慢加急性肝衰竭肠源性内毒素血症(IETM)的临床疗效,探讨其阻断IETM的可能机制。方法:收集2013年1月至2016年10月符合纳入标准的HBV相关慢加急性肝衰竭肠源性内毒素血症患者120例,按随机双盲双模拟对照原则分为对照组和治疗组,后者又分为口服乳果糖组、口服护肠清毒微丸组,每组各40例,观察治疗前后中医临床证候积分,血浆内毒素,肿瘤坏死因子-α(TNF-α),白细胞介素(IL)-1,IL-6,IL-8,IL-10,血D-乳酸,血二胺氧化酶(DAO),凝血,尿乳果糖/甘露醇(L/M)等的变化,并比较两种药物的疗效差别。结果:治疗组在治疗后症状指标改善情况及综合疗效方面均优于治疗前及对照组(P<0.05),且护肠清毒微丸组在中医证候积分,总胆红素(TBIL),前白蛋白(PA),凝血酶原活动度(PTA),血浆内毒素,炎性细胞因子,血D-乳酸,血二胺氧化酶等方面改善最为明显,优于乳果糖组(P<0.05)。结论:护肠清毒微丸结肠靶向释放给药可通过抑制炎性细胞因子的释放、纠正肠黏膜通透性、稳定内环境、避免肠道菌群失调,改善机体内环境,从而有效阻断肠源性内毒素血症的发生,达到修复肝组织损伤的目的,整体疗效优于乳果糖。

Objective： To observe the curative effect of colon-targeted Huchang Qingdu pellets in blocking intestinal endotoxemia in patients with HBV-related acute on chronic liver failure,and investigate the possible mechanism. Method： Totally 120 cases of HBV-related acute on chronic liver failure with intestinal endotoxemia（ IETM） and syndrome of interior stasis toxin were collected from January 2013 to October2016. According to double-blind double-dummy randomized control principle,these patients were divided into oral colon-targeted Huchang Qingdu pellets group,lactulose group and control group,with 40 cases in each group.Some clinical indices,such as traditional Chinese medicine（ TCM） clinical symptom score,plasma endotoxin,tumor necrosis factor-α（ TNF-α）,interleukin（ IL）-1,IL-6,IL-8,plasma D-lactic acid,plasma diamine oxidase（ DAO）,coagulation function and L/M were observed before and after treatment. And differences among the three groups were compared. Result： The clinical indices of TCM syndrome integral,plasma endotoxin,inflammatory cytokines,plasma D-lactic acid,and plasma diamine oxidase in treatment groups were significantly superior to those before treatment and in control group（ P〈0. 05）. Colon-targeted Huchang Qingdu pellets group was more effective than lactulose group in TCM syndrome score, TBIL, PA, PTA, plasma endotoxin, inflammatory cytokines,plasma D-lactic acid,and plasma diamine oxidase（ P〈0. 05）. Conclusion： Colon-targeted Huchang Qingdu pellets can inhibit the release of inflammatory cytokine,correct the permeability of the intestinal mucosa,regulate blood coagulation function and internal environment,so as to effectively prevent the occurrence of intestinal endotoxemia,a repair liver tissue injury,with a better overall effect than lactulose.