解毒化瘀颗粒对慢性肝衰竭毒热瘀结证患者炎症状态的影响

Effect of Jiedu Huayu Granules on Inflammatory State of Patients with Chronic Hepatic Failure with Toxic Heat and Stasis Syndrome

目的:评价解毒化瘀颗粒治疗慢性肝衰竭(CLF)毒热瘀结证的疗效及对炎症状态的影响。方法:将136例患者随机分为对照组和观察组,每组各68例。两组患者均给予西医综合治疗措施,对照组口服茵陈蒿汤配方颗粒,1剂/d;观察组口服解毒化瘀颗粒,10 g/次,3次/d。均连续8周。检测治疗前后内毒素(ET),二胺氧化酶(DAO),芳香族氨基酸(AAA),支链氨基酸(BCAA),血氨,降钙素(PCT),肿瘤坏死因子-α(TNF-α),白细胞介素(IL)-1,IL-6,IL-17,调节性T细胞(Treg细胞),辅助性T细胞17(Th17),Th17/Treg,总胆红素(TBil),白蛋白(Alb),丙氨酸氨基转移酶(ALT),天冬氨酸氨基转移酶(AST),凝血酶原活动度(PTA)和D-二聚体(D-D)水平。进行治疗前后肝功能Child-Pugh分级评分,毒热瘀结证评分和终末期肝病模型(MELD)评分;随访48周记录病死率和生存情况。结果:治疗后,观察组ET,DAO和血氨水平低于对照组,BCAA/AAA高于对照组(P<0.01);观察组PCT,TNF-α,IL-1,IL-6和IL-17水平均低于对照组(P<0.01);观察组Treg细胞高于对照组,Th17和Th17/Treg低于对照组(P<0.01);观察组TBil,ALT,AST和D-D低于对照组,Alb和PTA高于对照组(P<0.01);观察组Child-Pugh分级评分,MELD评分和毒热瘀结证评分均低于对照组(P<0.01);观察组临床疗效总有效率为93.65%(59/63),高于对照组的79.03%(49/62),差异有统计学意义(χ2=5.683,P<0.05);在治疗后8周,观察组的病死率为6.35%(4/63),低于对照组的19.35%(12/62),差异有统计学意义(χ2=4.757,P<0.05);在治疗后16,24,48周两组病死率差异无统计学意义;经Log-rank检验,两组生存曲线差异无统计学意义。结论:解毒化瘀颗粒治疗CLF毒热瘀结证患者可清除体内毒素,调节免疫功能,减轻炎症,改善肝功能,减轻病情程度,临床疗效显著,值得临床使用。

Objective:To evaluate the curative effect of Jiedu Huayu granules(JDHY)in the treatment of chronic liver failure(CLF)with the syndrome of toxic heat and stasis and investigate the influence on the inflammatory state.Method:A total of 136 patients were randomly divided into a control group and an observation group with 68 cases in each group.In addition to the comprehensive western medicine treatment,patients in the control group received Yinchen Haotang granules orally at 1 dose/day and those in the observation group received JDHY at 10 g/time,3 times/day.The treatment lasted for eight weeks.The endotoxin(ET),diamine oxidase(DAO),aromatic amino acids(AAA),branched chain amino acids(BCAA),blood ammonia,calcitonin(PCT),tumor necrosis factor-α(TNF-α),interleukin(IL)-1,IL-6,IL-17,regulatory T cells(Treg cells),helper T cells 17(Th17),Th17/Treg ratio,total bilirubin(TBil),albumin(Alb),alanine aminotransferase(ALT),aspartate aminotransferase(AST),prothrombin activity(PTA),and D-dimer(D-D)levels before and after treatment were detected.The Child-Pugh grading scores of liver function,toxic heat and stasis syndrome scores,and the model scores of end-stage liver disease(MELD)before and after treatment were recorded.The fatality rate and survival were recorded at the follow-up for 48 weeks.Result:Compared with the control group after treatment,the observation group showed decreased ET,DAO,and blood ammonia,increased BCAA/AAA ratio(P<0.01),reduced PCT,TNF-α,IL-1,IL-6,and IL-17(P<0.01),elevated Treg cells,dwindled Th17 and Th17/Treg ratio(P<0.01),diminished TBil,ALT,AST,and D-D levels,and upregulated Alb and PTA(P<0.01).The Child-Pugh grading score,MELD score,and toxic-heat and stasis syndrome score of the observation group were lower than those of the control group(P<0.01).The total response rate in the observation group was 93.65%(59/63),which was higher than 79.03%(49/62)in the control group(χ2=5.683,P<0.05).The fatality rate of the observation group eight weeks after treatment was 6.35%(4/63),which was lower than 19.35%(12/62)of the control group(χ2=4.757,P<0.05).There was no significant difference in mortality between the two groups 16,24,and 48 weeks after treatment.As revealed by the Log-rank test,the difference in survival curves between the two groups was not statistically significant.Conclusion:JDHY can remove toxins from the body,regulate immune function,relieve inflammation,improve liver function,and reduce the severity of the disease in CLF patients with the syndrome of toxic heat and stasis.It is significant in clinical efficacy and worthy of clinical application.