益气和血法治疗失代偿期乙型肝炎肝硬化临床疗效的回顾性队列研究

Clinical efficacy of decompensated hepatitis B cirrhosis by replenishing qi and harmonizing blood method:A retrospective cohort study

目的:探讨益气和血法治疗失代偿期乙型肝炎肝硬化的长期临床疗效。方法:采用回顾性队列研究设计,纳入2015年5月至2019年11月首都医科大学附属北京中医医院和首都医科大学附属北京地坛医院失代偿期乙型肝炎肝硬化患者188例,倾向性评分最邻近匹配法1∶1匹配后获得符合条件的对照组65例及治疗组65例,两组均接受恩替卡韦抗病毒治疗24个月,对照组在抗病毒治疗的基础上加用复方鳖甲软肝片,或安络化纤丸,或扶正化瘀胶囊抗肝纤维化治疗;治疗组在抗病毒治疗的基础上加用益气和血法基础方,随证加减治疗。比较两组患者组内及组间治疗前及治疗后6、12、18、24个月的肝功能、血常规、凝血酶原活动度、脾脏长径、厚度及门脉宽度,比较两组患者组内及组间治疗前及治疗后24个月HBVDNA水平、Child-Pugh评分、APRI评分、肝癌发生率、再代偿率。结果:治疗组治疗后6、12、18、24个月,ALT、脾脏长径、脾脏厚度均较治疗前显著下降(P<0.05,P<0.01),PTA、NE、PLT较治疗前显著上升(P<0.01);治疗组治疗后12、18、24个月,AST、门脉宽度指标较治疗前显著下降(P<0.05,P<0.01),WBC较治疗前显著上升(P<0.05,P<0.01);治疗组治疗后18、24个月TBIL指标较治疗前显著下降(P<0.05,P<0.01);治疗组治疗后24个月APRI评分、Child-Pugh评分较治疗前显著下降(P<0.01)。治疗组治疗后24个月ALT、脾脏长径、脾脏厚度、门脉宽度、Child-Pugh评分显著低于对照组(P<0.05,P<0.01),再代偿率显著高于对照组(P<0.01)。结论:益气和血法联合恩替卡韦更能有效改善失代偿期乙型肝炎肝硬化患者的ALT、NE水平,改善脾脏大小、门脉宽度,降低Child-Pugh评分,有效延缓肝硬化进程,提高再代偿率,具有较高的临床应用价值。

Objective:To explore the long-term clinical efficacy of the method of replenishing qi and harmonizing blood in the treatment of decompensated hepatitis B cirrhosis.Methods:Patients with decompensated hepatitis B cirrhosis in Beijing Hospital of Traditional Chinese Medicine,Capital Medical University as well as Beijing Ditan Hospital Capital Medical University from May 2015 to November 2019 were enrolled with a total of 188 cases.Based on propensity score matching,according to general information,previous medical histories,laboratory indices,imaging markers,cirrhosis score,patients were assigned to the treatment group(65 cases) and the control group(65 cases) in a ratio of 1∶1.Both groups received entecavir antiretroviral therapy and follow-up for 24 months.Meanwhile,control group took anti-liver fibrosis drugs,including Biejia Ruanjian Tablets,Anluo Huaxian Pills,or Fuzheng Huayu Capsules,while treatment group took qi replenishing and blood harmonizing method.A retrospective cohort study design was used to compare the liver function,blood routine,prothrombin activity,spleen length,thickness,and portal veins before and after the treatments at intervals of 6 months,12 months,18 months,and 24 months between the two groups of patients,and to compare the HBVDNA levels,Child-Pugh,APRI score,incidence of liver cancer,and recompensation rate within and between the two groups before treatment and 24 months after treatment.Results:The ALT,spleen long diameter,and spleen thickness of the treatment group at 6 months,12 months,18 months,and 24months intervals after treatment decreased compared with those before treatment(P<0.05,P<0.01),PTA,NE,and PLT increased significantly compared with pre-treatment conditions( P<0.01).The indexes of AST and portal vein width in the treatment group at 12 months,18 months,and 24 months intervals after treatment were lower than those before treatment(P<0.05,P<0.01),and WBC were significantly higher than those before treatment(P<0.05,P<0.01).The TBIL index of the treatment group at 18 and 24 months intervals after treatment were lower than that before treatment(P<0.05,P<0.01).The APRI score and Child-Pugh of the treatment group at 24 months after treatment were significantly lower than those before treatment(P<0.01).The ALT,spleen length,thickness of the spleen,portal vein width,and Child-Pugh of the treatment group at 24 months after treatment were significantly lower than those of the control group(P<0.05,P<0.01),and the recompensation rate was significantly higher than that of the control group(P<0.01).Conclusion:The combination of qi replenishing and blood harmonizing method and entecavir can be used to effectively improve the ALT and NE levels of patients with decompensated hepatitis B cirrhosis,to improve the size of the spleen,to improve the width of the portal vein,to reduce the Child-Pugh,to effectively delay the progress of liver cirrhosis,and to increase the recompensation rate,which has high clinical application value.