健脾清化方联合恩替卡韦治疗慢性乙肝的随机对照研究

Randomized Controlled Trial of Jianpi Qinghua Formula Combined with Entecavir in Treatment of Chronic Hepatitis B

目的:观察健脾清化方联合恩替卡韦治疗慢性乙肝的治疗效果。方法:选取2017年1月-2019年12月浦东新区传染病医院收治的慢性乙型肝炎患者共120例,根据治疗方法分为治疗1组40例,治疗2组40例,对照组40例。治疗1组采用健脾清化方联合恩替卡韦治疗,治疗2组采用肝苏颗粒联合恩替卡韦治疗,对照组采用恩替卡韦治疗,3组观察周期均为48周。对3组病例的应答率进行比较,对中医证候积分进行分析,对肝功能血清ALT、AST和TBIL进行比较,同时比较血清HBV-DNA定量水平和HBsAg定量水平。结果:在总应答率方面,与对照组比较,治疗1组和治疗2组差异具有统计学意义(P<0.05);就中医证候积分而言,相较未干预时,干预后的3组差异具有统计学意义(P<0.05),同时相较治疗2组,治疗1组差异具有统计学意义(P<0.05),相较对照组,治疗2组和治疗1组差异均具有统计学意义(P<0.05);在血清TBIL、ALT与AST水平方面,相较未干预时,干预后的3组皆有所好转,且相较治疗2组,治疗1组差异具有统计学意义(P<0.05),相较对照组,治疗2组和治疗1组差异均具有统计学意义(P<0.05);对比HBV-DNA定量方面,相较未干预时,干预后3组差异具有统计学意义(P<0.05),其中在第4周、12周、24周的HBV-DNA水平上,与对照组比较,治疗1组差异具有统计学意义(P<0.05);在HBsAg定量方面,相较未干预时,干预后的3组差异具有统计学意义(P<0.05),其中相较对照组,另两组差异具有统计学意义(P<0.05)。结论:健脾清化方联合口服核苷酸药物恩替卡韦对慢乙肝肝郁脾虚型患者,能够有效改善肝功能情况,改善患者的临床证候,促进抑制乙肝病毒,提高早期的抗病毒疗效,进一步提高本病的应答率。

Objective:To observe the therapeutic effect of Jianpi Qinghua Formula combined with Entecavir in treating chronic hepatitis B.Methods:A total of 120 patients with chronic hepatitis B were randomly divided into the treatment group 1,the treatment group 2 and the control group,with 40 cases in each group.The treatment group 1 was treated with Jianpi Qinghua Formula combined with Entecavir,the treatment group 2 was treated with Gansu Granule combined with Entecavir,and the control group was only treated with Entecavir.The observation duration was 48 weeks.The response rate,TCM symptom score,the serum levels of ALT,AST,TBIL,as well as the quantitative levels of HBV-DNA and HBsAg were compared among the three groups after the treatment.Results:In terms of the total response rate,the other two groups had significant advantages compared with the control group(P<0.05).In terms of the TCM symptom score,it was improved after the intervention compared with that before the intervention in the three groups(P<0.05);compared with that in the treatment group 2,it was significantly different in the treatment group 1(P<0.05);compared with that in the control group,it was significantly different in the treatment group 2 and the treatment group 1(P<0.05).In terms of the serum levels of TBIL,ALT and AST,they were all improved after the intervention compared with those before the intervention in the three groups(P<0.05);compared with those in the treatment group 2,they were significantly different in the treatment group 1(P<0.05);compared with those in the control group,they were significantly different in the treatment group 2 and the treatment group 1(P<0.05).In terms of the quantitative level of HBV-DNA,the three groups showed advantages after the intervention compared with that before the intervention(P<0.05),and the treatment group 1 showed advantages compared with that in the control group at 4 w,12 w and 24 w(P<0.05).In terms of the quantitative level of HBsAg,the three groups showed advantages after the intervention compared with that before the intervention(P<0.05),and the other two groups showed advantages compared with the control group(P<0.05).Conclusion:Jianpi Qinghua Formula combined with Entecavir can effectively improve hepatic function,improve the clinical symptoms of the patients,inhibit hepatitis B virus to improve the early antiviral efficacy,and further improve the response rate of the disease in the patients with chronic hepatitis B of Liver depression and Spleen deficiency.