辨证与辨病应用软肝再生颗粒治疗慢乙肝肝纤维化疗效对比观察

A clinical comparative study on treating chronic hepatitis B fibrosis with the Ruan'gan Zaisheng granules

目的:探讨辨证论治与单纯辨病应用软肝再生颗粒联合恩替卡韦抗肝纤维化的疗效差异。方法:采用开放、非随机的方法纳入慢性乙型肝炎合并肝纤维化患者98例,经中医师辨证为瘀血阻络证(兼或可有肝郁脾虚或肝肾阴虚证)的47例患者作为辨证治疗组(简称辨证组);西医门诊接诊的单纯辨病治疗的患者51例作为辨病治疗组(简称辨病组)。两组患者均采用保肝、对症及综合支持治疗,抗乙肝病毒(HBV)采用恩替卡韦胶囊0.5mg,qd,均在抗病毒治疗的基础上服用我院制剂软肝再生颗粒12g,tid。疗程为48周,分别于治疗前、第24周、第48周比较两组肝功能和凝血功能、肝脏硬度值(LSM)、测量门静脉直径、脾静脉宽度和脾脏厚度,并记录患者的不良反应。结果:治疗后,两组患者ALT、AST、TBIL、ALB、PT均有明显改善;治疗第24周和48周,辨证组上述指标恢复情况均优于辨病组(P<0.01或P<0.05)。治疗48周,门静脉直径、脾静脉宽度和脾脏厚度缩小程度辨证组均优于辨病组(P<0.05)。治疗48周,辨证组肝纤维化指标及LSM改善程度明显优于辨病组(P<0.01)。两组不良反应比较,辨证组明显具有优势。结论:软肝再生颗粒联合恩替卡韦可显著改善患者肝功能,对于慢性乙型肝炎导致的肝纤维化有明显疗效,可抑制肝纤维化及脾肿大进展,辨证论治比辨病治疗疗效更好,不良反应更少,两者比较差异有显著性。

Objective： To investigate the diagnosis and treatment of chronic hepatitis B ifbrosis with Ruan’gan Zaisheng granules. Methods： 98 patients were selected, the TCM syndrome of Xueyu Zuluo in 47 patients, as the differentiation therapy group; 51 patients in Western medicine outpatient admissions, as identiifed disease treatment group （identiifed disease group）. Results： After treatment, in two groups ALT, AST, TBIL, ALB, PT were signiifcantly improved; after 24 weeks and 48 weeks, the recovery of all indekes in the clifferentiat syndrome group were better （P〈0.01 orP〈0.05）. With 48 weeks of treatment, the diameter of the portal vein, splenic vein width and thickness, spleen reduced degree in the clifferentiation group were better （P〈0.05）. Liver ifbrosis index and LSM in the clifferentiation group were improved signiifcantly （P〈0.01）. Conclusion： The Ruan’gan Zaisheng granules plus entecavir therapy can signiifcantly improve patients’ liver function, inhibit progression of liver ifbrosis and splenomegaly, with fewer side effects.