恩替卡韦联合肝爽颗粒治疗慢性乙型肝炎患者疗效研究

Auxiliary treatment of a herbal compound,Ganshuang granule,with entecavir for patients with chronic hepatitis B

目的 探讨应用恩替卡韦联合肝爽颗粒治疗慢性乙型肝炎(CHB)患者的近期疗效。方法 2019年1月~2021年1月我院诊治的CHB患者60例,被随机分为对照组和观察组,每组30例,分别给予恩替卡韦或恩替卡韦联合肝爽颗粒,连续治疗48 w。计算天冬氨酸氨基转移酶/血小板计数比率指数(APRI)、肝纤维化4因子指数(FIB-4),使用FibroTouch行肝硬度检测(LSM),采用放射免疫法检测血清透明质酸(HA)、层粘连蛋白(LN)、Ⅲ型前胶原(PC-Ⅲ)和Ⅳ型胶原(Ⅳ-C),采用ELISA法检测血清白介素-6(IL-6)、转化生长因子-β(TGF-β)、血小板衍生生长因子(PDGF)和C反应蛋白(CRP)。结果 治疗后,观察组血清ALT和AST水平显著低于对照组,差异具有统计学意义(P<0.05);两组血清HBV DNA阴转率均为100.0%,而血清HBeAg阴转率均为0.0%,无统计学差异(P>0.05);观察组APRI、FIB-4和LSM水平分别为(1.02±0.23)、(4.38±0.77)和(7.73±1.53),均显著低于对照组【分别为(1.30±0.33)、(5.26±0.85)和(9.68±2.02),P<0.05】;观察组血清IL-6、TGF-β、PDGF和CRP水平均显著低于对照组,差异具有统计学意义(P<0.05)。结论 应用肝爽颗粒辅助恩替卡韦治疗CHB患者可提高血生化学应答率,可能与其具有一定的抗肝纤维化和抑制炎性反应作用有关,需要进一步观察。

Objective The purpose of this clinical trial was to investigate the auxiliary treatment of a herbal compound,Ganshuang granule,with entecavir for patients with chronic hepatitis B(CHB).Methods 60 patients with CHB were enrolled in our hospital between January 2019 and January 2021,and were randomly divided into control and observation groups,with 30 cases in each.The patients in the control group received entecavir,and those in the observation were treated with entecavir and a herbal compound,Ganshuang granule,for 48 weeks.The AST to platelet ratio index(APRI),fibrosis 4 score(FIB-4)were obtained,and the liver stiffness measurement(LSM)was determined by FibroTouch scan.Serum interleukin-6(IL-6),transforming growth factor-beta(TGF-β),platelet-derived growth factor(PDGF)and C-reactive protein(CRP)levels were assayed by ELISA.Results At the end of 48 week treatment,serum ALT and AST levels in the observation group were significantly lower than in the control group(P<0.05);serum HBV DNA loss in the two groups were both 100.0%,and serum HBeAg negative rates were both 0.0%(P>0.05);the APRI,FIB-4 and LSM in the observation group were(1.02±0.23),(4.38±0.77)and(7.73±1.53),all significantly lower than[(1.30±0.33),(5.26±0.85)and(9.68±2.02),respectively,P<0.05]in the control;serum IL-6,TGF-β,PDGF and CRP levels in the observation were much lower than in the control(P<0.05).Conclusion The auxiliary treatment of Ganshuang granule at base of entecavir antiviral therapy could significantly improve biochemical response in patients with CHB,which might be related to the anti-fibrotic effect and inhibition of body inflammatory reaction of the herbal compound.