九味肝泰胶囊联合恩替卡韦治疗慢性乙型肝炎肝硬化的临床疗效观察

Clinical curative effect of nine kinds of Gantai capsule combined with entecavir in treatment of chronic hepatitis B cirrhosis

目的:观察九味肝泰胶囊联合恩替卡韦治疗慢性乙型肝炎肝硬化的临床疗效,分析其对肝功能及血清肝纤维化指标的影响机制。方法:将309例慢性乙型肝炎肝硬化患者,按随机原则分为恩替卡韦组、九味肝泰胶囊组和联合治疗组,3组患者分别服用恩替卡韦、九味肝泰胶囊和恩替卡韦加九味肝泰,疗程6个月。观察3组患者治疗前后肝功能、HBV DNA定量、血清肝纤维化指标、转化生长因子-β1(TGF-β1)、还原型谷胱甘肽(GSH)、丙二醛(MDA)、超氧化物歧化酶(SOD)等指标的变化及临床疗效。结果:治疗后,联合治疗组患者肝功能基本恢复正常,GSH和SOD明显提高,MDA明显降低,与恩替卡韦组患者比较,差异有显著性意义(P<0.05);肝纤维化指标均明显降低,与恩替卡韦组和九味肝泰组患者比较差异有显著性意义(P<0.05);TGF-β1和HBV DNA定量与九味肝泰组患者比较差异有显著性意义(P<0.05)。总有效率高于恩替卡韦组、九味肝泰组,差异有显著性意义(P<0.05)。结论:九味肝泰胶囊联合恩替卡韦治疗慢性乙型肝炎肝硬化疗效确切,可明显降低HBV DNA定量、促进患者肝功能恢复,较单一用药疗效更好。

Objective： To observe the clinical effect of nine kinds of Gantai Capsule Combined with entecavir in treatment of early cirrho- sis due to chronic hepatitis B and analy the mechanism of its effects on liver function and serum hepatic fibrosis . Methods： Three hundred and nine cases of chronic hepatitis B （CHB） with liver cirrhosis were randomly divided into entecavir group, Jiuwei Gantai group and com- bined treatment group; entecavir group were given entecavir; Jiuwei Gantai group with Jiuwei Gantai; combination therapy group with Jiuwei Gantai and entecavir capsule, three groups were treated for 6 months. 3 groups were observed before and after treatment in patients with liver function, alanine aminotransferase （ALT） and aspartate aminotransferase （AST） , total bilirubin （TBil）, bile acid （TBA）, glutamyl trans- ferase （GGT）, HBV DNA, quantitative serum liver fibrosis indexes of serum laminin （LN）, IV collagen （CIV）, hyaluronic acid （HA）, collagen type III （ PC-III）, transforming growth factor beta L （TGF-beta L）, glutathione （ GSH）, malondialdehyde （ MDA）, superoxide dis- mutase （SOD） and other indicators of change and clinical efficacy. Results： Compared with entecavir group, the TBil, TBA, GGT, ALT and AST in combined treatment group were returned to normal, GSH and SOD increased, MDA decreased significantly after treatment （ P 〈 0. 05） ; Compared with entecavir group and Jiuwei Gantai group, LN, cIV, HA and PC-III were decreased significantly in combined treatment group （P 〈 0.05） ; Compared with Jiuwei Gantai group, TGF-β1 and HBV DNA quantification were decreased significantly in combined treat- ment group （ P 〈 0. 05） ; The total efficiency is higher than that of entecavir group and nine kinds of Gantai group （ P 〈 0. 05 ）. Conclusion： The treatment of nine kinds of Gantai Capsule Combined with entecavir for chronic hepatitis B cirrhosis was effective. Entecavir inhibits viral DNA replication, nine kinds of Gantai Capsule could reduce liver fibrosis, the two drugs had synergistic effect, could significantly reduce the HBV DNA quantitative and promote the recovery of liver function, which is better than a single drug efficacy.