恩替卡韦联合复方甘草酸苷治疗代偿期活动性乙型肝炎肝硬化患者的临床研究

Clinical research of ETV combined therapy with compound glycyrrhizin acid treatment for compensatory phase active hepatitis B with cirrhosis

目的观察ETV分散片联合复方甘草酸苷治疗代偿期活动性乙型肝炎肝硬化患者的临床疗效并探讨其作用机制,为进一步提高代偿期活动性乙型肝炎肝硬化临床疗效提供依据。方法将60例代偿期活动性乙型肝炎肝硬化患者随机分为研究组和对照组,对照组应用ETV分散片0.5 mg/次,1次/d,晨起空腹口服。治疗组在对照组基础上联合复方甘草酸苷片75 mg/次,3次/d,口服。两组患者疗程均为48周。比较两组患者治疗前后肝功能、血清肝纤维化指标、肝硬度指标、血清病毒学(HBV DNA、HBeAg及抗-HBe)指标,运用彩色多普勒超声检查比较肝脏、脾脏和门静脉内径变化。结果两组患者治疗48周肝功能指标(ALT、AST、ALB、TBil)、血清肝纤维化指标(HA、LN、PCⅢ、Ⅳ-C)和肝硬度指标比较差异均有显著统计学意义(P均=0.000);两组患者治疗前后血清HBV DNA水平比较差异均有显著统计学意义(P均=0.000),但组间比较差异均无统计学意义(P=0.490、0.630)。对照组治疗48周发生HBeAg低于检测下限的比率为30.8%、血清学转换率23.1%;治疗组治疗48周发生HBeAg低于检测下限的比率为50.0%、血清学转换率为35.7%。两组患者HBeAg低于检测下限的比率和血清学转换率比较,差异均有统计学意义(P=0.029、0.040)。两组患者治疗前后门静脉内径、脾脏长径、脾脏厚度、脾静脉宽度比较差异均无统计学意义(P=0.830、0.350、0.870、0.490)。结论 ETV联合复方甘草酸苷对代偿期乙型肝炎肝硬化患者治疗有协同作用,其作用机制可能与抗-HBV、抗肝纤维化、改善肝功能、免疫调节等有关。

Observe To effect of ETV dispersible tablets combined therapy with compound glycyrrhizin acid treatment for compensatory phase active hepatitis B with cirrhosis and to explore its action mechanism, in order to further improve the compensatory phase active hepatitis B with cirrhosis provide evidence for clinical efficacy. Methods Total of 60 patients with compensatory phase active hepatitis B cirrhosis were randomly divided into treatment group （30 cases） and control group （30 cases）. Patients in two groups were given ETV dispersible tablets 0.5 mg once time, once-a-day, morning oral on an empty stomach, and patients in treatment group were also applied with joint compound glycyrrhizin glucoside piece of 75 mg once time, 3 times a day at the same time. Patients in both groups were treated for 48 weeks. Observed the changes of two groups before and after treatment in patients with liver function, serum liver fibrosis indexes and liver stiffness index, serum virology （HBV DNA, HBeAg and anti-HBe） indicators. Using the color doppler ultrasound examination compare the inner diameter changes of the liver, spleen, and portal vein diameter. Results After 48 weeks, the index of two groups of patients with liver function （ALT, AST, ALB and TBil）, serum liver fibrosis indexes （HA, LN, PC III, IV-C） and hepatic hardness index comparison differences had statistical significance （both P = 0.000）. Two groups of patients before and after treatment serum HBV DNA level comparative difference had statistical significance （both P = 0.000）. But the comparative differences between groups had no statistical significance （P = 0.490, 0.630）. After 48 weeks, the control group in HBeAg below the detection limit is 30.8%, the ratio of serological c0nve.rsion rate 23.1%, and the treatment group in HBeAg below the detection limit is 50.0%, the ratio of serological conversion rate of 35.7%. The ratio of two groups of patients with HBeAg below the detection limit and serological conversion rate comparison, difference had statistical significance （P = 0.029, 0.040）. In t）volgroups＇before and after treatment in patients with portal vein diameter. The spleen length to diameter, the thickness of the spleen, spleen vein width comparative differences had no statistical significance （P = 0.830, 0.350, 0.870, 0.490）. Conclusions ETV combined compound glycyrrhizic acid glycosides have synergy effect on treatment for patients with compensatory phase of hepatitis B cirrhosis of the liver, its mechanism may be related to anti-HBV, resisting hepatic fibrosis, improving liver function, immune regulation and so on.