扶正化瘀胶囊联合替诺福韦治疗乙肝肝纤维化的疗效观察

Efficiency of Fuzheng Huayu Capsule combined with tenofovir in treatment of hepatitis B liver fibrosis

目的观察扶正化瘀胶囊联合替诺福韦治疗乙肝肝纤维化的疗效。方法对116例慢乙肝肝纤维化患者的临床资料进行回顾性分析,根据用药的不同,分为单药组和联合组。单药组(56例)服用替诺福韦300 mg/次,1次/d,疗程72周;联合组(60例)服用替诺福韦(剂量及其疗程同单药组)加扶正化瘀胶囊1.5 g/次,3次/d,疗程72周;观察比较其治疗前后肝功能指标、乙肝病毒(HBV)DNA定量、HBV血清学标志物、肝纤维化4项、腹部超声及Fibrosean测量指标肝脏硬度值(LSM)肝纤维化无创指标的变化。结果两组患者肝功能均恢复正常;HBV DNA<500拷贝/m L的比例分别为82.14%(46/56)、86.67%(52/60),差异无统计学意义(P>0.05);HBe Ag血清学转换率为21.43%(12/56)、23.33%(14/60),差异无统计学意义(P>0.05);联合组肝纤维化4项指标较单药组显著下降(P<0.05);治疗后腹部超声检测指标门静脉直径、门静脉血流速度、脾脏厚度和门脉血流量组间比较差异均有统计学意义(P<0.05);LSM值治疗后均降低,且联合组与单药组比较,差异有统计学意义(P<0.05)。结论采用扶正化瘀胶囊与替诺福韦联合治疗乙肝肝纤维化较单纯西药疗效显著,是值得临床推广的新方法。

Objective To determine the curative effect of Fuzheng Huayu Capsule（ a prescription of traditional Chinese medicine based on anti-viral herbs） combined with tenofovir in treatment of hepatitis B liver fibrosis. Methods Clinical data of 116 patients with chronic hepatitis B liver fibrosis who admitted in the Southwest Hospital and the Affiliated Hospital of North China University of Science and Technology from July 2014 to January 2016 were collected and retrospectively analyzed. According to their treatment,the patients were divided into the single drug group（ n = 56,300 mg / d tenofovir,once per day,for 72 weeks）and the combined group（ n = 60,tenofovir at the same dose and course as the single drug group combinedwith 1. 5 g Fuzheng Huayu Capsule,3 times per day,for 72 weeks）. The liver function,HBV DNA copy number,HBV serological indicators,liver fibrosis indicators were measured,and abdomen ultrasonography and Fibroscan testing was carried out before and after the treatment. The above indicators and results were compared between the 2 groups. Results The liver function were returned to normal in the both groups of patients. The proportion of the patients with HBV DNA 500 copy / mL was 82. 14%（ 46 /56） in the single drug group and 86. 67%（ 52 /60） in the combined group,without significant difference（ P〉0. 05）. The rate of HBe Ag sero-conversion was 21. 43%（ 12 /56） in the former and 23. 33%（ 14 /60） in the latter group,and no statistical significance was found（ P〉0. 05）. The 4 indicators of liver fibrosis were significantly lower in the combined group than the single drug group（ P〈0. 05）. After treatment, abdominal ultrasound examination showed that obvious differences were seen in portal vein diameter and blood flow velocity,spleen length and portal blood flow between the 2 groups（ P〈0. 05）. The liver stiffness measure（ LSM） values were decreased after treatment,and statistical significance was observed between the 2 groups（ P〈0. 05）.Conclusion Combination of Fuzheng Huayu Capsule and tenofovir is more effective in the treatment of hepatitis B liver fibrosis,and it is worthy of clinical promotion.