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目的观察一贯煎加味联合阿德福韦酯片治疗HBeAg阴性慢性乙型肝炎活动性代偿期肝硬化患者的临床疗效。方法采用随机数字表法将68例初治的HBeAg阴性慢性乙型肝炎活动性代偿期肝硬化患者分为治疗组及对照组,每组34例。对照组单用阿德福韦酯片治疗,10 mg,每日1次。治疗组在此基础上予以中药一贯煎加味,每日1剂。两组疗程均为48周。每2周检测1次ALT、AST、总胆红素(TBil)水平;每4周检测1次乙肝病毒HBV-DNA及血清肝纤维化4项[Ⅳ型前胶原(PCIV)、透明质酸酶(HA)、Ⅲ型前胶原(PCⅢ)及层粘连蛋白(LN)]。治疗前后行腹部B超,记录门静脉内径及脾脏大小。采用肝脏瞬时弹性探测仪(Fibroscan)评估肝脏纤维化程度。观察治疗前后两组患者中医证候积分评价中医疗效,应用ChildPugh分级评分进行西医疾病疗效评价。结果与本组治疗前比较,治疗48周后,两组ALT、AST均恢复正常,HBV-DNA阴转(HBV-DNA≤1×102),且TBil、ALB、PCIV、HA、PCⅢ、LN水平明显降低(P<0.05,P<0.01),B超示门静脉内径及脾脏大小均减小,Fibroscan示肝脏弹性值明显降低(P<0.05),且治疗后治疗组PCIV、HA、PCⅢ、LN及肝脏弹性值下降程度较对照组更明显(P<0.01)。两组治疗后ALT、AST、TBil、ALB水平、门静脉内径及脾脏大小比较,差异无统计学意义(P>0.05)。与本组治疗前比较,两组患者治疗后中医证候积分及Child-Pugh评分均下降(P<0.05,P<0.01),且治疗组中医证候积分较对照组下降更明显(P<0.05)。治疗组有效率为88.24%(30/34),明显高于对照组的67.65%(23/34),差异有统计学意义(P<0.05)。结论一贯煎加味联合阿德福韦酯片治疗HBeAg阴性慢性乙型肝炎活动性代偿期肝硬化能显著改善患者的中医症状及肝脏纤维化程度。
Objective To observe the clinical efficacy of decoction combined with adefovir dipivoxil in the treatment of active decompensated cirrhosis of patients with HBeAg-negative chronic hepatitis B. Methods Sixty-eight patients with active HBeAg-negative chronic hepatitis B decompensated cirrhosis were randomly divided into treatment group and control group, with 34 cases in each group. The control group was treated with adefovir dipivoxil alone, 10 mg once daily. On the basis of the treatment group, the Chinese medicine has been fried plus one day. The two groups were treated for 48 weeks. The levels of ALT, AST and total bilirubin (TBil) were detected every 2 weeks. Four HBV-DNA and serum hepatic fibrosis were detected every 4 weeks [type IV procollagen (PCIV), hyaluronidase (HA), type III procollagen (PCIII) and laminin (LN)]. Abdominal ultrasound before and after treatment, recording portal vein diameter and spleen size. Liver fibrosis was assessed using Fibroscan. Observed before and after treatment of TCM syndrome scores of two groups of patients to evaluate the efficacy of traditional Chinese medicine, Child Pugh grading score evaluation of the efficacy of Western medicine. Results After treatment for 48 weeks, the levels of ALT and AST in both groups returned to normal and HBV-DNA was negative (HBV-DNA≤1 × 102), and the levels of TBil, ALB, PCIV, HA, PCⅢ and LN (P <0.05, P <0.01). The diameter of the portal vein and the size of the spleen were all decreased in B ultrasound. The liver elasticity of Fibroscan was significantly decreased (P <0.05). After treatment, PCIV, HA, PC Ⅲ, Liver elastic value decreased more significantly than the control group (P <0.01). There was no significant difference in ALT, AST, TBil, ALB level, portal vein diameter and spleen size between the two groups after treatment (P> 0.05). Compared with before treatment, the TCM syndrome score and Child-Pugh score of both groups decreased (P <0.05, P <0.01), and the TCM syndrome score of the treatment group decreased more significantly than that of the control group (P <0.05 ). The effective rate of the treatment group was 88.24% (30/34), which was significantly higher than that of the control group (67.65%, 23/34), the difference was statistically significant (P <0.05). Conclusion The combination of decoction with adefovir dipivoxil tablets in active decompensated cirrhotic patients with HBeAg-negative chronic hepatitis B can significantly improve TCM symptoms and hepatic fibrosis in patients.