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[目的]研究软肝化纤汤联合恩替卡韦治疗肝郁脾虚/瘀血阻络型慢性乙型肝炎(CHB)肝纤维化临床疗效。[方法]选取2014年7月~2016年10月我院门诊与住院治疗的108例肝纤维化患者。按照随机的方式将患者分成观察组与对照组(每组54例),对照组患者采用恩替卡韦治疗,观察组患者采用软肝化纤汤联合恩替卡韦治疗,疗程6个月。观察2组患者治疗前后中医症候积分、肝功能指标、APRI、血清肝纤维化指标、乙肝病毒定量、肝脾彩超改善程度。[结果]观察组患者的总有效率显著高于对照组的总有效率(90.74%vs.74.07%)(P<0.05)。治疗后观察组患者HBV-DNA转阴率为88.89%,对照组为87.04%,2组比较差异无统计学意义。治疗后观察组患者TBiL、ALT和AST检测结果为(18.64±9.34)μmol/L、(35.62±12.34)U/L、(35.14±24.17)U/L,显著低于对照组(P<0.05)。治疗后观察组患者HA、LN、Ⅳ-C、PCⅢ值为(91.35±31.29)mg/L、(105.24±52.34)μg/ml、(47.26±25.48)μg/L、(86.29±25.67)μg/L,显著低于对照组(P<0.05)。治疗后观察组患者门静脉内径、脾静脉内径、脾脏厚度为(10.25±1.59)mm、(9.24±1.02)mm、(3.14±0.12)cm,显著低于对照组(P<0.05)。[结论]软肝化纤汤联合恩替卡韦对CHB肝纤维化患者有较好的临床疗效,值得在临床上推广使用。
[Objective] To study the clinical effect of Ruanghuanglian Decoction combined with entecavir on liver fibrosis induced by liver depression and spleen deficiency / blood stasis syndrome in patients with chronic hepatitis B (CHB). [Methods] From July 2014 to October 2016 in our hospital outpatient and inpatient treatment of 108 cases of liver fibrosis patients. The patients were randomly divided into observation group and control group (54 cases in each group). Patients in the control group were treated with entecavir. Patients in the observation group were treated with Ruanghuangxian Decoction combined with entecavir for 6 months. The TCM symptom score, liver function index, APRI, serum liver fibrosis index, hepatitis B virus quantification, hepatopancreas and ultrasonography were observed before and after treatment in two groups. [Results] The total effective rate in the observation group was significantly higher than that in the control group (90.74% vs 74.07%) (P <0.05). After treatment, the HBV-DNA negative rate in the observation group was 88.89%, while that in the control group was 87.04%. There was no significant difference between the two groups. The results of TBiL, ALT and AST in observation group were (18.64 ± 9.34) μmol / L, 35.62 ± 12.34U / L and 35.14 ± 24.17U / L, respectively, which were significantly lower than those in control group (P <0.05) . The serum levels of HA, LN, Ⅳ-C and PCⅢ in the observation group were (91.35 ± 31.29) mg / L, (105.24 ± 52.34) μg / ml and (47.26 ± 25.48) μg / L and (86.29 ± 25.67) μg / L, significantly lower than the control group (P <0.05). After treatment, the diameter of portal vein, the diameter of splenic vein and the spleen thickness of the observation group were (10.25 ± 1.59) mm, (9.24 ± 1.02) mm and (3.14 ± 0.12) cm, respectively, which were significantly lower than those in the control group (P <0.05). [Conclusion] Ruanganyuxian Decoction combined with entecavir has good clinical efficacy in patients with CHB liver fibrosis, which is worth popularizing in clinic.