丹叶胶囊治疗慢性乙型肝炎肝纤维化的临床研究

Clinical Study of Danye Capsules in the Treatment of Liver Fibrosis in Chronic Hepatitis B

目的观察丹叶胶囊治疗慢性乙型肝炎肝纤维化的疗效。方法选择慢性乙型肝炎肝纤维化患者120例,随机分为对照组和治疗组,两组各60例。对照组采用常规保肝治疗,治疗组在常规治疗的基础上加用丹叶胶囊治疗;观察治疗后两组患者总体疗效,肝功能〔丙氨酸氨基转氨酶(ALT)、总胆红素(TBiL)、白/球蛋白比(A/G)以及肝纤维化血清指标包括透明质酸(HA)、层黏蛋白(LN)、Ⅲ型前胶原肽(P-Ⅲ-P)I、V型胶原(IV-C)、血清转化生长因子β1(TGFβ1)、基质金属蛋白酶抑制剂-1(TIMP-1)〕和肝血流动力学变化。结果两组均有一定疗效,但治疗组总体疗效明显优于对照组,差异有统计学意义(P<0.01);两组治疗后肝功能ALT、TBiL均明显下降,A/G比值显著上升,与治疗前比较差异统计学意义(P<0.01);治疗组治疗后肝纤维化血清标志物HA、LN、P-Ⅲ-P、Ⅳ-C及TGFβ1、TIMP-1含量均较治疗前明显下降,且显著优于对照组(P<0.01);同时彩色多普勒显示治疗组患者治疗后门静脉内径及血流量、脾脏厚度均明显下降(P<0.01),而门脉平均血流速度较治疗前增加(P<0.05)。结论丹叶胶囊能较好地改善慢性乙型肝炎肝纤维化患者血清肝纤维化指标和血流动力学,对阻断及逆转肝纤维化进程有一定的疗效。

Objective To observe the efficacy of danye capsules on liver fibrosis for chronic hepatitis B.Methods 120 cases of liver fibrosis in chronic hepatitis B were divided randomly into a control group and a treatment group,60 cases in each one.In control group,the conventional liver protection program was administered.In treatment group,on the basis of conventional treatment,danye capsules were prescribed.The overall efficacy,liver functions[alamine aminotransferase（ALT）,total bilirubin（TBiL）,albumin/globulion（A/G）,serum markers of liver fibrosis such as hyluronic acid（HA）,laminin（LN）,type Ⅲ procollagen peptide（P-Ⅲ-P）,type IV collagen（IV-C）,transforming growth factorβ1（TGFβ1）and tissue inhibitor of metalloproteinase-1（TIMP-1）]and the changes of hepatic hemodynamics were observed after treatment in two groups.Results A certain efficacy was achieved in either group.But the overall efficacy in treatment group was obviously superior to that in control group,indicating statistical significant difference（P0.01）.After treatment,in either group,ALT and TBiL decreased obviously,A/G increased significantly,indicating statistical significant difference as compared with those before treatment（P0.01）.In treatment group after treatment,the serum markers of liver fibrosis such as HA,LN,P-Ⅲ-P and IV-C,as well as TGFβ1 and TIMP-1 decreased remarkably as compared with those before treatment,which was superior significantly to those in control group（P0.05）.Additionally,the color Doppler indicated that portal vein diameter,blood flow and spleen thickness reduced apparently for the patients after treatment in treatment group（P0.01）,and the average velocity of portal flow increased as compared with that before treatment（P0.05）.Conclusion Danye capsules better improves in serum markers of liver fibrosis and hemodynamics and achieves a certain efficacy of blocking and reversing the progression of liver fibrosis for the patients of liver fibrosis in chronic hepatitis B.