恩替卡韦联合复方鳖甲软肝片治疗乙型肝炎肝硬化对肝纤维化指标的影响

Entecavir with compound biejia ruangan tablets^(TM) combined in patients with hepatitis B complicating liver cirrhosis:effects on indices of liver fibrosis

目的:观察恩替卡韦联合复方鳖甲软肝片治疗乙型肝炎肝硬化对肝纤维化指标的影响。方法:收集2009年9月至2011年4月株洲市一医院消化内科门诊及住院的乙型肝炎肝硬化患者60例,随机分为恩替卡韦组和联合治疗组,每组30例;根据临床表现和肝功能检查结果将患者分为肝功能代偿期和失代偿期,恩替卡韦组和联合治疗组均有代偿期患者20例和失代偿期患者10例。恩替卡韦组予恩替卡韦治疗,联合治疗组加用复方鳖甲软肝片,疗程均为24周。治疗前和治疗后不同时间点检测血清HBVDNA水平、血生化指标及血清肝纤维化指标层粘连蛋白(LN)、透明质酸(HA)、Ⅲ型前胶原肽(PCⅢ)、Ⅳ型胶原(Ⅳ-C)水平,并评价治疗效果。结果:治疗前2组患者肝纤维化指标差异无统计学意义(均P>0.05)。治疗24周2组患者肝纤维化指标LN、HA、PCⅢ和Ⅳ-C与治疗前比较均显著下降(均P<0.05),联合治疗组血清肝纤维化指标较恩替卡韦组降低[LN:(76.01±38.76)ng/mL比(102.75±23.01)ng/mL;HA:(151.28±80.71)ng/mL比(236.12±92.12)ng/mL;PCⅢ:(15.69±7.02)ng/mL比(26.88±8.44)ng/mL;Ⅳ-C:(88.25±31.92)ng/mL比(129.71±29.10)ng/mL,均P<0.05]。2组乙型肝炎肝硬化代偿期患者的疗效均优于失代偿期患者(均P<0.05);乙型肝炎肝硬化代偿期患者中,联合治疗组的疗效优于恩替卡韦组(P<0.05),而失代偿期患者中2组疗效差异无统计学意义(P>0.05)。结论:恩替卡韦联合复方鳖甲软肝片联合治疗乙型肝炎肝硬化能明显提高疗效。

Objective： To determine the effects of entecavir with Compound Biejia Ruangan TabletsTM combined on the indices of liver fibrosis in patients with hepatitis B complicating liver cirrhosis. Methods： A total of 60 patients with hepatitis B complicating liver cirrhosis were enrolled between September 2009 and April 2011 from the out-patient clinic and department of gastroenterology, Zhuzhou First People＇ s Hospital and were randomly assigned into entecavir group（ n =30） and combined treatment group （n =30）. Additionally, subjects were further categorized into compensated period and decompensated period, based on their clinical manifestations and measurement of liver function, with 20 patients in compensated period and 10 patients in decompensated period in both groups. The 24-week entecavir treatment was applied alone in entecavir group, and was administered in combination with Compound Biejia Ruangan TabletsTM in combined treatment group. Serum HBV-DNA level, blood biochemical parameters and serum indices of liver fibrosis, including laminin （LN）, hyaline acid （HA）, pre-collagen peptide III （PC III） and type IV collagen （IV-C） were detected at various time points prior to and after treatment for assessment of treatment outcomes. Results： The indices of both groups representing liver fibrosis did not differ statistically prior to the treatments （ P 〉 0.05 ）. At week 24 after treatment, both groups exhibited a marked reduction in LN, HA, PC III and IV-C as compared with that piror to the treatment （ all P 〈 0. 05 ）. Furthermore, a more significant decrease in these serum indices was noted in combined treatment group [ LN： （76.01 ± 38.76） ng/mL vs. （ 102.75 ± 23.01 ） ng/mL; HA： （ 151.28 ± 80. 71） ng/mL vs. （236.12 ±92.12） ng/mL; PC III ： （ 15.69 ±7.02） ng/mL vs. （26.88 ± 8.44） ng/mL; IV-C： （88.25 ± 31.92） ng/mL vs. （129.71 ± 29. 10） ng/mL, all P 〈0.05] as compared with that of entecavir group. Patients during compensated period benefited more from both treatments as compared with those during decompensated period （ both P 〈 0.05 ）. Conclusion ： Entecavir in combination with Compound Biejia Ruangan TabletTM confers remarkably superior efficacy in patients with hepatitis B complicating liver cirrhosis.