恩替卡韦联合复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化的临床效果评价
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摘要
目的探讨恩替卡韦联合复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化的临床疗效。方法选取2014年4月—2016年3月于我院治疗的64例慢性乙型肝炎肝纤维化患者作为研究对象,按照随机、双盲、安慰剂对照原则将其分为对照组(恩替卡韦联合安慰剂治疗)和治疗组(恩替卡韦联合复方鳖甲软肝片治疗),例数分别为37例和27例。治疗期间定期进行血常规、血生化、HBV DNA、肝脏硬度(liver stiffness measurement, LSM)的检查,并观察2组患者治疗前和治疗72周时肝穿刺活检的疗效。结果入组64例患者,其中59例完成临床疗效观察。与治疗前相比,治疗后2组患者ALT、AST、TBIL、HBV DNA水平及LSM和肝纤维化评分均较治疗前明显下降(P均<0.05);在改善肝纤维化程度方面,治疗组有效率为66.7%,明显高于对照组的45.8%,差异有统计学意义(P <0.05)。结论恩替卡韦联合复方鳖甲软肝片治疗可改善慢性乙型肝炎肝纤维化患者的肝脏炎症和纤维化程度。
Objective To explore the clinical efficacy of entecavir with compound biejia ruangan tablet in the treatment of chronic hepatitis B hepatic fibrosis. Methods Sixty-four patients with chronic hepatitis B hepatic fibrosis were included in this study, who were treated in our hospital from April 2014 to March 2016. According to the principle of randomization,double blindness and placebo control, the involved patients were divided into control group(entecavir combined with placebo)and treatment group(entecavir combined with compound biejia ruangan tablet), with 37 cases and 27 cases, respectively. Blood routine, blood biochemistry, HBV DNA and liver stiffness measurement(LSM) were examined regularly during the treatment.The efficacy of liver biopsy before treatment and 72 weeks after treatment was observed in both groups. Results Among the 64 patients enrolled in the study, 59 cases of whom were completed in clinical observation. Compared with those pre-treatment, the levels of ALT, AST, TBIL, HBV DNA, LSM and liver fibrosis scores in the 2 groups after treatment were significantly decreased(P <0.05). As for the improving degree of hepatic fibrosis, the effective rate of the treatment group was 66.7%, which was significantly higher than 45.8% in the control group(P <0.05). Conclusions Entecavir combined with compound biejia ruangan tablet can improve the degree of liver inflammation and hepatic fibrosis in patients with chronic hepatitis B hepatic fibrosis.
Objective To explore the clinical efficacy of entecavir with compound biejia ruangan tablet in the treatment of chronic hepatitis B hepatic fibrosis. Methods Sixty-four patients with chronic hepatitis B hepatic fibrosis were included in this study, who were treated in our hospital from April 2014 to March 2016. According to the principle of randomization,double blindness and placebo control, the involved patients were divided into control group(entecavir combined with placebo)and treatment group(entecavir combined with compound biejia ruangan tablet), with 37 cases and 27 cases, respectively. Blood routine, blood biochemistry, HBV DNA and liver stiffness measurement(LSM) were examined regularly during the treatment.The efficacy of liver biopsy before treatment and 72 weeks after treatment was observed in both groups. Results Among the 64 patients enrolled in the study, 59 cases of whom were completed in clinical observation. Compared with those pre-treatment, the levels of ALT, AST, TBIL, HBV DNA, LSM and liver fibrosis scores in the 2 groups after treatment were significantly decreased(P <0.05). As for the improving degree of hepatic fibrosis, the effective rate of the treatment group was 66.7%, which was significantly higher than 45.8% in the control group(P <0.05). Conclusions Entecavir combined with compound biejia ruangan tablet can improve the degree of liver inflammation and hepatic fibrosis in patients with chronic hepatitis B hepatic fibrosis.
引文
[1]中华医学会肝病学分会,中华医学会感染病学分会.慢性乙型肝炎防治指南(2010年版)[J].中华肝脏病杂志,2011,19(1):13-24.
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[8]曹建彪,陈永平,成军,等.瞬时弹性成像技术(TE)临床应用专家共识(2015年)[J].中国肝脏病杂志(电子版),2015,7(2):12-18.
[9]Chen YP,Liang XE,Zhang Q,et al.Larger biopsies evaluation of transient elastography for detecting advanced fibrosis in patients with compensated chronic hepatitis B[J].J Gastroenterol Hepatol,2012,27(7):1219-1226.
[10]杨元素,李丽,黄夏寒.恩替卡韦治疗慢性乙型肝炎的临床研究[J].传染病信息,2017,30(1):34-37.
[11]Jiyao Wang.Clinical utility of entecavir for chronic hepatitis B in Chinese patients[J].Drug Des Devel Ther,2014,8:13-24.
[12]张健,任姣姣,李冰,等.恩替卡韦治疗慢性乙型肝炎及乙型肝炎肝硬化患者的疗效分析[J].传染病信息,2013,26(3):158-160.
[13]陈菊梅,杨永平,陈德永,等.复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化的临床研究[J].中华实验和临床病毒学杂志,2007,21(4):358-360.
[14]张瑞凤,姚云洁,游忠岚,等.复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎肝纤维化的观察[J].第三军医大学学报,2014,36(18):1961-1963.
[15]姚云洁,杨才兴,巫继.恩替卡韦联合复方鳖甲软肝片治疗慢性乙型肝炎患者疗效观察[J].实用肝脏病杂志,2015,18(4):356-359.
[16]吴刚,何鸿雁,李烨,等.复方鳖甲软肝片联合恩替卡韦对HBV相关肝硬化患者的临床疗效观察[J].中华肝脏病杂志,2014,22(8):604-608.
[17]杨年欢,袁国盛,周宇辰,等.恩替卡韦联合复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化96周的临床疗效[J].南方医科大学学报,2016,36(6):775-779.
[2]Friedman SL.Mechanisms of hepatic fibrogenesis[J].Best Pract Res Clin Gastroenterol,2011,25(2):195-202.
[3]Friedman SL.A deer in the headlights:BAMBI meets liver fibrosis[J].Nat Med,2007,13(11):1281-1282.
[4]Friedman SL.Hepatic fibrosis-overview[J].Toxicology,2008,254(3):120-129.
[5]DeMinicis S,Seki E,Oesterreicher C,et al.Reduced nicotinamide adenine dinucleotide phosphate oxidase mediates fibrotic and inflammatory effects of leptin on hepatic stellate cells[J].Hepatology,2008,48(6):2016-2026.
[6]Organization WH.Guidelines for the prevention,care and treatment of persons with chronic hepatitis B infection[EB/OL].http://www.who.int/hiv/pub/hepatitis/hepatitis-b-guidelines/en/.
[7]何肖敏,黄坚.肝纤维化血清学标志物研究新进展[J].中华肝脏病杂志,2015,23(11):874-877.
[8]曹建彪,陈永平,成军,等.瞬时弹性成像技术(TE)临床应用专家共识(2015年)[J].中国肝脏病杂志(电子版),2015,7(2):12-18.
[9]Chen YP,Liang XE,Zhang Q,et al.Larger biopsies evaluation of transient elastography for detecting advanced fibrosis in patients with compensated chronic hepatitis B[J].J Gastroenterol Hepatol,2012,27(7):1219-1226.
[10]杨元素,李丽,黄夏寒.恩替卡韦治疗慢性乙型肝炎的临床研究[J].传染病信息,2017,30(1):34-37.
[11]Jiyao Wang.Clinical utility of entecavir for chronic hepatitis B in Chinese patients[J].Drug Des Devel Ther,2014,8:13-24.
[12]张健,任姣姣,李冰,等.恩替卡韦治疗慢性乙型肝炎及乙型肝炎肝硬化患者的疗效分析[J].传染病信息,2013,26(3):158-160.
[13]陈菊梅,杨永平,陈德永,等.复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化的临床研究[J].中华实验和临床病毒学杂志,2007,21(4):358-360.
[14]张瑞凤,姚云洁,游忠岚,等.复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎肝纤维化的观察[J].第三军医大学学报,2014,36(18):1961-1963.
[15]姚云洁,杨才兴,巫继.恩替卡韦联合复方鳖甲软肝片治疗慢性乙型肝炎患者疗效观察[J].实用肝脏病杂志,2015,18(4):356-359.
[16]吴刚,何鸿雁,李烨,等.复方鳖甲软肝片联合恩替卡韦对HBV相关肝硬化患者的临床疗效观察[J].中华肝脏病杂志,2014,22(8):604-608.
[17]杨年欢,袁国盛,周宇辰,等.恩替卡韦联合复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化96周的临床疗效[J].南方医科大学学报,2016,36(6):775-779.