Objective To evaluate the clinical efficacy of compound Biejia Ruangan tablets using transient elastography in patients with hepatitis B- induced compensated liver cirrhosis who are concurrently treated with entecavir. Methods In this prospective, randomized, and controlled study, 100 patients with hepatitis B- induced compensated liver cirrhosis were randomly assigned to the control group and the experimental group in a ratio of 1: 1. The patients in the control group were treated with the anti- virus drug entecavir alone, whereas the patients in the experimental group were treated with entecavir and compound Biejia Ruangan tablets for anti- fibrosis therapy. The patients were followed up at 6 and 12months. After treatment, the changes in transient elasticity values were evaluated, and the transient elasticity values were compared between the two groups. Continuous variables were compared with the t test and categorical data as well as rates were compared with the chi- square test. Results Treatment with compound Biejia Ruangan tablets led to significantly lower transient elasticity values in the experimental group than in the control group at 6 and 12 months ( t = 2. 963, P = 0. 004; t = 2. 239, P = 0. 027) . Transient elasticity values at 6 and 12 months were significantly lower than their respective baseline levels in the control group ( t = 4. 295, P < 0. 001 for comparison between values at baseline and 6months; t = 6. 109, P < 0. 001 for comparison between values at baseline and 12 months; t = 5. 394, P < 0. 001 for comparison between values at 6 and 12 months) and the experimental group ( t = 8. 505, P < 0. 001 for comparison between values at baseline and 6 months; t = 9. 882, P<0. 001 for comparison between values at baseline and 12 months; t = 7. 930, P < 0. 001 for comparison between values at 6 months and 12months) . At 12 months, the proportion of patients with liver cirrhosis in the experimental group was significantly lower than that in the control group ( χ2= 4. 058, P = 0. 044) . Conclusion Entecavir can relieve liver fibrosis to some extent. Moreover, entecavir combined with compound Biejia Ruangan tablets can lead to further improvement in liver fibrosis at 6 and 12 months.
[1] FRIEDMAN SL.Molecular regulation of hepatic fibrosis, an integrated cellular response to tissue injury[J].J Bio Chem, 2000, 275:2247-2250.
|
[2]WANG HJ, WANG XT, WANG Q, et al.Influence of aprotinin in hepatocyte proliferation ability in rats with experimental chronic liver injury[J].J Jilin Univ:Med Edit, 2011, 37 (1) :18-20. (in Chinese) 王虹蛟, 王心童, 王强, 等.抑肽酶对实验性慢性肝损伤大鼠肝细胞增殖能力的影响[J].吉林大学学报:医学版, 2011, 37 (1) :18-20.
|
[3]CALVARUSO V, CRAXA.Fibrosis in chronic viral hepatitis[J].Best Pract Res Clin Gastroenterol, 2011, 25 (2) :219-230.
|
[4]Liver Disease Committee, Chinese Association of Integrative Medcine.Guidelines for the diagnosis and treatment of liver fibrosis in integrative medicine practice[J].Chin J Hepatol, 2006, 14 (11) :866-870. (in Chinese) 中国中西医结合学会肝病专业委员会.肝纤维化中西医结合诊疗指南[J].中华肝脏病杂志, 2006, 14 (11) :866-870.
|
[5]DIENSTAG J.The role of liver biopsy in chronic hepatitis C[J].Hepatology, 2002, 36:s152-s160.
|
[6]Chinese Saciety of Hepatology, Chinese Society of Infectious Diseases, Chinese Medical Association.Prevention and treatment of viral hepatitis[J].Infect Dis Info, 2000, 13 (4) :141-150 (in Chinese) .中华医学会肝病学分会, 中华医学会感染病学分会.病毒性肝炎防治方案[J].传染病信息, 2000, 13 (4) :141-150.
|
[7]DEGOS F, PEREZ P, ROCHE B, et al.Diagnostic accuracy of FibroScan and comparison to liver fibrosis biomarkers in chronic viral hepatitis:A multicenter prospective study (the FIBROSTIC study) [J].J Hepatol, 2010, 53 (6) :1013-1021.
|
[8]SHEN YY, KANG QJ.Clinical observation of compound traditional Chinese medicine preparation in treatment of hepatic fibrosis in hepatitisβpatients[J].J Changchun Univ Tradit Chin Med, 2011, 27 (30) :421-422. (in Chinese) 沈英宇, 康秋君.中药复方制剂治疗乙肝后肝纤维化临床观察[J].长春中医药大学学报, 2011, 27 (30) :421-422.
|
[9]CHEN JM, YANG YP, CHEN DY, et al.Efficacy and safety of Fufang Biejia Ruangan tablet in patients with chronic hepatitis B complicated with hepatic fibrosis[J].Chin J Exp Clin Virol, 2007, 21 (4) :358-360 (in Chinese) .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.
|
[10]ZHANG N, LING CQ, XIAO XH, et al.Meta analysis of FuFang BieJia RuanGanPian's effect on serum fibrotic markers in patients with hepatitis B and liver fibrosis[J].J Clin Hepatol, 2012, 15 (6) :524-526. (in Chinese) .张宁, 凌昌全, 肖小河, 等.复方鳖甲软肝片对乙型肝炎血清纤维化标志物作用的Meta分析[J].实用肝脏病杂志, 2012, 15 (6) :524-526.
|
[11]BROWN A, GOODMAN Z.Hepatitis B-associated fibrosis and fibrosis/cirrhosis regression with nucleoside and nucleotide analogs[J].Expert Rev Gastroenterol Hepatol, 2012, 6 (2) :187-198.
|
[12]ELLIS EL, MANN DA.Clinical evidence for the regression of liver fibrosis[J].J Hepatol, 2012, 56 (5) :1171-1180.
|
[13]CAO YN, LI SS.Research in the progress of non-invasive diagnosis of liver fibrosis[J].J Clin Hepatol, 2011, 27 (2) :214-217. (in Chinese) 曹玉宁, 李树森.肝纤维化无创诊断的研究进展[J].临床肝胆病杂志, 2011, 27 (2) :214-217.
|
[14]XUAN JQ, LI MX, SU S, et al.Evaluation of degree of liver fibrosis and liver functional reserve in patients with chronic hepatitis B using FibroScan score[J].J Clin Hepatol, 2012, 28 (4) :285-288. (in Chinese) 宣吉晴, 李明星, 苏松, 等.肝脏瞬时弹性值评估慢性乙型肝炎肝纤维化程度及肝脏储备功能的临床研究[J].临床肝胆病杂志, 2012, 28 (4) :285-288.
|
[15]MYERS RP, POMIER-LAYRARGUES G, KIRSCH R, et al.Discordance in fibrosis staging between liver biopsy and transient elastography using the FibroScan XL probe[J].J Hepatol, 2012, 56 (3) :564-570.
|