Lamivudine and thymosin α1 combination therapy for patients with chronic hepatitis B

( views:377, downloads:0 )
Author:
SHI Guang-feng(Department of Infectious Diseases,Huasban Hospital.Fudan University.Shanghai 200040,China)
ZHANG Yu-jie(Department of Infectious Diseases,Huasban Hospital.Fudan University.Shanghai 200040,China)
WAN Me-bin()
WU Shan-ming()
CAI Xiong()
Journal Title:
CHINESE JOURNAL OF CLINICAL INFECTIOUS DISEASES
Issue:
Volume 2, Issue 01, 2009
DOI:
10.3760/cma.j.issn.1674-2397.2009.01.004
Key Word:
Chronic hepatitis B;Thymosin etl;Lamivudine;Therapy

Abstract: Objective To evaluate the efficacy and safety of lamivudine combined with thymosin α1 therapy for patients with chronic hepatitis B.Methods Sixty-eight eligible patients with chronic hepatitis B were enrolled in this multi-center randomized controlled rlinical trial.Patients were randomized into the trial group and the control group(n=34 for each).Patients in trial group received thymosin α1 for 6 months and lamivudine for 12 menths:patients in control group received lamivudine for 12 months only.The rates of serum HBV DNA clearance.HBeAg loss,HBeAg seroconversion,ALT normalization and the safety of thymosin α1 were observed at 3rd.6th,12th and 18th month during and after the treatment.Results At 12th month of the treatment,there were significant differences in the rates of serum HBV DNA clearance,HBeAg loss and ALT normalization between two groups(χ2=31.17,7.17 and 5.92,P<0.05);at 6th month after the treatment.there were significant differences in the rates of sernm HBV DNA clearance and HBeAg loss between two groups(χ2=4.53 and 7.17,P<0.05).HBV DNA was not detected in 2 patients during 6-month follow-up study and no sever side effect was observed throughout the study.Conclusion The conlbination of lamivudine and thymosin α1 is safe and has better effect than the monotherapy of lamivudine in patients with chronic hepatitis B.

  • [1]Yao GB.Management of hepatitis B in China.J Med Virol,2000,61(3):392-397.
  • [2]Chinese Society of Hepatology and Chinese Society of Infectious Diseases of Chinese Medical Association.The guideline of prevention and treatment for chronic hepatitis B.Zhonghua Ganzangbing Zazhi,2005,13(12):881-891.(in Chinese)中华医学会肝病学分会、感染病学分会.慢性乙型肝炎防治指南.中华肝脏病杂志,2005,13(12):881-891.
  • [3]Cmldstein AL,Guha A,Zatz M,et al.Purification and biological activity of thymosin,a hormone of the thymus gland.Proe Natl Acad Set U S A,1972,69(7):1800-1803.
  • [4]Low TL,Goldslein AL.Thymosins:structure,function and therapeutic applications.Thymus,1984,6(1-2):27-42.
  • [5]Paul S,Sodhi A.Modulatory role of thymosin-alpha-1 in normal bone-marrow haematopoiesis and its effect on myelosuppression in T-cell lymphoma bearing mice.Immunol Left,2002,82(3):171-182.
  • [6]Armutcu F,Coskun 0,Gtiml A,et al.Thymosin alpha I attenuates lipid pemxidation and improves fructose-induced steatohepalitis in rats.Clin Biochem.2005,38(6):540-547.
  • [7]Li CL,Ting Z,Saihara T,et al.Thymosin α1 accelcrates restoration of T cell-mediated neutralizing antihody response in immunocompromised hosts.Int Immunophammcol,2002,2(1):39-46.
  • [8]Yao WY,Zhu Q,Yuan YZ,et al.Thymosin alpha 1 improves severe acute pancreatitis in rats via regulation of peripheral T cell humber and cytokine serum level.J Gastroenterol Hepatol,2007,22(11):1866-1871.
  • [9]Saruc M,Yuceyar H,Kucukmetin N,et al.Combination thymosin-alpha 1 and interferon-alpha 2b in the treatment of antiHBe-positive chronic hepatitis B in Turkey.Hepato-Gastroenterol.2002,49(25):798-802.
  • [10]Saruc M,Ozden N,Turkel N,et al.Long-term outcomes of thymosin-alpha 1 and interferon alpha-2b combinalion therapy in patients with hepatitis B e antigen(HBeAg)negative chronic hepatitis B.J Pharrn Set,2003,92(7):1386-1395.
  • [11]Chen J,Li L.Advances of combination therapy in patients with chronic hepatitis B.Zhonghua Chuanranbing Zazhi,2003,21(2):157-160.(in Chinese)成军,李莉.抗乙型肝炎病毒联合治疗方案的研究进展.中华传染病杂志,2003,21(2):157-160.
  • [12]Lin BL,Huang GM,Zhang XH,et al.Thymosin-αl improving efficacy of lamivudine treatment in palients with chronic hepatitis B.Zhonghila Chuanranbing Zazhi,2003,21(3):217-220.(in Chinese)林炳亮,黄桂梅,张晓红,等.胸腺肽α1联合拉米夫定治疗慢性乙型肝炎.中华传染病杂志,2003,21(3):217-220.
  • [13]Lau GKK,Nanji A,Hou J,et al.Thymosin-α1 and famciclovir combination therapy activates T-cell response in patients with chronic hepatitis B virus infection in immune-tolerant phase.J Viral Hepat,2002,9(4):280-287.
  • [14]Chien RN.Liaw YF.Thymalfasin for the treatment of chronic hepatitis B.Expert Rev Anti Infect Ther,2004,2(1):9-16.
  • [15]Hügle T,Cemy A.Current therapy and new molecular approaches to antiviral treatment and prevention of hepatitis C.Rev Med Virol,2003,13(6):361-371.
WanfangData CO.,Ltd All Rights Reserved
About WanfangData | Contact US
Healthcare Department, Fuxing Road NO.15, Haidian District Beijing, 100038 P.R.China
Tel:+86-010-58882616 Fax:+86-010-58882615 Email:yiyao@wanfangdata.com.cn