ZHOU Rongle 1 , SUN Xin 2 , LI Pan 1 , HE Lin 3 , ZHAO Liansan 4 , LI Youping 2
  • 1. West China School of Clinical Medicine, Sichuan University, Chengdu 610041, China 2. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China 3. Information Center, West China Hospital, Sichuan University, Chengdu, 610041, China 4. Center of Infectious Disease, West China Hospital, Sichuan University, Chengdu 610041, China;
LI Youping, Email: yzmylab@hotmail.com
Thymosin; Chronic hepatitis B; Efficacy; Safety; Randomized controlled trial; Meta-analysis
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Objectives 　To conduct a meta-analysis to evaluate the efficacy and safety of thymosin-α1 for HBeAg-positive chronic hepatitis B.
Methods　 We searched MEDLINE, Science Citation Index, Current Content Connect, Cochrane Controlled Trial Register and Chinese Biomedical Database (CBMdisc) to September 15, 2005, and screened the references of eligible trials by hand-searching. Randomized controlled trials (RCTs) comparing thymosin-α1 with non-antiviral interventions (placebo, no treatment and standard care) in patients with HBeAg positive chronic hepatitis B were eligible for inclusion. We conducted quality assessment and data extraction by two independent investigators with disagreement resolved by discussion. We used chi-square test and Galbraith plot to detect the heterogeneity, and used fixed (Mantel-Haenzel) and random effect model (DerSimonian-Laird) to pool the trials. When the results in two models differed, the results of random effect were reported. Subgroup analysis was performed to detect whether the duration affected the efficacy of thymosin.
Results 　Four RCTs were included. It was found that the rate of loss of HBeAg was 38.8% in thymosin, significantly higher than that of 12.4% in control groups (RR 2.22, 95%CI 1.55 to 3.21, P=0.000). Loss of HBV-DNA was 36.9% in thymosin-α1, significantly higher than that of 13.8% in control groups (RR 2.18, 95%CI 1.50 to 3.17, P=0.000). Both short-duration (8-13 weeks) and regular duration (26-52 weeks) of thymosin-α1 achieved higher loss of HBeAg and HBV-DNA. The complete response rate was 32.3% in thymosin-α1, significantly higher than the control, 11.3% (RR 2.91, 95%CI 1.71 to 4.94, P=0.000). No statistical significance was found for HBeAg seroconversion and ALT normalization. No significant adverse drug reactions were found.
Conclusions 　Thymosin-α1 might be efficacious in loss of HBeAg and HBV-DNA, and complete response for patients with HBeAg-positive chronic hepatitis B. Little evidence was available on HBeAg seroconversion, normalization of ALT, loss of HBsAg, and histological response. Further high-quality RCTs were needed for confirmation.

Citation： ZHOU Rongle,SUN Xin,LI Pan,HE Lin,ZHAO Liansan,LI Youping. Efficacy and Safety of Thymosin-α1 for Chronic Hepatitis B: A Meta-analysis of Randomized Controlled Trials. Chinese Journal of Evidence-Based Medicine, 2006, 06(3): 189-194. doi: Copy