| Object: Nucleos (t) ide analogs (NAs) as first-line antiviral drug is approved for chronic hepatitis B (CHB),its powerful antiviral effects and the advantage of convenient oral make it has been widely used in clinicalpractice. However, a short-time treatment with NAs can not achieve satisfactory effects and long-termtreatment can otfen occur YMDD motif of the viral polymerase gene mutation HBV variants, mutations inthe virus resistant incidence increased year by year. Thymosin alpha-1is an immunomodulatory agent.Theoretically, there is a certain synergy antiviral effect application NAs combined Thymosin alpha-1forCHB. NAs can strongly inhibit HBV replication in vivo, so replication of HBV at a low level quickly, andin vitro studies have suggested that Thymosin alpha-1can influence T-cell maturation and antigenrecognition, the stimulation of interferon and cytokine production, and the activity of natural killercell-mediated cytotoxicity. To compare the effect of NAs and thymosin alpha-1combination therapy withantiviral NAs monotherapy for HBeAg-positive CHB,Methods: The relevant randomized controlled trials were searched throughout MEDLINE, PubMed,EMBASE, CENTRAL，CNKI, VIP, CBM disc and Wan Fang since January1990. Every study wasevaluated and heterogeneity was examined by Chi-square test. Meta-analysis was carried out with RevMan5.2sotfware. The odds ratio was used to measure the magnitude of the efficacy.Results:36randomized controlled trials with2655patients were included in the study. The results ofmeta-analyses showed that the combination therapy was remarkably more effective than monotherapy bothat the end of the treatment and the follow-up in terms of ALT normalization rate(86.8%versus(vs.)72.0%,OR=2.60，95%C/=2<.04?3.31， Z=7.73,^0.01；7,7%vs.39.7%, OR=6.S9,95%C/=4.18-11.34, Z=7.58,^<0.01, respectively) and HBV-DNA negative rate (81.3%vs.69.8%, OR=2.05,95%C/=1.69-2.42, Z=7.29,PO.Ol;73.1%vs.59.3%, OR=\.94,95%C7=1.25?3.02，Z=2.95,尸<0.01’ respectively) and HBeAg lossrate (54.6%vs.24.2%,(9/?-3.82,95%C/=3<.15-4.63, Z=13.64,？0.01;53.1%vs.15.5%, OR=6ASt95%C/=3.80~11.05, Z-6.87,/*<0.01, respectively) and HBeAg seroconversion rate (40.6%v^.16.7%,OR=3.61,95%C/=3.03?4.43，Z=13.39,尸<0.01;40.7%v^.9.3%, OR=6.16995%C7=3.67?12.46，Z=6.13,/*<0.01，respectively). At the end of treatment, the combined group is lower than the monotherapy group intreatment-resistant HBV-DNA mutation rate(6.7%vs.19.0%, OR=0.26^95%C/=0.12-0.56, Z=3.37,尸<0.01). There was no statistically significant difference in the HBsAg negative rate and adverse reactionsbetween the two groups at the end of treatment.Conclusion: NAs and thymosin alpha-1combination therapy might achieves superior effect in terms ofALT normalization rate, HBV-DNA negative rate，HBeAg loss rate, HBeAg seroconversion rate andsustained response rate compared with NAs monotherapy for HBeAg-positive chronic hepatitis B. Therewere no statistically significant differences in both of the HBsAg negative rate and adverse reactionsbetween the two groups at the end of treatment. |
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