Safety and immunogenicity of SARS-CoV-2 vaccines in Chinese patients with cirrhosis: a prospective multicenter study.

BACKGROUND: Data on safety and immunogenicity of coronavirus disease 2019 (COVID-19) vaccination in patients with compensated (C-cirrhosis) and decompensated cirrhosis (D-cirrhosis) are limited. METHODS: In this prospective multicenter study, adult participants with C-cirrhosis and D-cirrhosis were enrolled and received two doses of inactivated whole-virion COVID-19 vaccines. Adverse events were recorded within 14 days after any dose of vaccination, and serum samples of enrolled patients were collected and tested for SARS-CoV-2 neutralizing antibodies at least 14 days after the second dose. Risk factors for negative neutralizing antibody were analyzed. RESULTS: In total, 553 patients were enrolled from 15 centers in China, including 388 and 165 patients with C-cirrhosis and D-cirrhosis. The vaccines were well tolerated, most adverse reactions were mild and transient, and injection site pain (23/388 [5.9%] vs 9/165 [5.5%]) and fatigue (5/388 [1.3%] vs 3/165 [1.8%]) were the most frequently local and systemic adverse events in both the C-cirrhosis and D-cirrhosis groups. Overall, 4.4% (16/363) and 0.3% (1/363) of patients were reported Grades 2 and 3 alanine aminotransferase (ALT) elevations (defined as ALT > 2 upper limit of normal [ULN] but ≤ 5 ULN, and ALT > 5 ULN, respectively). The positive rates of COVID-19 neutralizing antibodies were 71.6% (278/388) and 66.1% (109/165) in C-cirrhosis and D-cirrhosis groups. Notably, Child-Pugh score of B and C levels was an independent risk factor of negative neutralizing antibody. CONCLUSIONS: Inactivated COVID-19 vaccinations are safe with acceptable immunogenicity in cirrhotic patients, and Child-Pugh score of B and C levels is associated with hyporesponsive to COVID-19 vaccination.

Safety and Immunogenicity of SARS-CoV-2 Vaccines in Patients With Chronic Liver Diseases (CHESS-NMCID 2101): A Multicenter Study.

BACKGROUND & AIMS: We aimed to assess the safety and immunogenicity of inactivated whole-virion severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with chronic liver diseases (CLD) in this study. METHODS: This was a prospective, multi-center, open-label study. Participants aged over 18 years with confirmed CLD and healthy volunteers were enrolled. All participants received 2 doses of inactivated whole-virion SARS-CoV-2 vaccines. Adverse reactions were recorded within 14 days after any dose of SARS-CoV-2 vaccine, laboratory testing results were collected after the second dose, and serum samples of enrolled subjects were collected and tested for SARS-CoV-2 neutralizing antibodies at least 14 days after the second dose. RESULTS: A total of 581 participants (437 patients with CLD and 144 healthy volunteers) were enrolled from 15 sites in China. Most adverse reactions were mild and transient, and injection site pain (n = 36; 8.2%) was the most frequently reported adverse event. Three participants had grade 3 aminopherase elevation (defined as alanine aminopherase >5 upper limits of normal) after the second dose of inactivated whole-virion SARS-CoV-2 vaccination, and only 1 of them was judged as severe adverse event potentially related to SARS-CoV-2 vaccination. The positive rates of SARS-CoV-2 neutralizing antibodies were 76.8% in the noncirrhotic CLD group, 78.9% in the compensated cirrhotic group, 76.7% in the decompensated cirrhotic group (P = .894 among CLD subgroups), and 90.3% in healthy controls (P = .008 vs CLD group). CONCLUSION: Inactivated whole-virion SARS-CoV-2 vaccines are safe in patients with CLD. Patients with CLD had lower immunologic response to SARS-CoV-2 vaccines than healthy population. The immunogenicity is similarly low in noncirrhotic CLD, compensated cirrhosis, and decompensated cirrhosis.

[Treatment of early and mid-term primary biliary cirrhosis by Qingying Huoxue Decoction Combined ursodeoxycholic acid: a clinical observation].

UNLABELLED: OBJECTIVE To observe the clinical efficacy by Qingying Huoxue Decoction (QHD) combined ursodeoxycholic acid (UDCA) in treating patients with early and mid-term primary biliary cirrhosis (PBC). METHODS Totally 78 patients were randomly assigned to the treatment group and the control group, 39 in each group. All patients received basic treatment and took UDCA (at the daily dose of 13-15 mg/kg). Patients in the treatment group took QHD, one dose per day. The treatment course for all was 6 weeks. Clinical efficacy, gamma-glutamyl transferase (γ-GGT), alkaline phospatase (ALP), TBIL, alanine aminotransferase (ALT), and aspartate transaminase (AST) were observed before and after treatment. RESULTS Totally 21 (53. 8%) patients obtained complete response in the treatment group, with statistical difference when compared with that of the control group (11 cases, 30. 8%). Levels of GGT, ALP, ALT, AST, and TBIL decreased in the two groups after treatment (P < 0.01). Levels of ALP, GGT, and TBIL were obviously lower in the treatment group than in the control group (P < 0.05). CONCLUSIONS: QHD combined UDCA in treating early and mid-term PBC patients was superior to the effect of using UDCA alone. It also could improve patients' liver function.

The efficacy and safety of entecavir in patients with advanced schistosomiasis co-infected with hepatitis B virus.

OBJECTIVE: To evaluate the efficacy and safety of entecavir (ETV) in patients with advanced schistosomiasis and hepatitis B virus (HBV) co-infection. METHODS: Sixty-seven patients with advanced schistosomiasis and HBV co-infection were enrolled in this study. The patients were randomly divided into the ETV treatment group (n=35) and the control group (n=32). The patients in the control group adopted routine supportive therapy for 52 weeks, and those in the ETV treatment group received ETV at a dose of 0.5mg once daily on the basis of routine supportive therapy for 52 weeks. Hepatic fibrosis markers (hyaluronic acid, type III procollagen, type IV collagen, laminin, and fibronectin), Ishak fibrosis score, alanine transaminase (ALT), HBV DNA, and Child-Pugh score were compared between the two groups. The intention to treat (ITT) population was used for the analysis. The measurement data and count data were analyzed by t-test and Chi-square test, respectively. RESULTS: After 52 weeks of treatment, the hepatic fibrosis markers (hyaluronic acid, type III procollagen, type IV collagen, laminin, and fibronectin) were significantly improved in the ETV treatment group compared to the control group (all p<0.05). A ≥1-point improvement in the Ishak fibrosis score was found in 25.7% (9/35) of the ETV group, and the mean change from the baseline in the Ishak fibrosis score was a 0.3-point reduction. The control group showed disease progression in the Ishak fibrosis score. More patients in the ETV group than in the control group had undetectable serum HBV DNA levels (82.9% vs. 3.1%, p<0.05) and ALT normalization (68.6% vs. 18.3%, p<0.05). The ETV treatment group demonstrated an improvement in Child-Pugh score at week 52 (-3.7 vs. 0.3, p<0.05). In addition, no obvious adverse reactions were observed during ETV treatment. CONCLUSION: ETV is safe and effective in patients with advanced schistosomiasis and HBV co-infection.

[Relationship between effect of lamivudine in the treatment of cirrhotic patients with uncompensated hepatitis B with HBV genotypes and cytotoxic T lymphocyte].

OBJECTIVE: To explore relationship between effect of Lamivudine in the treatment of cirrhotic patients with uncompensated hepatitis B with hepatitis B virus (HBV)genotypes and HBV specific cytotoxic T lymphocytes (CTL). METHODS: 80 cases of uncompensated cirrhotic hepatitis B (40 cases with genotype B and 40 with genotype C), HBV DNA positive, HBeAg positive and human leukocyte antigen (HLA)-A2 positive,were treated with Lamivudine 100 mg/d, one year later, its effect and relationship with HBV genotypes and HBV specific CTL were observed. RESULTS: HBV DNA turned negative:40 cases with genotype B turned negative (100%). In the 9th and 10th month of treatment, there was one case with genotype C had YMDD variation respectively and Adefovir dipivoxil was used for treatment, of the rest 38 cases, HBV DNA of 26 cases (68.42%) turned negative,HBV DNA negative rate of patients with genotype is lower than that of patients with genotype B, chi2 = 14.91, P < 0.01. HBeAg turned negative: 18 cases with genotype B (45%) turned negative, more than that of patients with genotype C (7 cases, 18.42%), chi2 = 6.32, P < 0.05. Peripheral blood HBV specific CTL level: before treatment, it was (0.33 +/- 0.03)% of patients with genotype B,higher than that of patients with genotype C [(0.11 +/- 0.02)%], t = 8.12, P < 0.001. 1 year after treatment: it was (0.44 +/- 0.04)% of patients with genotype B, higher than that before treatment, t = 4.01, P < 0.001, it was also higher than that of patients with genotype C 1 year after treatment [(0.23 +/- 0.03)%], t = 5.63, P < 0.01, alanine amino-transferase (ALT) returned to normal: 38 cases with genotype B (95%) returned to normal, more than that of patients with genotype C (28 cases, 73.68%), X2 = 6.79, P < 0.01. CONCLUSION: Effect of Lamivudinein the treatment of cirrhotic patients with uncompensated hepatitis B is better in patients with genotype B than patients with genotype C, its mechanism may be related to lower level of HBV specific CTL in patients with genotype C than patients with genotype B.

Overexpression of Fc receptor-like 1 associated with B-cell activation during hepatitis B virus infection

The role of B cells in the pathogenesis of hepatitis B virus (HBV) infection has not been explored in depth. In the present study, the activation status of B cells from peripheral blood of healthy controls (N = 20) and patients with acute hepatitis B (AHB, N = 15) or chronic hepatitis B (CHB, N = 30) was evaluated by measuring the expression levels of B-cell activation markers CD69 and CD86, using quantitative real-time PCR and flow cytometry. Moreover, the potential mechanism underlying B-cell activation during HBV infection was further investigated by analyzing the expression profile of FCRL1, an intrinsic activation molecule of B cells. An elevation in the levels of B-cell activation markers including CD69 and CD86 was observed in the AHB patients (44.31 ± 9.27, 27.64 ± 9.26%) compared to CHB patients (30.35 ± 11.27, 18.41 ± 6.56%, P < 0.05), which was still higher than healthy controls (12.23 ± 7.84, 8.22 ± 3.43%, P < 0.05). Furthermore, the expression of FCRL1 was found to be similar to B-cell activation markers, which was highest in AHB patients (70.15 ± 17.11%), lowest in healthy donors (36.32 ± 9.98%, P < 0.05) and half-way between these levels in patients with CHB (55.17 ± 12.03%, P < 0.05). The results were positively associated with aberrant B-cell activation. These data suggest that B cells can play a role in HBV infection, and therefore more effort should be devoted to exploring their functions.

[Study on effects of kurarinol combined with glycyrrhizic acid on cellular immunity of patients with chronic hepatitis B].

OBJECTIVE: To explore effects of kurarinol combined with Diammonium Glycyrrhizinate on specific cellular immunity of patients with chronic hepatitis B (CHB). METHODS: Sixty-three CHB patients were randomly divided into two groups, 32 cases in group of kurarinol combined with Diammonium Glycyrrhizinate group (combined therapy group) were treated with 600 mg kurarinol glucose injection intravenously, once a day for one month, then 200 mg kurarinol capsule was used orally, three times a day for two months. 150 mg Diammonium Glycyrrhizinate for Injection was added to 250 ml 10% glucose injection for intravenous drip, once a day for one month, then 150 mg Diammonium Glycyrrhizinate capsule was used orally, three times a day for two months; 31 case in kurarinol group (single drug group) only used kurarinol, methods and dosage were the same as those of treatment group. HBV specific CTL, T cell subgroups, change of Th1 and Th2 level, HBV-DNA and HBeAg negative rate of the two groups were compared. RESULTS: Three months after treatment, HBV specific CTL, CD4 + and Th1 of combined therapy group were higher than those before treatment, and higher than those of single drug group after treatment (P < 0.01). CONCLUSION: HBV-DNA and HBeAg negative rate between the two groups had no statistic significance (P > 0.05). CONCLUSION: Kurarinol combined with Diammonium Glycyrrhizinate can further increase HBV specific CTL, CD4+ and Th1 level of CHB patients.

Overexpression of Fc receptor-like 1 associated with B-cell activation during hepatitis B virus infection.

The role of B cells in the pathogenesis of hepatitis B virus (HBV) infection has not been explored in depth. In the present study, the activation status of B cells from peripheral blood of healthy controls (N = 20) and patients with acute hepatitis B (AHB, N = 15) or chronic hepatitis B (CHB, N = 30) was evaluated by measuring the expression levels of B-cell activation markers CD69 and CD86, using quantitative real-time PCR and flow cytometry. Moreover, the potential mechanism underlying B-cell activation during HBV infection was further investigated by analyzing the expression profile of FCRL1, an intrinsic activation molecule of B cells. An elevation in the levels of B-cell activation markers including CD69 and CD86 was observed in the AHB patients (44.31 ± 9.27, 27.64 ± 9.26%) compared to CHB patients (30.35 ± 11.27, 18.41 ± 6.56%, P < 0.05), which was still higher than healthy controls (12.23 ± 7.84, 8.22 ± 3.43%, P < 0.05). Furthermore, the expression of FCRL1 was found to be similar to B-cell activation markers, which was highest in AHB patients (70.15 ± 17.11%), lowest in healthy donors (36.32 ± 9.98%, P < 0.05) and half-way between these levels in patients with CHB (55.17 ± 12.03%, P < 0.05). The results were positively associated with aberrant B-cell activation. These data suggest that B cells can play a role in HBV infection, and therefore more effort should be devoted to exploring their functions.

Effect of oxymatrine on specific cytotoxic T lymphocyte surface programmed death receptor-1 expression in patients with chronic hepatitis B.

BACKGROUND: Oxymatrine has certain antiviral effects in the treatment of chronic hepatitis B (CHB), but its exact mechanism is unclear. The objective of the present study was to explore oxymatrine's antiviral mechanism by studying its effect on the hepatitis B virus (HBV) specific cytotoxic T lymphocyte (CTL) surface programmed death receptor-1 (PD-1) expression in CHB patients. METHODS: Sixty-five CHB patients who had HBV DNA(3)10(4) copies/ml, positive HBeAg, positive human leukocyte antigen (HLA)-A2, alanine aminotransferase (ALT) > 2 x upper limit of normal value (ULN) were randomly divided into two groups: treatment group (n = 33), treated with an intravenous infusion of 600 mg oxymatrine in glucose solution once a day for a month, then with a 200 mg oxymatrine oral capsule three times a day, and a 200 mg silibin meglumine tablet three times a day; control group (n = 32) patients were treated only with silibin meglumine tablet, method and dosage were the same as those of treatment group. Three months later, peripheral blood HBV-specific CTL surface PD-1 expression, HBV-specific CTL level, HBV DNA, HBeAg, and results of liver function tests were analyzed and compared. RESULTS: Three months post-treatment, in the treatment group, peripheral blood HBV-specific CTL surface PD-1 expression ((19.42 ± 15.94)%) decreased significantly compared to the pretreatment level ((31.30 ± 24.06)%; P < 0.05), and decreased significantly compared to that of control group three months after treatment ((29.45 ± 21.62)%; P < 0.05). HBV-specific CTL level ((0.42 ± 0.07)%) significantly increased compared with the pretreatment ((0.29 ± 0.15)%; P < 0.01), and the control group posttreatment level was (0.31 ± 0.15)% (P < 0.05). HBV DNA level in 11 cases became negative (HBV DNA < 500 copies/ml, 33.33%), which was higher than that of the control group after treatment (two cases, 6.25%; χ(2) = 7.45, P < 0.01), HBeAg of nine cases turned negative (27.27%), which was higher than that of the control group after treatment (one case, 3.13%; χ(2) = 7.27, P < 0.01). CONCLUSION: Oxymatrine could downregulate peripheral blood HBV-specific CTL surface PD-1 expression in CHB patients, increase HBV-specific CTL level, which may be one of the possible mechanisms by which oxymatrine clears or inhibits HBV in CHB patients.

[Effect of kurarinol on peripheral blood CTL surface PD-1 expression of patients with chronic hepatitis B].

OBJECTIVE: To explore the anti-viral mechanism of kurarinol through studying its influence on cytotoxic T lymphocyte (CTL) surface program death receptor-1 (PD-1) expression of patients with chronic hepatitis B (CHB). METHODS: 69 cases of CHB, HBV DNA > or = 10(4) copies/ml, HBeAg positive, human leukocyte antigen (HLA)-A2 positive, alanine aminotransferase (ALT) > 2 x upper limit of normal value(ULN).69 cases were randomly divided into two groups:34 cases in treatment group,600 mg of kurarinol glucose injection was used for intravenous dripping, once a day, one month later, 200 mg of kurarinol capsule was used orally,three times a day and 200 mg of silybin meglumine tablet was used orally, three times a day. 35 cases in control group, only silibin meglumine tablet was used, method and dosage were the same as those of treatment group. Three months later, their peripheral blood HBV specific CTL surface PD-1 expression, non-specific CTL surface PD-1 expression and level of HBV specific CTL,HBV DNA and HBeAg negative rate and liver functions were analyzed and compared. RESULTS: 3 months after treatment, peripheral blood HBV specific CTL surface PD-1 expression of the treatment group decreased compared with that before treatment (t = 2.39, P < 0.05), it also decreased compared with that of the control group 3 months after treatment (t = 2.26, P < 0.05), HBV specific CTL increased compared with that before treatment( t = 3.01, P < 0.01), it also increased compared with that of the control group after treatment (t = 2.65, P < 0.05). There was no significant difference of non-specific CTL surface PD-1 expression compared with that before treatment (P > 0.05), and there was no significant difference compared with that of the control group after treatment (P > 0.05). HBV DNA of 11 cases (32.5%) turned negative ( HBV DNA < 500 copies/ ml), higher than that of the control group after treatment (2 cases, 5.71%) chi2 = 7.99, P < 0.01, HBeAg of 9 cases (26.47%) turned negative, higher than that of the control group after treatment (1 case, 2.86%), chi2 = 7.75, P < 0.01. CONCLUSION: Kurarinol can increase level of HBV specific CTL by down-regulating peripheral blood HBV specific CTL surface PD-1 expression of CHB patients, which may be one of the possible mechanisms that kurarinol can remove or inhibit HBV of CHB patients.

The expression profile of Fc receptor-like Y in B lymphocytes with hepatitis B virus induced diseases.

The Fc Receptor-like Y (FcRY) molecule is preferentially expressed by B lymphocytes and has recently been considered as a potential therapeutic target for B cell malignancies. In this study, we investigated the correlation between FcRY expression profile, B lymphocytes population and different HBV infection disease status. The FcRY expression level on B lymphocytes and the number of B lymphocytes population from peripheral blood in 27 healthy controls (HC) and 65 patients with HBV-induced diseases, including chronic hepatitis B (CHB), liver cirrhosis (LC) and hepatocellular carcinoma (HCC), were analyzed using quantitative real-time PCR and flow cytometry. The results showed the level of FcRY expression and frequency of germinal center (GC) B lymphocytes from peripheral blood were significantly correlated with the HBV-related disease status, which was highest in HCC and LC patients, lowest in healthy donors, and in the middle in patients with CHB. Our study indicates that there is a significant correlation between FcRY expression profile, B lymphocytes population and HBV-induced diseases. However, the roles of FcRY and B lymphocytes in HBV-induced diseases are unclear and need further investigation.

[The efficacy of antiviral therapy for hepatitis B virus related decompensated cirrhosis].

Not Abstract.

[Therapeutic effect of dahuangzhechong pills on advanced schistosomiasis].

OBJECTIVE: To evaluate the therapeutic effect and safety of Dahuangzhechong pills on advanced schistosomiasis. METHODS: Sixty-two patients with advanced schistosomiasis were divided randomly into two groups, a treatment group and a control group, and treated with Dahuangzhechong pills and routine therapy, respectively. The course of treatment was 52 weeks in the two groups. Before and after the 52-week treatment, the indexes of liver function and hepatic fibrosis, prothrombin time (PT), Child-Pugh scores and changes of B-type ultrasonic images were detected for all the patients. RESULTS: There were significant differences in the levels of alanine aminotransferase (ALT) and total bilirubin (TBIL), the indexes of hepatic fibrosis, portal venous inside diameters and portal venous flow between the two groups after 52 weeks treatment (P < 0.05). In addition, there were no obvious adverse effects during the treatment in the patients of the Dahuangzhechong pill group. CONCLUSION: Dahuangzhechong pill treatment is a safe and effective therapy for the patients with advanced schistosomiasis.

Comparison and significance of specific and non-specific cellular immunity in patients with chronic hepatitis B caused by infection with genotypes B or C of hepatitis B virus.

The present study was designed to investigate possible relationships between the genotypes of hepatitis B virus (HBV) and the HBV-specific cytotoxic T lymphocyte (CTL) responses. HBV genotypes, HBV specific CTL HBV DNA and other markers of HBV infection were determined in 138 patients with chronic hepatitis B. The results showed that the patients infected with genotype C (n=62) had a significantly lower HBV-specific CTL response than those who were infected with HBV genotype B (P<0.01). HBV DNA titer was higher in patients infected with HBV genotype C than in those infected with HBV genotype B (P<0.01). Both alanine aminotransferase (ALT) and total bilirubin (TBIL) were higher in HBV genotype C infected patients than in those infected with genotype B (P<0.01 and <0.05, respectively). These results suggest that compared with CHB patients infected with HBV genotype B, the higher HBV DNA level and more severe liver damages in the patients infected with genotype C of HBV may be associated with genotype C of the virus.

[Influence of Kurarinol on specific and non-specific cell immunity in patients with chronic hepatitis B].

OBJECTIVE: To explore influence of Kurarinol on specific and non-specific cell immunity in patients with chronic hepatitis B. METHODS: 74 cases of CHB were randomly divided into two groups, 36 cases in treatment group, treated with 600 mg Kurarinol glucose injection, IV, once a day. After one month, Kurarinol capsule was used orally, three times a day for 2 months, 200 mg Silybin Meglumine Tablets orally, three times a day for 3 months. 38 cases in control group, only Silybin Meglumine Tablets was used, method and dosage were the same as treatment group. Compare HBV specific CTL, non-specific CTL, sub-group of T cells, changes of Th1 and Th2, negative conversion rate of HBV DNA and HBeAg of the two groups. RESULTS: In treatment group, 3 months after treatment with Kurarinol, HBV specific CTL is higher than that before treatment (P < 0.01), it is also higher than that of control after treatment, P < 0.05) . Non-specific CTL is higher than that before treatment (P < 0.05), it is also higher than that of control after treatment (P < 0.01). CD4 is higher than that before treatment (P <0.05), it is also higher than that of control after treatment (P < 0.01), Thl is higher than that before treatment (P < 0.05), it is also higher than that of control after treatment (P < 0.01) . Negative conversion of HBV DNA and HBeAg is higher than that of control (P < 0.01). CONCLUSION: Kurarinol can improve specific and non-specific cell immunity in patients with CHB. It is one of the mechanisms that Kurarinol can clear or inhibit HBV of patients with CHB.

[Relations between ALT level and count of HBV special CTL and non-specific CTL in patients with chronic hepatitis B].

OBJECTIVE: To explore relations between ALT level and hepatitis B virus (HBV) specific CTL and non-specific CTL in patients with chronic hepatitis B (CHB). METHODS: 148 cases of CHB were divided into three groups according to ALT level. 35 cases in group A, ALT > or =2 x upper limit of normal value (ULN)--5 x ULN (100-250 IU/L); 53 cases in group B, ALT > 5 x ULN-- < or =10 x ULN (251-500 IU/L); 60 cases in group C, ALT > 10 x ULN ( > 500 IU/L). Flow cytometry is used to determine non-specific CTV. HBV specific CTL was tested on 74 cases of CHB (17 in group A, 27 in group B and 30 in group C) with positive (HLA)-A2. Compare HBV specific CTL, non-specific CTL, HBV DNA levels and positive rate of HBeAg. RESULTS: HBV specific CTL: Group A (0.42 +/- 0.10)% is higher than group B (0.25 +/- 0.08)%, t = 6.37, P < 0.01, group B is higher than group C (0.17 +/- 0.004)%, t = 5.14, P < 0.01; Non-specific CTL: Group A (15.01 +/- 3.01)% is lower than group B (18.1 +/- 5.02)%, t = 2.81, P < 0.01, group B is lower than group C (21.5 +/- 6.11)%, t = 3.07, P < 0.01; HBV DNA level: Group A [(4.97 +/- 0.86) log10 copies/ml] is lower than group B [(5.92 +/- 0.92) log10 copies/ml], t = 4.87, P < 0.01. Group B is lower than group C [(6.37 +/- 0.71) log10 copies/ml], t = 2.92, P < 0.01; Positive HBeAg: Group A (15 cases, 42.86%) is lower than group B (32 cases, 60.38%), chi2 = 2.59, P > 0.05. Group B is lower than group C (41 cases, 68.33%), chi2 = 0.78, P > 0.05. Group A is lower than group C, chi2 = 5.929, P < 0.05. CONCLUSION: The higher the non-specific CTL of patients with CHB is, the higher the ALT level would be, whereas the lower the HBV specific CTL is, the stronger the HBV replication would be.