Study | Inclusion criteria | Exclusion criteria |
---|---|---|
Lau G.K.K. 2005 | 1. Adults | 1. Treatment within 6 m |
 | 2. HBsAg positive for > 6 m and HBeAg positive | 2. HIV infection, hepatitis C or D |
 | 3. HBV DNA > 500 000 copies/ml | 3. Decompensated liver disease |
 | 4. Evidence of inflammation on biopsy and 1 ULN < ALT < 10 ULN | 4. Serious medical or psychiatric illness |
 |  | 5. Alcohol or drug use within 1 y |
 |  | 6. Neutrophils < 1500/mm3, platelets < 90 000/mm3, or creatinine > 1.5 ULN |
Marcellin P. 2004 | 1. Adults | 1. Treatment within 6 m |
 | 2. HBsAg positive for > 6 m and HBeAg negative | 2. HIV infection, hepatitis C or D |
 | 3. HBV DNA > 100 000 copies/ml | 3. Decompensated liver disease |
 | 4. Evidence of inflammation on biopsy and 1 UNL < ALT < 10 ULN | 4. Serious medical or psychiatric illness |
 |  | 5. Alcohol or drug use within 1 y |
 |  | 6. Neutrophils < 1500/mm3, platelets < 90 000/mm3, or creatinine > 1.5 ULN |
Marcellin P. 2009 | 1. Adults | 1. Treatment within 6 m |
 | 2. HBsAg positive for > 6 m and HBeAg negative | 2. HIV infection, hepatitis C or D |
 | 3. HBV DNA > 100 000 copies/ml | 3. Decompensated liver disease |
 | 4. Evidence of inflammation on biopsy and 1 ULN < ALT < 10 ULN | 4. Serious medical or psychiatric illness |
 |  | 5. Alcohol or drug use within 1 y |
 |  | 6. Neutrophils < 1500/mm3, platelets < 90 000/mm3, or creatinine > 1.5 ULN |
Chan H.L.Y. 1 2005 | 1. 18-65 years old | 1. Decompensated liver disease or a history of interferon or antiviral agent use |
 | 2. HBsAg positive for > 6 m and HBeAg positive | 2. HIV infection, hepatitis C or D |
 | 3. HBV DNA > 500 000 copies/ml | 3. History of hepatocellular carcinoma |
 | 4. 1.3 ULN < ALT < 5 ULN | 4. Other causes of liver disease |
 |  | 5. Serious medical or psychiatric illness |
 |  | 6. Concurrent use of corticosteroid or immunosuppressive agents |
 |  | 7. Pregnancy |
Chan H.L.Y.2 2005 | 1. 18-65 years old | 1. Decompensated liver disease or a history of interferon or antiviral agent use |
 | 2. HBsAg positive for > 6 m and HBeAg positive | 2. HIV infection, hepatitis C or D |
 | 3. HBV DNA > 500 000 copies/ml | 3. History of hepatocellular carcinoma |
 | 4. 1.3 ULN < ALT < 5 ULN | 4. Other causes of liver disease |
 |  | 5. Serious medical or psychiatric illness |
 |  | 6. Concurrent use of corticosteroid or immunosuppressive agents |
 |  | 7. Pregnancy |
Janssen HLA 2005 | 1. ≥ 16 years old | 1. Antiviral or immunosuppressive therapy within 6 m |
 | 2. HBsAg positive for > 6 m and HBeAg positive on two occasions within 8 w of randomization | 2. HIV infection, hepatitis C or D |
 | 3. Evidence of inflammation by two measurements of ALT > 2 ULN within 8 w of randomization | 3. Advanced liver disease or carcinoma |
 |  | 4. Serious medical or psychiatric illness, or uncontrolled thyroid disease |
 |  | 5. Substance abuse within 2 y |
 |  | 6. Pregnancy or inadequate contraception |
 |  | 7. Leucocytes ≤ 3000/mm3, neutrophils ≤ 1800/mm3, or platelets ≤ 100 000/mm3 |
Buster E.H.C.J 2008 | 1. ≥ 16 years old | 1. Antiviral or immunosuppressive therapy within 6 m |
 | 2. HBsAg positive for > 6 m and HBeAg positive on two occasions within 8 w of randomization | 2. HIV infection, hepatitis C or D |
 | 3. Evidence of inflammation by two measurements of ALT > 2 ULN within 8 w of randomization | 3. Advanced liver disease or carcinoma |
 |  | 4. Serious medical or psychiatric illness, or uncontrolled thyroid disease |
 |  | 5. Substance abuse within 2 y |
 |  | 6. Pregnancy or inadequate contraception |
 |  | 7. Leucocytes ≤ 3000/mm3, neutrophils ≤ 1800/mm3, or platelets ≤ 100 000/mm3 |
Kaymakoglu S. 2007 | 1. ≥ 18 years old | 1. Other cause of chronic liver disease |
 | 2. HBsAg positive for > 6 m, HBeAg negativity on two occasions in the past 3 m, ALT > 1.3 ULN on two occasions during the preceding 3 m | 2. Received immunosuppressive or antiviral treatment in the previous 6 m |
 | 3. HBV DNA positivity (lower limit of detection [LLD], 4 pg/ml) | 3. Exhibited hepatocellular carcinoma |
 | 4. Compensated liver disease with histological evidence of chronic hepatitis |  |
Tian YL 2007 | 1. 18-60 years old | 1. Pregnancy or lactation |
 | 2. Without using antiviral or immunosuppressive therapy within 6 m | 2. Serum albumin < 3.5 g/L; PT prolong ≥ 4 s; serum bilirubin > 34 μmol/L; pretreatment neutrophils < 1.5 × 109/L; Platelets < 90 × 109/L; hemoglobin (male) < 125 g/L, (female) < 115 g/L |
 | 3. HBV DNA > 500 000 copies/ml | 3. Hepatitis A, C, D or E |
 | 4. At least two occasions of ALT > 100-500 U/L within 6 m before treatment, and at least one occasion within 35 d before treatment, interval time ≥ 14 d | 4. Serious medical or psychiatric illness |
 |  | 5. Autoimmune liver disease or alcoholic hepatitis |
Huang ZL 2010 | 1. HBsAg positive for > 6 m and HBeAg positive | 1. Leucocytes ≤ 3.0 × 109/L, platelets ≤ 75 × 109/L |
 | 2. HBV DNA > 100 000 copies/ml | 2. Pregnancy or lactation |
 | 3. Without using antiviral therapy within 6 m and ALT > 2 ULN within 3 m | 3. HIV infection, other viral hepatitis |
 |  | 4. Malignant tumor |
 |  | 5. Serious medical or psychiatric illness, or uncontrolled thyroid disease, diabetes mellitus, autoimmune disease et al |
Cui JJ 2006 | 1. HBsAg positive for > 6 m, HBeAg positive, HBV DNA > 100 000 copies/ml | Not reported |
 | 2. 2 ULN < ALT < 10 ULN |  |
 | 3. Without other viral hepatitis or HIV infection |  |
 | 4. Without using antiviral or immunosuppressive therapy within 6 m |  |
 | 5. Neutrophils > 15 × 109/L, Platelets > 90 × 109/L |  |
 | 6. Without serious medical, psychiatric illness or decompensated liver disease |  |
Li ZQ 2010 | 1. HBsAg positive for > 6 m, HBeAg positive | Not reported |
 | 2. ALT > 80 U/L, HBV DNA > 104IU/ml |  |
 | 3. Without other viral hepatitis |  |
 | 4. Without using antiviral or immunosuppressive therapy within 6 m |  |
Guan LJ 2006 | 1. Course of disease is 2-8 y | Not reported |
 | 2. 18-55 years old |  |
 | 3. Pretreatment 1.5 ULN < ALT < 10 ULN, HBsAg positive, HBeAg negative, HBV DNA > 100 000 copies/ml |  |
 | 4. Without other viral hepatitis |  |
 | 5. Without using antiviral therapy pretreatment and without contraindication of antiviral therapy |  |
Shi XF 2006 | 1. 16-60 years old | 1. Decompensated liver disease |
 | 2. Without using antiviral therapy within 6 m or virological relapse or YMDD mutation after more than 1 y LAM treatment | 2. Serious medical or psychiatric illness |
 | 3. HBsAg positive, HBeAg positive | 3. Neutrophils < 1500/mm3, Platelets ≤ 70 000/mm3 |
 | 4. HBV DNA > 100 000 copies/ml, or relapse (increase 2 log 10 copies/ml) | 4. Hepatitis A, C, D or E |
 | 5. Serum total bilirubin < 40 umol/L | 5. alcohol or drugs abuse within 1 y |
 | 6. PEG-IFNα-2a monotherapy group 2 ULN < ALT < 10 ULN; PEG-IFNα-2a combination with LAM group ALT < 10 ULN |  |