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