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Table 2 Patient selection criteria of studies included in the meta-analysis

From: Peginterferon alpha-based therapy for chronic hepatitis B focusing on HBsAg clearance or seroconversion: a meta-analysis of controlled clinical trials

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  
  1. HBsAg: hepatitis B surface antigen; HBeAg: hepatitis B e antigen; HBV: hepatitis B virus; ALT: alanine aminotransferase; ULN: upper limit of normal; HIV: human immunodeficiency virus; PEG-IFNα-2a: pegylated interferon alpha-2a; LAM: lamivudine; d: days; m: months; y: years.
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BMC Infectious Diseases

ISSN: 1471-2334

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