Chronic Hepatitis B HBeAg positive | Chronic Hepatitis B HBeAg negative
Item
1. subjects diagnosed of hbeag positive or negative chronic hepatitis b
boolean
C0524909 (UMLS CUI [1,1])
C0392390 (UMLS CUI [1,2])
C0524909 (UMLS CUI [2,1])
C0948827 (UMLS CUI [2,2])
Age
Item
2. aged 18 to 70 years old，male or female
boolean
C0001779 (UMLS CUI [1])
Hepatitis B surface antigen positive | HBeAg positive | Hepatitis B DNA Measurement | HBeAg negative
Item
3. patients with previously hbsag-positive, hbeag-positive for 24 weeks, hbv-dna> 105copies/ml. hbeag-negative for 24 weeks or more, hbv-dna> 105 copies/ml.
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
C3641250 (UMLS CUI [3])
C0948827 (UMLS CUI [4])
Alanine aminotransferase increased
Item
4. 1.3 times the upper normal limit (1.3 × uln) ≤ alanine aminotransferase (alt) ≤ 10 ×
boolean
C0151905 (UMLS CUI [1])
Serum total bilirubin measurement
Item
5. total serum bilirubin (tbil) ≤ 2.5 × uln.
boolean
C1278039 (UMLS CUI [1])
Prothrombin Activity Measurement | Prolonged prothrombin time
Item
6. prothrombin activity (pta) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
boolean
C3274435 (UMLS CUI [1])
C2673577 (UMLS CUI [2])
White Blood Cell Count procedure | Platelet Count measurement | Serum albumin measurement
Item
7. wbc ≥ 3.5 × 109 / l, plt ≥ 70 × 109 / l, serum albumin (alb)≥ 35 g / l.
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0523465 (UMLS CUI [3])
Creatinine measurement, serum
Item
8. creatinine (cr) ≤ 1.5 × uln.
boolean
C0201976 (UMLS CUI [1])
Interferon | Nucleoside Analogs | alpha1-thymosin
Item
9. if patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
boolean
C3652465 (UMLS CUI [1])
C1579410 (UMLS CUI [2])
C0076612 (UMLS CUI [3])
Informed Consent | Compliance behavior
Item
10. patients signed an informed consent form and compliance was good.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Hepatitis A | Hepatitis C | Hepatitis D Infection | Hepatitis E | Cytomegalovirus Infections | Epstein-Barr Virus Infections | HIV Infections
Item
1. patients were infected with other viruses as hav, hcv, hdv, hev, cmv, ebv, hiv etc.
boolean
C0019159 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0011226 (UMLS CUI [3])
C0085293 (UMLS CUI [4])
C0010823 (UMLS CUI [5])
C0149678 (UMLS CUI [6])
C0019693 (UMLS CUI [7])
Liver Cirrhosis | Malignant neoplasm of liver
Item
2. patients with cirrhosis or liver cancer.
boolean
C0023890 (UMLS CUI [1])
C0345904 (UMLS CUI [2])
Study Subject Participation Status
Item
3. patients have participated in another therapeutic clinical trial in 3 months.
boolean
C2348568 (UMLS CUI [1])
Granulocyte count | Hemoglobin measurement | Serum alpha-fetoprotein (AFP) measurement | Space-occupying lesion B mode ultrasound
Item
4. granulocyte count <1.5 × 109 / l, hemoglobin (hb)<100g / l, sera alpha-fetoprotein(afp)> 100μg / l, patients' b ultrasonography pointed space-occupying lesions.
boolean
C0857490 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0546833 (UMLS CUI [3])
C0332562 (UMLS CUI [4,1])
C1302166 (UMLS CUI [4,2])
Heart Diseases Severe | Kidney Diseases Severe | Endocrine System Diseases Severe | Hematological Disease Severe | Neuropsychiatric syndrome Severe
Item
5. patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0014130 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C3203509 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Metabolic Diseases | Autoimmune Diseases | Lupus Erythematosus, Systemic
Item
6. patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
boolean
C0025517 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
Pregnancy | Breast Feeding | Hypersensitivity Investigational New Drugs
Item
7. pregnant woman, lactating women or those who wre allergic for study drug.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])