paroxymal nocturnal hemoglobinuria
Conditions
Interventions
A1:DA chemotherapy regimen plus G-CSF
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. meet the diagnostic criteria of PNH; 2. no response to prednisone(more than one month); 3. age between 16 and 75 years old, male or female; 4. recurence after dosage of prednisone decrease; 5. adverse events happended when prednisone using, including sever infections,diabetes, hepertension,gastrointestinal bleeding, Osteonecrosis of the Femeral Head; 6. score of EOCG was less than 2; 7. normal ECG; 8. patients have fully understand the the study, voluntary take the test and informed agreement signed.
Exclusion criteria
Exclusion criteria: 1. HBsAg positive or copies of hepatitis B was more than 105/ml; 2. sever disfunction of heart, lung, liver or kidney; 3. pregnant,breast feeding period or no contraception during the research; 4. severe immnodeficiency, autoimmune disease (for example SLE) or severe virus infection(for example HIV); 5. in the past six months, cardiac diseases (for example congestive heart failure, coronary artery disease with severe symptoms and uncontroleed arrhythmia) or myocardial infarction occured; 6. for any reason, the researchers think any not suitable for the situation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dosage of prednisone;hemoglobin level and Transfusion dependent;Serum free hemoglobin level;Serum bilirubin level;serum LDH level;serum AST level;Urinary Rous test;Ham's test;CD59 expression on PB granulocyte;CD55 expression on PB granulocyte;CD55 expression on PB granulocyte; | — |
Secondary
| Measure | Time frame |
|---|---|
| physical condition;quality of life; | — |
Countries
China
Contacts
Public ContactShao Zonghong
Tianjin Medical University General Hospital
Outcome results
None listed