aplastic anemia
Conditions
Interventions
A:ATO+CsA
B:CsA
Sponsors
Henan Province Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or Female patient aged 18 to 65 years old; 2. Patient has provided written informed consent to participate in the study after the purpose and nature have been clearly explained to him/her; 3. Patient with first documented diagnosis of AA according to domstic diagnosis criteria; 4. The ECOG score is 0-2; 5. Liver and renal funcation is qualified(ALT= 2 times normal toplimit,AST= 2 times normal toplimit,TBIL= 1.5 times normal toplimit, SCr=2mg/dl); 6. Patient mentally and physically able to answer the questionnaire.
Exclusion criteria
Exclusion criteria: 1. Accepted stem cells allograft; 2. Have a history of active malignancy, which was treated within past 3 years(not including no treatment or relapse patients within 5 years before enrollment); 3. Have the active bacteria or virus infection,which can not control using appropriate treatment; 4. The patients with mental illness or the other disease can not complete the study; 5. Pregnant and breastfeeding women, approaching childbirth female or unwilling to take birth control measures during the study; 6. Have a history of allergy or hypersensitivity to any component of study drug(ATO and CsA); 7. Hypertension uncontroll well and angiocardiopathy with clinical significance,eg.cerebrovascular accidents (within 6 months of enrollment), myocardial infarction(within 6 months of enrollment),unstable angina pectoris,congestive heart failure of two or above classfied by NYHA, or serious arrhythmia contorlled poorly, or disease with potentially influence on treatment; 8. With other autoimmune diseases(SLE); 9. Treated with the other study drug or study medical instrument at enrolment, or within past 3 months of enrolment; 10. Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood routine examination;bone marrow examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemical examination;ECG; | — |
Countries
China
Contacts
Public ContactBaijun Fang
He'nan Province Cancer Hospital
Outcome results
None listed