Aplastic anemia
Conditions
Interventions
The on-demand glucocorticoid group:After the 5-days p-ALG transfusion period, subjects will not receive glucocorticoid until the serum sickness occurs, and glucocorticoid with different dose ranges wi
The usual glucocorticoid group:After the 5-days p-ALG transfusion period, subjects will receive 21 days of usual glucocorticoid therapy, and when serum sickness occurs, glucocorticoid will be added to
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects suitable for enrolment in this study must meet all of the following criteria: 1) Age between 14-70 years, male or female 2) Aplastic anemia patients received IST (p-ALG combined CsA) 3) Subjects have voluntarily signed an informed consent form, understanding the purpose and procedure of clinical study and voluntarily complying with the trial requirements
Exclusion criteria
Exclusion criteria: Participants who met any of the following criteria were not eligible for inclusion in this study: 1) The physical status score of the Eastern Cancer Collaboration Group (ECOG) >2 points 2) Uncontrolled active infection 3) Uncontrolled hypertension (>=140/90mmHg), diabetes mellitus (fasting blood glucose >=7.0 mmol/L or random blood glucose >=11.1 mmol/L) 4) Concurrent serious diseases of other systems 5) Aspartic aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal 6) Creatinine level >= 2.5 times the upper limit of normal 7) Subjects with any other condition or circumstance that would, in the opinion of the Investigator, make the subject unsuitable for participation in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe serum sickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence and outcomes of serum sickness of different severity;Incidence of glucocorticoid-related adverse reactions;Treatment response; | — |
Countries
China
Contacts
Public ContactZhang Fengkui
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed