connective tissue disease associated thrombocytopenia
Conditions
Interventions
Treatment group:Baseline treatment+high-dose dexamethasone+MMF/TAC/CsA
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Age range: 18 to 75 years old 2: Connective tissue diseases associated thrombocytopenia, including primary Sjogren's syndrome (according to the 2002 ACR/EULAR international classification criteria), SLE (according to the 1997 or 2009 ACR classification criteria), and undifferentiated connective tissue disease (according to the 1999 international classification criteria) 3: Platelet count <50×10^9/L 4: Maintain stable levels of glucocorticoids, immunosuppressants (including hydroxychloroquine and azathioprine), and thrombopoietin (TPO) receptor agonists such as eltrombopag for at least 14 days prior to the first administration of high-dose dexamethasone (HD-DEX) 5: Good compliance, signing informed consent form
Exclusion criteria
Exclusion criteria: 1: With life-threatening important organ bleeding (including but not limited to central nervous system bleeding, gastrointestinal bleeding), or with intracranial bleeding within 6 months before the screening period 2: Thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, or other causes (sepsis, EB virus, CMV virus, medication, etc.) leading to thrombocytopenia 3: Hematological disorders such as myelodysplastic syndrome, paroxysmal nocturnal hemoglobinuria, aplastic anemia, leukemia, lymphoma, myelofibrosis, etc 4: Severe cardiovascular disease: an unstable or uncontrollable disease or condition related to or affecting heart function (such as unstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia); Arterial and venous thromboembolism events; Currently receiving antiplatelet or anticoagulant therapy; Clinically significant electrocardiogram changes; QTc>450ms (male), QTc>470ms (female) 5: Severe pulmonary lesions: Unstable or uncontrollable diseases or conditions related to or affecting respiratory function [such as diffuse alveolar hemorrhage, severe pulmonary arterial hypertension, severe interstitial lung disease (peripheral oxygen saturation6 g/24 hours or endogenous creatinine clearance rate30mg/day (calculated as prednisone) upon enrollment 18: Unstable anticoagulant therapy dosage within 14 days 19: Poor blood sugar control, HbA1c%>9% at enrollment 20: Researchers believe that participants who are not suitable for this experiment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional remedial treatment time (treatment failure time) and proportion;bleeding scale;overall remission rate;Time to relapse and proportion;Adverse events related to treatment;Proportion of patients with reduced glucocorticoid decrease;Proportion of TPO reduction;Sever adverse events related to treatment; | — |
Countries
China
Contacts
Public ContactYongjing Cheng
Beijing Hospital
Outcome results
None listed