Primary immune thrombocytopenia
Conditions
Interventions
Experimental group:High-dose dexamethasone followed by low-dose prednisone maintenance treatment
Control group:Placebo-controlled after high-dose dexamethasone treatment
Sponsors
The Second Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form voluntarily; 2.Aged 18 to 60 years, regardless of gender; 3.Clinically diagnosed patients with relapsed chronic/persistent ITP (according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Primary Immune Thrombocytopenia (2020 version), ITP was diagnosed, and the platelet count continued to decrease for more than 3 months; after the treatment was effective, the platelet count decreased Below 30x10^9/L or less than twice the basic value or bleeding symptoms are defined as recurrence]; 4.The patient can achieve a complete response after the first glucocorticoid treatment (platelet count >=100x10^9/L); 5.Women with fertility must have a negative serum pregnancy test at the time of screening and undergo regular pregnancy checks in accordance with the research protocol. During the entire study period and 28 days after the end of the study or the suspension of the study, the patients took an approved effective contraceptive method.
Exclusion criteria
Exclusion criteria: 1) HCV antibody positive; 2) HIV antibody positive; 3) HBsag-positive patients with HBV-DNA quantitation exceeding 100cps/ml; 4) life expectancy less than 3 months; 5) participated in any drug clinical trial within 30 days before enrollment; 6) liver function (ALT, AST) more than 2 times the upper limit of normal value or renal function (BUN, Cr) more than 2 times the upper limit of normal value; 7) severe heart disease, including arrhythmia, myocardial infarction, heart failure grade 3 or above; 8) cerebral hemorrhage, pulmonary hemorrhage and other severe hemorrhage; 9) patients with hepatosplenomegaly 10) patients with thrombosis 11) patients with severe liver disease; 12) post-splenectomy or planned splenectomy; 13) previous or current allergy to prednisone or dexamethasone; 14) patients with immunodeficiency diseases 15) patients treated with TPO-RA, cyclosporine, rituximab, or traditional Chinese medicine within 30 days before enrollment; 16) with diabetes mellitus; 17) of hypertension; 18) combined mental illness; 19) with glaucoma patients; 20) a history of cancer or hematopoietic stem cell transplantation; 21) test during the 28 days after, the end of the study or to suspend the study are reluctant to take effective contraceptive measures; 22) pregnant, breastfeeding, or intending to breastfeed during the study period; Any other researchers that might affect the compliance and/or complete test participants related operations, or test related clinical contraindication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient's time to relapse; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient's recurrence rate;The ratio of CR/R/NR in patients;Proportion of patients requiring concomitant treatment;Quality of life; | — |
Countries
China
Contacts
Public ContactLai Yinghui
The Second Affiliated Hospital of Guangxi Medical University
Outcome results
None listed