To address the clinical need for improving early response rates, maintaining sustained responses, reducing relapse rates, and minimizing adverse events in the treatment of immune thrombocytopenia (ITP), the investigators developed a comprehensive in-hospital and post-discharge management strategy. In this study, hospitalized participants will receive a 14-day regimen of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO), followed by a 10-week course of oral eltrombopag olamine dry suspension after discharge. The investigators aim to evaluate the efficacy and safety of this sequential treatment strategy in adult ITP patients.
Age between 12 and 75 years, regardless of gender;
ECOG performance status of 0-1;
Diagnosis of primary ITP confirmed by bone marrow biopsy (valid within 3 months) and other relevant assessments; baseline platelet count (PLT) <20×10⁹/L within 48 hours prior to administration of study medication;
Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; no abnormalities unrelated to ITP, except a) PLT <20×10⁹/L at Day 1 or within 48 hours of Day 1 is allowed; b) Hemoglobin: If anemia is clearly due to ITP-related bleeding, hemoglobin lower than the lower limit of normal (LLN) may be permitted at investigator's discretion.
Refractory ITP (failure to respond to first- and second-line TPO-RAs, anti-CD20 therapy, or splenectomy);
Pregnant or lactating women;
Evidence of secondary ITP (e.g., untreated Helicobacter pylori, leukemia, lymphoma, autoimmune diseases such as SLE, Hashimoto's thyroiditis), drug-induced thrombocytopenia (e.g., due to anticonvulsants, antibiotics, heparin), or multi-lineage autoimmune cytopenias (e.g., Evans syndrome);
History or presence of any primary disease other than ITP that may cause thrombocytopenia (e.g., myelodysplastic syndrome, congenital bone marrow failure syndromes such as Fanconi anemia or dyskeratosis congenita, aplastic anemia), as judged by the investigator;
Parallel
Eltrombopag
DrugParticipants assigned to the observation group will be treated with eltrombopag oral suspension (EPAG-pfos).
Placebo
Other interventionParticipants in the control group will receive a placebo at the same dose, instead of eltrombopag oral suspension (EPAG-pfos).
Sustained response rate (SRR) at 3 months of treatment.
Sustained response rate (SRR) at 3 months of treatment.
The proportions of patients achieving response (R);
The proportions of patients achieving response (R);
Platelet count levels at 3 months after treatment
Platelet count levels at 3 months after treatment
The proportions of patients achieving complete response (CR);
The proportions of patients achieving complete response (CR);
The proportions of patients achieving and platelet counts ≥50×10⁹/L;
The proportions of patients achieving and platelet counts ≥50×10⁹/L;
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