Primary immune thrombocytopenia
Conditions
Interventions
experimental group:Montelukast sodium 10mg/day
rhTPO 15000 units
control group:rhTPO 15000 units
Sponsors
Department of Hematology, Second Medical Center, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged over 14 years. 2. Patients who meet the diagnostic criteria of Chinese guidelines for the treatment of acute primary immune thrombocytopenia (2018 Edition) formulated by the thrombosis and hemostasis group of Hematology branch of Chinese Medical Association, and are confirmed as persistent, chronic, severe or refractory ITP by clinical diagnosis. 3. Patients who have received regular treatment, including adrenal glucocorticoid, IVIG, splenectomy, thrombopoietin drugs, anti-CD20 monoclonal antibody and other first-line and second-line treatment, but the treatment effect is poor, that is, according to the Chinese guidelines for treatment of adult primary immune thrombocytopenia (2018 Edition), they are diagnosed as invalid or relapse. 4. The subjects with ECoG score of 0 to 2. 5. Subjects who did not participate in other clinical trials in the first three months. 6. Conscious patients without cognitive impairment. 7. Patients who have signed the informed notice.
Exclusion criteria
Exclusion criteria: 1. Patients with other secondary thrombocytopenia: such as autoimmune diseases, thyroid diseases, lymphoproliferative diseases, myelodysplasia, hematological malignancies, chronic liver diseases, hypersplenism, common variant immunodeficiency diseases and infections. 2. Patients with severe heart, liver, kidney dysfunction and other diseases. 3. Patients with psychosis, including severe hysteria, and those without autonomy. 4. Patients who are receiving other treatments (conflict with the trial protocol). 5. Patients who are allergic or intolerant to drugs that may be used. 6. Pregnant or lactating women, or women preparing for pregnancy. 7. Patients who underwent major surgery within 4 weeks before the start of the study, or planned to arrange surgery during the course of the study. 8. The researchers judged that patients with poor compliance could not strictly implement the protocol. 9. Any history or concomitant disease that the researcher believes may reduce the patient's study compliance, or interfere with the evaluation of the efficacy and safety of the trial drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PLT;PLT;Hb;Hb;WBC; | — |
Countries
China
Contacts
Public ContactXuechun Lu
The Second Medical Center of PLA General Hospital
Outcome results
None listed