Malignant tumor
Conditions
Interventions
rhTPOSecondary Prevention Group:rhTPO was given to Shenyang Sansheng Pharmaceutical Co., LTD., Sinopuncture approved word S20050048, specification 15000U/ml. The dose of rhTPO was 300U/ (kg·d), and rh
Control Group:If PLT =100×10^9 / L) or the drug was stopped after two weeks.
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.18 years old =2 thrombocytopenia (PLT =1.5×10^9/L; Hemoglobin (Hb) >=90 g/L; 2) Blood biochemistry: total bilirubin (TBIL) <=1.5 times the upper limit of normal value (ULN), for known Gilbert's syndrome patients, TBIL<=2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=1.5×ULN; 3) Coagulation: international normalized ratio (INR) and activated partial thromboplastin time (APTT) <=1.5 times the upper limit of normal, unless drugs known to alter INR and APTT are used; 10. No history of serious heart, lung, liver, kidney and other important organs and endocrine system; 11. Patients of childbearing age (including female patients and female partners of male patients) must take effective contraceptive measures, and if they are female patients of childbearing age, they must have a negative pregnancy test; 12. Voluntarily participate in this study, sign the informed consent form, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Persons were excluded from the trial if they: 1. Patients with severe bone metastases affecting hematopoietic function; 2. Previous radiotherapy that affected bone marrow function; 3. Patients with malignant tumors of other organs; 4. Patients with bone marrow hematopoietic dysfunction or hematological diseases at diagnosis, such as ITP, aplastic anemia, myelodysplastic syndrome, leukemia, etc. 5. Combined with autoimmune diseases (systemic lupus erythematosus, Sjogren's syndrome, etc.); 6. Any history of arterial or deep venous thrombosis within 6 months before enrollment; 7. Patients with severe cardiovascular disease (e.g., NYHA class III-IV), arrhythmia known to increase the risk of thromboembolism (e.g., atrial fibrillation), after coronary stent implantation, angioplasty and coronary artery bypass grafting (CABG) within 6 months; 8. Use of other investigational drugs within 4 weeks; 9. Patients with any spontaneous bleeding or bleeding events >=CTCAE grade 3, severe unhealed wounds, ulcers, or fractures within 4 weeks before enrollment; 10. Received a platelet transfusion within 2 days before enrollment; 11. Known to be allergic to rhTPO; 12. Current infection that is severe or difficult to control; 13. Adjuvant chemotherapy should be combined with other anti-tumor treatments such as radiotherapy; 14. Thrombocytopenia was considered to be caused by non-platinum-based chemotherapy; 15. Persons considered by the investigator to be ineligible for inclusion, such as any other medical, social, or psychological factors that may affect safety or adherence to study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Count of platelet; | — |
Secondary
| Measure | Time frame |
|---|---|
| Platelet count <=50×10^9/L for days;The trend of platelet count during the chemotherapy cycle;The proportion of chemotherapy interruption or delay due to thrombocytopenia;The lowest platelet count;Bleeding status (grade), times and volume of platelet transfusion; Proportion of patients receiving platelet transfusions;The occurrence of adverse events after rhTPO platelet upgrading therapy, including thrombosis, dizziness, fatigue, allergic reactions, etc; | — |
Countries
China
Contacts
Public ContactGuorong Zou
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed