chemotherapy-induced thrombocytopenia
Conditions
Interventions
Romiplostim group:Romiplostim N01, 3 µ g/kg, once a week. Start using Lopsetin N01 within 6-24 hours after chemotherapy and continue for 3 weeks. If the platelet count is = 100 × 10 ^ 9/L during the s
Observation/ rhIL-11 group:Observation / rhIL-11 treatment
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with malignant lung tumors aged 18 years or older, both male and female, are eligible. 2. The tumor stage is classified as stage ? or ? (referring to the 8th edition of the TNM staging system of the American Joint Committee on Cancer). 3. The diagnosis of malignant tumor is definite by histological or cytological examination (if there is no histological or cytological diagnosis, the clinical diagnosis proposed by clinical guidelines and expert consensus can also be adopted). 4. Expected survival period >= 3 months. 5. Radical treatment (including surgery, radiotherapy, chemotherapy and other anti-tumor treatments) cannot be carried out. 6. Patients who have received at least one cycle of chemotherapy regimen. 7. The lowest platelet count in the Xth chemotherapy cycle was less than 100×10?/L, and the (X+1)th cycle is planned to continue with the same chemotherapy regimen and dosage. 8. One week before enrollment, organ function levels should meet the following criteria: 1) Blood routine: Neutrophil count >= 1500/mm³; platelet count >= 100×10?/L; hemoglobin >= 5.6 mmol/L (9 g/dl); white blood cell count >= 4.0×10?/L or neutrophil count >= 2.00×10?/L. 2) Liver and kidney function: Serum total bilirubin (TBIL) = 2+, then 24-hour urine protein quantification must show protein = 50 ml/min (Cockcroft-Gault formula); 3) Normal coagulation function, no active bleeding or thrombotic disease (international normalized ratio INR, activated partial thromboplastin time APTT, prothrombin time PT <= 1.5 times the upper limit of normal); 4) Cardiac function: No myocardial infarction within one year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency. 9.Before the onset of the disease, there should be a definite application of a certain chemotherapy drug that can cause thrombocytopenia (or combined with targeted, immunotherapy drugs, etc.), and after drug withdrawal, the symptoms and signs caused by thrombocytopenia gradually alleviate or the platelet count returns to normal. 10.Exclude other causes of thrombocytopenia, especially the underlying diseases and complications, such as aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenia, hypersplenism and bone marrow infiltration by tumor cells, etc. 11.Exclude the use of non-antitumor drugs that can cause thrombocytopenia, including chemotherapy, targeted therapy, immunotherapy, etc., such as sulfonamide drugs, etc. 12.Exclude pseudothrombocytopenia caused by ethylenediaminetetraacetic acid (EDTA) anticoagulant. 13.The patients voluntarily participated in this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. There are patients with active bleeding. 2. Refractory or difficult-to-correct thrombocytopenia. 3. Patients in urgent need of platelet transfusion. 4. Patients who have known allergies or allergic histories to the active substances contained in this product, any excipients, or any products derived from Escherichia coli. 5. Severe liver and kidney dysfunction. 6. The patient is unable to cooperate or refuses treatment. 7. Patients who are undergoing radiotherapy and chemotherapy (those who have completed chemotherapy for more than 6 hours can meet the inclusion criteria). 8. Pregnant or lactating women, or those who cannot take contraceptive measures during the study period. 9. Other situations where researchers believe that patients should not participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a delay of >= 4 days or a dose reduction of = 15% in the next chemotherapy cycle (Cycle X + 2) due to platelet count.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;Incidence of treatment related adverse events;Platelet response rate;The incidence rate of bleeding events in the (X + 1)th cycle;The proportion of grade III-IV thrombocytopenia in the (X+1)th cycle;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactZuo Wei
The First Affiliated Hospital of Nanchang University
Outcome results
None listed