gynecological oncology
Conditions
Interventions
Group 1:PEG-rhG-CSF was injected subcutaneously 24-48 hours after the end of chemotherapy
Group 2:Rhg-csf (2-5ug/kg) was injected daily for 48h after the end of chemotherapy
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients with gynecological malignancies such as ovarian cancer, cervical cancer and endometrial cancer diagnosed by histopathology or cytology were clinically treated with chemotherapy, and the chemotherapy regimen was PT. (2) The expected survival time was more than 6 months and at least 2 cycles of chemotherapy. (3) There were no obvious signs of hematological diseases. (Hb=8g/dL, WBC=3.5×10^9/L, ANC=1.8×10^9/L, PLT= 80× 10^9/L). The hematopoietic function of bone marrow was normal. (4) The coagulation function is normal. (5) Electrocardiogram examination showed no obvious abnormality and no obvious cardiac dysfunction. (6) Liver function indexes: ALT, TBIL and AST were within 2.5 times of the upper limit of normal value. (7) Renal function indexes: Cr, BUN were within 1.5 times of the upper limit of normal value. (8) Those with no previous history of chemoradiotherapy were enrolled in the primary prevention treatment group and those with a history of chemoradiotherapy were enrolled in the secondary prevention treatment group. (9) Aged 18 to 75 years old. (10) KPS>60. (11) Informed about the study and signed the informed consent. (12) Comply with the test and blood sample collection procedures.
Exclusion criteria
Exclusion criteria: (1) Diseases affecting the blood system. (2) Abnormal hematopoietic function of bone marrow. (3) Liver function indexes: ALT,TBIL and AST were all greater than the upper limit of 2.5 times normal value. (4) Renal function index: Cr, BUN greater than 1.5 times normal value upper limit. (5) Abnormal coagulation function. (6) The patient's infection is difficult to control or get HIV. (7) Patients with a history of mental illness, neurological disease, or brain metastasis from a tumor cannot accurately describe their condition. (8) Previous patients with hematopoietic stem cells or organ transplantation. (9) Patients are undergoing clinical trials of other drugs and medical devices. (10) Patients with uncontrollable diabetes, heart disease, cerebrovascular diseases and so on. (11) Allergic to experimental drugs or other genetically engineered e. coli derived biological products. (12) The investigator believes that it is not suitable for inclusion. (13) Does not meet inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and duration of grade III / IV neutrophil (ANC) reduction /FN was observed in patients in each group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients in each group the ANC after reached its lowest point back to 2 * 10^9 / L;The incidence of FN in each group;Duration of neutropenia was observed in each group;Length of hospitalization associated with granulose-deficiency was observed in each group;The incidence of chemotherapy dosage adjustment;The incidence of or delayed chemotherapy;Safety of each chemotherapy cycle;Treatment costs of patients in each group; | — |
Countries
China
Contacts
Public ContactLiu Shujuan
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed