Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy

Exclusion Criteria

• •1. The subjects who have received radiation therapy within 4 weeks prior to randomization;
• •2. Those who have received hematopoietic stem cell transplantation or bone marrow transplantation
• •3. Patients who have been treated with G-CSF analogs or PEG-G-CSF analogs within 4 weeks prior to randomization;
• •4. Subjects with a history of chronic granulocytic leukemia or myelodysplastic syndromes;
• •5. People at high risk for ARDS;
• •6. Patients with unexplained splenomegaly on physical examination and/or CT scan or ultrasound, as well as any condition that may cause splenomegaly (e.g., thalassemia, glandular fever, malaria, etc.);
• •7. Patients who currently have or have had sickle cell anemia;
• •8. Those with a combined history of malignant tumors (except for the following: cured non-melanoma skin cancer, cervical cancer in situ, limited prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years);
• •9. Those diagnosed with advanced breast cancer combined with distant metastases;
• •10. Patients with known cerebrovascular malformations (e.g., cerebral hemangiomas), epilepsy;
• •11. Patients with severe mental or neurological disorders;
• •12. Patients with severe cardiovascular disease: history of myocardial infarction within 1 year prior to first administration of study drug; sick sinus syndrome, atrioventricular block II or greater, ventricular fibrillation, torsional ventricular tachycardia, sustained ventricular tachycardia; electrocardiogram indicative of abnormal clinically significant QRS wave lowering; congenital prolonged history of the QT interval; left ventricular ejection fraction \<50%; NYHA cardiac function class III or IV; poorly controlled hypertension. Poorly controlled hypertension: blood pressure \>160 mmHg systolic and/or \>100 mmHg diastolic despite antihypertensive medications; congestive heart failure; stable coronary artery disease; unstable angina pectoris;
• •13. Liver function indexes: ALT, AST, TBIL ≥1.5 times the upper limit of normal before enrollment; Kidney function indexes: Scr ≥1.5 times the upper limit of normal;
• •14. Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood Hepatitis B Virus (HBV) DNA test is greater than the normal range; Positive for Hepatitis C Virus (HCV); Positive for Human Immunodeficiency Virus (HIV);
• •15. Those with a current active infection (and a temperature ≥38°C) or who have received systemic anti-infective therapy within 72 hours prior to chemotherapy;
• •16. Patients with severe mouth ulcers;
• •17. Participated in 3 or more clinical trials of a drug within the last year, or participated in any clinical trial of a drug within the last 3 months, as a subject and actually used the test drug;
• •18. Hypersensitivity to the adjuvant or neoadjuvant chemotherapeutic agents used (e.g., docetaxel, epirubicin, carboplatin, cyclophosphamide) and to PEG-G-CSF and G-CSF analogs;
• •19. Lithium-treated patients were required during the clinical trial;
• •20. Alcohol-dependent individuals or those with a history of substance abuse;
• •21. Lactating and pregnant females and those planning a pregnancy within 6 months of the last injection of the test drug in this study;
• •22. Combined primary diseases of the cerebrovascular, hepatic, renal, endocrine, and hematologic systems of a severity judged by the investigator to be inappropriate for participation in this clinical trial;
• •23. Other patients who, in the judgment of the investigator, are not suitable subjects for this trial.