FIELD: medicine.
SUBSTANCE: group of inventions relates to a method of treating chemotherapy-induced neutropenia and a method of stimulating the survival of neutrophils, including the joint administration of plinabulin and one or more G-CSF medicinal products, a kit for use in a method of treating chemotherapy-induced neutropenia, a method of reducing bone pain caused by G-CSF medicinal product, and a method of attenuating the immunosuppressive effect caused by G-CSF medicinal product comprising administering an effective amount of plinabulin, a method of treating chemotherapy-induced neutropenia or promoting survival neutrophils, including one or more cycles of a chemotherapy regimen, the use of plinabulin in combination with one or more G-CSF medicinal products for the treatment of chemotherapy-induced neutropenia, the use of the above agents to promote neutrophil survival, the use of plinabulin to reduce bone pain caused by G-CSF medicinal product, the use of plinabulin to attenuate the immunosuppressive effect of G-CSF medicinal product, the use of plinabulin in combination with one or more G-CSF medicinal products to treat chemotherapy-induced neutropenia, or to promote neutrophil survival in one or more cycles of a chemotherapy regimen. A method of the treatment of chemotherapy-induced neutropenia comprising the co-administration of plinabulin and one or more medicinal products that are granulocyte colony stimulating factors (G-CSF), where the total dose of the said G-CSF medicinal product used in a 21-day cycle is 1–8 mg and the total dose of plinabulin is 19–22.5 mg/m2 for a 21-day cycle; where the said G-CSF medicinal product is administered at least 24 hours after chemotherapy, where plinabulin is administered within 30 minutes after chemotherapy. A method of stimulating the survival of neutrophils, including the joint administration of plinabulin and one or more G-CSF medicinal products, where the total dose of the said G-CSF medicinal product used in a 21-day cycle is 1–8 mg and the total dose of plinabulin is 19–22, 5 mg/m2 for a 21-day cycle; where the specified G-CSF medicinal product is administered at least 24 hours after chemotherapy, where plinabulin is administered within 30 minutes after chemotherapy. A kit for use in the above method of the treatment of chemotherapy-induced neutropenia containing a chemotherapeutic agent, 1 mg to 80 mg of plinabulin and 0.1 mg to 20 mg of G-CSF, the said chemotherapy, G-CSF and plinabulin being provided in separate sterile containers. A method of reducing bone pain caused by G-CSF medicinal product, which includes administering an effective amount of plinabulin, where the total dose of the said G-CSF medicinal product used in a 21-day cycle is 1–8 mg and the total dose of plinabulin is 19–22.5 mg/m2 for a 21-day cycle; where the said G-CSF medicinal product is administered at least 24 hours after chemotherapy, where plinabulin is administered within 30 minutes after chemotherapy. A method of attenuating the effect of immunosuppression caused by G-CSF medicinal product, including the introduction of an effective amount of plinabulin, where the total dose of the said G-CSF medicinal product used for a 21-day cycle is 1–8 mg and the total dose of plinabulin is 19–22.5 mg/m2 for a 21-day cycle; where the said G-CSF medicinal product is administered at least 24 hours after chemotherapy, where plinabulin is administered within 30 minutes after chemotherapy. A method of treating chemotherapy-induced neutropenia or promoting neutrophil survival, comprising one or more cycles of a chemotherapy regimen, wherein each cycle of said chemotherapy regimen independently comprises: administration of one or more chemotherapeutic agents on day 1, administration of plinabulin on day 1, and administration of one or more G-CSF medicinal products on day 2, with plinabulin being administered within 30 minutes of administration of the said one or more chemotherapeutic agents, the total dose of the said G-CSF medicinal product used for a 21-day cycle is 1–8 mg and the total dose of plinabulin is 19–22.5 mg/m2 for a 21-day cycle. The use of plinabulin in combination with one or more G-CSF medicinal products for the treatment of chemotherapy-induced neutropenia, where the total dose of the said G-CSF medicinal product used in a 21-day cycle is 1–8 mg and the total dose of plinabulin is 19–22.5 mg/m2 for a 21-day cycle; where the said G-CSF medicinal product is administered at least 24 hours after chemotherapy, where plinabulin is administered within 30 minutes after chemotherapy. The use of plinabulin in combination with one or more G-CSF medicinal products for the treatment of chemotherapy-induced neutropenia, where the total dose of the said G-CSF medicinal product used in a 21-day cycle is 1–8 mg and the total dose of plinabulin is 19–22.5 mg/m2 for a 21-day cycle; where the said G-CSF medicinal product is administered at least 24 hours after chemotherapy, where plinabulin is administered within 30 minutes after chemotherapy. The use of plinabulin in combination with one or more G-CSF medicinal products for the treatment of chemotherapy-induced neutropenia, where the total dose of the said G-CSF medicinal product used in a 21-day cycle is 1–8 mg and the total dose of plinabulin is 19–22.5 mg/m2 for a 21-day cycle; where the said G-CSF medicinal product is administered at least 24 hours after chemotherapy, where plinabulin is administered within 30 minutes after chemotherapy. The use of plinabulin to reduce the effect of immunosuppression caused by G-CSF medicinal product, where the total dose of the said G-CSF medicinal product used in a 21-day cycle is 1–8 mg and the total dose of plinabulin is 19–22.5 mg/m2 for a 21-day cycle; where the said G-CSF medicinal product is administered at least 24 hours after chemotherapy, where plinabulin is administered within 30 minutes after chemotherapy. Use of plinabulin in combination with one or more G-CSF medicinal products to treat chemotherapy-induced neutropenia or promote neutrophil survival in one or more cycles of a chemotherapy regimen, each cycle of the said chemotherapy regimen independently comprising administration of one or more chemotherapeutic agents for 1 day, the introduction of plinabulin on the 1st day and the introduction of one or more G-CSF medicinal products on the 2nd day, and plinabulin is administered within 30 minutes after the administration of these one or more chemotherapeutic agents, the total dose of the said G-CSF medicinal product used for a 21-day cycle is 1–8 mg and the total dose of plinabulin is 19–22.5 mg/m2 for a 21-day cycle.
EFFECT: above group of inventions provides a significant therapeutic synergistic effect in the treatment of neutropenia.
51 cl, 8 dwg, 4 tbl, 4 ex
