Clinical Study on Safety and Efficacy of JiSaiXin (Recombinant Human Granulocyte Colony Stimulating Factor Injection Manufactured in China) for Chinese Undergoing Chemotherapy


Objectives: To assess safety and efficacy of JiSaiXin (Recombinant Human Granulocyte Colony StimulatingFactor Injection manufactured in China, G-CSF) 150ug per day for three days and whether this regimen couldreduce the incidence of febrile neutropenia caused by chemotherapy.
Method: From July 2014 to December2014 patients treated by chemotherapy in our hospital were randomly divided into two groups: Group A withprophylactic use of G-CSF (JiSaiXin) 24 hours after chemotherapy for consecutive 3 days; and Group B withG-CSF (JiSaiXin) after neutropenia. Routine blood tests were performed 7 days and 14 days after chemotherapy.
Results: A total of 100 patients fulfilled study criteria, and the incidence of severe neutropenia (grade III/IV)and the incidence of febrile neutropenia in Group A were lower than those in Group B. Nine patients were foundsevere neutropenia (grade III/IV) in Group B, but one in Group A, three febrile neutropenia in Group B, but 0 inGroup A.
Conclusions: This study suggested that prophylactic use of G-CSF (JiSaiXin) 150ug per day 24 hoursafter chemotherapy for consecutive 3 days is safe and could be effective for preventing febrile neutropenia inpatients with chemotherapy.