Clinical Trial Phase Ⅱ on rhG-CSF in Prevention of Neutropenia after Chemotherapy / 中国肿瘤生物治疗杂志

ABSTRACT

Objective: To evaluate the efficacy and side effects of rhG-CSF(recombinant human granulocyte colony stimulating factor) in chemotherapy induced neuteropenia.Methods: 63 cases with malignacies confirmed by pathology or cytology were enrolled. All patients were divided into group AN or BA at randomly self-control cross-over test.At the time of 48 hours after chemotherapy,rhG-CSF was given at a dose of 5 g.kg-1 .d-1 for 7 to 14 days in group A. In group B, the patients received chemotherapy alone without rhG-CSF as control.Bolld routine examination was taken every other day from the start of chemother- apy.The change of absolute neutrophil and neukocyte counts were observed.Results:In the trial group,neutrophil count in- creased rapidly with the first peak after 48 born of rhG-CSF injection. The second peak occurred on the tenth day. In the control group,the absolute neuterophil and leukocyte counts decreased gradually,lower than that of the trial group all the time.There is a significant difference between the trial and control groups (P