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Clinical Trial Phase Ⅱ on rhG-CSF in the Prevention of Neutropenia after Chemotherapy
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Abstract:
To evaluate the efficacy and side effects of rhG-CSF (recombinant human granulocyte colony stimulating factor) in chemotherapy induced neutropenia. Methods: 63 cases with malignacies confirmed by pathology or cytology were enrolled. All patients were divided into group AB 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 μg?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. Blood routine examination was taken every other day from the start of chemotherapy. The change of absolute neutrophil and neukocyte counts were observed. Results: In the trial group, neutrophil count increased rapidly with the first peak after 48 hours of rhG-CSF injection. The second peak occurred on the tenth day. In the control group, the absolute neutrophil 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<0.05) on the nadir of WBC and ANC counts, the duration of WBC<4.0×10 9/L and ANC<2.0×10 9/L, and the number of patients with WBC<4.0×10 9/L on the twenty-first day after chemotherapy. The rates of bone pain and local response of injection were 25.8% and 27.4% respectively. Influenzal symptom was infrequent. Conclusion: rhG-CSF plays an important role in accelerating the recovery of leukocyte and absolute neutrophil induced by chemotherapy. The patients were well toleranced. It is suggested that rhG-CSF be a favourably adjuvant drug in the high dose intensive chemotherapy.
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