Phase IIClinical Trials on rhG-CSF in Prevention of Leukopenia after Chemotherapy

To evaluate the efficacy and adverse effects of Ruo Mei Si(rhG CSF)in chemotherapy induced leukopenia and neutropenia.Thirty four patients were randomly divided into AB and BA groups.AB group was treated with chemotherapy plus rhG CSF and chemotherapy alone in the 1st and 2nd cycles respectively.The treatment of BA groups was just contrary to AB group.rhG CSF at a dosage of 5μg/kg,qd was subcutaneously injected 48h after the last administration of chemotherapeutic agents.The value of WBC count and ANC count were assayed accordingly.rhG CSF significantly reduced the severity and the duration of leukopenia and neutrophilic granulocytopenia,the incidence of infection,and the chance of antibiotic administration.ANC increased rapidly with the first peak after d2 of rhG CSF injection.The second peak occurred at the d8.rhG CSF had no effects on platelet.rhG CSF caused some side effects including slight bone pain(30%),fatigue(6%),and local pain of the injection site(6%).These symptoms were toleable.[Conclusion]rhG CSF plays an important role in accelerating the recovery of leukopenia and neutsophilic granunlocytopenia induced by chemotherapy.It is also safe to patients.We suggest that rhG CSF is a favorably adjuvant drug in the high dose intensive chemotherapy.