OBJECTIVE: To investigate resistance and safety of HHPG-19K in treating non-small cell lung cancer patients. METHODS:A total of 30 cases were selected and randomly divided into 5 groups: three HHPG-19K groups of different dosage (60 μg/kg/day, 100 μg/kg/day, 200 μg/kg/day), positive control group (Filgrastim, namely G-CSF5 μg/kg/day) and negative control group. Safety indexes of 5 groups were observed and compared. RESULTS: All patients had adverse event (100%) in three HHPG-19K groups, and increased ALP, ALT and AST were main events. The degree was mild to moderate. There was no significant difference in the incidence of adverse event between dosage groups and positive control group no difference. But the incidence of negative control group was 13%, which was significantly lower than dosage groups and positive control group. CONCLUSIONS: non-small cell lung cancer patients have satisfactory tolerance to HHPG-19K, and have no resistance. Besides, dosage at 100 μ g/kg is the most safe.
RCT Entities:
OBJECTIVE: To investigate resistance and safety of HHPG-19K in treating non-small cell lung cancerpatients. METHODS: A total of 30 cases were selected and randomly divided into 5 groups: three HHPG-19K groups of different dosage (60 μg/kg/day, 100 μg/kg/day, 200 μg/kg/day), positive control group (Filgrastim, namely G-CSF5 μg/kg/day) and negative control group. Safety indexes of 5 groups were observed and compared. RESULTS: All patients had adverse event (100%) in three HHPG-19K groups, and increased ALP, ALT and AST were main events. The degree was mild to moderate. There was no significant difference in the incidence of adverse event between dosage groups and positive control group no difference. But the incidence of negative control group was 13%, which was significantly lower than dosage groups and positive control group. CONCLUSIONS:non-small cell lung cancerpatients have satisfactory tolerance to HHPG-19K, and have no resistance. Besides, dosage at 100 μ g/kg is the most safe.