【摘要】 目的:考察非小细胞肺癌患者化疗后对HHPG-19K的耐受性及该药物的安全性。方法:随机将招募受试者30例平均分成设五个试验组:HHPG-19K 3个剂量组(60μg/Kg、100μg/Kg、200μg/Kg)、阳性对照组(惠尔血,即G-CSF 5μg/Kg/天)和阴性对照组,对比5组的安全性观察指标。结果:3个剂量组均出现不良事件,占总人数的100%;另外,实验室检查值的异常主要有ALP、ALT及AST升高等。不良事件的类型和严重程度均为轻中度,与阳性对照组无差异(P<0.05)。而阴性对照组发生不良事件为13%,少于剂量组与阳性对照组(P<0.05)。结论:试验用药物HHPG-19K在非小细胞肺癌化疗患者中具有较好的耐受性,且不产生耐药性抗体,其中100μg/kg安全性更好。更多还原

【Abstract】 Objective: To investigate the tolerance of the patients with non-small cell lung cancer after chemotherapy for HHPG 19 k and the drug safety.Methods: Randomly recruit 30 cases and divide into five treatment group in average: HHPG-19k three dose group(60 μg/Kg,100 μg/Kg,200 μg/Kg),positive control group(huier blood,namely g-CSF5 μg/Kg/day) and negative control group,compared to 5 groups of safety observation index.Results: Three dose groups all appear adverse events,accounting for 100 % of the total number of;In addition,laboratory examination of abnormal value mainly ALP,ALT and AST rise,etc.Adverse events type and severity both are mild and moderate,and has no difference with the positive control group(P<0.05).And the proportion of adverse events in the negative control group is 13%,less than the dose group and the positive control group(P<0.05).Conclusion: Test the use of drugs HHPG-19 k in non-small cell lung cancer patients with chemotherapy has a good tolerance,and do not produce resistance antibody,of which 100 μ g/kg better safety.更多还原