聚乙二醇重组人粒细胞集落刺激因子治疗 Ib 期非小细胞肺癌患者的安全性。
Safety of polyethylene glycol recombinant human granulocyte colony-stimulating factor in treating non-small cell lung cancer patients at I b stage.
机构信息
Respiratory Department, Affiliated Chest Hospital of Shanghai Jiaotong University, Shanghai 200030, China.
出版信息
Asian Pac J Trop Med. 2013 Nov;6(11):912-5. doi: 10.1016/S1995-7645(13)60163-7.
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.
目的
研究 HHPG-19K 治疗非小细胞肺癌患者的耐药性和安全性。
方法
共选择 30 例患者，随机分为 5 组：HHPG-19K 三个不同剂量组（60μg/kg/天、100μg/kg/天、200μg/kg/天）、阳性对照组（Filgrastim，即 G-CSF5μg/kg/天）和阴性对照组。观察并比较 5 组的安全性指标。
结果
三组 HHPG-19K 组患者均出现不良反应（100%），主要表现为 ALP、ALT 和 AST 升高，程度为轻至中度。各剂量组与阳性对照组的不良反应发生率无差异，但阴性对照组的发生率为 13%，明显低于剂量组和阳性对照组。
结论
非小细胞肺癌患者对 HHPG-19K 具有良好的耐受性，无耐药性。此外，100μ g/kg 剂量最安全。
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