中国临床药理学与治疗学2013，Vol.18Issue(3)：302-306,5.
聚乙二醇化重组人粒细胞刺激因子注射液Ⅰ期临床耐受性试验
Phase Ⅰ clinical trail tolerance of pegylated recombinant human granulocyte colony-stimulating factor injection
孙成春 1王宝成 1毕经旺 1吕伟伟 1胡君莉 1康长清 1张立志1
作者信息
摘要
Abstract
To evaluate the safety and tolerance of PEG-rhG-CSF in tumor patients, and to explore its efficacy of enhancing absolute neutrphil count(ANC). METHODS: This study was open-labeled, dose-escalation trial. All patients received 1 day chemotherapy. Patients received a single injection of PEG-rhG-CSF (30, 60,100,150, or 200 jug/kg) 48 h after administration of chemotherapy drug. Each dose group had 3 patients. RESULTS: All the 15 patients enrolled were evaluable for safety and efficacy of PEG-rhG-CSF. Main adverse events related to
PEG-rhG-CSF were fatigue ( 4/15 ), musculo-skeletal pain (1/15). All adverse events were mild, and they were reversible without treatment. PEG-rhG-CSF enhanced ANC in a dose-dependent manner to some extent. CONCLUSION: PEG-rhG-CSF is well tolerated, with no serious adverse event in this trial.关键词
聚乙二醇化/粒细胞刺激因子/工期/临床试验/耐受性Key words
Pegylation/ Granulocyte colony-stimulating factor/ Phase I / Clinical trail/ Drug tolerance分类
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孙成春,王宝成,毕经旺,吕伟伟,胡君莉,康长清,张立志..聚乙二醇化重组人粒细胞刺激因子注射液Ⅰ期临床耐受性试验[J].中国临床药理学与治疗学,2013,18(3):302-306,5.
