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

作　　者：孙成春[1] 王宝成[2] 毕经旺[2] 吕伟伟[1] 胡君莉[2] 康长清[1] 张立志 

机构地区：[1]济南军区总医院药剂科 [2]济南军区总医院肿瘤科 [3]齐鲁制药有限公司

出　　处：《中国临床药理学与治疗学》2013年第3期302-306,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的:评价聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)用于肿瘤患者的安全性和耐受性,初步观察化疗后PEG-rhG-CSF升高外周血中性粒细胞的效果。方法:本研究为单中心、开放性剂量递增试验。所有受试者采用1d化疗方案,于化疗药物给药结束后48h给予PEG-rhG-CSF。PEG-rhG-CSF的初始剂量为30μg/kg,递增剂量依次为60、100、150、200μg/kg,每一剂量组3例受试患者。结果:入组15例患者均可评价疗效和安全性。与PEG-rhG-CSF相关的不良反应主要有乏力4例(4/15),肌肉酸痛1例(1/15),均为1度,无需特殊处理。无PEG-rhG-CSF的剂量限制性毒性。PEG-rhG-CSF对中性粒细胞的升高均有较为明确的效果,维持时间较长,有明显的量效关系。结论:PEG-rhG-CSF显示良好的耐受性,未出现严重不良事件。AIM. 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 pa tients received 1 day chemotherapy. Patients re- ceived a single injection of PEG-rhG-CSF （30, 60,100,150, or 200 ug/kg） 48 h after adminis- tration of chemotherapy drug. Each dose group had 3 patients. RESULTS.All the 15 patients en- rolled were evaluable for safety and efficacy of PEG-rhG-CSF. Main adverse events related toPEG-rhG-CSF were fatigue （4/15）, musculo- skeletal pain （1/15）. All adverse events were mild, and they were reversible without treat- ment. PEG-rhG-CSF enhanced ANC in a dose- dependent manner to some extent. CONCLU- SION： 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 I期 临床试验 耐受性 

分 类 号：R969[医药卫生—药理学]