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中国临床药理学与治疗学 ›› 2013, Vol. 18 ›› Issue (3): 302-306.

• 临床药理学 • 上一篇    下一篇

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

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3   

  1. 1济南军区总医院药剂科
    2肿瘤科,济南 250031,山东
    3齐鲁制药有限公司,济南 250100,山东
  • 收稿日期:2012-11-02 修回日期:2012-12-20 出版日期:2013-03-26 发布日期:2013-04-02
  • 作者简介:孙成春,女,硕士,主任药师,硕士生导师,研究方向:临床药理学和临床药学。Tel: 13583137132 E-mail: cchunsun65@sina.com

PhaseⅠ clinical trail tolerance of pegylated recombinant human granulocyte colony-stimulating factor injection

SUN Cheng-chun1, WANG Bao-cheng2, BI Jing-wang2, LV Wei-wei1, HU Jun-li2, KANG Chang-qing1, ZHANG Li-zhi3   

  1. 1Department of Pharmacy
    2Department of Oncology, General Hospital of Jinan Military PLA, Jinan 250031, Shandong, China
    3Pharmaceutical Company of Qilu, Jinan 250100, Shandong, China
  • Received:2012-11-02 Revised:2012-12-20 Online:2013-03-26 Published:2013-04-02

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1 d化疗方案,于化疗药物给药结束后48 h给予PEG-rhG-CSF。PEG-rhG-CSF的初始剂量为 30 μg/kg,递增剂量依次为60、100、150、200 μg/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。

关键词: 聚乙二醇化, 粒细胞刺激因子, Ⅰ期, 临床试验, 耐受性

Abstract: 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 patients received 1 day chemotherapy. Patients received a single injection of PEG-rhG-CSF(30,60,100,150, or 200 μg/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), musculoskeletal 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.

Key words: Pegylation, Granulocyte colony-stimulating factor, Phase Ⅰ, Clinical trail, Drug tolerance

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