重组人血小板生成因子注射液的Ⅰ期临床耐受性试验  

Phase I clinical tolerance study of recombinant human thrombopoietin for injection

作　　者：沈彤[1] 文爱东[1] 赵磊[1] 王萌[1] 白庆咸[2] 王文清[2] 马忠英[1] 

机构地区：[1]第四军医大学西京医院药剂科,西安710033 [2]第四军医大学西京医院血液内科,西安710033

出　　处：《中国新药杂志》2006年第11期907-909,共3页Chinese Journal of New Drugs

摘　　要：目的:研究国产重组人血小板生成因子注射液(rhTPO)在健康志愿者体内的耐受性和安全性。方法:随机选择健康志愿者27例,分别单次皮下注射rhTPO 0．5,1．0,2．0μg·kg-1,进行耐受性研究,动态观测健康志愿者用药后血象、血小板形态、凝血酶原时间和血清生化指标等。结果:除1例受试者用药36 h后四肢出现皮疹外,其余未观察到明显毒性反应;血小板计数约于给药后14 d达高峰,给药后21 d基本回落至基础水平,血小板升高时形态、功能及凝血酶原时间无明显改变。结论:单次皮下注射rhTPO 0．5～2．0μg·kg-1对人体是安全的,不良反应轻微,具有特异性和剂量依赖性升高血小板作用,对血小板形态和功能无明显影响。推荐Ⅱ期临床给药剂量为皮下注射1．0μg·kg-1,qd,连续7 d。Objective ：To evaluate the tolerability and safety of recombinant human thrombopoietin （rhTPO） for injection made in China. Methods：Twenty-seven healthy volunteers were randomly administered with a single subcutaneous injection of rhTPO at 0.5, 1.0 and 2. 0μg. kg^- 1 respectively. The tolerance and safety of rhTPO were assessed based on changes of hemogram, complete blood count, platelet morphosis, thrombin time and serum chemistry. Results：Only one subject showed tetters on limbs in 36 hours after the injection. The platelet counts of the subjects reached at the maximum at day 14 and backed to normal at the day 21 after the injection, rhTPO increased peripheral platelet counts and had no effect on its form and aggregation function. All subjects had better tolerance. Conclusion：A subcutaneous injection 1.0μg. kg^- 1 daily for 7 days in phase Ⅱ clinical study is recommended.

关 键 词：重组人血小板生成因子 Ⅰ期临床试验 人体耐受性 血小板计数 

分 类 号：R969.1[医药卫生—药理学] R973.1[医药卫生—药学]