重组人血小板生成素临床耐受性试验

被引：32

作者：

赵永强

姜杰玲

焦力

潘家琦

陈书长

王书杰

单渊东

沈悌

武永吉

机构：

[1] 中国医学科学院中国协和医科大学北京协和医院血液科,中国医学科学院中国协和医科大学北京协和医院血液科,中国医学科学院中国协和医科大学北京协和医院血液科,中国医学科学院中国协和医科大学北京协和医院血液科,中国医学科学院中国协和医科大学北京协和医院血液科,

来源：

中华医学杂志 | 2001年 / 24期

关键词：

血小板生成素; 药物耐受性; 血小板计数; 血小板聚集;

D O I：

暂无

中图分类号：

R550.5 [];

学科分类号：

摘要：

目的　评估国产重组人血小板生成素 (rhTPO)在人体内的安全性。观察其对血象、血小板聚集功能等的影响及注射后抗体产生情况。方法　 2 7名正常人分为 4组 ,分别单次皮下注射rhTPO 0 2 5、0 5、1 0 μg/kg或 2 0 μg/kg ,5例化疗后急性白血病 ,2例非霍奇金淋巴瘤患者每日皮下注射rhTPO 1 0 μg/kg,连续 7～ 14d ,动态观测血象、血小板聚集、血清生化指标和抗rhTPO抗体等。结果　 2 7名正常人单次皮下注射rhTPO后仅 1例在给药后 6h体温一度至 37 4℃ ;1例给药次日出现轻度乏力、纳差和思睡 ;1例出现一过性丙氨酸转氨酶和天门冬氨酸转氨酶轻度升高。血小板数约于给药后第 14d达高峰 ,与给药前相比 ,平均升高 2 4%～ 5 2 % ,给药后 2 1d基本回落至基础水平。血小板升高时聚集功能无明显改变。 7例血液肿瘤患者接受连续皮下注射rhTPO后未出现与药物相关的不适反应 ;1例出现一过性丙氨酸转氨酶和天门冬氨酸转氨酶轻度升高 ;4例用药后血小板数出现不同程度的升高 ;1例给药后血清中检出一过性低滴度 (1∶5 )抗rhTPO抗体。结论　rhTPO单次皮下注射(0 2 5～ 2 0 μg/kg)和每日 1次皮下注射 (1 0 μg/kg ,7～ 14d)对人体是安全的 ,不良反应轻微。rhTPO具有特异性和剂量依赖性升血小板作用 ,对血小板聚集功能

引用

页码：39 / 42

页数：4

共 12 条

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