重组人血小板生成素治疗特发性血小板减少性紫癜的临床对照试验  

A clinical comparative study on treatment of idiopathic thrombocytopenic purpura with recombinant human thrombopoietin

作　　者：赵娟[1] 邹萍[1] 罗毅[1] 王晓聪[1] 洪梅[1] 

机构地区：[1]华中科技大学同济医学院附属协和医院血液病研究所,武汉430022

出　　处：《临床血液学杂志》2009年第5期457-459,共3页Journal of Clinical Hematology

摘　　要：目的:评价重组人血小板生成素(rhTPO)对特发性血小板减少性紫癜(ITP)的疗效和安全性。方法:21例ITP患者采用随机区组,分成试验组和对照组2组。试验组皮下注射rhTPO 1.0μg/kg,1次/d,疗程14 d。对照组在服用达那唑14 d后如血小板仍≤20×109/L,加用rhTPO皮下注射,1.0μg/kg,疗程14 d。2组在整个试验阶段均服用达那唑,0.2 g,每日3次。结果:试验组用药前血小板计数的中位数为8.0(4.0～15.0)×109/L,用rhTPO后血小板最高值为100.0(49.0～118.5)×109/L,与用药前相比P<0.01。停药后血小板计数逐渐回落,至开始治疗后28 d,血小板计数降至39.0(22.0～68.5)×109/L。对照组用药前血小板计数的中位数为6.0(4.0～10.0)×109/L,第1阶段(1～14 d)仅用达那唑治疗血小板最高值为33.0(23.0～72.0)×109/L。第2阶段(14～28 d)加用rhTPO,血小板计数最高值为111.5(60.0～152.0)×109/L,与用药前及第1阶段最高值相比均P<0.01。停药后血小板计数逐渐下降,至42 d降至33.0(22.5～46.0)×109/L。近期有效率84.2%,其中显效47.4%,良效36.8%。不良反应轻微,仅2例出现头痛,未发现有肝肾功能、凝血功能的影响。结论:rhT-PO治疗ITP短期疗效显著,不良反应轻微。Objective;To evaluate the efficacy and safety of human recombinant thrombopoietin （rhTPO） in idiopathic thrombocytopenic purpura （ITP）. Method;Twenty-one patients with ITP were divided into two groups in random. The patients in test group were received rhTPO at a dose of 1.0 μg/kg daily via subcutaneous administration, and the maximum was 14 doses. The patients in control group were received rhTPO at the same dose if whose platelet count was less than 20 × 10^9/L after treated with danazol for 14 days. And then, all patients were received danazol at a dose of 0.2 g, three times a day. Result..At the beginning of treatment, the median counts of platelet in test group was 8.0（4.0-15.0）× 10^9/L, and the maximum value was increased to 100.0（49-118.5）× 10^9/L after the administration of rhTPO （P〈0. 01）. The median platelet counts in control group was increased from 6.0（4.0-10.0）× 10^9/Lto 33.0（23.0-72.0）× 10^9/Lat the first stage（danazol single）. After adding rhTPO, the platetet counts increased to 111.5（60.0-152.0）× 10^9/L （P〈0.01）. After restreated the rhTPO, the platelet count in two group was decreased gradually. The overall effiecent rate was 84.2 % in both group. The remarkable was 47.4%, the positive rate was 36.8%. Adverse effect was little. Only 2 patients had headache. Damage of liver, kidney and coagulation were not observed. Conclusion：Administration of rhTPO had significant efficacy in short term in patients with ITP with tolerable adverse effects.

关 键 词：紫癜 血小板减少性 特发性 血小板生成素 临床试验 

分 类 号：R554.6[医药卫生—血液循环系统疾病]