JOURNAL OF SHANDONG UNIVERSITY (HEALTH SCIENCES) ›› 2011, Vol. 49 ›› Issue (7): 117-.

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Clinical efficacy and safety of rhTPO in the treatment of idiopathic  thrombocytopenic purpura: a randomized controlled trial

ZHANG Chun-qing, WANG Lin, QIN Ping, CHEN Feng, CHEN Chun-yan, HOU Ming   

  1. Department of Hematology, Qilu Hospital of Shandong University, Jinan 250012, China
  • Received:2011-02-01 Online:2011-07-10 Published:2011-07-10

Abstract:

Objective       To investigate the efficacy and safety of recombinant human thrombopoietin (rhTPO) in the treatment of adult steroid-resistant idiopathic thrombocytopenic purpura(ITP). Methods        74 patients with steroid-resistant ITP were randomly divided into the observation group and the control group, 37 in each group. Patients in the observation group were treated with 1.0μg/kg·d of rhTPO, ih(300U/kg·d)and danazol, 600mg/d, three times a day, for 14d. Patients in the control group were treated with danazol, 600mg/d, three times a day, for 14d, and when the platelet count≤20×109/L after 14d, rhTPO, 1.0μg/kg·d, ih(300U/kg·d), was added for 14d. In a 14d observation period, the increase of platelet and safety of rhTPO were analyzed. Results          The mean platelet count and the increased number of platelets in the observation group were higher than those in the control group(P<0.01). The area under the curve of the platelet count in the observation group was larger than that in the control group(P=0.001). The complete response rate(the platelet count≥100×109/L after treatment) was higher in the observation group(16 cases, 43.24%) than that in the control group(3 cases, 8.10%)(P<0.01). The good response(the platelet count≥30×109/L after treatment) had no difference in the observation group(9 cases, 24.32%) comparted with the control group(10 cases, 27.03%)(P>0.01).  The overall efficacy in the observation group was higher than that in the control group(67.56% vs 35.14%, P<0.05). In the control group, patients who had no response to danazol within 14d were treated with rhTPO, and the overall efficacy rate was 62.5%. rhTPO had no effect on platelet function and anti-platelet antibodies. No severe side effect was observation. Conclusion          rhTPO is an effective and safe treatment method for adult steroidresistant ITP.

Key words: Thrombopoietin,recombinant; Purpura, thrombocytopenic, idiopathic

CLC Number: 

  • R558
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