急性白血病_____重组人血小板生成素；

重组人血小板生成素治疗特发性和血液肿瘤化疗后血小板减少症的Ⅲ期临床研究

http://www.100md.com 《第四军医大学学报》 2004年第3期

急性白血病,,重组人血小板生成素；,急性白血病；,特发性血小板减少性紫癜；,非霍奇金淋巴瘤；,临床试验,Ⅲ期,0引言,1

     ·研究原著·

    Treatment of thrombocytopenia with recombinant human thrombopoietin in patients with idiopathic thrombocytopenic purpura and hematological malignancies following chemotherapy: Phase Ⅲ clinical cohort study

    CHEN XieQun, BAI QingXian, WANG YiWei, ZHANG YongQing, ZHANG Tao, WANG WenQing, DONG BaoXia, QIAO QingDa, ZHANG WeiPing

    Department of Hematology, Xijing Hospital, Fourth Military Medical University, Xi’an 710033, China

    【Abstract】 AIM: To assess the clinical safety and efficiency of recombinant human thrombopoietin (rhTPO) for treatment of idiopathic and chemotherapyinduced thrombocytopenia. METHODS: Four patients with nonHodgkin’s lymphoma (NHL) entered randomized, crosscontrolled group, and 6 patients with acute leukemia for consolidation treatment entered nonrandomized, selfcontrolled group. Also, 9 patients with refractory idiopathic thrombocytopenic purpura (ITP) were enrolled in the trial. rhTPO was daily administered subcutaneously at a dose of 1 μg/kg for a duration of 14 days. All the trial data were analyzed with statistical software SPSS 10.0. RESULTS: After therapy with rhTPO in patients with hematological malignancies, both median platelet count and median peak platelet count were increased; there was significant difference in median differential platelet count between trial cycle and control cycle (P<0.05); the days with platelet count <50×109/L and days for platelet recovering ≥75×109/L or ≥100×109/L were shorter to a different degree. After treatment of refractory ITP with rhTPO, the median platelet count gradually rose to maximum of 101×109/L; the median differential platelet count between before and after administration was 85.67×109/L; the days for platelet count ≥30×109/L, ≥50×109/L and ≥100×109/L were 9.89, 13.56 and 19.78, respectively. CONCLUSION: rhTPO seems to be safe and may attenuate idiopathic or chemotherapyinduced thrombocytopenia without obviously adverse action. ......

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