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重组人血小板生成素在急性髓系白血病诱导缓解期后的临床运用 被引量:7

A trial of domestic recombinant human thrombopoietin(rhTPO) as an adjunct to post-induction chemotherapy for patients with acute myeloid leukemia
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摘要 目的 :研究国产全长人血小板生成素 (rhTPO)对急性髓系白血病 (AML)患者化疗后血小板减少的疗效和安全性。方法 :采用非随机自身对照。 2 8例AML诱导缓解后的患者在试验周期化疗后 ,皮下注射rhTPO1.0 μg/kg ,每日 1次 ,疗程 14d。对照周期不用rhTPO。动态观察全血细胞计数 ,定期复查肝肾功能、凝血酶原时间 (PT)、活化的部分凝血活酶时间 (aPTT)和纤维蛋白原、心电图。结果 :试验周期化疗后血小板最低值为(16 .93± 2 0 .2 7)× 10 9/L ,血小板 <2 0× 10 9/L的持续天数为 (4 .75± 5 .97)d ,输血小板的次数和量分别为 (1.5 4± 1.79)次和 (2 1.6 1± 2 9.73)u ,与对照周期相比差异均无统计学意义 (P >0 .0 5 )。化疗后血小板最高值及血小板计数恢复的增加值 (差值 )试验周期分别为 (2 5 5 .89± 2 13.0 7)× 10 9/L和 (2 38.96± 2 10 .4 3)× 10 9/L ,明显高于对照周期的 (15 0 .2 2± 10 7.6 4 )× 10 9/L和 (135 .0 7± 10 5 .75 )× 10 9/L(P <0 .0 5 )。用rhTPO对其他监测指标无明显影响。不良反应也少而轻微。结论 :国产全长rhTPO治疗AML耐受性良好 ,确实能提高AML化疗后的血小板计数 ,但对总体血小板恢复时间及血小板输注的需要没有明显影响。 Objective:To evaluate the effect on the thrombocytopenia resulting from the post-induction chemotherapy and toxicity of domestic rhTPO in the patients with acute myeloid leukemia(AML).Method:A non-randomized, self-controlled trial was undertaken. 28 patients with AML had achieved complete remission after induction chemotherapy. In study course of chemotherapy, rhTPO were used by the dose of 1.0 ug/Kg, i.h, qd for 14 days; In the control course, rhTPO were not used. Peripheral blood cell counts, the function of liver and kidney, prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen and electrocardiograph(ECG) were monitored.Result:The minimum of platelet count of study course was 16.93± 20.27×10 9/L;there were median 4.75± 5.97 days when platelet count was less than 20×10 9/L; the frequency and amount of platelet transfusion were 1.54± 1.79 times and 21.61± 29.73 units separately; all are not significantly different from that in control course(P> 0.05). A median peak and value of increase of platelet count were 255.89± 213.07×10 9/L and 238.96± 210.43×10 9/L separately in study course; which were much higher than 150.22± 107.64×10 9/L and 135.07± 105.75×10 9/L separately in control course with significant difference(P< 0.05). There were no effect on the functions of liver and kidney, blood coagulation and ECG. The other side effects were not found.Conclusion:Domestic rhTPO can be well tolerated in the treatment of AML. It can increase the platelet count after chemotherapy. However, there were no significantly effects on the duration of thrombocytopenia and the platelet transfusion requirement.
出处 《临床血液学杂志》 CAS 2004年第3期143-145,148,共4页 Journal of Clinical Hematology
关键词 重组人血小板生成素 白血病 髓系 急性 治疗 Recombinant human thrombopoietin Acute myeloid leukemia Therapy
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参考文献5

  • 1Cripe L, Neuberg D, Tallman M, et al. A pilot study of recombinant human thrombopoietin (rhTPO) and GM-CSF following induction therapy in patients older than 55 years with acute myeloid leukemia (AML).Blood, 1998, 92:616a-616a.
  • 2Archimbaud E, Ottmann O G, Yin J A L, et al. A randomized, double-blind, placebo-controlled study with pegylated recombinant human megakaryocyte growth and development factor(PEG-rHuMGDF) as an adjunct to chemotherapy for adults with de novo acute myeloid
  • 3Schiffer C A, Miller K, Larson R A, et al. A double blind, placebo controlled trial of pegylated recombinant human megakaryocyte growth and development factor as an adjunct to induction and consolidation therapy for patients with acute myeloid leukemia. B
  • 4Linker C. Thrombopoietin in the treatment of acute myeloid leukemia and in stem-cell transplantation. Semin in Hematol, 2000,2 (suppl 4): 35 - 40.
  • 5Kaushansky K. Thrombopoietin: the primary regulator of paltelet production. Blood, 1995, 86:419-431.

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