摘要
目的 :评估重组人血小板生成素 (rhTPO)治疗特发性和化疗后血小板减少的临床安全性和有效性 .方法 :①病例分组 :4例非霍奇金淋巴瘤 (NHL)患者入选随机交叉对照组 ,6例巩固治疗期急性白血病患者入选非随机自身对照组 ;难治性血小板减少性紫癜 (ITP)组入选 9例患者 ;②用药方法 :rhTPO 1 μg/kg ,皮下注射 ,每日 1次 ,疗程 1 4d ;③统计分析 :病例资料采用SPSS软件统计分析 .结果 :①血液肿瘤组 :试验组rhTPO治疗后血小板数均值、最高值皆大于对照 ,两周期血小板数用药前后差值相差显著 (P <0 .0 5 ) ,试验组血小板数低于 5 0× 1 0 9/L的持续日数、恢复至 75× 1 0 9/L和 1 0 0× 1 0 9/L以上需要日数均有不同程度缩短 ;②难治性ITP组 :rhTPO治疗后患者血小板数均值渐升高 ,至 1 7d达 1 0 1× 1 0 9/L ;用药前后血小板差值为 85 .6 7× 1 0 9/L ,其中血小板数达 30× 1 0 9/L ,5 0× 1 0 9/L及 1 0 0× 1 0 9/L所需日数分别为 9.89,1 3.5 6及 1 9.78d .结论 :rhTPO对部分难治性ITP及血液肿瘤化疗所致的血小板减少有一定疗效 。
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 <50×10 9/L and days for platelet recovering ≥75×10 9/L or ≥100×10 9/L were shorter to a different degree. After treatment of refractory ITP with rhTPO, the median platelet count gradually rose to maximum of 101×10 9/L; the median differential platelet count between before and after administration was 85.67×10 9/L; the days for platelet count ≥30×10 9/L, ≥50×10 9/L and ≥100×10 9/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.
出处
《第四军医大学学报》
北大核心
2004年第3期261-264,共4页
Journal of the Fourth Military Medical University
关键词
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
recombineant human thrombopoietin
acute leukemia
purpura refractory thrombocytopenic, idiopathic
non Hodgkin's lymphoma
clinical cohort study, phase Ⅲ