甲磺酸伊马替尼治疗慢性髓系白血病慢性期疗效及不良反应分析

Observation on the Effect and Adverse Effects of Imatinib Mesylatee for Chronic Myelogenous Leukemia in Chronic Phase

目的探讨甲磺酸伊马替尼(格列卫)治疗慢性髓系白血病慢性期(CML-CP)的疗效,并对其不良反应进行了初步分析。方法 20例CML-CP患者口服伊马替尼300～800mg/d,监测血常规指标、染色体核型及bcr/ablP210转录本表达,用药期间观察其不良反应。结果中位随访时间15个月(3～36个月),累积获得的完全血液学缓解(CHR)率为90.0%(18/20例),主要细胞遗传学缓解(MCyR)率80.0%(16/20例),分子生物学缓解(CMoR)率为42.9%(6/14例)。不良事件:(1)非血液学毒性,如体表水肿(体液潴留)9/20例,肌肉骨骼疼痛7/20例,关节痛6/20例,头痛3/20例;3个月以后均未发现以上不良反应。(2)血液学不良事件:中性粒细胞减少症13/20例(3个月)、7/18例(6个月)、3/10例(12个月),血小板减少症9/20例(3个月)、5/18例(6个月)、3/10例(12个月),贫血2/20例(3个月)、2/18例(6个月)、0/10例(12个月),SGOT/SGPT升高0/20例,胆红素升高0/20例。结论甲磺酸伊马替尼治疗可以使CML-CP患者获得极高的血液学缓解率和较高的细胞遗传学缓解率,其不良反应多发生于甲磺酸伊马替尼治疗的早期,与其清除恶性克隆有关。随正常造血的恢复,其治疗相关不良反应发生率明显减少。

Objective To evaluate the effccts and to analyse the adverse effects of imatinib mesylate for patients with chronic myelogenous leukemia in chronic phase. Methods Twenty patients with CML - CP were treated with 300 ~ 800 mg/d of imatinih mesylate. To monitore the routine blood test, karyotype and the transcripts expression of bcr/abl P210. To adverse re- actions observed during the treatment. Results 20 cases of CMLpatients with median follow - up time for 15 months, 18 cases （90.0%） achieved CHR, 16 cases （80. 0% ） achieved the main cytogenetics remission, and 6 cases （42. 9% ） received the molecular biology remission. Adverse effects： （1） Non -hematologic toxicity： such as superficial edema （fluid retention） for 9 cases, Musculoskeletal pain for 7 cases, Joint pain for 6 cases, headache for 3 cases. These adverse effects were disappeared after 3 months. （2） Hematologic toxicity： After the treatment for 3 months, in all 20 cases, there were 13 cases had panleuko- penia, 9 cases had thrombocytopenia and 2 cases had anemia. After 6 months, in 18 cases, there were 7 cases had panleukope- nia, 5 cases had thrombocytopenia and 2 cases had anemia. After 12 months, in 10 cases, there were 3 cases had panleukope- nia, 3 cases had thrombocytopenia and there was no cases had anemia. None had SGOT/SGPT or bilirubin increased. Conclu- sion Imatinib mesylatee can receive high a Complete Hematologic Remission rate and a high rate of the main cytogenetics remis- sion in CML - CP patients. The adverse effects occurred in the early phase of the imatinib mesylatee treatment, related with its clearing malignant clone. The incidence of adverse events associated with the treatment significantly reduce with the restoration of normal hematopoiesis.