甲磺酸伊马替尼治疗慢性粒细胞白血病的临床观察

Experience of imatinib in the treatment of chronic myelogenous leukemia

目的：总结甲磺酸伊马替尼（IM）治疗Ph阳性慢性粒细胞白血病（CML）患者的临床观察体会。方法：收集110例Ph阳性CML慢性期（CP）患者、6例加速期（AP）患者和4例急变期（BC）患者分别口服IM 400、600或800 mg/d。通过血液学、细胞遗传学和分子遗传学指标来判断疗效。结果：CP患者完全血液学反应（CHR）率、主要细胞遗传学反应（MCyR）率和完全细胞遗传学反应（CCyR）率分别为98.2%、90.9%和80.9%;AP分别为66.7%、33.3%和16.7%,P值分别为0.002、0.000和0.000。其中CP患者中肝肾功能不全的患者需减少IM剂量。27例经干扰素治疗失败的CP患者IM治疗仍有效。第1年高随访（1次/月）CP患者CCyR达81.9%,非高随访则为63.6%,P=0.005 2。服药前肾功能不全和肝功能不全较脏器功能正常的CP患者服药6个月内发生3~4级血液学毒副反应概率增高,服药6个月后有所减少。结论：IM对CP患者包括干扰素治疗失败的有较高疗效,对AP和BC患者有一定近期疗效。肝肾功能不全的患者易出现血液学毒副反应,需要药物剂量调整。

OBJECTIVE： To summarize the experience of imatinib mesylate（IM） in the treatment of patients with Philadelphia chromosome-positive（Ph-positive） chronic myeloid leukemia（CML）.METHODS：Totally 110 patients with Ph-positive CML in chronic phase（CP） were treated with IM 400 mg/d;6 CML patients of accelerated phase（AP） and 4 CML patients with blastcrisis（BC） were treated with IM 600 mg/d and 800 mg/d respectively.RESULTS： Overall complete hematological response（CHR） rate,major cytogenetic response（MCyR） rate and complete cytogenetic response（CCyR） rate of CP were 98.2%,90.9% and 80.9% respectively;while those of AP were 66.7%,33.3% and 16.7%（P were 0.002,0.000 and 0.000）.Dose reductions were performed in of 97 patients with renal and liver dysfunction.IM was effective in 27 patients with CP who failed in previous IFN-α therapy.CCyR of CP patients with high follow-up（every 1 months）of CP patients was 81.9% in the first 12 months,however,of CP patients with non high follow-up was 63.6%（P=0.005 2）;The rate of grade 3-4 hematologic toxicities of patients with pre-existing renal dysfunction and liver dysfunction was more than that of normal organ function during intitial 6 months after treatment with IM.After 6 months,the adverse events were lower.CONCLUSIONS： IM induced MCyR and CCyR of patients with CP including patients who failed in previous IFN-α therapy are achieved by neceiving IM.Most patients with pre-existing liver and/or renal dysfunction may have a higher rate of hematologic toxicity and required more frequent dose reductions.