【摘要】 目的评价对伊马替尼耐药或不耐受的慢性粒细胞白血病(CML)患者接受尼洛替尼治疗的远期疗效和安全性。方法 26例对伊马替尼耐药或不耐受CML患者接受尼洛替尼400～800 mg/d治疗,随访观察近5年,定期监测血液学、细胞遗传学及分子生物学指标,记录用药后患者临床表现及各项生化指标,评价其疗效、不良反应。结果 26例对伊马替尼耐药或不耐受的CML患者,尼洛替尼中位治疗时间17个月,中位随访时间51个月。累计获得完全血液学缓解(CHR)16例(61.5%),获得主要细胞遗传学缓解(MCyR)13例(50.0%),获得完全细胞遗传学缓解(CCyR)9例(34.6%),获得主要分子生物学缓解(MMR)7例(26.9%)。尼洛替尼治疗相关的非血液学不良反应多为l～2级,主要为胆红素升高(69.2%)和皮疹(57.7%)。3～4级血液学不良反应包括血小板减少(53.8%)、中性粒细胞减少和贫血(分别为26.9%和19.2%)。相比进展期患者,尼洛替尼对慢性期和缓解期的患者疗效更佳、血液学副作用更少。结论尼洛替尼为对伊马替尼耐药和不耐受的CML患者提供了一个有效并安全的治疗选择,尤其对非进展期CML患者更为安全和有效。更多还原

【Abstract】 Objective To evaluate the long-term clinical efficacy and safety of nilotinib in the treatment of chronic myelogenous leukemia(CML) patients with imatinib resistance or intolerance.Methods Twenty-six CML patients with imatinib resistance or intolerance received nilotinib treatment at the dose of 400 mg once or twice daily.The patients were followed up for nearly 5 years with regular monitoring of the hematologic,cytogenetic and molecular biological markers and recording of the clinical manifestations and biochemical indicators to evaluate the therapeutic effect and adverse events.Results The median duration of nilotinib therapy was 17(1-56) months,and the patients were follow up for a median of 51 months.At the last follow-up,16(61.5%) patients achieved a complete hematologic response,13(50.0%) achieved a major cytogenetic response,9(34.6%) achieved a complete cytogenetic response,and 7(26.9%) achieved a major molecular response accumulatively.Nonhematologic adverse events were mostly of grade l or 2.The most common adverse effects possibly related to nilotinib were increased bilirubin(69.2%) and rash(57.7%).Grade 3 or 4 hematologic adverse events included thrombocytopenia(53.8%),neutropenia(26.9%) and anemia(19.2%).The patients in chronic and remission phase had better efficacy and fewer hematological side effects than those in advanced phase.Conclusion Nilotinib is an effective and safe treatment option for imatinib-resistant or-intolerant CML patients,especially for those in chronic and remission phase.更多还原