伊马替尼和尼洛替尼治疗慢性粒细胞白血病的疗效比较研究

Observation of Imatinib and Nilotinib in the Treatment of Chronic Myeloid Leukemia

摘要: 目的：探讨选择不同TKIs药物治疗慢性粒细胞白血病的疗效。方法：选取接受一代TKIs-伊马替尼(IM)或二代TKIs-尼洛替尼(NI)治疗的CML患者，检测不同时间节点外周血的BCR-ABL融合基因mRNA表达水平，评价治疗效果。结果：有效性评估：以MMR (BCR-ABLIS ≤ 0.1%)作为评估患者预后的指标，A、B、C、D组3个月的MMR率分别为7.3%、0%、27.6%、4.8%；6个月的MMR率分别为21.8%、6.7%、48.3%、19.0%；12个月MMR率29.6%、6.7%、85.7%、42.8%；18个月MMR率分别为38.8%、7.1%、78.9%、42.8%；24个月MMR率分别为44.9%、14.3%、89.5%、42.8%。结论：伊马替尼治疗新诊断CML患者的疗效优于非初治患者。与伊马替尼相比，尼洛替尼能使患者达到更早更深的分子缓解。尼洛替尼对于伊马替尼耐药或不耐受患者有较好的疗效。

Abstract: Objective: To investigate the difference of efficacy between imatinib and nilotinib in patients with chronic myeloid leukemia. Methods: A total of 120 patients treated with TKIs were enrolled in this study. The mRNA expression levels of BCR-ABL fusion gene in blood were detected in different times. The clinical data and follow-up results were analysed retrospectively to evaluate the ther-apeutic effect. Results: Evaluation of efficacy: The rates of major molecular response (MMR) at 3 months in four groups were 7.3%, 0%, 27.6% and 4.8%. The rates of MMR at 6 months in four groups were 21.8%, 6.7%, 48.3% and 19.0%. MMR rates at 12 months in four groups were 29.6%, 6.7%, 85.7% and 42.8%. MMR rates at 18 months in four groups were 38.8%, 7.1%, 78.9%, 42.8%. MMR rates at 24 months in four groups were 44.9%, 14.3%, 89.5% and 42.8%. Conclusion: The ef-ficacy of imatinib in the treatment of newly diagnosed CML patients was better than that of patients who were diagnosed for more than 6 months. Nilotinib induced strikingly higher and faster major molecular response, with a statistically significant difference compared with imatinib. Nilotinib was confirmed to be effective for patients with imatinib-resistant or intolerant.