不同TKI靶向药物对初诊慢性髓性白血病慢性期患者血液学缓解率和细胞遗传学缓解率的影响分析  

Effect of Target Therapy with Different Tyrosine Kinase Inhibitors on Hematologic and Cytogenetic Remission Rates in Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia

作　　者：韩阳利[1] 王双玲 王战芳[1] HAN Yangli;WANG Shuangling;WANG Zhanfang(The First People's Hospital of Pingdingshan,Pingdingshan,467000)

机构地区：[1]河南省平顶山市第一人民医院,467000 [2]汕头大学医学院附属二医院,515041

出　　处：《实用癌症杂志》2022年第10期1726-1729,共4页The Practical Journal of Cancer

摘　　要：目的 对比不同酪氨酸激酶抑制剂(TKIs)对初诊慢性髓性白血病慢性期(CML-CP)患者血液学缓解率以及细胞遗传学缓解率的影响。方法 采用随机盲法将68例CML-CP患者均分为伊马替尼组(n=34)与尼罗替尼组(n=34),治疗1年后,评估两组治疗效果。结果 两组患者治疗3个月后均获得完全血液学反应(CHR)。尼罗替尼组3个月后达到BCR-ABL^(IS)≤10%、治疗6个月后达到BCR-ABL^(IS)≤1%以及治疗12个月达到BCR-ABL^(IS)≤0.1%的患者占比均显著高于伊马替尼组(P<0.05)。两组治疗3个月后主要分子学反应(MMR)获得率比较无显著性差异(P>0.05),但治疗6个月及12个月后,尼罗替尼组MMR获得率均显著高于伊马替尼组(P<0.05)。两组治疗3、6、12个月后,完全细胞遗传学反应(CCyR)获得率均无显著性差异(P>0.05)。两组血液学不良反应,包括中性粒细胞计数减少、血小板减少、贫血发生率比较无显著性差异(P>0.05),尼罗替尼组非血液学不良反应中水钠潴留、胃肠道反应发生率均显著低于伊马替尼组(P<0.05),其余不良反应比较无显著性差异(P>0.05)。结论 尼罗替尼在初诊CML-CP患者中的应用价值高于伊马替尼,有望成为CML-CP的一线用药。Objective To compare the hematologic and cytogenetic remission rates in patients with newly diagnosed chronic-phase chronic myeloid leukemia(CML-CP)after target therapy with different tyrosine kinase inhibitors(TKIs).Methods 68 patients with CML-CP were randomly divided into imatinib group(n=34)and nilotinib group(n=34).After 1 year of treatment, the clinical response rate was compared between the 2 groups.Results Both groups achieved complete hematologic response(CHR)after 3 months of treatment.The proportions of breakpoint cluster region-Abelson murine leukemia viral oncogene homolog transcript level on International Scale(BCR-ABL)≤ 10 % at 3 months, BCR-ABL≤1% at 6 months, and BCR-ABL≤0.1% at 12 months were significantly higher in nilotinib group than in imatinib group(P<0.05).The major molecular response(MMR)rate yielded no statistical difference between the 2 groups at post-treatment 3 months(P>0.05),while was significantly higher in nilotinib group than in imatinib group at post-treatment 6 and 12 months(P<0.05).The complete cytogenetic remission(CCyR)rate at post-treatment 3,6 and 12 months presented no statistical difference between the 2 groups(P>0.05).The incidence of hematological adverse reactions including neutropenia, thrombocytopenia or anaemia demonstrated no statistical difference between the 2 groups(P>0.05),while the incidence of non-hematologic adverse reactions including water-sodium retention and gastrointestinal adverse events were significantly lower in nilotinib group than in imatinib group(P<0.05),meantime, no significant differences was found in the incidence of remaining adverse reactions(P>0.05).Conclusion Nilotinib is of greater value in newly diagnosed CML-CP patients than imatinib, and is expected to become the first-line drug for CML-CP.

关 键 词：伊马替尼 尼罗替尼 慢性髓性白血病 慢性期 血液学缓解率 细胞遗传学缓解率 

分 类 号：R733.72[医药卫生—肿瘤]