摘要
目的比较尼洛替尼与伊马替尼治疗慢性粒细胞白血病(CML)的早期(3个月时)疗效以及安全性。方法选取2007年1月至2017年12月安徽省立医院确诊CML的患者129例,采用随机数字表法按照1∶7分为尼洛替尼组(18例)和伊马替尼组(111例)。两组患者服药3个月后门诊复查骨髓形态学、BCR-ABL融合基因国际标准值(BCR-ABLIS),比较两组患者的BCR-ABLIS结果,评价两组患者的疗效(主要指标为BCR-ABLIS≤10%的达标率、BCR-ABLIS≤0.0032%的比例)以及药物的安全性(白细胞减少、血小板减少、贫血等血液学毒性;Q-T间期延长,以及肝功能损害、骨骼肌肉疼痛、水肿、皮疹、消化道症状等不良反应发生情况)。结果尼洛替尼组患者治疗3个月时达到BCR-ABLIS≤10%、BCR-ABLIS≤0.0032%的比例均高于伊马替尼组(94.44%vs 69.37%;55.55%vs 27.92%),差异均有统计学意义(P<0.05);两组患者药物安全性比较,差异无统计学意义(P>0.05)。结论尼洛替尼治疗CML的早期分子学反应达标率以及患者分子学反应的深度均高于伊马替尼组,两种药物不良反应发生情况无显著差异。
Objective To compare the efficacy and safety of nilotinib and imatinib in the early treatment （ three months） of chronic myelogenous leukemia （CML）. Methods A total of 129 cases of chronic myelogenous leukemia patients admitted to our hospital from Jan 2007 to Dec 2017 were selected and randomized into two groups according to the ratio of 1 7, among whom 18 patients were treated with nilo- tinib 300 ~400mg twice a day, and 111 patients with imatinib 300 ~400mg once daily. Bone marrow morphology and BCR - ABLIS were as-sessed after three months of medication, and the efficacy （ the proportion of BCR - ABLIS^IO% , BCR - ABLIS^O. 0032% ） and safety （the occurrence of leukopenia, thrombocytopenia, anemia, prolongation of Q - T interval, and liver dysfunction, skeletal muscle pain, ede-ma, rash, gastrointestinal symptoms and other adverse reactions） were compared. Results The percentage of patients with BCR - ABOS^ 10% and BCR - ABLIS ^ 0. 0032% in nilotinib group was both higher than that in imatinib group （94. 44% vs 69. 37% ; 55. 55% vs 27.92% ） after three months of medication, and the differences were statistically significant. There were two cases in nilotinib group （11.11% ） . There was no significant difference in the incidence of adverse reactions between the two groups （ P 〉 0. 05 ） . Conclusion The early molecular response rate of nilotinib is higher than imatinib in the treatment of CML, and the depth of remission is better than imatinib. No difference exists in the occurrence rate of adverse reactions.
作者
薛磊
杨会志
王兴兵
刘欣
朱薇波
XUE lei;YANG Huizhi;WANG Xingbing(Department of Hematology,Anhui Provincial Hospital y Hefei 230001,China)
出处
《安徽医学》
2018年第8期944-947,共4页
Anhui Medical Journal
