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[目的]观察尼勒替尼联合12-氧-十四烷酰佛波醇-13-乙酸酯(TPA)治疗伊马替尼(格列卫)耐药的慢性粒细胞白血病(CML)急变期患者的临床疗效及毒性反应。[方法]选择常规剂量伊马替尼耐药的CML急性期患者72例,随机分为两组,分别应用尼勒替尼或尼勒替尼联合TPA治疗,每周复查肝肾功能,1个月后每周复查外周血涂片、血常规,每月1次进行骨髓细胞形态学检查,每3个月进行细胞遗传学检查,记录治疗过程中的不良反应,观察其血液学缓解率、细胞遗传学缓解率。[结果]尼勒替尼治疗组完全血液学缓解(CHR)6例,部分血液学缓解(PHR)12例,返回慢性期12例,无效6例,血液学缓解率(包括CHR和PHR)50%。完全细胞遗传学缓解(CCR)6例,部分细胞遗传学缓解(PCR)10例,总遗传学缓解率(包括CCR和PCR)50%率达44%。尼勒替尼联合TPA治疗组完全血液学缓解(CHR)8例,部分血液学缓解(PHR)18例,返回慢性期8例,无效2例,血液学缓解率(包括CHR和PHR)72.2%。完全细胞遗传学缓解8例,部分细胞遗传学缓解(PCR)16例,总遗传学缓解率率达67%,均高于单独用尼勒替尼治疗组。两组间血液学缓解和细胞遗传学缓解总有效率差异均有统计学意义。两组不良反应差异均无统计学意义。[结论]尼勒替尼联合TPA是治疗伊马替尼耐药CML急变期患者可行的治疗方案,其治疗慢粒急变期患者疗效理想。
[Objective] To observe the effect of nilotinib combined with 12-oxo-tetradecanoylphorbol-13-acetate (TPA) in the treatment of Imatinib-resistant chronic myeloid leukemia (CML) Period of clinical efficacy and toxicity of patients. [Methods] 72 patients with conventional CML-resistant acute myeloid leukemia were randomly divided into two groups. The patients were treated with nilotinib or nilotinib in combination with TPA. Liver and kidney function was checked weekly, and 1 Week after week review of peripheral blood smear, blood routine, once a month bone marrow cell morphology examination, cytogenetic examination every 3 months, record the adverse reactions in the course of treatment, observe the hematological response rate, the cells Genetics remission rate. [Results] Six cases of complete hematological response (CHR), 12 cases of partial hematological relief (PHR), 12 cases of chronic phase return, 6 cases of ineffectiveness, and hematological remission rate (including CHR and PHR) %. Complete cytogenetic response (CCR) in 6 cases, partial cytogenetic response (PCR) in 10 cases, the total genetic response rate (including CCR and PCR) 50% rate of 44%. Eight cases were completely hematologically relieved (CHR), 18 were partial hematological response (PHR), 8 were returned to chronic phase, 2 were ineffective, hematologic remission rate (including CHR and PHR) was 72.2% . Complete cytogenetic remission in 8 cases, partial cytogenetic response (PCR) in 16 cases, the total genetic response rate was 67%, were higher than those treated with nilotinib alone. There was significant difference between the two groups in the total effective rate of hematological remission and cytogenetic remission. No significant difference in adverse reactions between the two groups. [Conclusion] The combination of nilatatinib and TPA is a feasible treatment for patients with IMLT in CML patients, and the curative effect is good in the treatment of CML patients.