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目的甲磺酸伊马替尼作为治疗慢性粒细胞白血病(chronic myelogenous leukemia,CML)-慢性期(chronic phase,CP)患者的一线治疗药物,国产药物应用的安全性和有效性尚缺乏系统评价参考。本研究探讨国产甲磺酸伊马替尼治疗初诊CML-CP患者的早期血液学、细胞遗传学、分子学反应与安全性。方法收集2014-03-01-2015-10-31就诊于新疆自治区人民医院血液科的43例初诊CML-CP患者,给予国产甲磺酸伊马替尼(昕维○R)400mg/d口服,治疗3、6、12个月时进行骨髓细胞学、染色体、FISH与骨髓BCR-ABL融合基因转录本水平评估,观察评估患者血液学反应、细胞遗传学反应和分子学反应及安全性。结果 43例患者治疗满3个月时,42例(97.7%)达完全血液学反应(complete hematologic response,CHR);35例(81.4%)达主要细胞遗传学反应(major cytogenetic response,MCyR),其中11例(25.6%)达完全细胞遗传学反应(complete cytogenetic response,CCyR);30例(69.8%)达国际标准化BCR-ABL转录本水平(BCR-ABL~(IS))≤10%,4例(9.3%)达BCR-ABLIS≤0.1%。17例患者治疗满6个月时,均达CHR(100.0%);11例(64.7%)达CCyR;12例(70.6%)达BCR-ABLIS≤1%,其中4例(23.5%)达BCR-ABLIS≤0.1%。5例患者治疗满12个月,4例达CCyR;2例BCR-ABLIS≤1%,2例BCR-ABLIS≤0.1%,1例BCR-ABLIS>10%。血液学不良反应:3/4级白细胞减少、血小板减少和贫血发生率分别为20.9%、23.3%和16.3%。非血液学不良反应发生率分别为水肿76.7%,恶心呕吐51.2%,骨关节肌肉酸痛39.5%),皮疹20.9%,发热11.6%,腹泻11.6%,肝功能损害2.3%。无4/4级血液学与非血液学不良反应。结论国产甲磺酸伊马替尼治疗初诊CML-CP患者的近期疗效肯定,不良反应可耐受,但仍需长期观察研究。
Objective To evaluate the safety and efficacy of imatinib mesylate as a first-line treatment for patients with chronic myelogenous leukemia (CML) and chronic phase (CP). . This study was to investigate the early hematology, cytogenetics, molecular response and safety of domestic imatinib mesylate in the treatment of newly diagnosed CML-CP patients. METHODS: Forty-three newly diagnosed CML-CP patients were enrolled in Department of Hematology, People’s Hospital of Xinjiang Uygur Autonomous Region from March 1, 2014 to January 20, 2014. Patients were given oral imatinib mesylate (Xinwei ○ R) 400mg / d, The bone marrow cytology, chromosomal, FISH and bone marrow BCR-ABL fusion gene transcript levels were evaluated at 3, 6, and 12 months of treatment. Hematological, cytogenetic and molecular responses and safety were evaluated. Results Complete hematologic response (CHR) was found in 42 patients (97.7%) and major cytogenetic response (MCyR) in 35 patients (81.4%) after 43 months of treatment. Among them, 11 cases (25.6%) had complete cytogenetic response (CCyR); 30 cases (69.8%) reached the level of BCR-ABL transcripts (BCR-ABL Cases (9.3%) up to BCR-ABLIS ≤ 0.1%. Eleven patients (64.7%) had CCyR, 12 (70.6%) had BCR-ABLIS ≤1%, of which 4 (23.5%) had BCR -ABLIS ≦ 0.1%. Five patients were treated for 12 months and 4 had CCyR; 2 had BCR-ABLIS ≤ 1%, 2 had BCR-ABLIS ≤ 0.1% and 1 had BCR-ABLIS> 10%. Haematological adverse reactions: Grade 3/4 leukopenia, thrombocytopenia and anemia were 20.9%, 23.3% and 16.3%, respectively. The incidences of non-hematological adverse reactions were 76.7% for edema, 51.2% for nausea and vomiting, 39.5% for soreness of bone and joint, 20.7% for rash, 11.6% for fever, 11.6% for diarrhea and 2.3% for liver dysfunction. No grade 4/4 hematology and non-hematologic adverse reactions. Conclusion The recent efficacy of imatinib mesylate in the treatment of newly diagnosed CML-CP patients is affirmative. Adverse reactions are tolerable, but long-term observation is still needed.