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目的:评价国产甲磺酸伊马替尼(商品名格尼可)一线治疗慢性髓系白血病慢性期患者的血液学、细胞遗传学、分子生物学反应和安全性,为临床用药提供循证学依据。方法:纳入年龄≥14岁,除羟基脲、干扰素外既往未使用任何酪氨酸激酶抑制剂的慢性髓系白血病慢性期患者47例,给予国产伊马替尼一线治疗(每次400mg,口服,每日1次),对患者在接受国产伊马替尼治疗第3、6、12个月时的血液学、细胞遗传学、分子生物学反应和安全性进行评价。结果:47例患者接受国产伊马替尼治疗时间≥3个月,其中32例治疗时间≥6个月,21例治疗时间≥12个月。治疗3个月时,完全血液学反应(CHR)率为93.6%(44/47),完全细胞遗传学反应(CCyR)率为38.3%(18/47),主要分子学反应(MMR)率为10.6%(5/47);治疗6个月时,CHR率为96.9%(31/32),CCyR率为56.3%(18/32),MMR率为18.8%(6/32);治疗12个月时,CHR率为100.0%(21/21),CCyR率为61.9%(13/21),MMR率为28.6%(6/21)。国产伊马替尼的不良反应以非血液学常见,其发生率依次为浮肿(76.6%)、恶心呕吐(40.4%)、肌肉酸痛(31.9%)、骨骼疼痛(23.4%)、头痛头晕(12.8%)、皮疹(10.6%)、腹泻(8.5%)和肝功能异常(4.3%);血液学不良反应发生率依次为血小板减少(34.0%)、白细胞减少(31.9%)和贫血(23.4%);无药物毒性相关性死亡。结论:国产伊马替尼对慢性髓系白血病慢性期患者的血液学、细胞遗传学和分子生物学反应良好,安全性高。
OBJECTIVE: To evaluate the hematological, cytogenetic, molecular biological response and safety of the domestic first-line chronic myeloid leukemia patients treated with imatinib mesylate (a trade name Geniposil), providing evidence-based medicine for clinical use in accordance with. Methods: Forty-seven patients with chronic myeloid leukemia who had never used any tyrosine kinase inhibitor besides hydroxyurea and interferon were enrolled in this study. First-line domestic imatinib treatment was given (400mg, orally , Once daily) were used to evaluate the hematology, cytogenetics, molecular biology response and safety of the patients at the 3rd, 6th and 12th months of receiving imatinib treatment. Results: 47 cases received imatinib treatment for more than 3 months, of which 32 cases were treated for more than 6 months and 21 cases were treated for more than 12 months. At 3 months of treatment, the complete hematologic response (CHR) rate was 93.6% (44/47), the complete cytogenetic response (CCyR) rate was 38.3% (18/47), and the major molecular response (MMR) rate was 10.6% (5/47). At 6 months, the CHR rate was 96.9% (31/32), the CCyR rate was 56.3% (18/32) and the MMR rate was 18.8% (6/32) Month, the CHR rate was 100.0% (21/21), the CCyR rate was 61.9% (13/21), and the MMR rate was 28.6% (6/21). The adverse reactions of domestic imatinib were common in non-hematology. The incidence of edema was 76.6%, nausea and vomiting (40.4%), muscle soreness (31.9%), skeletal pain (23.4%), headache and dizziness The incidence of hematologic adverse reactions was thrombocytopenia (34.0%), leucopenia (31.9%) and anemia (23.4%), respectively. No drug-related deaths. Conclusion: The domestic imatinib has a good response to hematology, cytogenetics and molecular biology in patients with chronic myeloid leukemia and high safety.