国产伊马替尼治疗初诊及羟基脲转换CML患者的疗效及安全性分析

Efficacy and Safety Analysis of Newly Diagnosed and Hydroxyurea Conversion CML Patients Treated with Generic Imatinib

目的评估国产伊马替尼(IM)治疗初诊慢性髓性白血病(CML)患者及长期使用羟基脲治疗后转换患者的疗效和安全性。方法分析2013年5月~2017年5月在我院使用国产伊马替尼治疗的初诊慢性期CML患者和长期使用羟基脲后转换为国产伊马替尼治疗CML慢性期患者病历资料。结果共收集到44例初诊组和9例转换组患者的病历资料。治疗3月时,BCR-ABLIS定量≤10%的比例分别为70.5%和33.3%;治疗6月时,BCR-ABLIS定量≤1%的比例分别为66.7%和14.3%;治疗12月时,BCR-ABLIS定量≤0.1%的比例分别为36.8%和28.6%。常见不良反应有白细胞减少、血小板减少、贫血、水肿、恶心、肌肉痉挛等,患者耐受性良好。结论长期使用羟基脲治疗的CML患者,改用国产IM治疗后的耐受性良好,仍有获得满意分子生物学反应的可能,并可能因而改善预后。羟基脲治疗的CML患者,应尽快转换为伊马替尼治疗。

Objective To evaluate the efficacy and safety,which included generic imatinib （IM） in the treatment of newly diagnosed chronic myelogenous leukemia （CML） patients （newly diagnosis） ,and patients who have been treated with hydroxyurea for a long-term and then switched to generic IM （conversion）Methods To analyze the medical records of chronic phase CML patients in our hospital from May 2013 to May 2017.Results A total of 44 cases of newly diagnosed patients and 9 cases of conversion patients were collected.At 3 months of treatment, the rates of BCR-ABLIS transcripts ≤10% were 70.5% and 33.3%,respectively; at 6 months,the rates of BCR-ABLIS transcripts≤1% were 66.7% and 14.3%,respectively;at 12 months,BCR-ABLIS transcripts≤0.1% of the rates were 36.8% and 28.6%,respectively.Adverse events were leukopenia,thrombocytopenia,anemia,edema,nausea,muscle cramps,etc.Domestic imatinib is well tolerated.Conclusion CML patients who have been treated with hydroxyurea for a long time are well tolerated after administrating generic IM,and they still have the possibility of obtaining a satisfactory molecular biological response and thus improve the prognosis.CML patients treated with hydroxyurea should be converted to imatinib as soon as possible.