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目的:评价对伊马替尼和(或)尼洛替尼/氟马替尼耐药或不耐受的慢性髓系白血病(CML)患者接受依尼舒治疗的疗效和安全性。方法:15例对伊马替尼和(或)尼洛替尼/氟马替尼耐药或不耐受CML患者,接受依尼舒100 mg qd,评价其血液学、细胞遗传学、分子学疗效、总体生存和疾病进展及不良反应。结果:15例患者中位随访时间12.3(8~20)个月,服用依尼舒中位时间12.3(2.7~17.6)个月。11例治疗前未达主要细胞遗传学反应(MCyR)患者,9例(82%)获得MCyR,中位时间2.9(2.6~5.4)个月;13例未达完全细胞遗传学反应(CCyR)患者,8例(62%)获得CCyR,中位时间3.1(2.9~7.9)个月;15例未达主要分子学反应(MMR)患者,7例(47%)获得MMR,中位时间6.3(2.6~9.1)个月;1例(7%)患者于治疗后3个月获得MR4.5。2例患者于治疗后3个月及8个月进展至急变期,均检出T315I突变,分别于治疗后8个月、10个月死亡;1例于治疗11个月时死于第二肿瘤。15个月预期无进展生存率为78%,总生存率为77%。血液学不良反应:3~4级中性粒细胞减少1例(6.7%),3~4级血小板减少4例(26.7%)。非血液学不良反应轻微,未发生3~4级不良反应。结论:伊马替尼和(或)尼洛替尼耐药和(或)不耐受的CML慢性期患者,应用依尼舒获得了较高的CCyR及MMR率。依尼舒治疗的近期观察中耐受性好,不良反应轻微,未出现胸腔积液及心脏毒性不良事件。
PURPOSE: To evaluate the efficacy and safety of enoxaparin in patients with chronic myeloid leukemia (CML) who are refractory to imatinib and / or nilotinib / flumastinib. METHODS: Fifteen patients with imatinib and / or nilotinib / flumastine resistant or intolerant CML received 100 mg qd of enyzepin to evaluate their hematology, cytogenetics, molecular Efficacy, overall survival and disease progression and adverse reactions. Results: The median follow-up time was 12.3 (8-20) months in 15 patients and 12.3 (2.7-17.6) months in enoxaparin group. Of the 11 patients who did not achieve major cytogenetic response (MCyR) before treatment, 9 (82%) received MCyR with a median time of 2.9 months (2.6-5.4) months; 13 patients who did not achieve complete cytogenetic response (CCyR) , CCyR was obtained in 8 patients (62%) with a median time of 3.1 months (2.9 to 7.9) months. MMR was found in 15 patients and in 7 patients (47%) with a median MMR of 6.3 (2.6 ~ 9.1) months. One patient (7%) got MR4.5 at 3 months after treatment. The patients with MR4.5.2 progressed to acute phase at 3 months and 8 months after treatment. The T315I mutations were detected in Eight months after treatment, 10 months died; one died of the second tumor at 11 months of treatment. The 15-month expected progression-free survival was 78% and the overall survival was 77%. Haematological adverse reactions: Grade 3 to 4 neutropenia in 1 case (6.7%), grade 3 to 4 thrombocytopenia in 4 cases (26.7%). Non-hematologic minor adverse reactions, did not occur 3 to 4 adverse reactions. CONCLUSIONS: In patients with Imatinib and / or Nilotinib-resistant and / or intolerant CML, high CCyR and MMR rates were achieved with enoxis. In the recent observation of intiixe, the patients were well tolerated with mild adverse reactions and no pleural effusion and cardiotoxic adverse events occurred.