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目的:比较国产酪氨酸激酶抑制剂(TKI)达沙替尼(依尼舒)和原研达沙替尼(施达赛)二线治疗慢性髓系白血病慢性期(CML-CP)患者的有效性。方法:收集湖北省慢粒协作组成员医院二线服用依尼舒(55例)和施达赛(12例)CML患者的病例资料,回顾性统计分析患者的基本资料,服用依尼舒和施达赛后3、6和12个月的疗效及依尼舒的不良反应发生率。结果:依尼舒和施达赛二线治疗后3个月BCR-ABL~(IS)≤10%或Ph~+≤65%,6个月BCR-ABL~(IS)≤10%或Ph~+≤35%和12个月BCR-ABL~(IS)≤1%或Ph~-患者,分别达78.6%(33/42)vs50.0%(5/10)(P=0.109),63.9%(23/36)vs 44.4%(4/9)(P=0.449),50.0%(11/22)vs 60.0%(6/10)(P=0.605)。同时依尼舒治疗耐受性较好。结论:依尼舒二线治疗CML-CP患者的疗效和安全性与原研药类似,可作为CML-CP患者的二线用药选择,但仍需大样本研究证实。
OBJECTIVE: To compare the efficacy of the domestic tyrosine kinase inhibitor (dasatinib) and the naive dasatinib second-line treatment of chronic myeloid leukemia (CML-CP) patients . Methods: The data of cases of CML patients taking Yi Nishu (55 cases) and Shi Dasai (12 cases) in the second-line hospital of Cochrane Cooperatives in Hubei Province were collected. The basic statistical data of patients were retrospectively analyzed. The efficacy of 3, 6 and 12 months after the race and the incidence of adverse reactions of enoxaparin. Results: BCR-ABL ≤10% or Ph ~ + ≤65%, BCR-ABL (IS) ≤10% or Ph ~ + (P = 0.109) and 63.9% (P = 0.109) in patients with BCR-ABL ≤1% or Ph ~ 23/36) vs 44.4% (4/9) (P = 0.449), 50.0% (11/22) vs 60.0% (6/10) (P = 0.605). At the same time, according to the treatment of good tolerance Nishu. CONCLUSION: The efficacy and safety of second-line in-treatment of CML-CP with enyzepine is similar to that of the original drug and may be used as a second-line drug in patients with CML-CP. However, large sample studies are still needed.