原研伊马替尼转用仿制伊马替尼治疗慢性髓性白血病慢性期的疗效与安全性分析

Evaluation of the efficacy and safety of generic imatinib (Gnico) in patients with CML-CP switching from branded imatinib (Gleevec)

目的:探讨原研伊马替尼(格列卫)转用仿制伊马替尼(格尼可)治疗慢性髓性白血病慢性期(CMLCP)患者的疗效与安全性。方法:回顾性分析13例格列卫转用格尼可治疗CML-CP患者的临床资料,比较分析2个用药时期的疗效和不良反应。结果:13例CML-CP患者中,11例服用格列卫期间(平均用药时间58个月)获得主要分子学反应(MMR),1例服用格列卫期间(用药时间46个月)未获得MMR,1例因服用格列卫仅1个月尚无法评估疗效。11例获得MMR的患者中,2例停用格列卫复发,转用格尼可后,均在监测时间点获得最佳反应;9例直接由格列卫转为格尼可,并维持获得MMR。1例未获得MMR的患者转用格尼可后,BCR-ABLIS值不断降低。1例服用格列卫仅1个月尚无法评估疗效的患者,因呕吐不能耐受转用格尼可,9个月达MMR。格列卫和格尼可的血液学不良反应发生率相似,主要有贫血(38.5%vs 30.8%)、白细胞减少(23.1%vs 15.4%)和血小板减少(23.1%vs 15.4%);常见的非血液学不良反应为恶心呕吐(38.5%vs 7.7%),皮疹、关节疼痛、四肢麻木、肝酶异常、手指脚趾脱屑等不良反应在服用格列卫与格尼可期间无明显差异。结论:格列卫转用格尼可治疗CML-CP患者过程中,格尼可有较好的疗效和安全性,且格尼可价格便宜,可作为CML-CP患者的用药选择,但本次研究样本量少,可能存在误差,仍需大样本研究证实。

Objective：To evaluate the efficacy and safety of generic imatinib（Gnico）in patients with CML-CP switching from branded imatinib（Gleevec）.Method：Thirteen patients with CML-CP switched from Gleevec to Gnico were enrolled.We comparatively analyzed the efficacy and adverse reactions of the two medication periods.Result：In the 13 patients with CML-CP,11 patients received MMR during Gleevec（mean time in 58 months）,1 patient did not obtain MMR（46 months）,and 1 patient took Gleevev one month and the efficacy of Gleevec cannot be evaluated due to short mediation time.In the 11 patients with CML-CP who received MMR,2 patients discontinued Gleevec and relapsed,then received the best response at the monitoring time after switching to Gnico;9 patients maintained with MMR after switching to Gnico.BCR-ABLIS value reduced in 1 patient who did not obtain MMR with Gleevec after switching to Gnico.One patient switched to Gnico due to intolerance of emisis,and achieved MMR after 9 medication months of Gnico.Hematological adverse reactions of Gleevec and Gnico were similar,including anemia（38.5% vs 30.8%）,leukopenia（23.1% vs 15.4%）and thrombocytopenia（23.1% vs15.4%）.Common non-hematological adverse reaction of Gleevec and Gnico were nausea and vomiting（38.5% vs7.7%）.There was no significant difference in rash,joint pain,limb numbness,liver enzyme abnormalities,finger toes scaling and other adverse reactions between the two medication periods.Conclusion：Gnico has a good efficacy and safety in the treatment of patients with CML-CP and can be an option for CML-CP patients for its lower price.There may be errors for the sample size of this study is small,large sample study is still needed to confirm the conclusion.