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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 investigate the efficacy and safety of imatinib (Gleevec) in the treatment of patients with chronic myeloid leukemia (CMLCP) treated with generic imatinib. Methods: The clinical data of 13 patients with CML-CP treated with Gleevec were retrospectively analyzed. The curative effects and adverse reactions of the two drugs were compared. RESULTS: Of the 13 CML-CP patients, 11 received the main molecular response (MMR) during their use of Gleevec (mean duration of medication was 58 months), 1 was not obtained during the use of Gleevec (medication duration 46 months) MMR, 1 case because of taking Gleevec only 1 month still can not assess the efficacy. Of the 11 MMR patients, 2 were relapsed after Gleevec relapse and were switched to Gynicon the best response at the monitoring time point; 9 were converted from Gleevec to Gnostic and were maintained MMR. One case of non-MMR patients switched to gonorrhea, BCR-ABLIS values continue to decline. One patient who did not respond to Gleevec for 1 month was not able to assess the efficacy of givir because of vomiting can not tolerate conversion to gnostic, 9 months up to MMR. The incidence of adverse reactions to gleevec and geniposil was similar, with anemia (38.5% vs 30.8%), leukopenia (23.1% vs 15.4%), and thrombocytopenia (23.1% vs 15.4%); common Adverse reactions to hematology were nausea and vomiting (38.5% vs 7.7%), rash, joint pain, numbness of the limbs, abnormal liver enzymes, scaling of the fingers and toes, and no significant difference between taking gleevec and gnostic. CONCLUSIONS: Gleevec has better efficacy and safety during the conversion of Gleevec to CML-CP, and Gnostic is inexpensive and can be used as a medication option for patients with CML-CP, but this time Small sample size, there may be errors, still need a large sample of studies confirmed.