原研伊马替尼转换国产伊马替尼治疗慢性髓性白血病慢性期的疗效和安全性

Efficacy and safety of conversion from original imatinib to domestic imat inib for chronic myelogenous leukemia

目的:观察为使用原研伊马替尼的慢性髓性白血病慢性期(CML-CP)患者转换使用国产伊马替尼(商品名:格尼可)进行治疗的疗效和安全性。方法:回顾分析51例接受国产伊马替尼转换治疗的CML-CP患者(接受转换治疗前均获得稳定分子学反应)的临床资料。比较接受转换治疗前及接受转换治疗后第3个月、第6个月、第9个月、第12个月时其获得的分子学反应及不良反应的发生率,评估其对国产伊马替尼的接受度。结果:在接受转换治疗前后各随访时间点,这些患者获得分子学反应的等级相比,差异无统计学意义(P>0.05)。与接受转换治疗前相比,接受转换治疗后这些患者恶心症状的发生率较低,P=0.048;其他血液学不良反应及非血液学不良反应的发生率与接受转换治疗前相比,P>0.05。至随访期末,有48例(94.1%)患者表示愿意转换使用国产伊马替尼进行治疗。结论:为使用原研伊马替尼的CML-CP患者转换使用国产伊马替尼进行治疗的疗效良好,且安全性较高。

Objective:To observe the efficacy and safety of switching to domestic imatinib(trade name:Ginic)for chronic myeloid leukemia(CML-CP)patients who received original imatinib.Methods:The clinical data of 51 CML-CP patients who received domestic imatinib conversion therapy(all had stable molecular responses before conversion therapy)were reviewed.The incidence of molecular reactions and adverse reactions were compared before and after conversion therapy at 3,6,9 and 12 months,and the acceptance of domestic imatinib was evaluated.Results:There was no significant difference in the grade of molecular response before and after conversion therapy(P>0.05).These patients had a lower incidence of nausea after conversion therapy compared to before conversion therapy(P=0.048);The incidence of other hematological and non-hematological adverse reactions was compared with that before conversion therapy(P>0.05).At the end of follow-up,48 patients(94.1%)were willing to switch to domestic imatinib treatment.Conclusions:The conversion of domestic imatinib to treatment of CML-CP patients with original imatinib has good efficacy and high safety.