伊马替尼与氟马替尼治疗初诊慢性粒细胞白血病的慢性期疗效与安全性比较

Comparison of efficacy and safety of imatinib and flumatinib in the treatment of newly diagnosed chronic myelogenous leukemia

目的探讨伊马替尼与氟马替尼治疗初诊慢性粒细胞白血病(CML)的慢性期疗效与安全性比较。方法选取2020年4月~2021年10月某院确诊的CML患者80例,按照治疗方案不同分为对照组(n=40例)与观察组(n=40例)。对照组接受伊马替尼治疗,观察组接受氟马替尼治疗。比较两组6个疗程后的疗效以及安全性情况,其中以主要分子学缓解率(MMR)、血液学缓解率、平均BCR-ABLIS值、细胞遗传学缓解率(CyR)作为评判疗效的指标,以不良事件发生作为评判安全性的指标。结果治疗6个疗程后,观察组MMR率明显高于对照组(P<0.05);观察组完全CyR率显著高于对照组(P<0.05)。两组的血液学缓解率均为100%,对比差异无统计学意义(P>0.05)。观察组与对照组的平均BCR-ABLIS值均随着治疗周期延长均呈现降低趋势,但观察组的BCR-ABLIS≤1%的比例显著高于对照组(P<0.05),观察组和对照组患者Ⅲ~Ⅳ级不良事件的发生率分别77.50%、82.50%,对比差异无统计学意义(P>0.05)。结论氟马替尼治疗CML患者具有显著的临床疗效,MMR率高,平均BCR-ABLIS值低,BCR-ABLIS≤1%的比例高,而伊马替尼与氟马替尼治疗CML患者的血液学缓解率与不良反应差异均无统计学意义。

Objective To compare the efficacy and safety of imatinib and flumatinib in the chronic phase of newly diagnosed chronic myeloid leukemia(CML).Methods A total of 80 CML patients diagnosed in our hospital were selected from April 2020 to October 2021 and divided into control group(n=40 cases)and observation group(n=40 cases)according to different treatment plans.The control group received imatinib therapy,and the observation group received flumatinib therapy.The efficacy and safety of the two groups after 6 courses of treatment were compared.The main molecular remission rate(MMR),hematological remission rate,average BCR-ABLISvalue,and cy togenetic remission rate(CyR)were used as indicators to evaluate efficacy,and adverse events were used as indicators to evaluate safety.Results After 6courses of treatment,the MMR rate in the observation group was significantly higher than that in the control group(P<0.05);the complete CyR rate and the main CyR rate in the observation group were significantly higher than those in the control group(P<0.05).The hematologic remission rates of the two groups were both 100%,and there was no significant difference between the two groups(P>0.05).The average BCR-ABLISvalues of the observation group and the control group showed a decreasing trend with the prolongation of the treatment period,but the proportion of BCR-ABLIS≤1%in the observation group was significantly higher than that in the control group(P<0.05).The incidences of gradeⅢ~Ⅳadverse events in the group were 77.50%and 82.50%,respectively,and the difference was not statistically significant(P>0.05).Conclusion Flumatinib has significant clinical efficacy in the treatment of CML patients,with high MMR rate,low mean BCR-ABLISvalue,and high proportion of BCR-ABLIS≤1%,while there was no significant difference in hematological remission rate and adverse reaction between imatinib and flumatinib in CML patients.