作　　者： (倪勋）; (邹兴立）; (王静）; (谢坤莹）; (罗文丰）; (魏锦）;

机构地区： 川北医学院附属医院血液科,四川南充637000

出　　处： 《内蒙古医学杂志》 2017年第7期775-778,共4页

摘　　要： 目的观察国产伊马替尼治疗慢性髓系白血病的疗效和安全性是否与进口伊马替尼一致。方法回顾分析2012年1月至2015年12月在我院收治的慢性期慢性髓系白血病患者58例,其中35例接受国产伊马替尼治疗,23例接受进口伊马替尼治疗,比较两组患者治疗第3、6、12个月的疗效、不良反应和生存情况。结果治疗第3个月,国产组完全血液学缓解率(CHR)和早期分子生物学缓解率(EMR,BCRABLIS≤10%)分别为94.3%和71.4%,与进口组的95.7%和73.9%相比没有显著差别(P>0.05);治疗第6个月,国产组CHR和EMR分别为97.1%%和80%,与进口组的100%和82.6%相比没有显著差别(P>0.05);治疗第12个月,国产组CHR、部分分子生物学缓解(BCR-ABLIS≤1%)率和主要分子生物学缓解(BCR-ABLIS≤0.1%)率分别为94.3%、85.7%和42.9%,与进口组的95.7%、87.0%和43.5%相比没有显著差别(P>0.05)。两组患者均无治疗相关死亡,两组患者血液学和非血液学不良反应发生率均无差别。结论国产和进口伊马替尼治疗慢性髓系白血病均具有较好的疗效和安全性,二者疗效和安全性没有明显差别。 Objective To observe whether the efficacy and safety of domestic imatinib in the treatment of chronic myeloid leukemia（CML） is consistent with that of imported imatinib. Methods 65 CML patients with chronic phase were retrospectively analyzed in this study from January 2012 to December 2015, 35 patients received domestic imatinib treatment, 23 patients received imported imatinib treatment, the efficacy at the treat- ment time of 3, 6, 12 month, adverse reactions and survial were compared between two groups. Result At the treatment time of 3 month, the rate of complete hematologic response （CHR） and early molecular response （EMR, BCR-ABLIS ≤ 10%） in domestic group were 94.3% and 71.4%, respectively compared with 95. 7 % and 73.9 % in imported group, there was no significant difference between two groups（P 〉0.05）; At the treatment time of 6 month, the rate of CHR and EMR in domestic group were 97.1% and 80%, respectively compared with 100 % and 82.6 % in imported group（P 〉0.05）. At the treatment time of 12 month, the rate of CHR, partial molecular response （ BCR - ABLIS ≤ 1% ） and major molecular response （BCR - ABLIS ≤ 0. 1% ） in domestic group were 94.3 %, 85.7 % and 42.9 %, respectively compared with 95.7 %, 87.0 % and 43.5 % in imported group（P 〉0.05）. No treatment- related deaths were found in both groups, there were no difference of hematological and non- hematological adverse mestic and imported imatinib ference of efficacy and safety have good efficacy and safety between two groups. reactions between two groups. Conclusion Both doin the treatment of CML, there is no significant difference of efficacy and safety between two groups.

关 键 词： 伊马替尼 慢性髓系白血病 疗效