摘要
目的评价伊马替尼治疗儿童慢性髓系白血病慢性期(CML-CP)的有效性与安全性,分析进口原研药伊马替尼(格列卫)和国产仿制药(昕维)有效性与安全性的差别。方法回顾性收集2014年1月至2018年1月北京儿童医院初次确诊35例CML-CP患儿,其中15例患儿为原研药组,20例患儿为仿制药组;评价3个月、6个月和12个月时两组间血液学、细胞遗传学和分子学反应及安全性,组间比较采用χ2检验或秩和检验。结果35例CML-CP患儿中治疗时间>3个月35例,>6个月31例,>12个月25例。治疗3个月时,原研药组和仿制药组各有15例(100%)和16例(80%)患儿获得主要细胞遗传学反应(χ^2=3.387,P=0.119);6个月时,原研药组和仿制药组各有12例(80%)和10例(63%)患儿获得完全细胞遗传学反应(χ^2=1.435,P=0.390);12个月时,原研药组和仿制药组各有11例(92%)和10例(77%)患儿BCR-ABL^IS≤ 0.1%(χ^2=1.009,P=0.593),各阶段治疗效果两组间差异均无统计学意义(P均>0.05)。血液学不良反应发生的比例为20%(7例),非血液学不良反应依次为恶心(8例,23%)、疼痛(8例,23%)、水肿(6例,17%)、呕吐(2例,6%)、发热(2例,6%)、乏力(1例,3%)、皮疹(1例,3%)。不良反应易控制,无药物毒性相关性死亡。原研药组与仿制药组不良反应差异均无统计学意义(P均>0.05)。结论伊马替尼治疗新诊断儿童CML-CP患者具有良好的有效性和安全性,国产伊马替尼疗效与进口原研药差异无统计学意义。
Objective To evaluate the efficacy and safety of imatinib in the treatment of newly diagnosed chronic myeloid leukemia during chronic phase (CML-CP) in children and to analyze the difference of the efficacy and safety between imported original imatinib (Gleevec) and domestic generic imatinib (Xinwei). Methods Clinical data of 35 children with newly diagnosed CML-CP in Beijing Children′s Hospital from January 2014 to January 2018 were collected,among which 15 cases were treated with the imported original imatinib (original drug group) and 20 cases were treated with the domestic generic imatinib (generic drug group).The hematological,cytogenetic and molecular reactions and safety of the treatments were monitored at months 3,6 and 12.Chi square test or rank sum test was used for the comparison between two groups. Results A total of 35 cases were treated for over 3 months,31 cases were treated for over 6 months and 25 cases were treated for over 12 months.At 3 months,main cytogenetic response was obtained in 15 (100%) cases in the original drug group and 16 (80%) cases in the generic drug group respectively (χ^2=3.387,P=0.119).At 6 months,complete cytogenetic response was obtained in 12 (80%) cases in the original drug group and 10 (63%) cases in the generic drug group (χ^2=1.435,P=0.390).At 12 months,BCR-ABL^IS ≤ 0.1% was obtained in 11 (92%) cases in the original drug group and 10 (77%) cases in the generic drug group (χ^2=1.009,P=0.593).There was no significant difference at all stages (all P>0.05).Hematologic toxicity occurred in 7(20%) cases.The non-hematologic adverse reactions include nausea in 8 (23%) cases,pain in 8 (23%) cases,edema in 6 (17%) cases,emesis in 2 (6%) cases,fever in 2 (6%) cases,weakness in 1 (3%) case,rash in 1 (3%) case.The adverse reactions were easy to control and no drug toxicity related deaths occurred.There was no significant difference in the adverse reactions between original drug group and generic drug group (P>0.05). Conclusions Imatinib had a good efficacy and safety in the
作者
张利强
郑杰
陈振萍
李斯丹
马洁
吴润晖
Zhang Liqiang;Zheng Jie;Chen Zhenping;Li Sidan;Ma Jie;Wu Runhui(Hematology Oncology Center,Beijing Children's Hospital,Capital Medical University,Beijing 100045,China)
出处
《中华儿科杂志》
CAS
CSCD
北大核心
2019年第2期113-117,共5页
Chinese Journal of Pediatrics
关键词
儿童
白血病
髓样
慢性期
细胞遗传学
Child
Leukemia, myeloid, chronic-phase
Cytogenetics
