Zhang L Q, Zheng J, Chen Z P, Li S D, Ma J, Wu R H
Hematology Oncology Center, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China.
Zhonghua Er Ke Za Zhi. 2019 Feb 2;57(2):113-117. doi: 10.3760/cma.j.issn.0578-1310.2019.02.010.
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). 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. 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, 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, 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, 0.593). There was no significant difference at all stages (all 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 (0.05). Imatinib had a good efficacy and safety in the early treatment of newly diagnosed CML-CP in children. The efficacy and safety of generic imatinib is similar to that of imported imatinib.
评估伊马替尼治疗儿童新诊断慢性期慢性髓性白血病（CML-CP）的疗效和安全性，并分析进口原研伊马替尼（格列卫）与国产伊马替尼（昕维）疗效和安全性的差异。收集2014年1月至2018年1月在北京儿童医院新诊断为CML-CP的35例儿童的临床资料，其中15例接受进口原研伊马替尼治疗（原研药组），20例接受国产伊马替尼治疗（仿制药组）。在第3、6和12个月监测治疗的血液学、细胞遗传学和分子反应及安全性。两组间比较采用卡方检验或秩和检验。共35例治疗超过3个月，31例治疗超过6个月，25例治疗超过12个月。在3个月时，原研药组15例（100%）获得主要细胞遗传学反应，仿制药组16例（80%）获得主要细胞遗传学反应（χ(2)=3.387，P=0.119）。在6个月时，原研药组12例（80%）获得完全细胞遗传学反应，仿制药组10例（63%）获得完全细胞遗传学反应（χ(2)=1.435，P=0.390）。在12个月时，原研药组11例（92%）BCR-ABL(IS)≤0.1%，仿制药组10例（77%）BCR-ABL(IS)≤0.1%（χ(2)=1.009，P=0.593）。各阶段均无显著差异（均P>0.05）。7例（20%）发生血液学毒性。非血液学不良反应包括恶心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%）。不良反应易于控制，未发生药物毒性相关死亡。原研药组与仿制药组不良反应无显著差异（P>0.05）。伊马替尼在儿童新诊断CML-CP的早期治疗中疗效和安全性良好。国产伊马替尼的疗效和安全性与进口伊马替尼相似。
