甲磺酸伊马替尼治疗儿童慢性粒细胞白血病的临床研究

发布时间：2018-05-18 01:32

本文选题：儿童 + 慢性粒细胞白血病　；参考：《广西医科大学》2017年硕士论文

【摘要】：目的:通过回顾性分析儿童慢性粒细胞白血病患儿的临床资料,探讨甲磺酸伊马替尼对于治疗儿童慢性粒细胞白血病的近期疗效及安全性,比较进口药格列卫与国产药昕维的安全性及疗效差异。方法:对广西医科大学第一附属医院儿科在2012年3月-2016年11月收治的12例儿童慢性粒细胞白血病患儿的临床资料进行回顾性分析,随访时间为接受甲磺酸伊马替尼治疗后1周至2017年3月,观察治疗不同时期的临床表现、血常规、骨髓细胞形态学、骨髓染色体、BCR/ABL融合基因等情况,参照NCCN制定的慢性期治疗反应的定义及中国伊马替尼疗效标准对疗效进行判定;回顾并比较两组患儿血常规、肝肾功能情况;应用SPSS21.0统计学软件对格列卫组和昕维组外周血、骨髓细胞形态学达到完全血液学反应的时间分别进行统计学分析,比较两者疗效及安全性差异。结果:1.12例慢性粒细胞白血病患儿均为慢性期,男女比率为1.4:1,诊断及开始治疗的中位年龄为6岁。2.12例患儿在伊马替尼治疗后3个月临床症状、血常规达到完全血液学反应,3例患儿在治疗后3个月骨髓细胞形态学达到完全血液学反应,8例患儿在3个月-17个月间达到完全血液学反应标准,1例患儿未复查骨髓细胞形态学。3.4例患儿达到完全分子生物学反应,1例达到主要分子生物学学反应,6例患儿达到完全血液学反应,1例患儿外周血达到完全血液学反应标准。4.随访中发现患儿有头晕、恶心、鼻衄、关节疼痛症状;治疗过程中12例患儿均无骨髓抑制及肝肾功能损害表现。5.12例患儿中有6例口服格列卫,6例口服昕维,以SPSS 21.0对两组进行比较,年龄(P=0.907)、用药剂量(起始量P=0.193;维持量P=0.949)、外周血达到完全血液学反应标准的时间(P=0.936)无统计差异,骨髓细胞形态学达到完全血液学反应标准的时间有统计学差异(P=0.004),昕维组较格列卫组能更快达到骨髓细胞学完全缓解。结论:1.甲磺酸伊马替尼对于治疗慢性期儿童慢性粒细胞白血病有较好的近期疗效及安全性。2.格列卫与昕维对儿童慢性粒细胞白血病的疗效和安全性无显著差异。
[Abstract]:Objective: to study the efficacy and safety of imatinib mesylate in the treatment of chronic myeloid leukemia in children. To compare the safety and curative effect difference between imported drug Glevir and domestic drug Xinwei. Methods: the clinical data of 12 children with chronic myeloid leukemia admitted in pediatrics department of the first affiliated Hospital of Guangxi Medical University from March 2012 to November 2016 were retrospectively analyzed. The follow-up period was from 1 week to March 2017 after treatment with imatinib mesylate. The clinical manifestations, blood routine examination, bone marrow cell morphology, bone marrow chromosome BCR / ABL fusion gene and so on were observed. According to the definition of chronic stage therapy reaction established by NCCN and the Chinese standard of imatinib curative effect, the curative effect was judged, the blood routine, liver and kidney function of the two groups were reviewed and compared, and the peripheral blood of Glewei group and Xinwei group were analyzed by SPSS21.0 software. The time of complete hematological response of bone marrow cells was statistically analyzed to compare the efficacy and safety of the two methods. Results the ratio of male to female was 1.4: 1. The median age of diagnosis and treatment was 6 years old. 2. 12 cases had clinical symptoms 3 months after treatment with imatinib. Blood routine reached complete hematological response in 3 children with bone marrow cell morphology reached complete hematological response in 3 months after treatment. 8 cases reached complete hematological response standard in 3 to 17 months. Medullary morphology. 3.4 cases of children achieved complete molecular biological response and 1 case of major molecular biological reaction. 6 cases of children with complete hematological response and 1 case of peripheral blood reached the standard of complete hematological reaction .4. During the follow-up, dizziness, nausea, epistaxis and joint pain were found in the children. SPSS 21.0 was used to compare the two groups. There was no statistical difference between the two groups in terms of age, dosage (initial dose P0. 1993; maintenance dose: P0. 949; time for peripheral blood to reach the standard of complete hematological response, P 0. 936). The time of bone marrow cell morphology reaching the standard of complete hematological reaction was significantly different (P0. 004), and the complete remission of bone marrow cytology in Xinwei group was faster than that in Gliewei group. Conclusion 1. Imatinib mesylate has good short-term efficacy and safety in the treatment of chronic myeloid leukemia in children. There was no significant difference in efficacy and safety between Gliewei and Xinwei in the treatment of chronic myeloid leukemia in children.
【学位授予单位】：广西医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R733.72

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