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甲磺酸伊馬替尼治療兒童慢性粒細胞白血病的臨床研究

發(fā)布時間:2018-05-18 01:32

  本文選題:兒童 + 慢性粒細胞白血病; 參考:《廣西醫(yī)科大學》2017年碩士論文


【摘要】:目的:通過回顧性分析兒童慢性粒細胞白血病患兒的臨床資料,探討甲磺酸伊馬替尼對于治療兒童慢性粒細胞白血病的近期療效及安全性,比較進口藥格列衛(wèi)與國產藥昕維的安全性及療效差異。方法:對廣西醫(yī)科大學第一附屬醫(yī)院兒科在2012年3月-2016年11月收治的12例兒童慢性粒細胞白血病患兒的臨床資料進行回顧性分析,隨訪時間為接受甲磺酸伊馬替尼治療后1周至2017年3月,觀察治療不同時期的臨床表現、血常規(guī)、骨髓細胞形態(tài)學、骨髓染色體、BCR/ABL融合基因等情況,參照NCCN制定的慢性期治療反應的定義及中國伊馬替尼療效標準對療效進行判定;回顧并比較兩組患兒血常規(guī)、肝腎功能情況;應用SPSS21.0統(tǒng)計學軟件對格列衛(wèi)組和昕維組外周血、骨髓細胞形態(tài)學達到完全血液學反應的時間分別進行統(tǒng)計學分析,比較兩者療效及安全性差異。結果:1.12例慢性粒細胞白血病患兒均為慢性期,男女比率為1.4:1,診斷及開始治療的中位年齡為6歲。2.12例患兒在伊馬替尼治療后3個月臨床癥狀、血常規(guī)達到完全血液學反應,3例患兒在治療后3個月骨髓細胞形態(tài)學達到完全血液學反應,8例患兒在3個月-17個月間達到完全血液學反應標準,1例患兒未復查骨髓細胞形態(tài)學。3.4例患兒達到完全分子生物學反應,1例達到主要分子生物學學反應,6例患兒達到完全血液學反應,1例患兒外周血達到完全血液學反應標準。4.隨訪中發(fā)現患兒有頭暈、惡心、鼻衄、關節(jié)疼痛癥狀;治療過程中12例患兒均無骨髓抑制及肝腎功能損害表現。5.12例患兒中有6例口服格列衛(wèi),6例口服昕維,以SPSS 21.0對兩組進行比較,年齡(P=0.907)、用藥劑量(起始量P=0.193;維持量P=0.949)、外周血達到完全血液學反應標準的時間(P=0.936)無統(tǒng)計差異,骨髓細胞形態(tài)學達到完全血液學反應標準的時間有統(tǒng)計學差異(P=0.004),昕維組較格列衛(wèi)組能更快達到骨髓細胞學完全緩解。結論:1.甲磺酸伊馬替尼對于治療慢性期兒童慢性粒細胞白血病有較好的近期療效及安全性。2.格列衛(wèi)與昕維對兒童慢性粒細胞白血病的療效和安全性無顯著差異。
[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.
【學位授予單位】:廣西醫(yī)科大學
【學位級別】:碩士
【學位授予年份】:2017
【分類號】:R733.72

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