国产甲磺酸伊马替尼治疗慢性髓性白血病慢性期早期疗效和安全性的前瞻性、多中心临床研究
目的评价国产甲磺酸伊马替尼(商品名昕维,江苏豪森药业股份有限公司产品)治疗新诊断慢性髓性白血病慢性期(CML—CP)患者的早期血液学、细胞遗传学、分子学反应和安全性。方法107例年龄≥18岁、初次确诊、除羟基脲外未接受其他任何抗CML治疗的CML—CP患者,给予国产甲磺酸伊马替尼400mg每日1次治疗,评价3、6个月时的血液学、细胞遗传学和分子学反应及安全性。结果107例患者均治疗≥3个月,其中54例患者治疗≥6个月。治疗3个月时,完全血液学反应(CHR)率为98.1%(105/107);57例进行了细胞遗传学检测的患者中47例(82.5%)获得主要细胞遗传学反应(MCyR),其中20例(35...
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| Published in | 中华血液学杂志 Vol. 36; no. 8; pp. 651 - 655 |
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| Main Author | |
| Format | Journal Article |
| Language | Chinese |
| Published |
100044,北京大学人民医院、北京大学血液病研究所%哈尔滨血液病肿瘤研究所%浙江大学附属第一医院%苏州大学附属第一医院%南方医科大学南方医院%福建医科大学附属协和医院%中国医学科学院、北京协和医学院血液学研究所、血液病医院%广东省人民医院%四川大学附属华西医院
2015
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0253-2727 |
| DOI | 10.3760/cma.j.issn.0253-2727.2015.08.005 |
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| Abstract | 目的评价国产甲磺酸伊马替尼(商品名昕维,江苏豪森药业股份有限公司产品)治疗新诊断慢性髓性白血病慢性期(CML—CP)患者的早期血液学、细胞遗传学、分子学反应和安全性。方法107例年龄≥18岁、初次确诊、除羟基脲外未接受其他任何抗CML治疗的CML—CP患者,给予国产甲磺酸伊马替尼400mg每日1次治疗,评价3、6个月时的血液学、细胞遗传学和分子学反应及安全性。结果107例患者均治疗≥3个月,其中54例患者治疗≥6个月。治疗3个月时,完全血液学反应(CHR)率为98.1%(105/107);57例进行了细胞遗传学检测的患者中47例(82.5%)获得主要细胞遗传学反应(MCyR),其中20例(35.1%)获得完全细胞遗传学反应(CCyR);106例进行了分子学检测的患者中77例(72.6%)国际标准化BCR—ABL转录本水平(BCR-ABL^IS)≤10%,其中11例(10.4%)BCR—ABL^IS≤0.1%。治疗6个月时,CHR率为100%(54/54);CCyR率为71.8%(28/39);37例(68.5%)BCR—ABL^IS≤1%,其中18例(33.3%)BCR-ABL^IS≤0.1%。Ⅲ级白细胞减少、血小板减少和贫血发生率分别为19.5%、23.0%和13.8%,无Ⅳ级血液学不良反应发生。最常见的非血液学不良反应依次为水肿(74.7%)、恶心(48.3%)、骨关节痛(42.5%)、皮疹(36.8%)、腹泻(34.5%)、发热(23.0%)、肌肉痉挛(11.5%)和肝功能损害(3.4%)。无一例患者出现Ⅳ级非血液学不良反应。无药物毒性相关性死亡。结论国产甲磺酸伊马替尼初始治疗新诊断CML—CP的早期血液学、细胞遗传学和分子学反应优异,安全性良好。 |
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| AbstractList | 目的 评价国产甲磺酸伊马替尼(商品名昕维,江苏豪森药业股份有限公司产品)治疗新诊断慢性髓性白血病慢性期(CML-CP)患者的早期血液学、细胞遗传学、分子学反应和安全性.方法 107例年龄≥18岁、初次确诊、除羟基脲外未接受其他任何抗CML治疗的CML-CP患者,给予国产甲磺酸伊马替尼400 mg每日1次治疗,评价3、6个月时的血液学、细胞遗传学和分子学反应及安全性.结果 107例患者均治疗≥3个月,其中54例患者治疗≥≥6个月.治疗3个月时,完全血液学反应(CHR)率为98.1%(105/107);57例进行了细胞遗传学检测的患者中47例(82.5%)获得主要细胞遗传学反应(MCyR),其中20例(35.1%)获得完全细胞遗传学反应(CCyR);106例进行了分子学检测的患者中77例(72.6%)国际标准化BCR-ABL转录本水平(BCR-ABLIs)≤10%,其中11例(10.4%)BCR-ABLIS≤0.1%.治疗6个月时,CHR率为100%(54/54);CCyR率为71.8%(28/39);37例(68.5%)BCR-ABLIS≤1%,其中18例(33.3%) BCR-ABIS≤0.1%.Ⅲ级白细胞减少、血小板减少和贫血发生率分别为19.5%、23.0%和13.8%,无Ⅳ级血液学不良反应发生.最常见的非血液学不良反应依次为水肿(74.7%)、恶心(48.3%)、骨关节痛(42.5%)、皮疹(36.8%)、腹泻(34.5%)、发热(23.0%)、肌肉痉挛(11.5%)和肝功能损害(3.4%).无一例患者出现Ⅳ级非血液学不良反应.无药物毒性相关性死亡.结论 国产甲磺酸伊马替尼初始治疗新诊断CML-CP的早期血液学、细胞遗传学和分子学反应优异,安全性良好. 目的评价国产甲磺酸伊马替尼(商品名昕维,江苏豪森药业股份有限公司产品)治疗新诊断慢性髓性白血病慢性期(CML—CP)患者的早期血液学、细胞遗传学、分子学反应和安全性。方法107例年龄≥18岁、初次确诊、除羟基脲外未接受其他任何抗CML治疗的CML—CP患者,给予国产甲磺酸伊马替尼400mg每日1次治疗,评价3、6个月时的血液学、细胞遗传学和分子学反应及安全性。结果107例患者均治疗≥3个月,其中54例患者治疗≥6个月。治疗3个月时,完全血液学反应(CHR)率为98.1%(105/107);57例进行了细胞遗传学检测的患者中47例(82.5%)获得主要细胞遗传学反应(MCyR),其中20例(35.1%)获得完全细胞遗传学反应(CCyR);106例进行了分子学检测的患者中77例(72.6%)国际标准化BCR—ABL转录本水平(BCR-ABL^IS)≤10%,其中11例(10.4%)BCR—ABL^IS≤0.1%。治疗6个月时,CHR率为100%(54/54);CCyR率为71.8%(28/39);37例(68.5%)BCR—ABL^IS≤1%,其中18例(33.3%)BCR-ABL^IS≤0.1%。Ⅲ级白细胞减少、血小板减少和贫血发生率分别为19.5%、23.0%和13.8%,无Ⅳ级血液学不良反应发生。最常见的非血液学不良反应依次为水肿(74.7%)、恶心(48.3%)、骨关节痛(42.5%)、皮疹(36.8%)、腹泻(34.5%)、发热(23.0%)、肌肉痉挛(11.5%)和肝功能损害(3.4%)。无一例患者出现Ⅳ级非血液学不良反应。无药物毒性相关性死亡。结论国产甲磺酸伊马替尼初始治疗新诊断CML—CP的早期血液学、细胞遗传学和分子学反应优异,安全性良好。 |
| Abstract_FL | Objective To evaluate the early hematologic,cytogenetic and molecular responses in newly diagnosed patients with chronic myelogenous leukemia in chronic phase (CML-CP) and initially treated with a generic imatinib (Xinwei),manufactured by Jiansu Hansoh Pharmaceutical Group Co.,Ltd.Methods 107 newly diagnosed patients of CML-CP,whose ages were above 18-year-old and who had never received any tyrosine kinase inhibitor (TKI) were treated with Xinwei 400 mg QD.The hematologic,cytogenetic and molecular responses were assessed at 3-and 6-month,and adverse effects were evaluated throughout the study.Results 107 patients were treated with Xinwei for at least 3 months,54 of them were treated for 6 months or more.At 3-month,the complete hematologic responses (CHR) rate were 98.1% (105/107);47/57 (82.5%) patients achieved major cytogenetic response (MCyR),and 20/57 (35.1%) patients complete cytogenetic response (CCyR);BCR-ABLIS was ≤10% in 77/106 patients (72.6%),11 of them (10.4%) achieved major molecular response (MMR,BCR-ABLIS was ≤0.1%).At 6-month,the CHR rate was 100% (54/54);28/39 patients (71.8%) achieved CCyR;BCR-ABLIS was ≤1% in 37/54 patients (68.5%),18 of them (33.3%) achieved MMR.The grade Ⅲ leukopenia,thrombocytopenia and anemia rates were 19.5%,23.0% and 13.8%,respectively.No grade Ⅳ hematologic toxicity occurred.The common non-hematologic toxicities were edema (74.7%),nausea (48.3%),bone pain(42.5%),rash (36.8%),diarrhea (34.5%),fever (23.0%),cramp (11.5%) and impaired liver function (3.4%).No patient experienced grade Ⅳ non-hematologic toxicity.No adverse effects related death occurred.Conclusions Our results revealed the excellent early haematology,cytogenetic and molecular responses and safety of Xinwei in treating patients with CML-CP. |
| Author | 江倩 赵东陆 金洁 吴德沛 孟凡义 胡建达 刘兵城 杜欣 刘霆 李艳 侯明 韩晓蘋 沈志祥 马军 |
| AuthorAffiliation | 北京大学人民医院、北京大学血液病研究所,100044 哈尔滨血液病肿瘤研究所 浙江大学附属第一医院 苏州大学附属第一医院 南方医科大学南方医院 福建医科大学附属协和医院 中国医学科学院、北京协和医学院血液学研究所、血液病医院 广东省人民医院 四川大学附属华西医院 中国医科大学附属第一医院 山东大学齐鲁医院 解放军总医院 上海交通大学附属瑞金医院 |
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| Keywords | Leukemia,myelogenous,chronic,BCR-ABL positive Treatment outcome 治疗结果 Generic imatinib 伊马替尼,国产 药物毒性 Drug toxicity 白血病,髓系,慢性,BCR-ABL阳性 |
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| Notes | Leukemia, myelogenous, chronic, BCR-ABL positive; Treatment outcome; Drug toxicity; Generic imatinib Objective To evaluate the early hematologic, cytogenetic and molecular responses in newly diagnosed patients with chronic myelogenous leukemia in chronic phase (CML-CP) and initially treated with a generic imatinib (Xinwei), manufactured by Jiansu Hansoh Pharmaceutical Group Co., Ltd. Methods 107 newly diagnosed patients of CML-CP, whose ages were above 18-year-old and who had never received any tyrosine kinase inhibitor (TKI) were treated with Xinwei 400 mg QD. The hematologic, cytogenetic and molecular responses were assessed at 3- and 6-month, and adverse effects were evaluated throughout the study. Results 107 patients were treated with Xinwei for at least 3 months, 54 of them were treated for 6 months or more. At 3-month, the complete hematologic responses (CHR) rate were 98.1% (105/107); 47/57 (82.5%) patients achieved major cytogenetic response (MCyR), and 20/57 (35.1%) patients complete cytogenetic resp |
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| Publisher | 100044,北京大学人民医院、北京大学血液病研究所%哈尔滨血液病肿瘤研究所%浙江大学附属第一医院%苏州大学附属第一医院%南方医科大学南方医院%福建医科大学附属协和医院%中国医学科学院、北京协和医学院血液学研究所、血液病医院%广东省人民医院%四川大学附属华西医院 |
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| Snippet | 目的评价国产甲磺酸伊马替尼(商品名昕维,江苏豪森药业股份有限公司产品)治疗新诊断慢性髓性白血病慢性期(CML—CP)患者的早期血液学、细胞遗传学、分子学反应和安全性。方... 目的 评价国产甲磺酸伊马替尼(商品名昕维,江苏豪森药业股份有限公司产品)治疗新诊断慢性髓性白血病慢性期(CML-CP)患者的早期血液学、细胞遗传学、分子学反应和安全性.方法... |
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| Title | 国产甲磺酸伊马替尼治疗慢性髓性白血病慢性期早期疗效和安全性的前瞻性、多中心临床研究 |
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