达沙替尼70 mg/d与100 mg/d一线对比治疗慢性髓性白血病慢性期患者的前瞻性随机对照多中心临床研究初步结果  

Preliminary results of a prospective randomized controlled multicenter clinical trial of dasatinib 70mg/d versus 100mg/d in the first-line treatment of chronic myeloid leukemia in chronic phase

作　　者：余丹[1] 程辉[1] 郭静明[2] 王龙[3] 张友山[4] 万楚成[5] 覃竣 袁国林[7] 姜道滋[8] 陈世明[9] 邹菁 邹秀平 韩丹壘[2] 蒋锐[3] 梁彩霞[4] 陈旭 王黎[6] 吕婷婷[7] 鄢丽 安宏玉[9] 杨壮志[11] 黎纬明[10] YU Dan;CHENG Hui;GUO Jingming;WANG Long;ZHANG Youshan;WAN Chucheng;QIN Jun;YUAN Guolin;JIANG Daozi;CHEN Shiming;ZOU Jing;ZOU Xiuping;HAN Danlei;JIANG Rui;LIANG Caixia;CHEN Xu;WANG Li;LV Tingting;YAN Li;AN Hongyu;YANG Zhuangzhi;LI Weiming(Wuhan No.1 Hospital,Wuhan,430000,China;Yichang Central People’s Hospital;Jingmen First People’s Hospital;Jingzhou First People’s Hospital;Shiyan Taihe Hospital;Shiyan People’s Hospital;Xiangyang Central Hospital;People’s Hospital of Wuhan University;Huangshi Central Hospital;Union Hospital Affiliated to Tongji Medical College,Huazhong University of Science and Technology;Suizhou Central Hospital)

机构地区：[1]武汉市第一医院,武汉430000 [2]宜昌市中心人民医院 [3]荆门市第一人民医院 [4]荆州市第一人民医院 [5]十堰市太和医院 [6]十堰市人民医院 [7]襄阳市中心医院 [8]武汉大学人民医院 [9]黄石市中心医院 [10]华中科技大学同济医学院附属协和医院 [11]随州市中心医院

出　　处：《临床血液学杂志》2021年第7期472-476,共5页Journal of Clinical Hematology

摘　　要：目的:对比达沙替尼70 mg/d和100 mg/d在慢性髓性白血病慢性期(CML-CP)患者中的疗效及不良反应。方法:将2019年7月—2020年8月确诊的51例CML-CP初治患者,随机分为70 mg/d组(29例)和100 mg/d组(22例),观察并比较2组患者的疗效及不良反应。结果:51例CML-CP患者中6例因不同原因在不同时期出组,治疗3个月时患者均获得血液学缓解,70 mg/d组和100 mg/d组患者在3个月时最佳反应率分别为87.50%vs 92.31%(P>0.05);在6个月时最佳反应率、完全细胞遗传学反应(CCyR)和主要分子学反应(MMR)率分别为91.67%vs 63.64%(P>0.05),91.67%vs 90.91%(P>0.05),66.67%vs 63.64%(P>0.05);在9个月时CCyR和MMR率分别为88.89%vs 88.89%(P>0.05),77.78%vs 77.78%(P>0.05);在12个月时CCyR和MMR率分别为87.50%vs 100.00%(P>0.05),75.00%vs 80.00%(P>0.05)。70 mg/d组29例患者中不良反应多不严重,其中3/4级血液学不良反应中白细胞数降低1例,中性粒细胞计数降低1例,贫血2例;100 mg/d组22例患者3/4级血液学不良反应中,白细胞数降低4例,中性粒细胞计数降低6例,贫血3例,血小板计数降低3例。2组患者不良反应发生率差异无统计学意义(P>0.05)。结论:达沙替尼70 mg/d和100 mg/d在CML-CP患者中的疗效及不良反应无明显差异。Objective: To compare the clinical efficacy and adverse events of domestic dasatinib 70 mg/d and 100 mg/d in the first-line treatment of patients with chronic myeloid leukemia in chronic phase(CML-CP). Methods: A total of 51 patients with newly diagnosed CML-CP from July 2019 to August 2020 were randomly assigned to receive dasatinib at a dose of 70 mg once daily(29 patients) or dasatinib at a dose of 100 mg once daily(22 patients). The efficacy and adverse events of the two groups were observed and compared. Results: Among the 51 CML-CP patients, 6 cases were out of the group for different reasons. After three months of treatment, all the patients achieved hematological remission. The best response rates in the dasatinib(70 mg QD) group and the dasatinib(100 mg QD) group were 87.50% and 92.31%(P>0.05), respectively at 3 months after treatment with dasatinib. The best response rates, CCyR and MMR ratios in the dasatinib(70 mg QD) group and the dasatinib(100 mg QD) group were 91.67% and 63.64%(P>0.05), 91.67% and 90.91%(P>0.05), 66.67% and 63.64%(P>0.05), respectively at 6 months after treatment with dasatinib. The CCyR and MMR ratios in the dasatinib(70 mg QD) group and the dasatinib(100 mg QD) group were 88.89% and 88.89%(P>0.05), 77.78% and 77.78%(P>0.05), respectively at 9 months after treatment with dasatinib. The CCyR and MMR ratios in the dasatinib(70 mg QD) group and the dasatinib(100 mg QD) group were 87.50% and 100.00%(P>0.05), 75.00% and 80.00%(P>0.05), respectively at 12 months after treatment with dasatinib. The hematological adverse events of 29 patients in the dasatinib 70 mg/d group were not serious, including 1 case of leucopenia, 1 case of neutropenia and 2 cases of anemia, were of the grade 3/4. Of the 22 patients in the dasatinib 100 mg/d group, the 3/4 grade hematological adverse events included 4 cases with leukopenia, 6 cases with neutropenia, 3 cases with anemia and 3 cases with thrombocytopenia. There was no significant difference in the incidence of adverse events between the two groups(P

关 键 词：慢性髓性白血病 达沙替尼 疗效 低剂量 

分 类 号：R733.72[医药卫生—肿瘤]