国产甲磺酸伊马替尼一线治疗慢性髓性白血病慢性期患者的临床效果及安全性分析  

Efficacy and safety of domestic imatinib mesylate as front-line treatment for chronic myelogenous leukemia patients in the chronic phase

作　　者：郑引索 田昱平 陈峰云 陈涛[1] 李小妮[1] 杨彩霞[1] 张玲[1] 贾少勋 兰春雨 姚亚洲[1] ZHENG Yinsuo;TIAN Yuping;CHEN Fengyun;CHEN Tao;LI Xiaoni;YANG Caixia;ZHANG Ling;JIA Shaoxun;LAN Chunyu;YAO Yazhou(Department of Hematology,Baoji Central Hospital,Baoji,721008,China)

机构地区：[1]宝鸡市中心医院血液风湿病科,陕西宝鸡721008

出　　处：《临床血液学杂志》2020年第5期640-643,共4页Journal of Clinical Hematology

摘　　要：目的:分析国产甲磺酸伊马替尼(商品名:格尼可)治疗慢性髓性白血病慢性期(CML-CP)患者的临床疗效和安全性。方法:回顾性分析62例一线服用格尼可治疗的CML-CP患者的临床资料。根据患者Sokal预后风险评分、耐受情况适当调整伊马替尼剂量,即300~600 mg/d。分析患者用药3、6、12个月获得的最佳反应、分子生物学反应,采用χ2检验比较各Sokal积分组达到的最佳反应率,统计药物引起的不良反应。结果:62例接受格尼可治疗的CML-CP患者,治疗后3个月时完全血液学缓解(CHR)率为90.32%,BCR-ABLIS≤10%为75.81%,分子学缓解为9.68%;治疗后6个月时CHR率为95.16%,BCR-ABLIS≤1%为70.97%,分子学缓解为30.65%;治疗后12个月时所有患者达到CHR,50.00%的患者获得分子学缓解。按照Sokal评分将62例患者分为高危组7例、中危组19例和低危组36例,在治疗后3、6、12个月,3组最佳反应发生率比较均差异无统计学意义(χ2=5.49、3.83、4.38,P=0.06、0.15、0.11);经两两比较,治疗后3个月低危组最佳反应发生率高于高危组(χ2=5.38,P<0.05)。大部分患者对格尼可耐受性好,引起的最常见的非血液不良反应依次为水肿(41.94%),胃肠道反应(20.97%),肌肉酸痛(14.52%)等,血液学不良反应主要为血小板减少(22.58%)和白细胞减少(14.52%)。结论:国产甲磺酸伊马替尼对CML-CP患者的血液学和分子学反应良好,安全性高,值得在临床上继续推广。Objective:To analyze the efficacy and safety of domestic imatinib mesylate(Gnico)as the front-line treatment for patients with chronic myeloid leukemia in chronic phase(CML-CP).Method:A total of 62 patients with CML-CP were selected.The dose of imatinib was adjusted from 300 to 600 mg/d according to the Sokal prognosis risk score and drug tolerance.The optimal response and molecular response rate of CML-CP patients in 3,6,and 12 months were analyzed,and the chi-square test was used to compare the optimal response rate of each Sokal score group.The adverse events caused by the Gnico were recorded.Result:At 3 months after treatment,the complete hematological remission(CHR)rate was 90.32%,BCR-ABLIS≤10%was 75.81%,and molecular remission rate was 9.68%.At 6 months,the CHR rate was 95.16%,BCR-ABLIS≤1%was 70.97%,and molecular reaction rate was 30.65%.All patients achieved CHR at 12 months,while 50.00%of patients achieved molecular remission.The 62 patients were divided into high-risk group(n=7),intermediate-risk group(n=19)and low-risk group(n=36)based on Sokal score.There was no significant difference in the optimal response rate among the three groups at 3,6,and 12 months after treatment(χ2=5.49,3.83,4.38,P=0.06,0.15,0.11,respectively).The rate of optimal response in the low-risk group was higher than that in the high-risk group(χ2=5.38,P<0.05).The Gnico was well tolerated in most patients,and the common non-hematologic adverse events were edema(41.94%),gastrointestinal reactions(20.97%)and muscle soreness(14.52%).The hematological adverse events were mainly thrombocytopenia(22.58%)and leukopenia(14.52%).Conclusion:Domestic imatinib mesylate is effective and safe as the first-front treatment for CML-CP patients.

关 键 词：慢性髓性白血病 慢性期 国产甲磺酸伊马替尼 有效性 安全性 

分 类 号：R733.72[医药卫生—肿瘤]