真实世界中国产伊马替尼治疗初诊慢性粒细胞白血病的疗效观察

Therapeutic Effect of Imatinib Made in Real World to Newly Diagnosed Chronic Myeloid Leukemia

目的:评价国产伊马替尼对初诊慢性粒细胞白血病(CML)慢性期(CP)患者的临床疗效及安全性。方法:57例初诊且未接受其他任何抗CML治疗的CML-CP患者,给予口服国产伊马替尼治疗,400 mg/d,每日1次,观察评估治疗3、6、12个月的血液学、细胞遗传学和分子学反应及安全性。结果:治疗≥3个月和6个月均有56例患者,其中50例患者治疗≥12个月。治疗满3个月时,49例患者进行了血液学检测,47例(95.9%)获得完全血液学反应(CHR);49例患者进行了细胞遗传学检查,39例(79.6%)获得主要细胞遗传学反应(MCyR),12例(24.5%)获得完全细胞遗传学反应(CCyR);49例患者进行了BCR-ABL水平检测,其中BCR-ABL^(IS)≤10%的患者41例(83.7%),达到主要分子学反应(MMR:BCR-ABL^(IS)≤0.1%)的患者5例(10.2%)。治疗满6个月时,49例患者进行了血液学检测,49例(100%)全部获得CHR;49例患者进行了细胞遗传学检查,其中41例(83.7%)获得MCyR,31例(65.3%)获得CCyR;49例患者进行了BCR-ABL水平检测,BCR-ABL^(IS)≤1%的患者有33例(67.4%),达到MMR的患者15例(30.6%)。治疗满12个月时,45例进行了血液学检测,所有患者(100%)获得CHR;45例患者进行了细胞遗传学检查,其中41例(91.1%)获得MCyR,35例(77.8%)获得CCyR;45例进行了BCR-ABL水平检测,达到MMR的患者24例(55.3%)。Ⅲ级白细胞减少、血小板减少及贫血发生率分别为14.0%、10.5%和8.7%。非血液学不良反应依次为水肿(64.9%)、恶心(50.9%)、呕吐(35.1%)、皮疹(24.5%)、发热(15.8%)、骨关节肌肉疼痛(38.6%)、腹泻(17.6%)、肝功能损害(3.5%)。无Ⅳ级血液学及非血液学不良反应。结论:在真实世界中,国产甲磺酸伊马替尼治疗初诊CML-CP患者的近期疗效肯定,安全性可靠,但仍需大宗数据进行长期追踪随访来验证其远期疗效。

Objective:To evaluate the clinical efficacy and safety of domestic imatinib(made in China)in patients with newly diagnosed chronic myeloid leukemia chronic phase(CML-CP).Methods:Fifty-seven newly diagnosed CML-CP patients who did not receive any other anti-CML treatment were treated by domestic imatinib 400 mg once a day.The hematological,cytogenetic and molecular reactions and safety were observed and evaluated after 3,6 and 12 months of treatment.Results:Fifty-six patients were treated for≥3 and 6 months,among which 50 patients were treated for≥12 months.After 3 months of treatment,49 patients underwent hematological examination,47 patients(95.9%)achieved complete hematological response(CHR),49 patients underwent cytogenetic examination,39 patients(79.6%)achieved major cytogenetic response(MCyR),and 12 patients(24.5%)achieved complete cytogenetic response(CCyR).49 patients underwent the level of BCR-ABL test,including 41 patients(83.7%)with BCR-ABL^(IS)≤10%,and 5 patients(10.2%)with major molecular response(MMR:BCR-ABL^(IS)≤0.1%).After 6 months of treatment,49 patients underwent hematological examination,and 49 patients(100%)all achieved CHR.49 patients underwent cytogenetic examined,of which 41 cases(83.7%)obtained MCyR and 31 cases(65.3%)obtained CCyR.49 patients underwent the level of BCR-ABL test,among which 33 patients(67.4%)showed BCR-ABL^(IS)≤1%,and 15 patients(30.6%)reached MMR.After 12 months of treatment,45 patients underwent hematological examination,and all the patients(100%)got CHR.45 patients underwent cytogenetic examined,of which 41 cases(91.1%)obtained MCyR and 35 cases(77.8%)obtained CCyR.45 cases were tested for BCR-ABL level,and 24 cases(55.3%)reached MMR.The incidence of gradeⅢleukopenia,thrombocytopenia and anemia were 14.0%,8.7%and 10.5%,respectively.Non-hematological adverse reactions were edema(64.9%),nausea(50.9%),vomiting(35.1%),rash(24.5%),fever(15.8%),bone and joint muscle pain(38.6%),diarrhea(17.6%)and liver function damage(3.5%).There were no grade IV hematological and non-hematological adverse reactions.Conclusion:In the real world,Domestics imatinib mesylate is effective and safe in the treatment of newly diagnosed CML-CP patients,but long-term follow-up data are still necessary to verify its long-term efficacy.