论文部分内容阅读
目的观察甲磺酸伊马替尼(IM)治疗 Ph 染色体阳性和(或)BCR/ABL 基因阳性的慢性髓性白血病(CML)的疗效和安全性。方法对90例 Ph 染色体阳性和(或)BCR/ABL 基因阳性CML 慢性期(CP)患者,持续口服 IM,400mg/d;30例 CML 疾病进展期(加速期/急变期)患者,持续口服 IM,600mg/d。服药期间定期复查血常规、骨髓细胞学、染色体和(或)BCR/ABL 基因等指标,并随访观察。结果 (1)CML-CP 患者总的完全血液学缓解率(CHR)、完全细胞遗传学缓解率(CCyR)和完全分子遗传学疗效(CMR)分别为73.3%(66/90)、66.7%(60/90)、54.4%(49/90);治疗前是否接受过干扰素治疗对 CHR、CCyR 和 CMR 均无明显影响;服药前病程≤6个月的 CMR 优于>6个月者。初次达到 CHR 的时间与首次达 CCyR 的时间、首次达 CCyR 的时间与 BCR/ABL 首次转阴时间之间均存在相关性,而初次达 CHR 的时间与 BCR/ABL 首次转阴时间则无明显相关性。(2)进展期 CML 患者的 CHR、CCyR、CMR 分别为43.3%(13/30)、25.9%(7/27)、25.0%(7/28),总病死率为30.0%(9/30)。(3)年龄≤25岁患者的病死率高于>25岁者,差异有统计学意义(P<0.05)。(4)白细胞减少达Ⅲ级者有19例(16.0%),发生于治疗后5～20周。血小板减少达Ⅲ级者有21例(18.0%),发生于治疗后3～16周。主要的非血液系统毒性为双下肢水肿、骨痛和皮疹等,但均程度轻微。结论IM 对初治 CML 及经干扰素治疗失败的 CML 有较高的 CHR 及 CCyR 且起效迅速,对 CML-CP 疗效显著优于进展期;不良反应程度轻微,患者易于耐受。
Objective To observe the efficacy and safety of imatinib mesylate (IM) in the treatment of Ph chromosome-positive and / or BCR / ABL-positive chronic myeloid leukemia (CML). Methods 90 patients with Ph chromosome positive and / or BCR / ABL positive CML chronic phase (CP) were enrolled in the study. Continuous oral IM (400 mg / d) and 30 patients with advanced CML (accelerated phase / blast crisis) , 600 mg / d. Periodic review of blood routine, bone marrow cytology, chromosome and (or) BCR / ABL genes and other indicators, and follow-up observation. Results (1) The overall complete hematological response (CHR), complete cytogenetic response (CCyR) and complete molecular genetic effect (CMR) of CML-CP patients were 73.3% (66/90) and 66.7% 60/90) and 54.4% (49/90). No significant effect of interferon treatment on CHR, CCyR and CMR was observed before treatment. CMR less than 6 months before treatment was better than 6 months. There was a significant correlation between the first CHr time and the first CCyR time, the first CCyR time and the first BCR / ABL negative time, while the first CHR time was not significantly correlated with the first negative BCR / ABL conversion time Sex. (2) The CHR, CCyR and CMR of patients with advanced CML were 43.3% (13/30), 25.9% (7/27) and 25.0% (7/28), respectively. The overall mortality was 30.0% (9/30) . (3) The mortality of patients aged ≤25 years was higher than that of> 25 years old, the difference was statistically significant (P <0.05). (4) There were 19 cases (16.0%) of leukopenia up to grade Ⅲ, which occurred in 5 to 20 weeks after treatment. Thrombocytopenia reached grade Ⅲ in 21 cases (18.0%), occurred in 3 to 16 weeks after treatment. The main non-hematological systemic toxicity was edema of both lower extremities, bone pain and rash, but to a lesser extent. Conclusions IM has a higher onset rate of CHR and CCyR in patients with newly diagnosed CML and those with failure of interferon therapy. The efficacy of CML-CP is significantly better than that of advanced CML. The degree of adverse reactions is mild and patients are easily tolerated.