CAJ | 학술논문

目的：探讨伊马替尼联合干扰素α2b( INF-α2b)治疗慢性粒细胞白血病( CML)的临床疗效及安全性。方法选择73例新诊断CML慢性期患者,随机分组,分别给予伊马替尼400mg/d(n=30),伊马替尼400mg/d和INF-α2b 300万U隔日一次(n=43)。观察两组患者不同时间的主要分子学反应(MMR)、完全细胞学反应(CCyR)和完全分子学反应( CMR),并比较两组患者总体生存( OS)、无进展生存( PFS)差异以及不良反应。结果联合组CCyR在用药6个月时高于伊马替尼组(60．5% vs.36．7%,P<0．05),12个月时差异消失。联合组MMR+CMR在用药6个月及12个月时均高于伊马替尼组(74．4% vs.43．3%,76．7% vs.46．7%,P<0．05),在24个月时两组之间差异无统计学意义(P>0．05)。联合组血液学不良反应发生率高于伊马替尼组(P<0．05),而非血液学不良反应率却与伊马替尼组差异无统计学意义(P >0．05)。24个月观察期内,两组患者OS率(u=0．458,P=0．504)、PFS率(u=0．598,P=0．423)差异无统计学意义。结论伊马替尼联合INF-α2b可以使CML患者更快获得遗传学及分子学反应,但并不能改善患者在用药24个月内的生存率,而且可能增加血液学不良反应发生率。
목적：탐토이마체니연합간우소α2b( INF-α2b)치료만성립세포백혈병( CML)적림상료효급안전성。방법선택73례신진단CML만성기환자,수궤분조,분별급여이마체니400mg/d(n=30),이마체니400mg/d화INF-α2b 300만U격일일차(n=43)。관찰량조환자불동시간적주요분자학반응(MMR)、완전세포학반응(CCyR)화완전분자학반응( CMR),병비교량조환자총체생존( OS)、무진전생존( PFS)차이이급불량반응。결과연합조CCyR재용약6개월시고우이마체니조(60．5% vs.36．7%,P<0．05),12개월시차이소실。연합조MMR+CMR재용약6개월급12개월시균고우이마체니조(74．4% vs.43．3%,76．7% vs.46．7%,P<0．05),재24개월시량조지간차이무통계학의의(P>0．05)。연합조혈액학불량반응발생솔고우이마체니조(P<0．05),이비혈액학불량반응솔각여이마체니조차이무통계학의의(P >0．05)。24개월관찰기내,량조환자OS솔(u=0．458,P=0．504)、PFS솔(u=0．598,P=0．423)차이무통계학의의。결론이마체니연합INF-α2b가이사CML환자경쾌획득유전학급분자학반응,단병불능개선환자재용약24개월내적생존솔,이차가능증가혈액학불량반응발생솔。
Objective To investigate the clinical value of imatinib plus IFN-α2b in chronic myeloid leukemia(CML). Methods We randomly assigned 73 newly diagnosed CP-CML patients to receive imatinib 400mg/d(n=30)alone, imatainib 400mg/d plus IFN--α2b million IU every other day(n=43). Molecular and cytogenetic responses, overall, progression-free sur-vival and adverse events were assessed. Results A higher rate of CCyR at 6 months occurred with imatinib plus IFN-α2b than with imatinib 400 mg/d(60. 5% vs. 36. 7%,P<0. 05), but no difference was observed lateron. The rate of MMR+CMR was significantly higher among patients received imatinib and IFN-α2b thanthe patients received 400 mg of imatinib alone(74. 4% vs. 43. 3%,76. 7% vs. 46. 7%,P<0. 05)at 6 and 12 months, but not form 24 mouths on. There was no significant difference of OS (u=0. 458,P=0. 504)or PFS(u=0. 598,P=0. 423). There were more patients with hematologic adverse events in the imatinib plus IFN-α2b combination therapy arm than in the imtinibmonotherapy arm(P<0. 05), but the rate of nonhematologic adverse e-vents was no difference. Conclusion As compared with other threatments, the addition of IFN-α2b to imatinib resulted in higher rates ofcytogenetic response and molecular response in patients with CP-CML, but it cannot influence the long-term overall and pro-gression free survival.