干扰素联合伊马替尼治疗慢性髓系白血病疗效及安全性分析

伊马替尼在目前被认为是慢性粒细胞白血病（CML）初治的首选治疗药物，但只有少部分患者能获得完全分子学缓解（CMR）。近年来临床和基础研究发现，干扰素联合伊马替尼有可能提高CML疗效。本研究分析多项临床研究结果，以伊马替尼单药治疗的结果为对照，系统评价干扰素联合伊马替尼方案治疗CML的疗效及安全性。本研究在ClinicalTrial网站和Cochrane协作网检索联合治疗的临床试验，并通过PubMed、EM等国内外文献数据库检索相关文献，对比联合治疗与单药治疗的疗效及不良事件数据。结果表明，共有7项临床研究，相关12篇文献符合纳入标准，病例总数697例。联合治疗组与单药组比较：完全细胞遗传学缓解（CCgR）6个月时为58％：42％（P=0．0001），12个月时74％：68％（P=0．004）；主要分子学缓解（MMR）6个月时为58％：34％（P=0．0001），12个月时66％：47％（P〈0．0001）；CMR6个月时为13％：2％（P=0．0002），12个月时14％：5％（P=0．0009）。联合治疗不良反应主要有皮疹、乏力、水肿、肌肉疼痛，较单药治疗更易引起中性粒细胞减少、血小板减少和轻度贫血。结论：干扰素联合伊马替尼治疗CML疗效优于伊马替尼单药治疗，并且能更早获得细胞遗传学和分子学缓解且安全性良好。

Efficacy and Safety Analysis of Interferon Combined with Imatinib in Treating Chronic Myeloid Leukemia

Imatinib has been recognized as the frontline therapy drug in chronic myeloid leukemia （CML）, however, only limited patients could achieve complete molecular remission （CMR）. Recent clinical and basic proofs indicated an improved treatment outcome by the combination of interferon and Imatinib. This study was purposed to evaluated syste- matically the efficacy and safety of interferon plus lmatinib in patients with CML. Data from relative clinical trials were from clinical trial of gov and Cochrane Collaboration. A comprehensive literature search was performed from data bases such as pubMed and EM. The results indicated that 7 clinical trials and 12 research papers met the criteria enrolled in study, included 697 cases in total. The combination group had higher complete cytogenetic remission （CCgR） rate than imatinib alone at 6 months （58% vs 42% ; P =0. 0001） and 12 months （74% vs 68% ; P =0. 004）. The major molecular remission （MMR） rate,was also higher in the combination group at 6 months （58% vs 34% ; P =0. 0001 ） and 12 months （ 66% vs 47% ; P 〈 0. 0001 ）. Furthermore, compared with single drug, the combination group had superior CMR rate at 6 months （ 13% vs 2% ; P = 0. 0002） and 12 months （ 14% vs 5% ; P = 0. 0009 ）. The major adverse effects of combination therapy were rash, asthenia, edema and musculoskeletal events, and combination therapy was more prone to inducing neutropenia, thrombocytopenia and mild anemia. It is concluded that compared with Ima- tinib alone, the combination of interferon and Imatinib has better clinical efficacy in treating CML with earlier cytogenetic and molecular remission. It is also a safe therapy in spite of slightly weaker tolerance than single drug therapy.