氟达拉滨联合中剂量阿糖胞苷治疗复发难治性急性髓系白血病效果观察

Effects of fludarabine combined with intermediate-dose cytarabine in treating relapsed refractory acute myeloid leukemia

目的 比较氟达拉滨（FLud）联合中剂量阿糖胞苷（Ara-C）（改良FLAG方案）与CAG 预激方案治疗复发难治性急性髓系白血病（AML）的疗效及患者不良反应.方法 49例复发难治性AML 患者,随机分为两种治疗方案组,改良FLAG治疗方案组：粒细胞集落刺激因子（G-CSF）每天200 μg/m2,第0天至第5天,Flud每天30 mg/m2,第1天至第5天;Ara-C每天1 g/m2,第1天至第5天.CAG预激治疗方案为：G-CSF每天200 μg/m2,第1天至第14天,阿柔比星20 mg/d,第1天至第4天,Ara-C 10 mg/m2,1次/12h,第1天至第14天.结果 改良FLAG组完全缓解（CR）率43 ％（10/23）,部分缓解（PR）率21％（5/23）,有效率64 ％;CAG预激组CR率23％（6/26）,PR率19％（5/26）,有效率42％,两组间比较差异有统计学意义（P＜0.05）;主要不良反应为骨髓抑制、感染,改良FLAG组感染发生率70％（16/23）,CAG组感染发生率为54％（14/26）,两组间比较差异无统计学意义（P＞0.05）.结论 改良FLAG方案可有效治疗复发难治性AML患者,加强感染防控措施,缩短骨髓抑制时间.CAG方案不良反应小,可分层个体化治疗复发难治性AML患者.

Objective To investigate the efficacy and toxicity of fludarabine combined with intermediate-dose cytarabine on relapsed refractory acute myeloid leukemia （AML）.Methods Forty-nine patients with relapsed or refractory AML were divided into modified FLAG group and CAG group.Modified FLAG group：G-CSF 200 μg·m-2·d-1 on days 0-5; fludarabine 30 mg·m-2·d-1 on days 1-5; Ara-C 1 g·m-2·d-1on days 1-5.CAG group：Ara-C 10 mg·m-2·12 h-1 on days 1-14,aclarubicin 20 mg/d on days 1-4,G-CSF 200 μg·m-2·d-1 on days 0-14.Results In modified FLAG group,the complete response （CR） rate was 43 ％（10/23） and the partial response （PR） rate was 21％ （5/23）,so the overall response（OR） rate was 64 ％.However,in CAG group,CR rate and PR rate were 23 ％ （6/26） and 19 ％ （5/26）,respectively,and OR rate was 42 ％.There was statistical difference between the two groups （P ＜ 0.05）.The main toxicities of these two groups were myelosupression and infection.The infection rate were 70 ％ （16/23） in modified FLAG group and 54 ％ （14/26） in CAG group.There was no statistical difference between the two groups （P ＞ 0.05）.Conclusions Fludarabine and intermediate-dose cytarabine are effective in treating relapsed refractory AML.The treatment produces the significant effect in strengthening control of infection measures and shortening the time of bone marrow suppression.CAG regimen has less adverse effects and could be utilized in stratified and personalized treatment for individuals with relapsed refractory AML.