含安丫啶的预激方案治疗难治/复发急性髓细胞白血病的临床研究

Clinical study of preexcitation program containing Amsacrine in the treatment of refractory or relapsed Acute Myeloid Leukemia

目的探讨安丫啶、小剂量阿糖胞苷和粒细胞集落刺激因子组成的预激方案治疗难治/复发性急性髓细胞白血病(RAML)的疗效及毒副反应。方法难治/复发性急性髓细胞白血病患者随机分成两组:研究组20例,给予安丫啶(Amsacrine)50 mg/d静脉滴注,1～7 d;阿糖胞苷(Ara-C)10 mg/(m2.d)皮下注射,1次/12 h,1～14 d;粒细胞集落刺激因子(G-CSF)300μg/d,从化疗前一天开始。对照组18例,应用MAE方案治疗。结果20例研究组患者12例获得CR,CR率60%,3例PR,总有效率(CR+PR)75%。对照组18例患者中CR 7例,CR率38.9%,PR 2例,总有效率(CR+PR)50%。两组CR率及总有效率有统计学差异(P<0.05)。血液学毒性两组比较有显著差异(P<0.05)。感染发生率:研究组25%,对照组94.4%,两组比较差异显著(P<0.01)。结论含安丫啶预激方案治疗难治/复发性急性髓细胞白血病(RAML)的疗效较MAE方案疗效好,不良反应显著减少,值得进一步临床推广应用研究。

Objective：To study the effect and side effect of preexcitation program containing Amsacrine,low dose Ara-C and granulocyte colony-stimulating factor on refractory or relapsed acute myeloid Leukemia（RAML）. Methods： The patients with RAML were divided into two groups randomly. The studying group （n = 20） received preexcitation program containing Amsacrine, low dose Ara-C and granulocyte colony-stimulating factor used one day before chemo-therapy. The control group （n = 18） received MAE regimen. Results：12 patients in the studying group achieved complete remission （CR）, the CR rate was 60%, 3 patients achieved partial remission （PR）, the total effective rate was 75%. In control group, 7 patients ahcieved CR, the CR rate was 38.9%, 2 patients showed PR, the total effective rate was 500/0. There were significantly statistic differences in the CR rates, the side effects and the total response rates between two groups （P〈 0.05）. Infection rates in studying group was 25%, 94.4% in control group. There were significantly statistic differences in the infection rates （P〈 0.01）. Conclusion： The effects of preexcitation project contained with amsacrine were better than MAE regimen on the treatment of patients with RAML,and the side effects were reduced significantly.