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本研究探讨高三尖杉酯碱(homoharringtonine)、阿糖胞苷(Ara-C)、去甲氧柔红霉素(idarubin)组成的联合化疗方案(HAI)治疗初治急性髓系白血病(AML)(除外急性早幼粒细胞白血病)的疗效和安全性。31例初治AML患者接受HAI诱导化疗,统计1个疗程的缓解率、长期生存率及无复发生存率,比较WHO亚型、遗传学及初始白细胞计数等不同预后分组患者疗效,按照WHO抗癌药物不良反应评估标准进行安全性评价。结果表明,26例患者1个疗程后获完全缓解(CR),CR率为84%。染色体核型预后良好组(n=10)、预后中等组(n=16)、预后不良组(n=5)患者1个疗程的CR率分别为90%、88%、60%,组间差异无统计学意义(p=0.28)。7例高白细胞数(白细胞计数≥100×109/L)患者均获CR,24例非高白细胞数组患者19例获CR。中位随访期15(2-56)个月,全部患者3年累积生存率44%。26例CR患者3年累积生存率52%,3年无复发生存率为51%。所有31例患者均完成HAI诱导化疗,无化疗相关死亡病例。在诱导治疗期间所有患者均发生严重骨髓抑制,中性粒细胞绝对值<0.2×109/L持续的中位时间为16(6-24)天。31例患者均发生Ⅲ-Ⅳ级严重感染,抑制期中位发热持续时间为6(1-36)天。败血症发生率为19.4%(6/31);侵袭性真菌病发生率45.2%(14/31),Ⅲ-Ⅳ级非血液学毒性反应以发热(非感染性)、谷丙转氨酶升高、腹泻、胆红素升高、口腔炎等最为常见,发生率分别为6.5%、6.5%、3.2%、3.2%、3.2%。结论:HAI方案治疗初治AML疗效肯定,特别是1个疗程的缓解率明显高于DA标准诱导方案。HAI方案安全性较好,除非发生严重感染。
This study was to investigate the efficacy and safety of HAI combined with homoharringtonine, Ara-C and idarubin in the treatment of newly diagnosed acute myeloid leukemia (AML) (Except for acute promyelocytic leukemia) efficacy and safety. Thirty-one newly diagnosed AML patients underwent HAI induction chemotherapy. The response rate, long-term survival rate and recurrence-free survival rate of one course of treatment were compared. The WHO subtypes, genetics and initial leucocyte count were compared in different prognosis groups. Adverse drug reaction evaluation criteria for safety evaluation. The results showed that 26 patients achieved complete remission (CR) after one course of treatment, with a CR rate of 84%. The CR rate of one course of treatment was 90%, 88% and 60% in the group with good prognosis (n = 10), moderate prognosis group (n = 16) and poor prognosis group Not statistically significant (p = 0.28). Seven patients with high white blood cell count (white blood cell count ≥100 × 109 / L) were CR, 24 patients with non-high white blood cell array in 19 patients were CR. The median follow-up period was 15 (2-56) months, with a 3-year cumulative survival rate of 44% for all patients. The 26-year CR patients had a 3-year cumulative survival rate of 52% and a 3-year disease-free survival rate of 51%. All 31 patients completed HAI induction chemotherapy without chemotherapy-related deaths. Severe myelosuppression occurred in all patients during the induction therapy, with a median neutrophil <0.2 × 109 / L median duration of 16 (6-24) days. All 31 patients developed serious grade Ⅲ-Ⅳ infection with a median duration of fever of 6 (1-36) days. The incidence of sepsis was 19.4% (6/31). The incidence of invasive fungal diseases was 45.2% (14/31). The grade Ⅲ-Ⅳ non-hematologic toxicities were fever (non-infectious), elevated alanine aminotransferase , Bilirubin, stomatitis and other most common, the incidence rates were 6.5%, 6.5%, 3.2%, 3.2%, 3.2%. Conclusion: The efficacy of HAI regimen in the treatment of untreated AML is definite. In particular, the remission rate of one course of treatment is significantly higher than that of DA standard induction regimen. HAI program is safe, unless a serious infection occurs.