2018 年第 10 期 第 13 卷

去甲氧柔红霉素剂量选择对年轻初发急性髓细胞白血病患者治疗效果及预后情况的影响

Effects of different doses of idarubicin on treatment and prognosis of primary acute myelocytic leukemia in young patients

作者：木合拜尔·阿布都尔阿孜古丽

英文作者：

单位：830001乌鲁木齐，新疆维吾尔自治区人民医院血液病科

英文单位：

关键词：急性髓细胞白血病；去甲氧柔红霉素

英文关键词：

• 摘要：

• 【摘要】目的    分析不同剂量去甲氧柔红霉素（IDA）对年轻初发急性髓细胞白血病 (AML)患者治疗效果及预后情况的影响。方法    选择2012年1月至2015年1月于新疆维吾尔自治区人民医院就诊的18～<60岁初发AML患者123例。按照随机数字表法分为A组、B组和C组，各41例。在静脉滴注注射用阿糖胞苷的基础上，A组采用≤8 mg/(m2·d) IDA的低剂量方案，B组采用9～10 mg/(m2·d)IDA的方案，C组采用12 mg/(m2·d)IDA的方案，连续应用3 d。比较3组患者的疗效、总生存期、无事件生存（EFS）和复发情况，以及不良反应发生情况和早期死亡情况，并应用多因素Cox回归模型探究影响患者预后的独立危险因素。结果    C组和B组的第1疗程完全缓解率［73.2%（30/41）比68.3%（28/41）］、完全缓解率［82.9%(34/41)比78.0%（32/41）］和总缓解率［97.6%（40/41）比92.7%（38/41）］差异均无统计学意义（P=0.627、0.577、0.608）,但均高于A组［46.3%（19/41），53.7%（22/41）和75.6%（31/41）］（均P>0.05）。A组患者的中位生存时间为20（2，36）个月，B组（风险比=0.526,95%置信区间：0.288～0.962，P=0.037）和C组(风险比=0.476,95%置信区间：0.258～0.877,P=0.017）的死亡风险明显低于A组。A组、B组和C组患者的中位EFS期分别为15（1，36）、26（3，36）和35（4，36）个月，B组（风险比=0.578,95%置信区间：0.333～0.984,P=0.032）和C组(风险比=0.468，95%置信区间：0.266～0.826，P=0.009）的事件发生风险明显低于A组。达到完全缓解的A组、B组和C患者在随访期间的复发率分别为54.6%、40.6%和38.2%，差异均无统计学意义（Log-rank χ2=1.478，P=0.478）。3组患者3级以上不良反应发生率和早期死亡发生率差异均无统计学意义（均P>0.05）。Cox回归分析显示，骨髓原始细胞比例≥80%，乳酸脱氢酶≥2倍正常上限是年轻初发AML患者死亡的独立危险因素，自体造血干细胞移植、预后分级良好是其保护因素（均P<0.05）。结论    标准剂量IDA对年轻初发AML患者的疗效较好，能够改善患者的总生存和无事件生存期，而安全性与低剂量相似。骨髓原始细胞比例、乳酸脱氢酶水平、干细胞移植、预后分级与该类患者预后有关。

• 【Abstract】Objective    To analyze the effects of different doses of idarubicin on the treatment and prognosis of primary acute myelocytic leukemia(AML) in young patients. Methods    A total of 123 AML patients（18-<60 years old） were enrolled from January 2012 to January 2015 in People′s Hospital of Xinjiang Uygur Autonomous Region. They were randomly divided into group A, group B and group C, with 41 cases in each group. All patients had intravenous administration of cytosine arabinoside; the group A had idarubicin≤8 mg/(m2·d); the group B had idarubicin 9-10 mg/(m2·d); the group C had idarubicin 12 mg/(m2·d); all groups were treated for 3 days. Curative effect, overall survival(OS), event-free survival(EFS), relapse, adverse events and early death were analyzed. Prognostic risk factors were analyzed by Cox multivariate regression. Results    Remission rate of the first course［73.2%（30/41） vs 68.3%（28/41）］, complete remission rate［82.9%(34/41) vs 78.0%（32/41）］, total remission rate［97.6%（40/41） vs 92.7%（38/41）］ showed no significant differences between the group B and group C（P=0.627, 0.577, 0.608）; but they were all significantly higher than those in the group A［46.3%（19/41）, 53.7%（22/41）, 75.6%（31/41）］（P=0.044, 0.013, 0.031, 004, 0.034, 0.004）. The median OS was 20(2, 36)months in the group A. Death risk in the group B［hazard ratio(HR)=0.526, 95%confidence interval(CI): 0.288-0.962, P=0.037］ and group C(HR=0.476, 95%CI: 0.258-0.877, P=0.017) was significantly lower than that in the group A. The median EFS was 15(1, 36), 26(3, 36) and 35(4, 36) months in the group A, B and C. Adverse event risk in the group B(HR=0.578, 95%CI： 0.333-0.984, P=0.032） and group C(HR=0.468， 95%CI： 0.266-0.826， P=0.009） was significantly lower than that in the group A. Recurrence rate was 54.6%, 40.6% and 38.2% in the group A, B and C; there was no significant difference among the three groups(Log-rank χ2=1.478， P=0.478). There was no significant difference in the incidences of severe complications（grade 3 or above） and early death among the three groups(P>0.05). Cox regression analysis showed that bone marrow blast cells radio≥80% and lactate dehydrogenase≥2 upper limits of normal were independent risk factors of death; autologous hematopoietic stem cell transplantation and good grading of prognosis were the protective factors(P<0.05). Conclusions    Standard dose of idarubicin has a good therapeutic effect on young patients with primary acute myelocytic leukemia. It can prolong OS and EFS with a good safety. Bone marrow blast cells radio, lactate dehydrogenase level, hematopoietic stem cell transplantation and prognosis grading are related to the prognosis.