中文摘要：

目的观察高三尖杉醋碱（HHT）联合全反式维甲酸（ATRA）治疗初诊急性早幼粒细胞白血病（APL）患者的疗效及诱导治疗期间的不良事件发生情况，并与柔红霉素（DNR）联合ATRA治疗方案进行对比分析。方法对2004年10月至2010年10月收治的115例APL患者的资料进行总结分析，其中HHT组54例、DNR组61例，对比分析两组患者的完全缓解（CR）率、总生存（OS）及无事件生存（EFS）情况。结果115例APL患者CR率100％，达CR的中位时间32（22～43）d，109例进入巩固治疗的患者PML—RARα融合基因全部转为阴性，中位生存期未达（0．23～77．34个月），中位EFS期未达（0．23～77．34个月）。3年OS率93％，5年OS率93％；3年EFS率85％，5年EFS率75％。诱导治疗后HHT组和DNR组PML—RARα融合基因转阴率分别为31．3％和15．5％；巩固治疗1个疗程后两组PML—RARα融合基因转阴率分别为68．6％和77．6％；DNR组有4例患者在巩固治疗〉1个疗程后转为阴性，但两组分子生物学复发率差异无统计学意义（9．8％和8．6％，P〉0．05）。生存分析显示：HHT组与DNR组的OS、EFS相似（P值分别为0．206、0．506）。两组5年OS率分别为87％和98％；5年EFS率分别为80％和71％。HHT组与DNR组的低／中危患者、高危患者OS、EFS亦相似（P值均〉0．05）。诱导治疗期间HHT组合并2级以上发热患者比例显著低于DNR组，而肝、肾、心功能损伤及血液学不良反应发生率两组相似。结论HHT和DNR为基础的方案治疗初诊APL疗效相似，同时在诱导治疗期间两者的耐受性无明显差异。

英文摘要：

Objective To essess complete remssion（CR） , the overall survival（OS） , event-free survival（EFS） and adverse events of newly diagnosised aeule promyeloeytic leukemia （APL） with homoharringtonine（HHT） plus ATRA, to evaluate the therapeutic effect by comparing HHT plus ATRA with daunorubicin plus ATRA as induction regimen （HA with DA as post-remission regimen）. Methods 115 APL patients （54 in HHT group, 61 in DNR group） after long-term follow-up were enrolled in the analyses of clinical feature, chromosome karyotype, molecular biology, OS and EFS. Results The overall CR of 115 patients was 100%, the median interval to achieve hematological CR was 32 （22- 43）days, the overall median OS was within 0.23 -77.34 months, median EFS was within 0.23 -77.34 months. 3-year OS rate was 93% ,5- year OS rate 93% , 3-year EFS rate 85% and 5-year RFS rate 75% respectively. Converting to PML-RARα PCR-negative after the induction therapy in the HHT and DNR group was 31.3% and 15.5% respectively, at the end of 1 consolidation course was 68.6% and 77.6% respectively, while the remaining 4 patients tested PML-RARα PCR-negative at the end of 2 consolidation courses in the DNR group. While both groups obtained the identical molecular biology relapse rate （9.8% and 8.6% , respectively）. Survival analysis indicated that no significant difference was found on OS and EFS between the HHT group and the DNR group （P =0. 206 and 0. 506）. 5-year OS rate was 87% for the HHT group while 98% for the DNR group, 5-yearsEFS rate was 80% for the HHT group while 71% for the DNR group. And the risk group was not the factor affecting OS and EFS（P =0. 615 and 0. 416）. Grade 2 fever in the HI-IT group was less than in the DNR group during induction therapy. And no difference was found in terms of liver dysfunction, renal dysfunction, cardiac dysfunction, and hematologic toxicity between two groups. Conclusion Our study demonstrated comparable therapeutic effect of HHT or DNR on APL. HHT was also well tolerated an