【作者】 王丽娟；

【导师】 宋强；

【作者基本信息】 山东大学 ， 血液学， 2012， 硕士

【摘要】 目的：研究DNA甲基化转移酶抑制剂—地西他滨治疗骨髓增生异常综合征及急性髓细胞白血病患者的疗效、中位生存期和不良事件,同时分析疗效及生存期的相关因素。方法：回顾性分析2010年3月—2012年3月期间山东大学齐鲁医院血液内科收治骨髓增生异常综合征患者20例、急性髓细胞白血病患者9例共29例患者的临床资料。病例为经MICM分型诊断明确的初治或复治MDS (IPSS积分≥0.5)及AML患者。29例患者均应用地西他滨25mg／d,持续静脉滴注1小时以上,连用5天,4周为1疗程。统计分析采用SPSS17.0统计软件,以α=0.05为检验水准。用x2检验和ILogistic回归分析比较不同因素在有效率方面有无差异,用Kaplan-Meier进行生存分析,Log-rank检验分析不同基线特征的生存差异。用Cox风险比例模型对应用地西他滨后的总生存期OS进行多因素分析。结果：20例MDS患者,中位疗程数为4.5个,总体改善率为64%(CR患者5例,mCR伴HI患者1例,mCR不伴HI患者2例,仅HI患者1例),7例(50%)患者获得不同程度的血液学进步；x2检验及Logistic多因素分析显示各个分组因素在疾病缓解率方面差别无统计学意义。20例MDS患者的中位随访时间为5个月,中位OS时间为10个月,1年的生存率为80%；Kaplan-Meier生存分析及Cox风险比例模型未见影响MDS患者总生存期的独立因素。9例AML患者最终均未获得疾病缓解,虽然其中4例患者于地西他滨治疗1-3疗程后曾获得程度不同的缓解,但疗效持续最长不超过3个疗程,最终均死亡或因疾病进展而更换方案。不同疾病类型影响患者的总生存期,MDS患者的总生存期较AML患者长,但经Cox多因素分析差别无统计学意义。在可评价的81个地西他滨应用总疗程中共15个疗程因发热事件而需要静脉滴注抗生素及住院治疗。结论：低剂量地西他滨治疗骨髓增生异常综合征有较好的近期疗效和生存益处；低剂量地西他滨治疗急性髓细胞白血病缓解率低,并且获得缓解后疗效持续时间短。因此,今后仍需对地西他滨治疗AML的最佳方案包括给药剂量、给药方式、给药时间和治疗周期以及是否需要联用其它化疗药物或单克隆抗体来提高AML缓解率开展进一步的研究。更多还原

【Abstract】 OBJECTIVE:To evaluate the efficacy of low-dose Decitabine on the median overall survival time and response rate of the patients with myelodysplastic syndrome or acute myeloid leukemia and to identify the survival and response associated factors.METHODS:From March2010to March2012,29consecutive patients with myelodysplastic syndrome or acute myeloid leukemia in Shandong university Qilu hospital,who received decitabine,were reviewed. Decitabine25mg/d was given intravenously over one hour for five consecutive days every four weeks. Efficacy and overall survival were analyzed by SPSS17.0software.RESULTS:As far as20patients with myelodysplastic syndrome were concerned. A median of4.5courses were delivered, The overall response rate was64%,(5complete responses,3marrow complete responses,and1hematologic improvement),? patients(50%)showed some hematologic improvement; There was no significant difference in ORR according to baseline patients’characteristics. With a median follow-up duration of5months, median overall survival was10.0months, One year survival rate was80%.9patients with acute myeloid leukemia showed no response in the end. Disease type had a significant impact on OS, Patients with MDS had significantly longer median survival time than AML, However, there was no independent prognostic factor of overall survival time of decitabine treatment by Cox proportional hazard models.Among81assessable treatment courses, there were15 fever episodes requiring intravenous antimicrobials in hospital.CONCLUSIONS:Low-dose Decitabine is effective and tolerable in the treatment for MDS. It can remarkably improve the disease control rate and disease-related symptoms, and also prolong survival in the responders. Low-dose Decitabine showed low overall response rate in the treatment for AML.更多还原