超低剂量地西他滨治疗老年中、高危骨髓增生异常综合征的临床观察  

Clinical observation of ultra low-dose decitabine in the treatment of elderly patients with moderate-high risk myelodysplastic syndrome

作　　者：冷青[1] 刘卓刚[2] 张晓东[3] 马瑀[1] 宋扬[1] 季征[1] 马清君[1] 吴音[1] 张桂敏[1] LENG Qing LIU Zhuo-gang ZHANG Xiao-dong MA Yu SONG Yang JI Zheng MA Qing-jun WU Yin ZHANG Gui-min(Department of Hematology, Anshan Central Hospital, Anshan 114001, China Department of Hematology, Shengjing Hospital of China Medical University, Shenyang 110004, China Department of Hematology, the People＇ s Liberation Army NO. 202 Hospital, Shenyang 110003, China)

机构地区：[1]鞍山市中心医院血液内科,辽宁鞍山114001 [2]中国医科大学附属盛京医院血液内科,沈阳110004 [3]中国人民解放军第二〇二医院血液内科,沈阳110003

出　　处：《实用药物与临床》2017年第10期1139-1143,共5页Practical Pharmacy and Clinical Remedies

摘　　要：目的观察超低剂量地西他滨(Decitabine,DAC)治疗老年中、高危骨髓增生异常综合征(Myelody splastic syndromes,MDS)患者的近期临床疗效及安全性。方法选择2014-2016年符合纳入标准的IPSS(International Prognostic Scoring System)评分相对高危(中、高危)老年(≥60岁)MDS患者33例。观察组(24例)给予DAC 7 mg/m2,持续泵入1 h以上,连用10 d,28 d为1个治疗周期,入组患者至少完成4个周期治疗。9例采用最佳支持治疗患者作为对照组。结果33例MDS患者中位年龄73岁(60~91岁),29例MDS及3例慢性粒单细胞白血病(Chronic myelomonocytic leukemia,CMML)患者缓解状况可评价,两组患者临床特征差异无统计学意义(P>0.05)。观察组完全缓解(Complete response,CR)率为13.04%,部分缓解(Partial remission,PR)率为8.69%,5例获得骨髓完全缓解(mCR)中2例伴血液学改善(Hematologic improvement,HI);对照组仅1例获得HI。观察组总体反应率(Overall response rate,ORR)为52.17%(12/23),显著高于对照组11.11%(1/9),差异有统计学意义(P<0.05)。随访12个月,观察组中位总生存期(OS)为8.5个月,较对照组(4.3个月)差异有统计学意义(P<0.05)。观察组患者耐受性较好,主要不良反应为Ⅰ、Ⅱ级骨髓抑制。观察组患者感染率(56.52%)略低于对照组(77.78%),差异无统计学意义(P>0.05)。结论超低剂量DAC治疗老年中、高危MDS/CMML患者疗效显著,治疗相关不良反应发生率低,可实现显著的生存获益。Objective To evaluate the efficacy and safely of ultra low-dose decitabine（ DAC） in the treatment of elderly patients with moderate-high risk myelodysplastic syndrome（ MDS）. Methods Totally 33 elderly patients（ ≥60 years old） with moderate-high risk MDS according to IPSS（ International Prognostic Scoring System）from 2014 to 2016 were divided into two groups. Patients in observation group（ n = 24） were given DAC 7 mg/m2 by vein daily over 1 h on day 1 ～ 10. Cycles were scheduled every 28 d, and patients were treated for a minimum of 4 cycles;9 patients（ control group） received best supportive treatment（ BST）. Results The median age of 33 patients was73（ 60 ～ 91） years old, and the response data was evaluable for 29 patients with MDS and 3 patients with Chronic myelomonocytic leukemia（ CMML）. There was no significant difference in patients＇ characteristics between the two groups（ P〈0. 05）. The rate of complete response（ CR） in observation group was 13. 04%, and the rate of partial remission（ PR） was 8. 69%. There were 5 cases with mCR in observation group, in which 2 case gained hematologic improvement（ HI）,while there was only 1 case with HI in control group. The overall response rate（ ORR） in observation group was higher than that of control group： 52. 17%（ 12/23） vs. 11. 11%（ 1/9）,P〈0. 05. The median OS in observation group was longer than that of control group（ 8. 5 months vs. 4. 3 months,P〈0. 05）. The most common adverse reaction was grade Ⅰ ～ Ⅱ myelosuppression. The infection rate in observation group was slightly lower than that of control group（ 56. 52% vs. 77. 78%,P〈0. 05）. Conclusion Ultra low-dose decitabine has good clinical efficacy in elderly patients with moderate-high risk MDS, and can achieve significant survival benefits with low incidence of adverse reactions.

关 键 词：骨髓增生异常综合征 老年 地西他滨 

分 类 号：R551.3[医药卫生—血液循环系统疾病]