老年中高危骨髓增生异常综合征患者应用超小剂量地西他滨治疗及不良反应分析  

Adverse Reactions of Ultra-low Dose Decitabine in Elderly Patients with Intermediate-to high-risk Myelodysplastic Syndromes

作　　者：常炳庆[1,2] 郭轶先 赵弘[2] 兰晓曦[2] 苏力[2] 孙婉玲[2] CHANG Bingqing;GUO Yixian;ZHAO Hong;LAN Xiaoxi;SU Li;SUN Wanling(Department of Hematology,Beijing Aerospace General Hospital,Beijing 100075,China;Department of Hematology,Xuanwu Hospital,Capital Medical University,Beijing 100053,China)

机构地区：[1]北京航天总医院血液科,北京100076 [2]首都医科大学宣武医院血液科,北京100053

出　　处：《中国药物警戒》2021年第8期776-779,792,共5页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(81000200)。

摘　　要：目的研究超小剂量地西他滨治疗老年中高危骨髓增生异常综合征(myelodysplastic syndromes, MDS)患者的疗效及不良反应。方法回顾性分析某院血液科于2014年7月1日至2018年12月31日期间收治的,19例接受含超小剂量地西他滨方案治疗的中高危MDS患者,分析年龄因素(年龄≥65岁/<65岁)对疗效及不良反应的影响。结果入组患者接受了81个周期含超小剂量地西他滨的方案治疗,其中老年患者(年龄≥65岁)8例,接受了26周期治疗。老年患者在改变疾病自然病程反应、完全缓解(complete remission, CR)及血液学改善-红细胞反应(HI-erythroid, HI-E)疗效均显著低于年龄<65岁患者(P分别为0.024、0.045、0.024)。其他的疗效、治疗后感染的发生率及Ⅲ-Ⅳ/Ⅳ级骨髓抑制发生率,均没有显著差异。随着化疗周期的增加,骨髓抑制的发生率无显著增加。结论老年中高危MDS患者应用含超小剂量地西他滨方案治疗,可获得较好的临床疗效、不良反应无明显增加。Objective To investigate the clinical efficacy and adverse reactions of ultra-low dose decitabine in elderly patients with intermediate-to high-risk myelodysplastic syndromes(MDS). Methods The clinical data on nineteen patients with intermediate-to high-risk MDS treated with ultra-low dose decitabine between July 1, 2014 and December 31, 2018 was retrospectively analyzed. The effect of age(aged ≥ 65/<65) on curative effects and adverse reactions was studied. Results Nineteen patients received a total of eighty-one cycles of ultra-low dose decitabine. Eight(aged ≥ 65) of these patients received a total of 26 cycles of treatment.Alteration of the natural course of disease response, complete remission(CR), and hematology improvementerythrocyte reaction(HI-E) were much less likely among elderly patients than among those under 65(P values were 0.024, 0.045, 0.024, respectively). There was no significant difference in other outcomes or in the incidence of post-treatment infection or grade Ⅲ-Ⅳ/Ⅳ myelosuppression. With the increase of chemotherapy cycles, the incidence of myelosuppression did not increase significantly. Conclusion For elderly patients with intermediateto high-risk MDS, the treatment with ultra-low dose decitabine can obtain better clinical efficacy without significant increase in adverse reactions.

关 键 词：超小剂量地西他滨 骨髓增生异常综合征 老年患者 中高危 不良反应 

分 类 号：R973[医药卫生—药品] R994.141[医药卫生—药学]