低剂量地西他滨治疗成人难治复发原发免疫性血小板减少症的临床研究  

Clinical trial of low-dose decitabine treatment of primary immune thrombocytopenia in adults

作　　者：孙艳花[1] 冉学红[1] 高梅 燕法红 卞倩玉 徐文君[1] 崔景英[1] SUN Yanhua;RAN Xuehong;GAO Mei;YAN Fahong;BIAN Qianyu;XU Wenjun;CUI Jingying(Department of Hematology,Weifang People's Hospital,Weifang,261041,China)

机构地区：[1]潍坊市人民医院血液科,山东潍坊261041

出　　处：《临床血液学杂志》2020年第6期759-761,766,共4页Journal of Clinical Hematology

基　　金：山东省潍坊市卫生计生委科研项目(No:2017wsjs104)。

摘　　要：目的:探讨低剂量地西他滨治疗成人难治复发性原发免疫性血小板减少症(ITP)的临床疗效、起效时间、疗效维持时间及不良反应。方法:采用同期非随机对照的前瞻性研究方法,将46例成人难治复发性ITP患者分为试验组和对照组。试验组21例,采用低剂量地西他滨治疗:3.5 mg/(m^2·d),连用3 d,每4周用药1次;对照组25例,给予达那唑治疗;治疗后比较2组的疗效及不良反应。结果:试验组21例患者治疗后完全反应5例(23.81%),有效6例(28.57%),总有效率52.38%(11/21);对照组25例患者治疗后完全反应1例(4.00%),有效8例(32.00%),总有效率36.00%(9/25);2组疗效比较差异有统计学意义(P<0.05)。试验组中位起效时间4(2~10)周,较对照组起效时间[10(8~18)周]明显缩短(P<0.05)。2组患者疗效维持时间均多在3~12个月。试验组较对照组有更少的不良反应,耐受性更好。结论:低剂量地西他滨治疗成人难治复发性ITP有一定疗效,不良反应可耐受。Objective:To investigate the clinical efficacy,onset time,response duration and adverse events of low-dose decitabine in adult patients with refractory or relapsed primary immune thrombocytopenia(ITP).Method:Forty-six patients with refractory or relapsed ITP were divided into 2 groups prospectively with concurrent control:21 cases in experimental group received intravenous decitabine at 3.5 mg/m^2 for three consecutive days per cycle with a four-week interval,the remaining 25 cases in control group were treated with danazol.The curative effects and adverse events were observed after treatment in two groups.Result:The complete remission rate and total response rate in experimental group were 23.81%(5/21) and 52.38%(11/21) respectively,while those corresponding rates in control group were 4.00%(1/25) and 36.00%(9/25),respectively.The therapeutic efficacy differences between two groups showed statistical significance(P<0.05).The median onset time of the experimental group was 4(2-10) weeks,which was significantly shorter compared with 10(8-18) weeks of the control group(P<0.05).The maintenance time of the two groups was mostly between 3 months and 12 months.The experimental group had fewer adverse events and better tolerance than the control group.Conclusion:Low-dose decitabine may be an effective and safe method for adult patients with refractory or relapsed ITP.

关 键 词：原发免疫性血小板减少症 难治性 地西他滨 疗效 不良反应 

分 类 号：R558.2[医药卫生—血液循环系统疾病]