地西他滨治疗骨髓增生异常综合征37例临床疗效分析

秦剑; 黄姗; 聂波

地西他滨治疗骨髓增生异常综合征37例临床疗效分析

秦剑¹,
黄姗²,
聂波¹

1. 昆明医科大学第一附属医院
2. University of Melbourne,Arts and Humanities Department

基金项目:

基金：云南省科技厅-昆明医科大学应用基础研究联合专项基金资助项目 (2014FB027);

计量
- 文章访问数: 1529
- HTML全文浏览量: 538
- PDF下载量: 71
- 被引次数: 0
出版历程
- 收稿日期: 2017-04-22

Clinical Efficacy and Safety of Decitabine in Treatment of 37 Cases of Myelodysplastic Syndrome

Funds:

基金：云南省科技厅-昆明医科大学应用基础研究联合专项基金资助项目 (2014FB027);

摘要

摘要: 目的探讨标准剂量地西他滨治疗方案治疗骨髓增生异常综合征 (MDS) 的临床疗效及安全性.方法2014年1月至2016年12月昆明医科大学第一附属医院血液科收治的接受地西他滨静脉滴注[20 mg/ (m2·d) , 连续5 d, 每4周为一疗程]的MDS患者37例.按照既定的治疗方案, 收集患者治疗效果和安全性事件, 并根据不同预后分组进行疗效差异分析.结果 20例 (54.1%) 在至少使用了4周期地西他滨后获得了临床疗效反应, 其中3例CR (8.10%) , m CR无HI 6例 (16.2%) , m CR伴HI 3例 (8.1%) , HI 8例 (21.6%) ;另外17例患者中, 脱离输血3例 (8.1%) ;SD 11例 (29.7%) , PD 3例 (8.1%) .将MDS的总反应率按患者年龄、WHO分型和预后危险分层统计, 地西他滨治疗方案对65岁以下患者的ORR高于65以上患者, 对RAEB-1/RAEB-2分型患者的ORR高于其他分型, 但差异均未见统计学意义 (χ2值分别为0.815和1.213, P>0.05) , IPSS预后危险积分中、高危组患者的ORR明显优于低危组, 差异有统计学意义 (P=0.044) , 对WPSS预后分层较高危组的ORR明显优于较低危组, 差异有统计学意义 (P=0.036) .不良反应以血小板计数降低、白细胞计数降低和中型粒细胞计数降低最为多见, 34级不良反应中以血小板计数降低、白细胞计数降低和中性粒细胞降低发生率最高, 发生率分别为65.5%、59.3%和53.8%.非血液学不良反应主要有感染、ALT增高、腹泻和皮疹, 且分级多以12级为主.结论地西他滨治疗MDS耐受性好, 不良反应发生合理可控, 能够达到预期疗效.
- 骨髓增生异常综合征 /
- 地西他滨 /
- 不良反应
Abstract: Objective To discuss the clinical efficacy and safety of an standard dosage of decitabine in the treatment of patients with myelodysplastic syndromes. Methods Totally 37 cases of MDS patients received the treatment of standard dose of decitabine, (20 mg/m2 each day, 5 days continued, each four weeks is a course of treatment) , which admitted in Hematology department of the First Affiliated Hospital of Kunming Medical University from January 2014 to December 2016. According to the established therapeutic regimen, collecting treatment effects and safety parameters of patients, and according to different groups factors to analyze the difference of effects. Results Twenty patients (54.1%) obtained the clinical effect after the treatment of decitabineafter at least 4 courses. There were 3 cases (8.10%) with complete remission (CR) , marrow CR (m CR) without hematological improvement (HI) in 6 cases (16.2%) , m CR with HI in 3 cases (8.1%) , and HI alone in 8 cases (21.6%) ; 3 cases (8.1%) achieved transfusion independence, and 11 cases (29.7%) with stable disease (SD) and 3 cases (8.1%) with progressive disease (PD) . The total response rate of MDS was calculated according to the patient age, WHO type and prognosis risk stratification, decitabine treatment of 65 patients under the age of ORR above, more than 65 patients of/RAEB RAEB-1-2 type ORR is higher than other types of patient, but the difference was not statistically significant (The 2 values were 0.815 and 1.213, P>0.05) . The ORR of patients with high risk group of IPSS prognostic risk score was significantly better than that of low-risk group, the difference was statistically significant (χ2=4.063, P=0.044) .The ORR of the high-risk group of WPSS prognosis was significantly better than that of the lower risk group, the difference was statistically significant (χ2=4.375, P=0.036) .Adverse reactions were most commonly seen in Blood platelet count decreased, white blood cell count decreased and medium granulocyte count decreased. Thehighest incidence of platelet count decreased, white blood cell count decreased and medium granulocyte count decreased that was found in 3 ~ 4 adverse reactions. The incidence rate was 65.5%, 59.3% and 53.8% respectively. Non-hematological adverse reactions mainly include infection, ALT, diarrhea and rashes, and most grades are given priority to 1 ~ 2 level. Conclusion Decitabine for treatment of MDS is well tolerated, and the adverse reactions occur reasonably and controllable, it can achieve the expected curative effect.
- Myelodysplastic syndrome /
- Decitabine /
- Adverse reactions

HTML全文

参考文献(12)

[1]	[1] KANTARJIAN H, OKI Y, GARCIA-MANERO G, et al.Results of a randomized study of 3 schedules of low-dose decitabine in higher risk myelodysplastic syndrome and chronic myelomonocytic leukemia[J].Blood, 2007, 109 (1) :52-57.
[2]	[2]LEE J H, JANG J H, PARK J, et al.A prospective multicenter observational study of decitabine treatment in Korean patients with myelodysplastic syndrome[J].Haematologica, 2011, 96 (10) :1441-1447.
[3]	[3]STEENSMA D P, BAER M R, SLACK J L, et al.Multicenter study of decitabine administered daily for 5 days every 4weeks to adults with myelodysplastic syndromes:the alternative dosing for outpatient treatment (ADOPT) trial[J].J Clin Oncol, 2009, 27 (27) :3842-3848.
[4]谢伟成, 程淑琴, 林翠芳.等.地西他滨治疗骨髓增生异常综合征的临床疗效研究[J].临床和实验医学杂志, 2014, 13 (11) :877-800.
[5]毛建平, 朱华渊, 沈文怡, 等.超小剂量地西他滨治疗骨髓增生异常综合征37例疗效及安全性评价[J].中国实用内科杂志, 2017, 37 (2) :141-144.
[6]	[6]SAUNTHARARAJAH Y.Key clinical observations after5-azacytidine and decitabine treatment of myelodysplastic syndromes suggest practical solutions for better outcomes[J].Hematol Am Soc Hematol Educ Program, 2013, 2013 (1) :511-521.
[7] 邵宗鸿.中高危骨髓增生异常综合征的治疗选择[J].中华血液学杂志, 2012, 33 (7) :508-511.
[8]	[8]LBBERT M, SUCIU S, BAILA L, et al.Low-dose decitabine versus best supportive care in elderly patients with Inter-mediate-or high-risk myelodysplastic syndrome (MDS) ineligible for intensive chemotherapy:final results of therandomized phaseⅢstudy of the European Organisationfor Research and Treatment of Cancer Leukemia Groupand the German MDS Study Group[J].J Clin Oncol, 2011, 29 (15) :1987-1996.
[9]	[9]WANG J, YI Z, WANG S, et al.The effect of decitabine on megakaryocyte maturation and platelet release[J].Thromb Haemost, 2011, 106 (2) :337-343.
[10]李杰平, 曾东风, 朱丽丹, 等.地西他滨治疗中、高危骨髓增生异常综合征的临床观察[J].中国药房, 2013, 24 (40) :3764-3767.
[11]许倩, 孙爱宁, 陈苏宁, 等.多疗程地西他滨治疗骨髓增生异常综合征及急性髓系白血病患者的回顾性分析[J].临床血液学杂志, 2017, 30 (3) :198-201, 205.
[12]田雅兰, 边桂芝, 张志勇.地西他滨上市后血液及淋巴系统疾病不良反应信号检测与分析[J].中国医院药学杂志, 2017, 37 (14) :1401-1404.

相关文章(20)

[1]	徐文秀, 莫小凤, 杨祥民, 杨丝露, 吴凡, 李特. Logistic回归与决策树模型在碘造影剂不良反应预测中的应用, 昆明医科大学学报. doi: 10.12259/j.issn.2095-610X.S20240911
[2]	许榛, 凌昱, 刘四香, 宋玉, 蓬阳, 孙晶晶. 昆明市特殊健康状态儿童疫苗接种不良反应情况及应对措施, 昆明医科大学学报. doi: 10.12259/j.issn.2095-610X.S20240321
[3]	张蓉, 宋兴菊, 段琳, 李倩, 陈旭. 丁苯酞对急性脑梗死患者NIHSS及血液流变学的影响, 昆明医科大学学报. doi: 10.12259/j.issn.2095-610X.S20220810
[4]	杨皓, 张国云, 王德财, 郭云瑞, 张业才, 杨建明. B超引导下股神经阻滞镇痛和口服镇痛在老年股骨中上段骨折术前镇痛中的应用效果, 昆明医科大学学报. doi: 10.12259/j.issn.2095-610X.S20210931
[5]	李娜, 陈洁, 罗季, 陈永刚, 彭江丽, 喻明丽, 李生浩. 抗结核药物不良反应 376例分析, 昆明医科大学学报. doi: 10.12259/j.issn.2095-610X.S20210422
[6]	叶吉明, 辜学忠, 储雨妍, 刘宇, 叶吉云. 地西他滨和沙利度胺两种方案治疗骨髓增生异常综合征的临床疗效, 昆明医科大学学报.
[7]	曹红花, 吴娜, 贺鸣, 张睿, 周叶英, 赖洵, 申政磊. 皮下注射硼替佐米为主化疗方案治疗多发性骨髓瘤, 昆明医科大学学报.
[8]	李德应, 王玉明, 柴华香, 董伟群. 218例输血不良反应的回顾性分析及预防策略, 昆明医科大学学报.
[9]	孙建明, 董芳. 儿童急性淋巴细胞白血病化疗后的不良反应, 昆明医科大学学报.
[10]	熊守庆. 两种路径行冠脉介入诊疗的效果及并发症比较, 昆明医科大学学报.
[11]	刘清华. 丙泊酚联合舒芬太尼对腹腔镜子宫肌瘤剔除术的镇痛、苏醒及不良反应的影响, 昆明医科大学学报.
[12]	刘萍. 静脉注射地佐辛对剖宫产术中不良反应发生的影响, 昆明医科大学学报.
[13]	桂琦. 曼月乐环治疗子宫腺肌病75例临床观察, 昆明医科大学学报.
[14]	邢文忠. 云南昆钢医院173例药品不良反应报告分析, 昆明医科大学学报.
[15]	徐应芳. 83例输血不良反应临床分析, 昆明医科大学学报.
[16]	唐辉蓉. MRCP与T管造影在胆道术后拔除T管前的对比分析, 昆明医科大学学报.
[17]	张颖. 普通肝素和低分子肝素在AECOPD合并肺栓塞中的临床观察, 昆明医科大学学报.
[18]	. 加味当归四逆汤防治卡培他滨相关性手足综合征的临床疗效观察, 昆明医科大学学报.
[19]	. 输血不良反应60例临床分析, 昆明医科大学学报.
[20]	谭晶. 吉西他滨联合奥沙利铂与吉西他滨单独化疗治疗晚期胰腺癌的近期疗效比较, 昆明医科大学学报.