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.
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.