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目的:探讨亚砷酸与沙利度胺联合治疗骨髓增生异常综合征(MDS)的疗效和安全性。方法:MDS患者68例随机分为观察组34例与对照组34例。对照组采用沙利度胺治疗,观察组在对照组基础上加用亚砷酸治疗。两组均以6周为1个疗程,连续治疗4个疗程。比较两组疗效和药品不良反应发生情况;观察两组患者治疗2个和4个疗程时的骨髓象变化以及治疗前后患者血象变化。结果:观察组总有效率高于对照组(P<0.05)。观察组治疗2个疗程和4个疗程时,原始细胞比例减少的发生率均高于对照组(P<0.05);且两组治疗4个疗程原始细胞比例减少的发生率均高于治疗2个疗程(P<0.05)。治疗后,两组患者WBC、Hb、Plt等指标较治疗前均有明显增加(P<0.05),且观察组各项指标均高于对照组(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:亚砷酸与沙利度胺联合治疗骨髓增生异常综合征的疗效肯定,且安全性好。
Objective: To investigate the efficacy and safety of combination of arsenious acid and thalidomide in the treatment of myelodysplastic syndrome (MDS). Methods: Sixty-eight patients with MDS were randomly divided into observation group (34 cases) and control group (34 cases). The control group was treated with thalidomide, and the observation group was treated with arsenious acid on the basis of the control group. Both groups took 6 weeks for a course of treatment, continuous treatment of 4 courses. The curative effects and side effects of adverse drug reactions were compared between two groups. The changes of bone marrow biopsy and the changes of blood before and after treatment were observed in two groups and two treatment groups. Results: The total effective rate in observation group was higher than that in control group (P <0.05). In the observation group, the incidences of the reduction of the proportion of blasts were higher in the 2 courses and 4 courses of treatment than those in the control group (P <0.05). The incidences of reduction of the proportion of blasts in the 4 groups were higher than those in the 2 groups Course of treatment (P <0.05). After treatment, the WBC, Hb, Plt and other indexes in both groups were significantly increased (P <0.05), and the indicators in the observation group were higher than those in the control group (P <0.05). The incidence of adverse reactions in the two groups, the difference was not statistically significant (P> 0.05). Conclusion: Arsenious acid combined with thalidomide treatment of myelodysplastic syndrome positive effect, and good safety.