西达本胺联合氟达拉滨治疗复发急性淋巴细胞白血病的疗效及安全性分析

The efficacy and safety of chidamide combined with fludarabine in the treatment of recurrent acute lymphoblastic leukemia

目的探讨西达本胺联合氟达拉滨治疗复发急性淋巴细胞白血病的疗效及安全性。方法根据随机数字表法将124例复发急性淋巴细胞白血病患者分为对照组和观察组各62例,对照组只使用氟达拉滨治疗,观察组采用西达本胺联合氟达拉滨联合治疗。对比两组治疗1个周期后疗效,治疗前、治疗1个周期时血清生化标志物表达水平,生存质量差异,随访3年记录两组复发率、生存率及治疗期间不良反应发生率。结果治疗1个周期后观察组总有效率高于对照组,且两组完全缓解、部分缓解、未缓解率差异有统计学意义(P<0.05)。与治疗前比较,治疗1个周期患者血清乳酸脱氢酶(LDH)、腺苷脱氨酶(ADA)水平均下降,WHOQOL BREF评分均升高,且同期观察组较对照组变化更显著(P<0.05)。观察组1年复发率和3年复发率均低于对照组,而1年生存率和3年生存率均高于对照组(P<0.05)。治疗期间,两组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论西达本胺联合氟达拉滨对复发急性淋巴细胞白血病患者的治疗效果优于氟达拉滨单一用药,能显著提升患者短期生存质量和长期生存率,且用药安全性较好,可应用于复发急性淋巴细胞白血病的临床治疗中。

Objective To investigate the efficacy and safety of chidamide combined with fludarabine in the treatment of recur rent acute lymphoblastic leukemia.Methods A total of 124 patients with recurrent acute lymphoblastic leukemia were divided into control group and observation group according to the random number table method,62 in each group.The control group was treated with fludarabine only,and the observation group was given chidamide combined with fludarabine.The efficacy after 1 cycle of treatment,and expression levels of serum biochemical markers and quality of life before treatment and after 1 cycle of treatment were compared between the two groups.The recurrence rate,survival rate and incidence rate of toxic and side effects during treatment were recorded during 3 years of follow up in the two groups.Results After 1 cycle of treatment,the overall effective rate(OR)in the observation group was significantly higher than that in the control group,and there were statistically significant differences in the complete remission(CR),partial remission(PR)and non remission(NR)between the two groups(all P<0.05).Compared with before treatment,serum LDH and ADA levels were significantly decreased after 1 cycle of treatment,and the WHOQOL BREF scores were significantly increased,and the changes in the observation group were more significant than those in the control group(all P<0.05).The 1 year recurrence rate and 3 year recurrence rate in the observation group were significantly lower than those in the control group,and the 1 year survival rate and 3 year survival rate were significantly higher than those in control group(all P<0.05).During treatment period,the total incidence rate of toxic and side effects in the observation group was not significantly different from that in the control group(P>0.05).Conclu sion Chidamide combined with fludarabine has better treatment effects than fludarabine alone in the treatment of patients with recurrent acute lymphoblastic leukemia.The combined therapy can significantly improve the short term quality of life and long term survival rate,and it has good medication safety.Therefore,it can be used in the clinical treatment of recurrent acute lymphoblastic leukemia.