甘露聚糖肽序贯联合化疗治疗急性早幼粒细胞白血病的临床观察

Clinical observation on acute promyelocytic leukemia treated by sequential mannaitde injection and chemotherapy

目的观察甘露聚糖肽序贯与全反式维甲酸、三氧化二砷联合化疗治疗急性早幼粒细胞白血病的临床疗效及安全性。方法选择我院肿瘤血液科2003年1月至2007年12月初诊为急性早幼粒细胞白血病患者60例,随机分为治疗组、对照组、空白组,每组20例,3组患者均采用全反式维甲酸、三氧化二砷联合化疗法,治疗组患者在住院期间加用甘露聚糖肽注射液,出院后口服甘露聚糖肽口服液,对照组患者住院期间加用胸腺肽注射液,出院后口服胸腺肽肠溶片,空白组患者住院期间静脉滴注同体积的氯化钠注射液,出院后口服等量的安慰剂。结果治疗组患者总有效率为90%,与对照组、空白组比较差异均有统计学意义(P值<0.05)。治疗组患者胃肠道反应如恶心、呕吐发生率为30%,中性粒细胞、血小板等骨髓抑制反应发生率为25%,肝功能异常率为10%,其中胃肠道反应发生率、骨髓抑制反应发生率均较对照组、空白组显著降低(P<0.05)。随访发现,治疗组5年无病生存率、5年生存率均显著高于对照组、空白组(P<0.05)。结论甘露聚糖肽序贯与全反式维甲酸、三氧化二砷联合化疗治疗急性早幼粒细胞白血病,不仅能显著提高临床疗效,降低不良反应发生率,还能延长患者生存期。

Objective To investigate the clinical efficacy and security of sequential and combination chemotherapy with mannatide,ATRA and arsenic trioxide on acute promyelocytic leukemia.Methods Sixty patients with initial acute promyelocytic leukemia in our hospital from January 2003 to December 2007 were randomly divided into treatment group,control group and blank group,with 20 patients in every group.ATRA and arsenic trioxide were infused into all patients.Treatment group were given extra mannatide injection during hospitalization and mannatide oral solution after discharge.Patients of control group were treated with thymosin injection during hospitalization and thymosin enteric-coated tablets after discharge.Patients hospitalized in the blank group were only given same volume of intravenous sodium chloride injection and oral placebo after discharge.Results The total effective rate was 90%in the treatment group,statistically different from that in control group（P〈0.05）and blank group（P〈0.05）.30% of patients in treatment group had gastrointestinal reactions such as nausea or vomiting,25% had bone marrow suppression in neutrophils and platelets,and 10% had abnormal liver function.Compared with control group and blank group,the rate of gastrointestinal adverse reactions and bone marrow suppression was significantly lower（P〈0.05）.Follow-up study showed that five-year disease-free survival rate and fiveyear survival rate of the treatment group were significantly higher than control group and blank group（P〈0.05）.Conclusion Sequential and combination chemotherapy with mannatide,ATRA and arsenic trioxide on acute promyelocytic leukemia can not only significantly improve clinical efficacy and reduce the incidence of adverse reactions,but also prolong survival of patients.