正元胶囊辅助甲氨蝶呤治疗儿童急性淋巴细胞白血病的有效性和安全性分析

Efficacy and Safety of Zhengyuan Capsule Combined with Methotrexate for Childhood Acute Lymphoblastic Leukemia

目的探讨正元胶囊辅助甲氨蝶呤治疗儿童急性淋巴细胞白血病的有效性和安全性以及对血清中B淋巴细胞刺激因子(BAFF)和增殖诱导配体(APRIL)水平的影响。方法 78例儿童急性淋巴细胞白血病随机分为对照组和观察组,各39例。对照组采取甲氨蝶呤治疗,观察组在对照组基础上于缓解期口服正元胶囊,1~3粒/次,3次/天,共治疗8周。比较2组近期疗效、治疗过程中不良反应。检测2组患儿血清中BAFF和APRIL水平。结果观察组近期总缓解率为89.74%,显著高于对照组的61.54%(P<0.01)。观察组患儿的口腔黏膜损害、肝功能损害、感染、骨髓抑制、胃肠道反应及皮肤损害发生少于对照组,但组间差异无统计学意义(P>0.05)。治疗后,观察组患儿血清中BAFF和APRIL水平显著低于对照组,差异有统计学意义(P<0.01)。结论金正元胶囊辅助甲氨蝶呤治疗儿童急性淋巴细胞白血病的疗效确切,安全性好,降低患儿血清中BAFF和APRIL水平可能与其疗效有关。

Objective To investigate efficacy and safety of Zhengyuan capsule combined with methotrexate for childhood acute lymphoblastic leukemia and its influence on serum levels of B cell activating factor（BAFF） and a proliferation-inducing lig- and（APRIL）. Methods 78 patients with childhood acute lymphoblastic leukemia were randomly divided into the control group and the observation group with 39 cases in each group. The control group was treated with methotrexate. Based on the control group,the observation group was given with Zhengyuan capsule, 1 -3 grains/time, tid, and for 8 weeks. The recent efficacy and adverse reactions were compared between the 2 groups. Serum levels of BAFF and APRIL were detected in the 2 groups. Results The total remission rate of the observation group was 89.74% ,which was obviously higher than the control group as 61.54% （P 〈 0. 01 ）. Patients with oral mucosal lesions, liver function injury, infection, bone marrow suppression, Gastrointestinal reactions, and skin lesions in the observation group were less than the control group, but there had no statistical significance between the 2 groups （ P 〉 0.05 ）. After treatment, serum levels of BAFF and APRIL were evidently lower than those of the control group, there had statistic difference （P 〈 0. 01 ）. Conclusion Efficacy of Zhengyuan capsule combined with methotrexate for childhood acute lymphoblastic leukemia is exact and safe, and may be relevant to down-regulation of serum levels of BAFF and APRIL.