正元胶囊辅助培门冬酶联合化疗治疗儿童急性淋巴细胞白血病的临床分析

Clinical Analysis of Zhengyuan Capsule Combined with Polyethylene Glycolconjugated Asparaginase for Children with Acute Lymphoblastic Leukemia

目的探讨正元胶囊辅助培门冬酶联合化疗治疗儿童急性淋巴细胞白血病(ALL)的疗效及对患儿血清中白细胞介素(IL-6)和肿瘤坏死因子(TNF)-α水平的影响。方法将90例儿童ALL随机分为对照组和观察组,均45例。对照组采取培门冬酶注射液组成的VDPAP方案。观察组在对照组基础上于缓解期内服正元胶囊,4粒/次,3次/天,连续治疗8周。比较2组近期疗效、治疗6个月和1年后的无事件生存率以及不良反应发生率。检测2组儿童ALL血清中IL-6和TNF-α的水平。结果观察组患儿的近期总缓解率为84.44%,显著高于对照组的64.44%(P<0.05)。对照组6个月和1年无事件生存率分别为95.56%和86.67%,观察组为97.78%和93.33%,2组无事件生存率比较均无统计学差异(P>0.05)。观察组患儿的肝功能损害、骨髓抑制、低白蛋白血症、口腔溃疡、胃肠道反应及凝血功能异常的发生率均少于对照组,但2组间差异无统计学意义(P>0.05)。治疗后,观察组治疗后患儿血清中IL-6和TNF-α水平明显高于对照组(P<0.01)。结论正元胶囊辅助培门冬酶联合化疗治疗儿童ALL的疗效明显,且安全性好,可能与其提高儿童ALL血清中IL-6和TNF-α水平有关。

Objective To investigate the efficacy of Zhengyuan capsule combined with polyethylene glycolconjugated as- paraginase for children with acute lymphoblastic leukemia （ALL） , and its influence on serum levels of interleukin （IL） -6 and tumor necrosis factor（TNF）-ct. Methods 90 cases of children with ALL were randomly divided into the control group and the observation group ,with 45 cases in each group. The control group was given with PEG-Asp containing VDPAP regimen. Based on the control group, the observation group received Zhengyuan capsule during catabasis ,4 grains/time, tid, for 8 weeks. Recent effi- cacy,6-month and 1-year survival rates after treatment, and adverse reactions were compared in both groups. Serum levels of IL-6 and TNF-α were detected in both groups. Results Total remission rate of the observation group was 84.44% , which was remark- ably higher than that of the control group ,64.44% （P 〈 0.05 ）. 6-month and l-year survival rates were 95.56% and 86.67%, re- spectively ,which were not obviously lower than the control group 97.78% and 93.33% （P 〉 0.05 ）. Liver function injury, bone marrow suppression, hypoalbuminemia, oral mucosal lesions, gastrointestinal reactions, and coagulation disorders in the observation group were less than those of the control group, but there had no statistically significant between the 2 groups （P 〉 0.05 ）. Serum levels of IL-6 and TNF-α in the observation group were remarkably higher than the control group （ P 〈 0.01 ）. Conclusion Zhengyuan capsule combined with polyethylene glycolconjngated asparaginase for children with acute lymphoblastic leukemia （ALL） is effective,which is related to increasing serum levels of IL-6 and TNF-α.