甘露聚糖肽和地榆升白片治疗非小细胞肺癌化疗性白细胞减少症对照试验

摘要

Objective:To evaluate the efficacy and safety of mannan peptide and Diyu-Shengbai tablet on the white blood cell count of NSCLC patients with chemotherapy.Methods:A prospective parallel randomized controlled clinical study was conducted to compare the efficacy and safety of one hundred and twenty-six cases with non-small cell lung cancer were randomly divided into two groups,mannan peptide group (62patients),the average daily dose is 2 capsules 3 times daily and GP chemotherapy;and Diyu-Shengbai tablet group (64 patients),the average daily dose is 3 tablets 3 times daily and GP chemotherapy.The patients were evaluated to white blood cell (WBC),hemoglobin (HB) and blood plates (PLT),as well as drug dose of rhG-CSF(recombinant human granulocyte colony stimulating factor).Results:The Significant efficiency between mannan peptide group and Diyu-Shengbai tablet group (51.67%vs 36.67%,P=0.035) the number of WBC in first weekand in third week,the minimum number of WBC and the means of used dose of rhG-CSF [(0.62±1.43) vs (2.17±4.05),P=0.005]with a statistics difference after follow-up.There are a few adverse reactions cases and they are not serious. Conclusion:The effect are similar between mannan peptide and Diyu-Shengbai tablet to prevent white blood cell reduction of NSCLC Patients with chemotherapy.However,mannan peptide is better than Diyu-Shengbai tablet in this study.%目的：评价口服甘露聚糖肽与地榆升白片在非小细胞肺癌化疗中改善白细胞减少症过程中的有效性及安全性。方法：应用前瞻性、开放性和平行对照方法,参照随机数列表纳入126例非小细胞肺癌(non-small cell lung cancer,NSCLC)患者,随机分为甘露聚糖肽组62例,口服甘露聚糖肽胶囊2粒/次,3次/d,加GP方案进行治疗；地榆升白片组64例,口服地榆升白片3片/次,3次/日,加GP方案。观察两者外周血常规变化及集落刺激因子用量。结果：甘露聚糖肽组与地榆升白片组在显效率(51.67% vs 36.67%,P=0.035)方面,白细胞数增加的效果方面在2次化疗期间第一周、第三周,白细胞数目的最低值以及两组人均惠尔血用量[(0.62±1.43) vs (2.17±4.05),P=0.005]具有统计学意义。另外两组试验中出现不良反应的病例较少,且症状轻微,恢复较快。结论：两组药物均能显著升高白细胞,然而甘露聚糖肽的临床疗效和安全性要优于地榆升白片。