益气温阳健脾汤联合低剂量重组人粒细胞集落刺激因子治疗恶性肿瘤化疗后白细胞减少症多中心随机平行对照研究

A Multi-center Random Parallel Clinical Trail on the Treatment of Chemotherapy Related Leucopenia in Patients with Malignant Tumor by the Combination of Tonifying Qi Warming Yang and Invigorating Spleen Decoction and low-dose rhG-CSF

[目的]观察益气温阳健脾汤联合低剂量重组人粒细胞集落刺激因子治疗恶性肿瘤化疗后白细胞减少症疗效。[方法]使用多中心随机平行对照方法,将60例住院患者按就诊顺序编号的方法随机分为两组,在WBC<4.0×109/L时开始疗程。对照组30例重组人粒细胞集落刺激因子皮下注射,150μg/d,连用3d。治疗组30例益气温阳健脾汤(党参20g,黄芪30g,当归l0g,生熟地黄各15g,黄精10g,鸡血藤20g,穿山甲珠10g,肉苁蓉15g,阿胶[烊化]20g;黄柏、桑枝各10g,茯苓20g,炒白术10g,大枣10枚,知母10g,生麦芽、仙灵脾各20g,补骨脂、首乌各10g)1剂/d,水煎分2次服,连续服用2周,西药治疗同对照组。观测临床症状、治疗后3d、8d、13d、21d外周血白细胞计数及中性粒细胞绝对值。[结果]白细胞计数治疗后3d、8d、13d、21d两组均有提升(P<0.05),治疗组优于对照组(P<0.01)。中性粒细胞绝对值治疗后8d、13d、21d两组均有提升(P<0.05),治疗组优于对照组(P<0.01)。[结论]益气温阳健脾汤联合低剂量重组人粒细胞集落刺激因子治疗恶性肿瘤化疗后白细胞减少症安全有效,值得推广。

[Objective]To observe the treatment of Tonifying Qi Warming Yang and Invigorating Spleen Decoction combination with low-dose rhG-CSF on leucopenia in patients with malignant tumor after chemotherapy.[Methods] 60 patients including inpatients were divided into experiment group and control group in the randomized parallel-controlled trial.The treatment was started when the WBC4.0×109/L.The control group（30 cases） was treated with rhG-CSF 150μg/d hypodermic injection for 3 consecutive days.The experiment group was treated with Tonifying Qi Warming Yang and Invigorating Spleen Decoction,one decoction per day for 2 weeks.The rhG-CSF treatment was the same as the control group.Observe the clinical symptoms,WBC and NEUT after treating 3days、8days、13days、21days.[Results]The WBC in both group was raised after the treatment in 3d、8d、13d、21d（P0.05）,the experiment group was superior to control group（P0.01）.The NEUT was raised after the treatment in 8d、13d、21d（P0.05）,also the experiment group was better（P0.01）.[Conclusion]The treatment of Tonifying Qi Warming Yang and Invigorating Spleen Decoction combination with low-dose rhG-CSF on leucopenia in patients with malignant tumor after chemotherapy is safe and effective.It Is worth to be popularized.