升白合剂治疗白细胞减少症的临床研究

Clinical research of Shengbai Mixtrues in treating leukopenia

目的:评价升白合剂治疗白细胞减少症的临床有效性和安全性。方法:采用随机、双盲、安慰药平行对照的临床研究方法。入选有效病例218例,其中试验组110例,口服升白合剂;对照组108例,口服升白合剂模拟剂。两组疗程皆为42d,分别观察治疗前及治疗后外周血白细胞计数、中性粒细胞数、淋巴细胞数、单核细胞数、嗜酸细胞数、嗜碱细胞数、中医症候积分等指标的变化。结果:与对照组比较,试验组能明显提升外周血白细胞计数及中性粒细胞(P<0.01)。试验组治疗42d后,总有效率为97.27%,对照组总有效率为30.56%,两组间比较差异有统计学意义(P<0.01)。试验组能明显降低中医症候总积分(18.34±3.56),与对照组(36.98±2.17)比较差异有统计学意义(P<0.01)。结论:升白合剂能有效提升外周血白细胞计数和中性粒细胞数,临床疗效确切,无明显不良反应。

Objective:To evaluate the clinical efficacy and safety of Shengbai Mixture in the treatment of leukopenia.Methods:A randomized, double-blind, placebo-controlled parallel clinical trial was adopted.A total of 218 effective cases were selected, of which 110 cases in test group were treated with Shengbai Mixture, 108 cases in control group treated with Shengbai Mixture preparation formulation.After treating for 42 days, the changes in peripheral white blood cell count, neutrophil count, lymphocyte count, mononuclear cell count, eosinophil count, basophil number and TCM syndromes were observed before and after treatment.Results:Compared with control group, the number of white blood cell count and neutrophil count in peripheral blood was significantly increased in the test group(P<0.01).After treating for 42 days, peripheral white blood cell count of test group increased significantly, and the total curative effect of test group and control group was 97.27% and 30.56% respectively, the difference between the two groups was significant(P<0.01).Total score of TCM syndromes of patients in test group(18.34±3.56) decreased significantly, compared with control group(36.98±2.17), the difference was significant(P<0.01).Conclusion:Shengbai Mixture can effectively improve the peripheral white blood cell count and neutrophil count with exact clinical efficacy and low adverse reactions.