复方浙贝颗粒减轻难治性白血病化疗后骨髓抑制的临床研究

Clinical study on effect of compound granule prescription of thunberg fritillary bulb in relieving post-chemotherapy bone marrow suppression in RAL patients

目的:观察复方浙贝颗粒减轻难治性急性白血病患者化疗后骨髓抑制的作用。方法:全国7家三甲医院共入组238例难治性急性白血病患者,按1∶1随机分为治疗组或(和)对照组,2组均按常规化疗方案进行化疗。于化疗前3 d服用复方浙贝颗粒或安慰剂,连续给药14 d,以1个标准化疗疗程为治疗周期。观察2组患者化疗前、后外周血象变化。结果:治疗后,治疗组和对照组的白细胞计数有明显统计学差异(P<0.05),而定性比较没有统计学意义;2组治疗前后外周血白细胞计数差值进行统计学比较,结果具有统计学意义(P<0.05),2组的外周血白细胞计数在治疗后均有所降低,且治疗组的白细胞减低幅度要明显小于对照组;治疗前、后血红蛋白和血小板定性及定量比较,均无统计学意义;治疗后2组血红蛋白和血小板均降低,但组间差异无统计学意义。结论:复方浙贝颗粒可以减轻难治性急性白血病患者化疗所致的骨髓抑制,并主要体现在减缓白细胞减少的程度上。

Objective： To observe the effect of compound granule prescription of thunberg fritillary bulb in relieving the post- chemotherapy bone marrow depression in refractory acute leukemia（RAL） patients. Method： Two hundred and thirty eight RAL pa- tients collected from 7 third-grade class-A hospitals were randomly divided into the treatment group and the control group. Both groups were treated with conventional chemotherapy. They were administered with compound granule prescription of thunberg fritillary bulb or placebo three days before chemotherapy for consecutively 14 days. A standardized chemotherapy course was a treatment cycle. The changes in peripheral hemogram of two groups were detected before and after chemotherapy. Result： After the treatment, the white blood cell counts of the two groups were significantly different （P 〈 0. 05 ）, but there was no statistical significance in qualitative com- parison. Before and after the treatment, the difference of the white cell counts of the two groups detected had significant statistics （ P 〈 O. 05. The white cell counts of both groups declined after chemotherapy, but the treatment group decreased more significantly than the control group. Before and after the treatment, there were no statistical significances in quantitative and qualitative comparisons both in HGB and PLT. After the treatment, HGB and PLT contents of both groups declined, but there was no statistical difference between the two groups. Conclusion： Compound granule prescription of thunberg fritillary bulb can relieve the bone marrow suppression in RAL pa- tients caused by the chemotherapy, which is mainly reflected by the slowdown of reduction in white blood cells.