复方浙贝颗粒联合不同化疗方案对难治性急性白血病临床疗效的影响  

Influence of Fufang Zhebei Granules combining different chemotherapy regimens on clinical effect of refractory acute leukemia

作　　者：王荣华[1] 陈信义[1] 李冬云[1] 许亚梅[1] 褚雨霆[1] 白桦[1] 

机构地区：[1]北京中医药大学东直门医院血液肿瘤科,北京100700

出　　处：《北京中医药大学学报》2014年第7期458-462,475,共6页Journal of Beijing University of Traditional Chinese Medicine

基　　金：国家科学技术部"十一五"科技支撑计划项目(No.2006BAI04A18)

摘　　要：目的观察复方浙贝颗粒联合不同化疗方案对难治性急性白血病临床疗效的影响。方法采用随机双盲、安慰剂对照、多中心临床试验方法,通过中央(网上)随机将符合难治性急性白血病诊断标准的238例患者分为对照组与治疗组。临床试验结束后,经核实剔除3例不符合入组标准患者后,经2次揭盲确定治疗组(复方浙贝颗粒联合化疗方案组)118例,对照组(安慰剂加化疗方案组)117例。1个化疗周期结束后,按照疗效标准统计疗效。结果治疗组完全缓解(CR)为32.35%、对照组CR为23.08%,经秩和检验和Cmh卡方检验,有统计学意义(P=0.0444)。与国内外文献报告的标准化疗方案CAG、MAE、FLAG与CsA加化疗方案1个化疗周期的缓解率(CR_1)比较,复方浙贝颗粒联合不同化疗方案均能提高缓解率,其中,以复方浙贝颗粒联合CAG、MAE化疗方案疗效最佳。结论复方浙贝颗粒联合CAG、MAE化疗方案能够明显提高难治性急性白血病1个周期的化疗缓解率。Objective To observe the influence of Fufang Zhebei Granules combining different chemotherapy regimens on clinical effect of refractory acute leukemia （RAL）. Methods The patients （n =238） diagnosed as RAL patients were randomly divided into control group and treatment group by applying randomized double-blind, placebo-controlled and multicenter clinical trial and central randomization system （online）. After the trial finished, 3 patients who were not eligible to the inclusion criteria were excluded, and then treatment group （n = 118, treated with Fufang Zhebei Granules combining different chemotherapy regimens） and control group （n = 117, treated with placebo combining different chemotherapy regimens ） were determined after double unblinding. The curative effect was reviewed according to efficacy criterion after one chemotherapy cycle. Results The rate of complete remission （CR） was 32.35% in treatment group and 23.08% in control group. The test of Z/Cmh showed P = 0. 0444. The comparison in rate of CR in one chemotherapy cycle between Fufang Zhebei Granules combining different chemotherapy regimens and standard chemotherapies reported by Chinese and foreign literature including CAG, MAE, FLAG and CsA showed that Fufang Zhebei Granules combining different chemotherapy regimens promoted the rate of CR, and the curative effects of Fufang Zhebei Granules combining CAG or MAE were the best. Conclusion Fufang Zhebei Granules combining CAG or MAE can significantly promote the rate of CR of RAL in one chemotherapy cycle

关 键 词：难治性急性白血病 复方浙贝颗粒 化疗方案 临床疗效 

分 类 号：R273.371[医药卫生—中西医结合]