摘要
OBJECTIVE: To observe the effect of compound Zhebei granules(CZBG) with chemotherapy in the treatment of refractory acute leukemia.METHODS: In this multicenter, double-blind, placebo-controlled clinical trial, we used a central(online) randomization system to assign 235 patients to two treatment groups. A total of 118 patients received chemotherapy combined with CZBG(4 g,twice daily) and 117 patients received chemotherapy plus placebo. The clinical efficacy was evaluated at the end of one chemotherapeutic cycle.RESULTS: In the full analysis set, in which deaths due to disease progression were regarded as inefficacy, the rates of complete remission(CR) and partial remission(CR + PR) were 32.35% and 50.00%,respectively, for the chemotherapy combined with CZBG group, and 23.08% and 35.58%, respectively,for the chemotherapy plus placebo group. There was a statistically significant difference between the two groups according to a ysis set(PPχ2test(P < 0.05). In the per protocol analS), the CR(33.67%),CR+PR(52.04%) response rates for the chemotherapy plus CZBG group were significantly different from the response rates of the control group(CR:24.24% and CR+PR: 37.37%), respectively(P < 0.05).CONCLUSION: CZBG plus chemotherapy can improve the clinical remission rate of refractory acute leukemia after one just one therapeutic cycle.
OBJECTIVE： To observe the effect of compound Zhebei granules（CZBG） with chemotherapy in the treatment of refractory acute leukemia.METHODS： In this multicenter, double-blind, placebo-controlled clinical trial, we used a central（online） randomization system to assign 235 patients to two treatment groups. A total of 118 patients received chemotherapy combined with CZBG（4 g,twice daily） and 117 patients received chemotherapy plus placebo. The clinical efficacy was evaluated at the end of one chemotherapeutic cycle.RESULTS： In the full analysis set, in which deaths due to disease progression were regarded as inefficacy, the rates of complete remission（CR） and partial remission（CR ＋ PR） were 32.35% and 50.00%,respectively, for the chemotherapy combined with CZBG group, and 23.08% and 35.58%, respectively,for the chemotherapy plus placebo group. There was a statistically significant difference between the two groups according to a ysis set（PPχ2test（P 〈 0.05）. In the per protocol analS）, the CR（33.67%）,CR＋PR（52.04%） response rates for the chemotherapy plus CZBG group were significantly different from the response rates of the control group（CR：24.24% and CR＋PR： 37.37%）, respectively（P 〈 0.05）.CONCLUSION： CZBG plus chemotherapy can improve the clinical remission rate of refractory acute leukemia after one just one therapeutic cycle.
基金
Supported by the Ministry of Science and Technology of People's Republic of China National Eleventh Five-Year Research Program of China,the Applied Research of TCM Intervention Therapy to Refractory Acute Leukemia During the Peri-chemotherapy Period(No.2006BAI04A18)
the Beijing Municipal Science&Technology Commission Ten Medications for Ten Diseases Project,Preclinical Study of Compound Zhebei Granules in Improving the Clinical Efficacy of Refractory Leukemia(No.Z151100003815027)
Beijing University of Chinese Medicine Key Subject Program,Clinical and Basic Research of Hematological Diseases Using Chinese Medicine
