A Randomized Clinical Trial: Compound Zhe Bei Granules (CZBG) combined with chemotherapy to improve the clinical efficacy of refractory acute leukemia treatment
Objective: To observe the effect of CZBG combined with chemotherapy to improve the clinical remission rate of patients with refractory acute leukemia (RAL).Methods: In this multicenter double-blind, placebo-controlled clinical trial,we randomly assigned 238 patients who met the diagnostic criteria of RAL to receive chemotherapy combined with CZBG or chemotherapy plus placebo using a central (online) randomization system.Clinical efficacy was calculated at the end of a chemotherapeutic cycle.At the end of the trial, we found that there were 118 subjects in chemotherapy combined with CZBG (4g each time, twice daily) group and 117 subjects in chemotherapy plus placebo (4g each time, twice daily) group.Three patients who were not eligible for the inclusion criteria after verification were excluded from the analysis.Results: In the Full Analysis Set (FAS) where deaths due to disease progression were regarded as inefficacy, the percentages of CR (complete remission, CR) ,CR + PR (Partial Remission, PR) were 32.35%, 50.00% respectively in chemotherapy combined with CZBG group, and 23.08%, 35.58% in chemotherapy plus placebo group.There was statistically significant difference between the two groups according to Z/Cmh test (P<0.05).In the Per Protocol Set (PPS) , the CR, CR + PR rates were 33.67%, 52.04% respectively in chemotherapy plus CZBG group and 24.24%, 37.37% in control group.According to Z/Cmh test, there was statistical difference between groups treated with and without CZBG (P<0.05).Conclusion: CZBG in combination with chemotherapy can improve clinical remission rate of RAL after one therapeutic cycle.
HOU Li CHEN Xinyi YANG Shulian YANG Wenhua ZHOU Yuhong LIU Feng YANG Hongyong SUN Weizheng LI Dongyun XU Yamei
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine Langfang Chinese Medicine Hospital Affiliated to Hebei Medical University First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Chinese Medicine Hospital of Zhejiang Province Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences First Affiliated Hospital of Guangzhou University of Chinese Medicine First Affiliated Hospital of Heilongjiang University of Chinese Medicine