Compound Zhebei granules combined with chemotherapy for the treatment of refractory acute leukemia: a randomized clinical trial

作者：Hou Li; Yang Shulian; Yang Wenhua; Zhou Yuhong; Liu Feng; Yang Hongyong; Sun Weizheng; Li Dongyun; Xu Yamei; Chen Xinyi^*

来源：Journal of Traditional Chinese Medicine, 2016, 36(5): 606-612.

DOI：10.1016/s0254-6272(16)30079-6

• Refractory acute leukemia
• Zhebei granules
• Chemotherapy remission rate
• Randomized clinical trial

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 chi(2) test (P < 0.05). In the per protocol analysis set (PPS), 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.

• 出版日期2016-10-15
• 单位中国中医科学院西苑医院; 北京中医药大学; 广州中医药大学; 中医学科学院; 黑龙江中医药大学; 河北医科大学; 广州中医药大学第一附属医院; 浙江中医药大学; 天津中医药大学