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...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.展开更多
Objective： To observe the effects of Compound Zhebei Granule （复方浙贝颗粒, CZBG） combined with chemotherapy on surface markers of leukemia stem cell （LSC） in the bone marrow of patients with acute myeloid leukem...Objective： To observe the effects of Compound Zhebei Granule （复方浙贝颗粒, CZBG） combined with chemotherapy on surface markers of leukemia stem cell （LSC） in the bone marrow of patients with acute myeloid leukemia （AML）. Methods： Seventy-eight patients with AML received bone marrow aspiration and the percentages of CD34＋CD123＋ and CD33＋CD123＋ cells were tested using flow cytometry method. A total of 24 refractory or relapsed AML patients were enrolled and treated with one cycle of standard chemotherapy combined with CZBG. Bone marrow samples were obtained before and after treatment, and the percentages of CD34＋CD123~ and CD33＋CD123＋ cells were examined by flow cytometry. Results： Compared with refractory or relapsed AML patients, patients achieved remission had a significant lower percentage of CD34＋CD123＋ cells （P〈0.01） and CD33＋CD123＋ cells （P〈0.01）, indicating that controlling the LSC percentage may be important for patients with AML to achieve sustainable remission. Compared with those before treatment, the expression levels of CD34＋CD123＋ were significantly decreased after CZBG combined with chemotherapy treatment （P〈0.01）. The percentages of CD34＋CD123＋ cells and CD33＋CD123＋ in patients achieving complete remission after CZBG combined with chemotherapy treatment were both significantly lower than those in patients with non- remission （P〈0.01）. Conclusion： CZBG combining chemotherapy could reduce the percentages of CD34＋CD123＋ and CD33＋CD123＋ LSC, which might improve the clinical efficacy of refractory or relapsed AML.展开更多
Objective: To observe the effects of Compound Zhebei Granules (复方浙贝颗粒 CZG) in chemotherapy for refractory acute leukemia. Method: Using a randomized, double-blind and multi-central concurrent control clinical re...Objective: To observe the effects of Compound Zhebei Granules (复方浙贝颗粒 CZG) in chemotherapy for refractory acute leukemia. Method: Using a randomized, double-blind and multi-central concurrent control clinical research project,the patients conformed with the diagnostic criteria, according to the drug randomized method, were divided into a CZG group and a control group. The patients of the two groups respectively took the observation drug or a placebo 3 days before chemotherapy, and the therapeutic effects were evaluated after one course of chemotherapy. According to the clinical research project, 137 patients were enrolled, including 71 cases in the CZG group and 66 cases in the control group. Results: The clinical complete remission (CR) rate was 42.3% in the CZG group with a total effective rate of 73.2%, and it was 25.8% in the control group with a total effective rate of 53.0%, showing a statistically significant difference between the two groups (P<0.05). Conclusion: CZG can increase the clinical remission rate for refractory acute leukemia during chemotherapy.展开更多
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
文摘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 Specialized Research Fund for the Doctoral Program of Ministry of Education of China (No.20100013110008)
文摘Objective： To observe the effects of Compound Zhebei Granule （复方浙贝颗粒, CZBG） combined with chemotherapy on surface markers of leukemia stem cell （LSC） in the bone marrow of patients with acute myeloid leukemia （AML）. Methods： Seventy-eight patients with AML received bone marrow aspiration and the percentages of CD34＋CD123＋ and CD33＋CD123＋ cells were tested using flow cytometry method. A total of 24 refractory or relapsed AML patients were enrolled and treated with one cycle of standard chemotherapy combined with CZBG. Bone marrow samples were obtained before and after treatment, and the percentages of CD34＋CD123~ and CD33＋CD123＋ cells were examined by flow cytometry. Results： Compared with refractory or relapsed AML patients, patients achieved remission had a significant lower percentage of CD34＋CD123＋ cells （P〈0.01） and CD33＋CD123＋ cells （P〈0.01）, indicating that controlling the LSC percentage may be important for patients with AML to achieve sustainable remission. Compared with those before treatment, the expression levels of CD34＋CD123＋ were significantly decreased after CZBG combined with chemotherapy treatment （P〈0.01）. The percentages of CD34＋CD123＋ cells and CD33＋CD123＋ in patients achieving complete remission after CZBG combined with chemotherapy treatment were both significantly lower than those in patients with non- remission （P〈0.01）. Conclusion： CZBG combining chemotherapy could reduce the percentages of CD34＋CD123＋ and CD33＋CD123＋ LSC, which might improve the clinical efficacy of refractory or relapsed AML.
文摘Objective: To observe the effects of Compound Zhebei Granules (复方浙贝颗粒 CZG) in chemotherapy for refractory acute leukemia. Method: Using a randomized, double-blind and multi-central concurrent control clinical research project,the patients conformed with the diagnostic criteria, according to the drug randomized method, were divided into a CZG group and a control group. The patients of the two groups respectively took the observation drug or a placebo 3 days before chemotherapy, and the therapeutic effects were evaluated after one course of chemotherapy. According to the clinical research project, 137 patients were enrolled, including 71 cases in the CZG group and 66 cases in the control group. Results: The clinical complete remission (CR) rate was 42.3% in the CZG group with a total effective rate of 73.2%, and it was 25.8% in the control group with a total effective rate of 53.0%, showing a statistically significant difference between the two groups (P<0.05). Conclusion: CZG can increase the clinical remission rate for refractory acute leukemia during chemotherapy.
