Cfmp Adjuvant Chemotherapy Refractory Acute Leukemia Clinical Efficacy And Safety Study

At present,the rotation of chemotherapy and increase of the dosage of anticancer drugs are the main treatment of refractory acute leukemia,but the clinical remission rate was only 30%-45%,and the serious adverse reactions caused by anti-cancer drugs are responsible of the decrease in the quality of patients' lives.Therefore, three main scientific problems exist in the treatment of refractory acute leukemia, the first is to improve the clinical remission rate;the second is to deal with the complications due to rotation of the chemotherapy or greater amount of anti-cancer drugs;the third is to improve the quality of life in patients of before and after chemotherapy.We choose previous clinical trials as the background information of the research. After repeatedly consulting a number of experts on clinic,evaluation,statistics and management, according to the requirements and the relevant provisions of the Key Projects in the National Science & Technology Pillar Program during the Eleventh Five-Year Plan Period,we further optimized the treatment regimen using Compound Fritillary Bulb Granule(CFBG) as the main clinical intervention.Objective:Through the standardization of clinical trials,Verify the "CFBG" based intervention program to improve refractory acute leukemia clinical remission rate of around chemotherapy efficacy.And based on clinical trial results,Refractory acute leukemia developed by Chinese interventions combined with standard chemotherapy of western medicine,in order to enhance clinical efficacy in refractory acute leukemia with evidence.Methods:the patients with refractory acute leukemia as subjects,According to the requirements of the "National Support Scheme" and GCP,using randomized double-blind,placebo-controlled and multi-center clinical research as principles, we combine Chinese interventions with standard chemotherapy of western medicine before and after chemotherapy,analyze and evaluate clinical remission rate (gold index of efficacy evaluation),in order to provide easy-to-intervention TCM program improving the clinical efficacy of refractory acute leukemia.Results:All cases data (238 cases of patients with refractory acute leukemia) were collected from 7 tertiary hospitals from May 2007 to November 2009.After exposing blind,197 cases were statistically analyzed,including 98 cases in the treatment group (CFBG group),and 99 cases in the control group (simulated agent group).Treatment group:complete remission (CR) 3 cases,accounting for 3.06%;bone marrow remission (CRi) 30 cases,accounting for 30.61%;partial remission(PR) 18 cases,accounting for 18.37%;no remission(NR) 47 cases,accounting for 47.96%;complete remission rate (CR+CRi) 33 cases,accounting for 33.67%;the total effective rate(CR+CRi+PR) 51 cases,accounting for 52.04%.Control group:complete remission (CR) 3 cases, accounting for 3.03%;bone marrow remission (CRi) 21 cases,accounting for 21.21%; partial remission (PR) 13 cases,accounting for 13.13%;no remission (NR) 62 cases, accounting for 56.88%;complete remission rate (CR+CRi) 24 cases,accounting for 24.24%;the total effective rate (CR+CRi+PR) 37 cases,accounting for 37.37%.After chi-square test,the complete remission rate and the effect of the total effective rate of two groups were statistically significant(P<0.05),and the treatment group were higher than the control group.Conclusion:CFBG combined with chemotherapy can improve significantly the clinical remission rate of refractory acute leukemia,and can decrease the hematological toxicity of chemotherapy.In the clinical use,no adverse affects were found in the safety index,such as urine routine,occult routine,liver and kidney function and electro-cardiogram.So we should further study on it.Innovation:â‘ the first time to systematically observe the clinical efficacy of CFBG combined with chemotherapy, in accordance with GCP standards and through randomized double-blind, placebo-controlled, multicenter clinical trialâ‘¡the first time to use clinical remission rate as the ultimate clinical evaluation index of Chinese intervention in the treatment of the RAL.â‘¢ncrease CRi as the evaluation criteria for refractory acute leukemia.