Cfmp Adjuvant Chemotherapy To Improve Refractory Acute Leukemia Clinical Symptoms Observed

BackgroundThe main reason for the failure of chemotherapy and recurrence of refractory acute leukemia (RAL) is due to multidrug resistance (MDR) of leukemic cells, i.e., leukemic cells simultaneously resist against various chemotherapeutics of different chemical structures and mechanisms of action. Drug resistant leukemic cells then lose their sensitivity to chemotherapeutics, thereby reducing the clinical effects. However, it is still lack of effective solutions for multidrug resistance in western medicine. Therefore, to develop drug resistance reversal agents of low toxicity under the guidance of Traditional Chinese Medicine theory has become the key issue in clinical treatment of RAL.Since 1994, our department has been engaged in research of reversing the leukemia multidrug resistance with Traditional Chinese Medicine. Based on the findings of pervious basic research and multi-center clinical trials, we developed the Fritillaria Thunbergii Bulb Complex Granules (FTBCG) by referring to domestic and oversea literature, and carried out clinical observation by using randomized, double-blind, multi-center controlled clinical research protocol. The result showed:The complete remission rate and the total effective rate were respectively 36.1% and 77.8% in the FTBCG group, and they were of statistical differences as compared to the placebo group with P＜0.05. On the frontline of medical research, FTBCG has drawn much attention in the treatment of leukemia multidrug resistance.Based on the Capital Medical Development Fund supported project (Project No:Ⅰ-2) and the State Administration of Traditional Chinese Medicine project (Project No:02-03LP14), this project was to observe changes in TCM symptoms and signs of RAL patients before and after treated by Fritillaria Thunbergii Bulb Complex Granules (FTBCG) combined with chemotherapy, to summarize the effects of FTBCG intervention on TCM symptoms, and to explore the mechanism of FTBCG in the treatment of refractory acute leukemia from the view of the Traditional Chinese Medicine, so as to improve the clinical efficacy of Traditional Chinese Medicine in the treatment of RAL.ObjectivesBy observing changes in TCM syndromes of RAL patients before and after treated by Fritillaria Thunbergii Bulb Complex Granules (FTBCG) combined with chemotherapy, to summarize the effects of FTBCG intervention on TCM symptoms, and provide reference for the treatment of RAL with syndrome differentiation combined with disease differentiation in TCM clinical practice.MethodsWe observed 40 refractory acute leukemia patients from November,2007 to December, 2009 in 3 third class grade A hospitals (Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, People's Hospital of Peking University, Beijing Tongren Hospital of Capital Medical University).3 patients died during the clinical observation, and 37 patients completed the study. Randomized, double-blind, multi-center controlled study method was used,"Fritillaria Thunbergii Bulb Complex Granules"and"malt granule"were respectively chosen as the treatment drug and control drug. Acute leukemia patients were selected as subjects, the uniform clinical research protocol, case observation form, and efficacy evaluation standards were established to observe the effects of FTBCG in the treatment of refractory acute leukemia at the peri-chemotherapy period. Standard chemotherapy regimens were used for the patients; 3 days before the start of chemotherapy, the interventional drug or placebo was added to the regimens in blind state, one bag each time,2 times a day for a consecutive 14 days; the course of standard chemotherapy was used as a treatment cycle.ResultsAfter the clinical trial was completed, the interventional drug was determined to be FTBCG (18 cases) and the simulated agent was the malt granule (19 cases) by unblinding for twice. The result shows:①A ccording to the standards for assessment of TCM syndromes, the improvement rate of TCM symptoms in the treatment group was9/18(50.0%), while it was only 2/19(10.5%) in the control group, and there was statistical significance between the two groups as shown by Fisher's test, with P= 0.013＜0.05.②According to the analysis and statistics of TCM syndromes, FTBCG showed different curative effectson the 3 common TCM syndromes associated with RAL:the effective rate was 7/8(87.5%) for the syndrome of qi and blood deficiency with phlegm and blood stasis stagnation,5/6(83.3%) for the syndrome of qi and yin deficiency with phlegm and blood stasis stagnation, andl/4(25%) for the syndrome of heat toxin brewing internally with phlegm and blood stasis stagnation, with P =0.04＜0.05 and statistical significance.ConclusionsFritillaria Thunbergii Bulb Complex Granules (FTBCG) combined with chemotherapy can improve the clinical remission rate of refractory acute leukemia, and it also can improve the efficacy on TCM symptoms and sighs. Meanwhile, it showed different curative effects on the 3 common TCM syndromes associated with RAL, moreover, it do the better effects for the syndrome of qi and blood deficiency with phlegm and blood stasis stagnation, qi and yin deficiency with phlegm and blood stasis stagnation.