| ObjectiveChouShi chemotherapy of neoadjuvant chemotherapy having higher curative effect than common chemotherapy has been confirmed. Through the comparison of ChouShi chemotherapy and regular time (12:30-17:30pm) chemotherapy for breast cancer after neoadjuvant chemotherapy in patients with hematology and non hematologic toxicity, evaluate whether ChouShi chemotherapy is safety or reduces the toxities. For alleviating neoadjuvant chemotherapy TA/EC (doxorubicin/doxorubicin or epirubicin/cyclophosphamide) the side effects in clinical to provides a new method, and to further expand the scope to solve the problem of breast cancer in clinical of traditional Chinese medicine.MethodsA randomized controlled trial design method:the patients have been diagnosed with breast cancer were randomly divided into two groups to completed three drive TAC/TEC regimens, the experimental group has 19 patients and control group has 17 patients. The chemotherapy period of two groups are experimental group during 1-3 a.m. and control group during 12:30-17:30pm. Observation titles and time:observing leukocyte, neutrophil, hemoglobin, platelet in d1、d5、d7、d9 in a cycle, observing ALT、AST、total bilirubin, alkaline phosphatasenausea in day 20. Observation of patients with nausea and vomiting, from the day before the start of chemotherapy, a total of 6 days of continuous record of nausea and vomiting. According to WHO anticancer drug show acute and subacute toxicity and indexing standard (0-Ⅳ degrees) side effects evaluated two groups of patients with laboratory indexes in a cycle. According to the 1989 European academic conference of clinical standard (0-Ⅲ degree) evaluation of two groups of patients with nausea and vomiting. The results of the 0 degree to fourth degree were converted to 0 points and 4 points for statistical analysis. By monitoring the process of chemotherapy in patients with blood, liver and kidney function, electrocardiogram, echocardiography and index evaluation Choushi chemotherapy.Results1. Baseline scenario:two groups of patient’s age, TNM stage, chemotherapy drugs reducing having no difference (P> 0.05). In terms of therapeutic drugs, the experimental group in 1,2,3 routine use of chemotherapy dose G-CSF was less than control group (P< 0.05), the experimental group used anti-nausea drugs frequency is lower than the control group (P< 0.05), the two groups in protect liver medicine, the use of composition blood transfusion has no difference (P> 0.05).2.In first, second, third TA/EC chemotherapy, the experimental group was lower than the control group, the degree of nausea and vomiting were lower than the control group, the level of white blood cells and neutrophils were higher than those of the control group (P<0.05).3. In the first, second, third course of TA/EC chemotherapy, there was no significant difference between the 0.05 groups (P>two), hemoglobin, platelet, and ALT (AST). The total bilirubin and alkaline phosphatase were 0, and the significance was not included in the statistical test.4. Safety analysis:besides monitoring indicators, in the side effects of allergic reactions, cardiac toxicity and the peripheral nervous system toxicity and renal toxicity, etc., two groups did not occur affecting the safety of life events, adverse events in the experimental group, diarrhea (> 3 times/day) in 1 case, granulocyte lack of fever in 2 cases,1 case of allergic dermatitis,1 case of extreme fatigue, adverse events in patients with a total of 3. Adverse events in the control group were 3 cases of diarrhea,5 cases of granulocyte deficiency fever,2 cases of allergic dermatitis,2 cases of extreme fatigue,8 patients with adverse events. The incidence of adverse events in the control group was higher than that in the experimental group (P<0.05).Conclusion1. Two groups of patients have no difference between statistics in general, can be compared between groups; some may affect the observation of side effects such as reducing chemotherapy drugs, therapeutic drugs, and indicators, have ruled out the interference factors of experimental observation index is better than that of control group.2. Chou Shi chemotherapy chemotherapy in reducing TA/EC new adjuvant chemotherapy for caused nausea and vomiting than ordinary time and reduce granule cells, white blood cells lack is better than that of ordinary time chemotherapy. Chou Shi chemotherapy and ordinary time chemotherapy of hemoglobin, platelet, amino transferase (ALT, AST) total bilirubin, alkaline phosphatase without significant difference in. Choushi chemotherapy can effectively alleviate the neoadjuvant chemotherapy TA/EC side effects caused by this method is economical and safe. |
PDF Full Text Request