Cohort Study On Fuzheng Xiaoliu Decoction In Preventing The Recurrence And Metastasis Of Postoperative Mammary Cancer

Subject sourcesAmong all the female cancers, the incidence of Mammary Cancer is the highest. Surgical operation brings a big bodily injury. Meanwhile, radiotherapy and chemotherapy carry much more considerable side effect for patients of breast cancer. They all can strongly injury the patients'immune function and quality of life. How to reduce the recurrence and metastasis rate of postoperative mammary carcinoma and improve the patients'quality of life has become a hot subject all over the world.Chinese medicine treatment has particular advantages in preventing the recurrence and metastasis of postoperative Mammary Cancer. On the basis of therapeutic experience and the theory of traditional chinese medicine professor Zhang Zhonghai points out that Post Operative Breast Cancer is "mammary carcinoma, zhengxuduchi Syndrome". He advocates the therapy of strengthening healthy qi to eliminate pathogens in order to prevent the recurrence and metastasis of postoperative Breast Cancer. And on this basis, he creates Fuzheng Xiaoliu Decoction. This subject, cohort study on Fuzheng Xiaoliu Decoction in preventing the recurrence and metastasis of postoperative Breast Cancer, is supported by Guangdong province's construction of powerful province of Traditional Chinese Medicine.ObjectiveIn order to reduce the recurrence and metastasis rate of postoperative mammary carcinoma and improve the patients'quality of life, take Fuzheng Xiaoliu Decoction as testing object, divide the patients randomly into treamtment and control groups, give them different therapies, and observe the recurrence and metastasis rate, the dynamic changes of clinical symptoms, hemogram, immune function, and patients' quality of life. Prove that Fuzheng Xiaoliu Decoction can reduce the 3-year recurrence and metastasis rate, relieve patients'discomfort, improve their immune function and quality of life. This subject can provide available methods and prescriptions for the postoperative Breast Cancer patients, and it has better social and economic benefit.MethodsA prospective cohort study was performed in 103 breast cancer patients. Divide the patients randomly into treamtment and control groups, take Fuzheng Xiaoliu Decoction as testing object, then observe the difference between the two treatments' clinical efficacy.Content and processDisease-free survival, the recurrence and metastasis rate;Evaluated results of clinical symptoms:Investigated and scored the 15 clinic symptoms in different therapy phases, such as spargosis, swelling and distension of upper extremity, pain, lack of power, short breath, distinclination to talk, sored lower extremities, cardiopalmus, dyspnea, hectic fever, nausea and vomitting, thirsty, insomnia, constipation and weight increase. Observed the changes of the patients' discomforts.The effect of the bone marrow cells on hematopoiesis:Routine blood tests were conducted before and after the therapy. Observed the level of numeration of leukocyt(WBC), hemoglobin (Hb), thrombocyte (PLT). Analyzed the effectiveness of Fuzheng Xiaoliu Decoction in protecting patients from the marrow depress effects.The effect on the immune function:Absolute numbers of T cell subsets(CD3+,CD3+CD4+,CD3+CD8+) and NK(CD56+)cells in peripheral blood after treatments were tested by flow cytometer. Studied changes of their absolute numbers and ratios.The effect on the patient' quality of life:We use revision of the chinese version of the FACT-B (4.0) for Patients with Breast Cancer to appraise and score the quality of life for patients with breast cancer.According to the requirments of cohort study, estimated the samples'number, and selected suitable samples for the study. All the suitable patients were randomly divided into two groups, and were given different treatments. All the cases were followed up for more than 3 years. We followed up all the patients by telephoto and hospitalization. We requested the patients to be in the hospital once every 3 months in the first 3 years and once every 4 months during the forth year and the fifth year. Made records of patients'routine blood tests, liver function, renal function, T cell subsets and the scores of patients'quality of life and their clinical symptoms. We recorded exactly the location and circumstance of the patients who had recurrence and metastasis. Collected and studied the patients'data before and after therapy when it has been 3 years from the patient became a case. Then statitics all the datas to find out the effect of Fuzheng Xiaoliu Decoction in preventing the recurrence and metastasis of postoperative Breast Cancer.ResultsThere is no case shed off, no case died. Fuzheng Xiaoliu Decoction group emerged 1 bone metastasis,1 lymph node metastasis. Its DFS is 96.3%, and its recurrence and metastasis rate is 3.7%. The only western medicine group emerged 3 bone metastasis,1 pulmonary metastasis,1 pulmonary metastasis and brain metastases,1 recurrence and lymph node metastasis,1 liver metastasis. Its DFS is 83.7%, and its recurrence and metastasis rate is 16.3%. Compare the DFS and recurrence and metastasis rate of Fuzheng Xiaoliu Decoction group with that of only western medicine group, we can find that the DFS of Fuzheng Xiaoliu Decoction was much higher than that of the only western medicine group, the recurrence and metastasis rate of Fuzheng Xiaoliu Decoction group was lower and the difference was significant(P=0.044<0.05). The result above shows that Fuzheng Xiaoliu Decoction can active reduce the recurrence and metastasis rate of postoperative Breast Cancer, prolong survival, and reduce the death rate.The average discomfort score after treatment of Fuzheng Xiaoliu Decoction group is (23.87±3.48). The average discomfort score after treatment of the only western medicine group is (26.96±4.46). Patients in Fuzheng Xiaoliu Decoction group had less discomfort and had a lesser degree. Fuzheng Xiaoliu Decoction can obviously reless the breast cancer patients'clinical symptoms. Their difference was significant(P=0.000<0.001). Fuzheng Xiaoliu Decoction can reduce the score of breast cancer patients'discomfort and reless the patients from the clinical discomfort symptoms.Because of the marrow depress effect, the 103 patients'numeration of leukocyt(WBC), hemoglobin (Hb), thrombocyte (PLT) have all decreased after radiotherapy and chemotherapy. And comparing Fuzheng Xiaoliu Decoction group with the only western medicine group, we can find that the Fuzheng Xiaoliu Decoction group has a smooth decrease. The only western medicine group's white blood cell after therapy was(4.05±0.80)×109/L. While Fuzheng Xiaoliu Decoction group's white blood cell after therapy was(5.27±0.94)×109/L. The only western medicine group's hemoglobin after therapy was(114.92±16.50)g/l. While Fuzheng Xiaoliu Decoction group's hemoglobin after therapy was(126.76±14.19) g/1. The only western medicine group's thrombocyte after therapy was(183.16±43.48)×109/L. While Fuzheng Xiaoliu Decoction group's thrombocyte after therapy was(202.87±41.73)X 109/L. The differences were significant(every P<0.05).The average CD3+T lymphocytes ratio of the 49 cases in the only western medicine group was (61.46±9.63)%. The average CD3+CD4+T lymphocytes ratio was (61.46±9.63)%. The average CD3+CD8+T lymphocytes ratio was (26.79±6.25)%. The ratio of CD3+CD4+ T lymphocytes to CD3+CD8+T lymphocytes was (1.22±0.46). The average NK cells ratio was (12.71±5.70)%. While in Fuzheng Xiaoliu Decoction group, the average CD3+T lymphocytes ratio of the 54 cases was (67.59±8.31)%. The average CD3+CD4+T lymphocytes ratio was (37.11±6.44)%. The average CD3+CD8+T lymphocytes ratio was (23.89±5.98)%. The ratio of CD3+CD4+ T lymphocytes to CD3+CD8+T lymphocytes was (1.67±0.57). The average NK cells ratio was (15.30±6.47)%.We compared the only western medicine group with Fuzheng Xiaoliu Decoction group and found that CD3+T lymphocytes ratio, CD3+CD4+T lymphocytes ratio and NK cells ratio all had decreased after therapy. Compared with Fuzheng Xiaoliu Decoction group, CD3+T lymphocytes ratio of the only western medicine group was less, and the difference was significant(P=0.001<0.05). Compared with Fuzheng Xiaoliu Decoction group, CD3+T lymphocytes ratio of the only western medicine group was less, and the difference was significant(P=0.001<0.05). Compared with Fuzheng Xiaoliu Decoction group, CD3+CD4+T lymphocytes ratio of the only western medicine group was much less. The difference was significant(P=0.000<0.05). Compared with Fuzheng Xiaoliu Decoction group, NK cells ratio of the only western medicine group was less, and the difference was also significant (P=0.034<0.05). Compared with Fuzheng Xiaoliu Decoction group, CD3+CD8+T lymphocytes ratio of the only western medicine group was bigger. The difference was significant (P=0.018<0.05). After therapies, the ratio of CD3+CD4+ T lymphocytes to CD3+CD8+T lymphocytes in Fuzheng Xiaoliu Decoction group was much bigger. The difference was significant(P=0.000<0.001).The average quality of life(QOL) before therapy in Fuzheng Xiaoliu Decoction group scored (85.48±14.67). While after therapy, it scored (101.31±17.30). The average quality of life before western medicine therapy in the only western medicine group scored (86.76±14.71). While after the therapy, it scored (94.96±14.89). The QOL of the two groups were both improved after therapies. And the QOL difference between the only western medicine group and Fuzheng Xiaoliu Decoction group was significant(P=0.000<0.05). The QOL in Fuzheng Xiaoliu Decoction group were enhanced more effectively. Compared the QOL after therapies between the two groups, we could find the difference was significant(P=0.049).The main conclusionsThe Fuzheng Xiaoliu decoction can reduce the recurrence and metastasis rate of breast cancer, enhance patients'disease-free survival, ease breast cancer patients' discomforts, detoxify, enhance immune function and improve patients'quality of life. Its clinical effect was definite.