| Objective:To evaluate the efficacy and safety of traditional Chinese medicine in the prevention of recurrence and metastasis of triple negative breast cancer(TNBC).Methods:In a multicenter,prospective cohort study,314 patients were selected from 9 grade-3 first-class hospitals in Beijing.According to whether they are willing to receive traditional Chinese medicine(TCM)treatment,they were divided into TCM cohort and observation cohort.According to the core symptoms and common symptoms of triple negative breast cancer patients after operation,the Chinese medicine queue formulates the basic formula and addition and subtraction formula,one dose per day,warm taking in the morning and evening,and taking dose?20 days per month.The observation queue does not accept any Chinese medicine treatment for tumor(including Chinese medicine decoction,Chinese patent medicine,etc.).Main outcome measures:the recurrence and metastasis rate after operation of TCM cohort and observation cohort for 1,2,3 years,and disease-free survival(DFS)for 3 years;Secondary outcome measures:The main symptoms and secondary symptoms of breast cancer,the functional assessment of cancer therapy breast cancer-specific(FACT-B),the Eastern Cooperative Oncology Group(ECOG),Pittsburgh sleep quality index,(PSQI),Piper Fatigue Scale(PFS),hospital anxiety and Depression Scale(HADS),safety indicators(including routine blood test,liver and kidney function,etc.).In addition to the baseline screening,two groups of patients need to be followed up every 3-6 months.The observation end point is the time of local recurrence or distant metastasis,the time of death or the end of the study.Results:a total of 314 patients were included in this study(TCM cohort had 198 patients and observation cohort had 116 patients);As of December 31,2019,31 patients had fallen off,and 2 patients had dropped out of the study due to pregnancy.(1)Characteristics of baseline data:there was no significant difference in age,height,weight,BMI index,nationality,education background,occupation,history of allergy,previous chronic history,primary site,pathological classification,lymph node metastasis,clinical stage,chemotherapy,radiotherapy,etc.among the cohorts(P>0.05).(2)Main outcome measures:?By single factor analysis,we foundthat whether the lymph node is positive,clinical stage,chemotherapy and whether to accept traditional Chinese medicine treatment are significantly related to DFS(P<0.05).?Cox regression analysis showed that whether to accept the treatment of traditional Chinese medicine(P=0.044<0.05)and chemotherapy(P=0.006<0.05)were the independent influencing factors of DFS;?The difference of recurrence and metastasis rate between the two groups:one year follow-up,the recurrence and metastasis rate of TCM group was significantly lower than that of the observation group(P=0.006<0.01);the recurrence and metastasis rate of TCM group was still significantly lower than that of the observation group(P=0.021<0.05)after two years follow-up;three years follow-up,some patients affected by the epidemic did not complete three years follow-up,there was no significant difference between the two groups(P=0.833>0.05).(3)Secondary outcome measures:?Main symptoms of TNBC:after 3-year follow-up,TCM treatment can significantly improve the total score of TCM main symptoms(P=0.001),but there is no significant difference than before in the observation queue(P=0.127>0.05);Chinese medicine treatment released the main symptoms of fatigue,shortness of breath,cold limbs,chest and flank pain,local tingling and pain(P<0.05).?Secondary symptoms of TNBC:after 2-year follow-up,the total score of main symptoms of TNBC can be significantly released by traditional Chinese medicine treatment(P=0.000<0.001),and there is a significant difference than before in the observation queue(P=0.001);among the two formations,the relief of secondary symptoms such as dizziness,hot flashes,night sweating and spontaneous sweating by traditional Chinese medicine treatment is more significant(P<0.05).?the functional assessment of cancer therapy breast cancer-specific(FACT-B):the baseline level of total quality of life score in TCM cohort was significantly lower than that in the observation cohort(P=0.000<0.001),and the total quality of life score after TCM treatment was significantly higher than that in the baseline(P=0.001),in which the influence of TCM Intervention on social/family status and emotional status was more significant.?the Eastern Cooperative Oncology Group(ECOG):The baseline level of ECOG score was different among the queues,and the physical condition of TCM queue was significantly worse than that of the observation queue(P=0.000);after TCM treatment,ECOG score could be significantly reduced(P=0.017).?Piper fatigue scale(PFS):The baseline level of behavioral,emotional,sensory,cognitive and total scores in the fatigue scale of TCM cohort was higher than that in the observation cohort(P>0.05);after three years of follow-up,the behavioral,emotional,sensory,cognitive and total scores of TCM cohort patients showed a downward trend,with a statistically significant difference(P<0.05).?Pittsburgh sleep quality index,PSQI):The effect of traditional Chinese medicine treatment on sleep quality of patients was not as good as that of the observation queue.After 2 years of follow-up,the sleep status of patients in the traditional Chinese medicine queue was significantly improved compared with the baseline(P=0.000<0.001),and the overall sleep status of the observation queue was also significantly relieved(P=0.000<0.001).?hospital anxiety and Depression Scale(HADS):The baseline level of anxiety in the TCM cohort was significantly higher than that in the observation cohort(P=0.000<0.001).After 2-year followup,the level of anxiety and depression in the observation cohort was significantly reduced compared with the baseline(P<0.001),and the level of anxiety and depression in the observation cohort was also reduced compared with the baseline(P<0.05).?the safety;After 3 years follow-up,the number of patients with abnormal and clinical significance in blood routine(red blood cells,white blood cells,platelets,hemoglobin)and liver and kidney function(alanine aminotransferase,aspartate aminotransferase,glutamyltranspeptidase,total bilirubin,urea nitrogen,creatinine)in the TCM cohort decreased compared with that before treatment.Conclusion:TCM treatment can effectively reduce the recurrence and metastasis rate of TNBC patients within 3 years after radiotherapy and chemotherapy,and prolong the independent influencing factors of disease-free survival period;it can alleviate the symptoms of TCM such as shortness of spirit,shortness of breath,cold limbs,chest and flank pain,local tingling,pain location,hot and night sweat,improve the physical condition,sleep quality,fatigue,anxiety and depression of patients with TNBC,and improve the quality of patients' life with TNBC,and the safety of traditional Chinese medicine treatment is satisfactory. |
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