| ObjectiveTo evaluate the efficacy and safety of Xiaopi Granule in improving the quality of life of patients with triple negative breast cancer(TNBC)in consolidation stage.MethodsA prospective randomized controlled study was conducted in this study.A total of 60 patients with triple negative breast cancer admitted to the Breast Department Outpatient Department of Guangdong Provincial Hospital of Traditional Chinese Medicine from January 2019 to June 2020 were selected,and 58 patients completed the experiment.Thirty patients received Xiaopi granules and 30 received placebo.The course of treatment was 3 months,and 1 course of treatment was observed.Follow-up was based on outpatient visits and communications by Wechat or telephone.The changes of life quality,anxiety,depression,sleep and CXCL-1 serum concentration were observed after one course of treatment.Quality of life(QOL)was measured by FACT-B Chinese questionnaire,which consisted of five measurement dimensions:physiological status,social/family status,emotional status,functional status and additional concerns.The higher the total score,the better the QOL.Self-rating Anxiety Scale(SAS)was used for anxiety state.The higher the score was,the more serious the anxiety symptoms were.Depression status was assessed by SelfRating Depression Scale(SDS),the higher the score was,the more severe the depressive symptoms were.The Pittsburgh Sleep Scale(PSQI)was used to observe the sleep quality of nearly 1 month.The total score ranged from 0 to 2L.The higher the score,the worse the sleep quality was.Blood samples were collected before and after treatment for CXCL-1.Before and after treatment,three routine examinations,liver and kidney function and ECG were performed.The results were Statistically analyzed by SPSS23.0 software and get the conclusions.Results1.Quality of life:before and after treatment,there was no significant difference in the total score of FACT-B and the scores of five sub-items between the two groups(P>0.05).The total score of FACT-B,physiological condition and additional attention before and after treatment in the treatment group were statistically significant(P=0.024,0.047 and 0.000,respectively).the score of FACT-B before treatment was 106.89±19.51 and after treatment was 114.0±20.61.The score of physiological condition before treatment was 22.46±4.33 and after treatment was 24.11 ±3.70.The score of additional attention was 24.86±5.87 before treatment and 28.25±5.29 after treatment.The scores of emotional state in the control group before and after treatment were statistically significant(P=0.043),which were 18.43±3.50 before treatment and 19.50±2.85after treatment.2.Anxiety state:Anxiety state:there was no statistical significance in the comparison between the treatment group and the control group before and after treatment,the comparison between the same group before and after treatment,and the difference between the two groups before and after treatment(P>0.05).3.Depression state:There was no significant difference between the treatment group and the control group before and after treatment as well as between the same group before and after treatment in the control group(P>0.05).The comparison between the same group and the difference between the two groups before and after treatment in the treatment group was statistically significant(P=0.026,0.043,respectively).The scores of the treatment group were 50.14± 10.50 points before treatment and 43.25±13.29 points after treatment.The difference between the treatment group and the control group was 6.89±15.50 points and-0.57±8.76 points respectively4.Sleep state:There was no statistical significance in the total score of PSQI and the scores of each subitem between the treatment group and the control group before and after treatment,the comparison between the control group before and after treatment and the difference between the two groups before and after treatment(P>0.05).The total score of PSQI,sleep disturbance and daytime function in the treatment group were significantly different before and after treatment(P=0.020,0.013,0.000,respectively).The score of PSQI before and after treatment was 9.43±4.32 and 7.71±3.90,respectively.The score of sleep disorder before treatment was 1.50±0.58 and after treatment was 1.18±0.55.The scores before and after treatment were 1.54±1.04 and 1.18±0.90.5.Microscopic indicators:There was no significant difference in CXCL-1 serum concentration between the treatment group and the control group before and after treatment,between the same group and the control group before and after treatment,or between the two groups before and after treatment(all P>0.05).The serum concentration of CXCL-1 in the treatment group before and after treatment was statistically significant(P=0.004).The serum concentration was 67.00±27.32 before treatment and 55.73±19.69 after treatment.ConclusionXiaopi Granules can significantly improve the quality of life,depression and insomnia of TNBC patients,and can reduce the concentration of CXCL-1 in serum,safe to take,indicating that Xiaopi Granules has certain clinical significance in the treatment of TNBC. |
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