| Objective:According to the latest data released by the International Agency for Research on Cancer of the World Health Organization,breast cancer has surpassed lung cancer to become the highest incidence of cancer in women in 2020,accounting for 11.7%of all cancers.The mortality rate of breast cancer is also the highest in most countries in the world,and the number of deaths from breast cancer was as high as 685000 in 2020.As one of the cancers with double high characteristics(high morbidity and high mortality),breast cancer has always been the focus of national cancer prevention and treatment.Breast cancer patients,as malignant tumor patients with high incidence and special location,are more likely to have bad emotions than other malignant tumor patients,especially those with generalized anxiety disorder,which seriously affect the prognosis and outcome of the disease.as well as affect the quality of life of patients,and bring a heavy social and economic burden to the family and society.Therefore,through a variety of measures to improve the bad psychological state of patients,effective treatment of breast malignant tumor patients with generalized anxiety disorder has important clinical value and research significance,is the key step of successful anti-tumor therapy.At present,there are mainly two modes of western medicine treatment:drug treatment and psychotherapy.The instability of vital signs caused by western medicine treatment,such as inhibition of respiration and affecting the quality of diurnal awakening(daytime drowsiness),digestive system symptoms(malignant,vomiting,etc.),rebound after drug withdrawal,addiction and other adverse reactions,and the intervention period is long,patients often have psychological resistance,poor compliance.Therefore,Western medicine treatment is often difficult to achieve satisfactory results,most of the patients’ condition has not been timely and effective diagnosis and treatment,thus causing delay.Traditional Chinese medicine treatment has a long history and rich theory.Generalized anxiety disorder is classified as "Yubing",mainly with traditional Chinese medicine,combined with acupuncture,massage,music and other non-drug treatment to promote the recovery of mental and physical health.However,there are many methods of traditional Chinese medicine,which are difficult to unify,and often lack of rigorous evidence-based medicine,so it is difficult to promote and further guide clinical practice.ShuGanTiaoShen modified and subtracted prescription is made by Lu Wenping,chief physician of Department of Oncology,Guanganmen Hospital,Chinese Academy of traditional Chinese Medicine,according to the gardenia qinggan decoction and guipi decoction,combined with many years of clinical experience,the clinical effect is remarkable.Auricular point therapy is also a convenient and non-invasive suitable technique of traditional Chinese medicine.Based on this,this study conducted a standardized prospective clinical study to observe the effects of ShuGanTiaoShen Prescription and ShuGanTiaoShen Acupuncture on the psychological state and immune function of breast cancer patients with generalized anxiety disorder.to verify the efficacy and safety of prescription and ear acupuncture treatment,and to explore the immune mechanism of traditional Chinese medicine therapy of soothing the liver and regulating mind to improve breast cancer complicated with generalized anxiety disorder.To provide a scientific basis for the application and promotion of traditional Chinese medicine therapy,and better guide the clinical practice.Methods:This study was designed as a prospective randomized controlled study.A total of 90 patients with breast cancer complicated with mild and moderate generalized anxiety disorder were included from August 2022 to February 2023 in the Department of Oncology,Guanganmen Hospital,Chinese Academy of traditional Chinese Medicine.For the patients who met the criteria,the informed consent form was signed,and the basic data and related scales of the patients were collected.According to the standard of evidence-based medicine,the patients were randomly divided into three groups:test group A,test group B and control group C.There were 30 subjects in each group at 1:1:1,and the baseline was evaluated.On the basis of the standard anti-tumor treatment of breast cancer in western medicine,the experimental group A was treated with ShuGanTiaoShen prescription,the experimental group B was treated with ShuGanTiaoShen ear acupuncture,and the control group C was given blank control.The course of treatment of the three groups was 8 weeks.The main efficacy indicators were Hamilton anxiety scale score and Self-rating anxiety scale score,and the secondary efficacy index was the World Health Organization quality of life measurement table.Exploratory indicators were immunological indicators(cytokine detection);safety indicators were blood routine,biochemical one and three.The Anxiety screening scale,Depression screening scale,Hamilton anxiety scale,Self-rating anxiety scale and World Health Organization quality of life scale were evaluated before entering the group,and cytokine test,blood routine test,biochemistry one and three were performed to evaluate the basic condition of the subjects before entering the group.At the end of the study,the changes of subjects’ scale scores and peripheral blood immune indexes before and after treatment were compared.The efficacy and safety of traditional Chinese medicine therapy of soothing the liver and regulating mind in the treatment of breast cancer patients with generalized anxiety disorder were statistically analyzed to provide data support for further clinical and research in the later stage.Results:At the end of this study,88 patients with breast cancer complicated with mild and moderate generalized anxiety disorder were included.Among them,30 cases were included in the traditional Chinese medicine group,30 cases in the auricular point group and 28 cases in the blank group.1 Baseline analysis:there was no significant difference among the three groups in age,marital status,family history of tumor,basic diseases,tumor-related data and the composition of the research index in the baseline period(before treatment,P>0.05),the baseline was comparable,and the interference of confounding factors was excluded for the later curative effect analysis.2 Effect of Hamilton anxiety scale after treatment:after treatment,the clinical cure rate,markedly effective rate,effective rate,ineffective rate and total effective rate of the traditional Chinese medicine group were 13.3%,66.7%,3.3%,16.7%and 83.3%,respectively,while those of the auricular point group were 13.3%,46.7%,16.7%,23.3%and 76.7%,respectively.In the blank group,the clinical cure rate was 0%,the markedly effective rate was 3.5%,the effective rate was 7.2%,the ineffective rate was 89.3%,and the total effective rate was 10.7%.There was significant difference among traditional Chinese medicine group,ear acupoint group and blank group(P<0.05),but there was no significant difference between traditional Chinese medicine group and ear acupoint group(P>0.05).3 Comparison in the scale group before and after treatment:Hamilton anxiety scale,Self-rating anxiety scale,World Health Organization quality of life measurement,physiological field,social relations field,environment field,family friction field,self-score,the scores of traditional Chinese medicine group and auricular point group were improved after treatment,there was statistical significance(P<0.05).In terms of psychological field,there was a significant improvement in the traditional Chinese medicine group before and after treatment(P<0.05),but there was no significant difference in the auricular point group(P>0.05).With regard to the field of appetite,there was no significant difference in the traditional Chinese medicine group before and after treatment(P>0.05),but the score in the auricular point group after treatment was significantly higher than that before treatment(P<0.05).4 Comparison between the scale groups after treatment,compared with the blank group,Hamilton anxiety scale,Self-rating anxiety scale,World Health Organization quality of life summary table physiological field,social relations field,environmental field score,family friction field,self-score,there was significant difference among the three groups after treatment(P<0.05).In the field of psychology and appetite,there was no significant difference among the three groups after treatment(P>0.05).There was no significant difference in the scores of each scale between the traditional Chinese medicine group and the auricular point group after treatment(P>0.05).5 Comparison of cytokines in the group before and after treatment:the levels of IL-1β,IL-8,IL-10,IL-2,IFN-γ and TNF-α in the traditional Chinese medicine group after treatment were significantly lower than those before treatment(P<0.05),and the levels in the auricular point group after treatment were also lower than those before treatment,but there was no significant difference(P>0.05).There was no significant difference in IL-4 and IL-6 between traditional Chinese medicine group and auricular point group before and after treatment(P>0.05).6 Comparison between the cytokines in the groups after treatment:compared with the blank group,IL-1β,IL-8,IL-10,IL-2 and TNF-α were significantly different among the three groups after treatment(P<0.05).There was no significant difference in IL-4,IL-6 and IFN-γamong the three groups after treatment(P>0.05).There were significant differences in IL-1β,IL-8,IL-10 and TNF-α between the traditional Chinese medicine group and the auricular point group after treatment(P<0.05).There was no significant difference in IL-2,IL-4,IL-6 and IFN-γ(P>0.05).Conclusions:1 TCM therapy of soothing the liver and regulating the mind,including prescriptions and auricular points,can effectively relieve the anxiety of patients,improve their quality of life,and is safe without side effects,so it has a certain clinical value.Compared with the blank group,there was statistical difference among the three groups(P<0.05),but there was no statistical difference between the traditional Chinese medicine group and the auricular point group(P>0.05).2 The modified prescription of soothing the liver and regulating the mind has an effect on the level of some cytokines(P<0.05),while the acupuncture therapy of soothing the liver and regulating the mind has no statistically significant effect on the level of cytokines(P>0.05). |
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