| Research backgroundCervical cancer is a serious threat to women’s health and life.In 2020,the global cervical cancer incidence rate was 6.5%and the mortality rate was 7.7%,both ranking the fourth among women’s cancers.In China,the cervical cancer incidence rate was 5.2%and the mortality rate was 7.0%,ranking the sixth and seventh among women’s cancers respectively.Patients with cervical cancer have developed to the middle or late stage at the initial diagnosis,and their treatment is mainly concurrent chemoradiotherapy.Cervical cancer patients receiving radiotherapy and chemotherapy will have many symptoms with different severity and distress,which will seriously affect the quality of life of patients.Radiotherapy can cause radiation cystitis,resulting in urgent urination,frequent urination,urinary pain and other symptoms;It can cause radiation enteritis,resulting in symptoms such as nausea,vomiting,diarrhea,irritability,discharge of mucus or blood like stool;It can cause lower limb lymphedema,resulting in lower limb swelling,and consciously feel heavy,tight and painful;It can also cause vulvitis and vaginitis,resulting in vulva pruritus,vulva burning and pain,increased vaginal secretions and other symptoms.Chemotherapy can cause systemic reactions,such as nausea,vomiting,loss of appetite,diarrhea and other symptoms in the digestive system;Fatigue,shortness of breath,chest tightness and other symptoms may occur in the circulatory and respiratory system;Tinnitus,limb numbness and other symptoms can appear in the nervous system.Symptom cluster research can provide medical staff with the basis of symptom management,prolong the survival time of patients to a certain extent,improve the quality of life of patients,and evaluate the effect of a therapy.It is found that TCM has a significant effect on the symptom management of cancer patients,and there is similarity between TCM syndrome and symptom cluster at the theoretical level.Therefore,the introduction of symptom cluster research in the field of TCM tumor can provide evaluation basis for the clinical efficacy of TCM and further lay a clinical foundation for the efficacy of TCM.Research objectiveThis study will be divided into two parts.By investigating the two dimensions of symptom incidence and severity of cervical cancer patients after radiotherapy and chemotherapy,evaluate their symptom distribution characteristics,determine their symptom clusters,and further investigate and explore the relationship between symptom clusters and TCM syndromes,so as to provide basis for clinical medical staff to improve symptom management,explore the application of symptom clusters in TCM curative effect evaluation,and provide basis for TCM intervention effect evaluation.Research methodStudy 1:Study on symptom clusters and TCM syndrome of patients with cervical cancer after radiotherapy and chemotherapyFrom September 202 0 to January 2022,250 patients with cervical cancer who met the inclusion and exclusion criteria within 6 months after radiotherapy and chemotherapy in the outpatient or inpatient department of the oncology department of Guang’anmen Hospital and the gynecological oncology clinic of Beijing Union Medical College Hospital were included.For patients who meet the research criteria,fill in the general information questionnaire and clinical symptom questionnaire.Adopt SPSS 24.0 statistical software for data analysis,which is entered into the computer by two people and verified.The statistical description of general data and clinical symptoms adopts mean,standard deviation,constituent ratio,etc;The incidence and severity of symptoms of cervical cancer patients after radiotherapy and chemotherapy are analyzed by means of mean,standard deviation and constituent ratio,and the symptom cluster of cervical cancer patients after radiotherapy and chemotherapy was extracted and identified by exploratory factor analysis;The TCM syndrome types and TCM syndrome elements are compared to analyze the distribution characteristics of TCM syndrome in patients with cervical cancer after radiotherapy and chemotherapy;Spearman correlation analysis was used to analyze the correlation between symptom clusters and TCM syndromes in patients with cervical cancer after radiotherapy and chemotherapy.Two sided test is used in hypothesis test.There was significant difference with P<0.05.Study 2:Study on intervention of traditional Chinese medicine on symptom clusters and TCM Syndromes of cervical cancer after radiotherapy and chemotherapyFrom September 2020 to January 2022,60 patients who met the inclusion and exclusion criteria in the outpatient or inpatient department of the oncology department of Guang’anmen Hospital within 6 months after radiotherapy and chemotherapy of cervical cancer treated with traditional Chinese medicine for 28 days were included.For patients who meet the research criteria,fill in the general information questionnaire,and fill in the clinical symptom questionnaire after enrollment and 28 days.The patients are treated with TCM syndrome differentiation decoction.The observation indexes are the change of symptom incidence and severity of moderate and severe symptoms before and after treatment,the change of moderate and severe symptom clusters before and after treatment,the change of TCM syndrome distribution before and after treatment,frequency and cluster analysis of intervention of traditional Chinese medicine.Adopt SPSS 24.0 statistical software for data analysis,which is entered into the computer by two people and verified.The statistical description of general data adopts mean,standard deviation,composition ratio,etc;The constituent ratio is used for the symptom incidence of the clinical symptom questionnaire,and the mean and standard deviation are used for the severity of moderate and severe symptoms and the severity of moderate and severe symptom clusters;The composition ratio is adopted for the distribution of TCM syndromes;The composition ratio and cluster analysis are used for the intervention of traditional Chinese medicine.Two sided test is used in hypothesis test,with P<0.05 as the statistical difference.Research resultsStudy 1:Study on symptom clusters and TCM syndrome of patients with cervical cancer after radiotherapy and chemotherapy1.The incidence and severity of symptoms:The incidence of 40 symptoms ranged from 2%to 84%,of which 15 symptoms were more than 50%,and the incidence of fatigue symptoms was the highest(84.0%).The rest were nocturia(83.2%),amnesia(74.4%),disturbed sleep(71.2%),dry mouth(68.0%),hot flashes(67.6%),upset heart(66.0%),lumbosacral pain(65.2%),shortness of breath(63.6%),sighing(60.4%),lower abdominal pain(57.6%)and numbness(56.0%)Distress(55.0%),pain(54.8%),poor appetite(54.0%).Symptom severity of cervical cancer patients within 6 months after radiotherapy and chemotherapy:the severity of 40 symptoms ranged from 0.04 ±0.27 to 1.44 ± 0.90.Among the top 15 symptoms,nocturia symptoms had the highest severity(1.44±0.90),followed by fatigue(1.14 ± 0.74),restless sleep(1.00 ± 0.78),hot flashes(0.95 ± 0.82),forgetfulness(0.93±0.70),dry mouth(0.87±0.73),lumbosacral pain(0.86±0.78),upset(0.84 ± 0.78),shortness of breath(0.82±0.75),poor appetite(0.75±0.83),sighing(0.74±0.73),numbness(0.72±0.76)Distress(0.72± 0.76),lower abdominal pain(0.66±0.65),pain(0.64 ± 0.65).2.Symptom clusters analysis:Nine symptom clusters were extracted and identified,and named according to the common characteristics of one or several symptoms with large load.Factor 1 is named as psycho emotional related symptom cluster,including four symptoms,namely sadness,distress,upset and sigh;Factor 2 is named pain insomnia related symptom cluster,including 6 symptoms,namely lumbosacral pain,pain,restless sleep,forgetfulness,lower abdominal pain and fatigue;Factor 3 is named climacteric like symptom cluster,which includes three symptoms:spontaneous sweating,night sweating and hot flashes;Factor 4 is named as urinary tract related symptom cluster,including three symptoms:frequent urination,urgent urination and nocturia;Factor 5 is named as nerve related symptom cluster,including 4 symptoms,namely tinnitus,dizziness,chest tightness and abdominal distension;Factor 6 is named constipation related symptom cluster,including three symptoms:dry stool,difficult defecation and painful urination;Factor 7 is named weight loss related symptom cluster,including three symptoms:weight loss,nausea and poor appetite;Factor 8 is named dry mouth-bitter mouth related symptom cluster,including bitter mouth,dry mouth and shortness of breath;Factor 9 is named loose stool related symptom cluster,including two symptoms,namely loose stool,urgency and severity.3.Analysis of the changes of symptom clusters in different months:Nine symptom clusters were extracted and identified for patients aged 0-3 months,namely psycho emotional related symptom cluster(sadness,distress,upset and sighing);Paininsomnia related symptom cluster(lumbosacral pain,restless sleep,lower abdominal pain,chest tightness,pain,shortness of breath,fatigue);Climacteric symptom cluster(spontaneous sweating,night sweating,hot flashes,dizziness,abdominal distension);Urinary tract related symptom cluster(frequent urination,urgency and pain);Defecation related symptom cluster(difficult defecation,dry defecation,internal urgency and severe illness);Weight loss related symptom cluster(weight loss,nausea,poor appetite);Dry mouth-bitter mouth related symptom cluster(dry mouth,bitter mouth);Loose stool-nocturia related symptom cluster(loose stool,nocturia);Tinnitus-amnesia related symptom cluster(tinnitus,amnesia).A total of 10 symptom clusters are identified for patients aged 3-6 months,namely psycho emotional related symptom cluster(sadness,distress,upset,like sighing,uneasy sleep);Urinary tract-Vaginal secretions related symptom cluster(frequent urination,urgent urination,nocturia and abnormal leucorrhea);Climacteric like symptom cluster(spontaneous sweating,night sweating,hot flashes);Shortness of breath related symptom cluster(shortness of breath,dry mouth,bitter mouth);Pain related symptom cluster(pain,abdominal distension,lower abdominal pain);Constipation related symptom cluster(dry stool,painful urination,difficult defecation);Numbness fatigue related symptom cluster(numbness,fatigue,chills);Loose stools related symptom cluster(loose stools,urgent inside and heavy after);Tinnitus related symptom cluster(tinnitus,dizziness and dizziness);Amnesia-poor appetite symptom cluster(amnesia,poor appetite).4.Distribution of TCM syndromes:After radiotherapy and chemotherapy,the syndrome elements of cervical cancer patients are Qi deficiency syndrome,with 207 cases,accounting for 82.8%.The other syndrome elements accounting for more than 50%are heat toxin syndrome(68.4%),yin deficiency syndrome(64.4%)and qi stagnation syndrome(60.8%).The syndrome types of cervical cancer after radiotherapy and chemotherapy are mainly Qi and yin deficiency syndrome,with 134 cases,and the constituent ratio is 53.6%.The remaining syndrome types are liver depression and fire transforming syndrome(48.4%),liver and kidney yin deficiency syndrome(33.2%),Qi deficiency and blood stasis syndrome(25.2%),Qi and blood deficiency syndrome(22.8%),bladder damp heat syndrome(16.8%),qi stagnation and blood stasis syndrome(15.6%),spleen and stomach weakness syndrome(14.8%),damp heat infusion syndrome(10.4%),intestinal damp heat syndrome(9.6%),liver depression and spleen deficiency syndrome(7.6%)Lower Jiao stasis syndrome(4.0%),damp heat accumulating spleen syndrome(3.2%).5.Correlation analysis between symptom clusters and TCM syndrome:There is a positive correlation between psychological emotional correlation cluster and liver depression and spleen deficiency syndrome and Qi and blood deficiency syndrome;It is positively correlated with Qi deficiency syndrome and blood deficiency syndrome.Pain-insomnia related symptom cluster are significantly positively correlated with liver and kidney yin deficiency syndrome and Qi and yin deficiency syndrome,and positively correlated with Qi and blood deficiency syndrome;It is positively correlated with Qi deficiency syndrome and negatively correlated with phlegm dampness syndrome.There was a significant positive correlation between climacteric like symptom cluster and liver depression and fire syndrome,liver and kidney yin deficiency syndrome and Qi and yin deficiency syndrome;There is a significant positive correlation with qi stagnation syndrome,yin deficiency syndrome and heat toxin syndrome,and a negative correlation with blood stasis syndrome.There was a significant positive correlation between urinary tract related symptom cluster and bladder damp heat syndrome;There is a significant positive correlation with damp heat syndrome.There was a positive correlation between nerve related symptom cluster and liver depression and fire syndrome and intestinal damp heat syndrome;There is a significant positive correlation with Qi deficiency syndrome.Constipation related symptom cluster are significantly positively correlated with intestinal damp heat syndrome and bladder damp heat syndrome,and positively correlated with liver depression and fire syndrome;There is a significant positive correlation with Qi deficiency syndrome,heat toxin syndrome and damp heat syndrome.The weight loss related symptom cluster are positively correlated with spleen and stomach weakness syndrome,Qi and blood deficiency syndrome and Qi and yin deficiency syndrome;There is a significant positive correlation with Qi deficiency syndrome.The dry mouth and bitter mouth related symptom cluster are significantly positively correlated with intestinal damp heat syndrome and Qi Yin deficiency syndrome;There is a significant positive correlation with Qi deficiency syndrome.There was a significant positive correlation between loose stool related symptom cluster and liver depression and fire syndrome and intestinal damp heat syndrome;It is positively correlated with qi stagnation syndrome and heat toxin syndrome.Study 2:Study on intervention of traditional Chinese medicine on symptom clusters and TCM Syndromes of cervical cancer after radiotherapy and chemotherapy1.Comparison of the incidence of symptoms and the severity of moderate and severe symptoms after treatment:After the intervention of traditional Chinese medicine,the symptoms with a reduction of more than 10%in the incidence of symptoms ranked from high to low,which are weight loss(23.4%),dry stool(15.0%),bitter mouth(13.3%),sighing(10.0%),sudden onset of illness(10.0%)and dizziness(10.0%).After the intervention of traditional Chinese medicine,the severity of moderate and severe symptoms decreased in varying degrees,including hot flashes,restless sleep,fatigue,lumbosacral pain,difficulty in defecation,chills,dry mouth,poor appetite,lower abdominal pain,weight loss,sighing,shortness of breath,internal urgency and weight loss,and significant reduction of oral pain.2.Comparative analysis of TCM Syndromes:Before and after treatment,cervical cancer patients are ranked from high to low according to the proportion of syndrome cases,yin deficiency syndrome(45.0%),heat toxin syndrome(38.3%),damp heat syndrome(28.3%),qi stagnation syndrome(13.4%),blood deficiency syndrome(11.7%),Qi deficiency syndrome(10%)and Phlegm dampness syndrome(1.7%).After radiotherapy and chemotherapy,patients with cervical cancer are ranked from high to low according to the proportion of syndrome types before and after treatment,including Qi Yin deficiency syndrome(26%),liver stagnation and fire transformation syndrome(20%),bladder damp heat syndrome(15%),intestinal damp heat syndrome(15%),Qi and blood deficiency syndrome(15%),lower injection of damp heat syndrome(10%),qi stagnation and blood stasis syndrome(5%),liver depression and spleen deficiency syndrome(5%),spleen and stomach weakness syndrome(6.7%),liver and kidney yin deficiency syndrome(3.3%)Lower coke stasis syndrome(1.6%).3.Changes in severity of moderate and severe symptom clusters:After radiotherapy and chemotherapy of cervical cancer,the severity of each moderate and severe symptom cluster decreased in varying degrees after traditional Chinese medicine treatment,including psychological emotion related symptom cluster(3.25±1.653 vs 1.50±1.317),pain insomnia related symptom cluster(4.24 ± 2.332 vs 3.03 ± 2.338),menopausal like symptom cluster(3.11±1.568 vs 1.44±1.149),urinary tract related symptom cluster(2.69 ±1.312 vs 1.97±1.210),nerve related symptom cluster(2.69 ±1.195 vs 1.31 ± 0.946),Constipation related symptom cluster(3.10±1.411 vs 1.90 ±1.375),weight loss related symptom cluster(2.93±1.639 vs 1.07 ± 1.072),dry mouth bitter mouth related symptom cluster(2.75±0.851 vs 1.25 ± 1.164)and loose stool related symptom cluster(3.00±1.279 vs 1.17±1.403).The above results are statistically significant.4.Intervention analysis of traditional Chinese medicine:In terms of medication frequency,the total frequency of 140 traditional Chinese medicine is 1174,of which 29 traditional Chinese medicine are used more than 20%.The drugs with the highest use frequency are:tangerine peel,Pinellia ternata,malt,raw Astragalus,fennel,Rhodiola,Anemarrhena,Radix Linderae,peony bark and dandelion.After cluster analysis of high-frequency drugs(use frequency ≥ 20%),nine categories of traditional Chinese medicine were obtained,which were as follows:cluster 1:tangerine peel,Rhizoma Pinelliae,malt;Cluster 2:bupleurum,Scutellaria baicalensis,Forsythia suspensa and Angelica sinensis;Cluster 3:Eucommia ulmoides and parasitic loranthus;Cluster 4:Fennel,Radix Linderae,cinnamon;Cluster 5:areca nut and Coptis chinensis;Cluster 6:Astragalus membranaceus and Rhodiola;Cluster 7:Sevenlobed Yam Rhizome,Semen plantaginis,dandelion;Cluster 8:Ramulus Cinnamomi,radix paeoniae rubra and Smilax pullulans;Cluster 9:Anemarrhena,Gardenia,peony bark,nocturnal vine,Caulis Polygoni multiflori,albizia bark,turtle shell and notopterygium.Research conclusion1.The study found that the incidence of fatigue was the highest among the 40 symptoms,and its severity ranked second,and the incidence of 15 symptoms was more than 50%.The symptoms of patients with cervical cancer after radiotherapy and chemotherapy were obvious and came from multiple systems and organs,which was complex.2.Nine symptom clusters were extracted and identified,including psychological emotion related symptom cluster,pain-insomnia related symptom cluster,menopause symptom clusters,urinary tract related symptom clusters,nerve related symptom cluster,constipation related symptom cluster,weight loss related symptom cluster,dry mouth bitter mouth related Symptom cluster and loose stool related Symptom cluster.The symptom management of patients with cervical cancer after radiotherapy and chemotherapy can be based on the symptom clusters.3.There is correlation between symptom clusters and TCM syndrome,and most of them are positive correlation.It is objective and feasible to take symptom cluster as the potential evaluation index and judgment standard of TCM syndrome.4.After the intervention of traditional Chinese medicine,the incidence of symptoms and the severity of moderate and severe symptoms decreased in varying degrees,and the severity of moderate and severe symptom clusters decreased after the intervention.Under the guidance of TCM syndrome differentiation and treatment,traditional Chinese medicine has obvious effect in treating complicated clinical symptoms caused by adverse reactions after radiotherapy and chemotherapy of cervical cancer,and has unique advantages in improving symptom clusters. |
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