| Objective: Radiation enteritis is a common complication in radiation therapy,which seriously affects the treatment effect and quality of life of patients.The treatment of radiation enteritis has achieved more results in recent years,but with the progress of radiotherapy,the symptoms are prone to repeat and even worse.Therefore,there is an urgent need for safe,effective and economical treatments in clinic.Fucoidan is a water-soluble polysaccharide composed of fucose and sulfate groups.Several studies have shown that fucoidan can improve intestinal function,but there is no report on the clinical research of fucoidan on radiation enteritis.The purpose of this study is to explore the clinical efficacy of fucoidan on acute radiation enteritis,and to provide one more option for the prevention and treatment of radiation enteritis.Methods: A total of 120 patients who underwent radiotherapy for pelvic tumors in the radiotherapy department of the Affiliated Hospital of Qingdao University from June 2018 to October 2019 were selected.120 patients who met the enrollment criteria were subject to strict standard procedures.After review and approval by the hospital ethics committee,they signed an informed consent before the experiment and were randomly divided into the experimental group and the control group according to the random number method,each group 60 example.Follow-up of the incidence of radiation enteritis,the control group patients were given conventional symptomatic treatment measures according to the RTOG score standard,and the experimental group added fucoidan on the basis of conventional treatment measures,3 capsules / time,3 times / day,450 mg each,from Radiotherapy starts to the end of radiotherapy.Count the number of completed groups,age,gender and tumor type of the two groups;record the number,grade and weekly increase of radiation enteritis in the two groups from the start of radiotherapy to 2 weeks after the end of radiotherapy;LENT-SOMA Symptom score and KPS function status score;detect the changes of inflammatory factors IL-1?,IL-6,IL-10,TNF-? in serum of two groups of patients before and after radiotherapy and the changes of microbiome analysis.Statistical software was used for chi-square test,t test,rank sum test and generalized estimation equation.Result:1.120 cases were enrolled,60 cases were in the control group and 60 cases in the experimental group;3 persons in the experiment group: 2 persons did not take oral drugs according to the regulations and 1 person was suspended due to the increase of diarrhea after taking fucoidan.The actual completion number was 117,the control group was 60,and the experimental group was 57.There was no significant difference between the two groups in terms of age,gender,tumor type,KPS score,number of surgeries and chemotherapy,and actual intestinal dose(P> 0.05).2.From the start of radiotherapy to 2 weeks after the end of radiotherapy,the number of patients with radioactive enteritis in Grade 1 to Grade 4 in the control group and experimental group was counted.The number of patients with radiation enteritis in the control group was 51(85%),and 23 cases in Grade 1(38.33%),26 cases of grade 2(43.33%),2 cases of grade 3(3.33%);the total number of patients with radiation enteritis in the experimental group was 40 cases(70.18%),22 cases of grade 1(38.60%),17 cases of grade 2(29.82 %),1 case of grade 3(1.75%).The incidence rate of the experimental group was lower than that of the control group,and the difference was statistically significant(Z =-2.081,P value = 0.037,P <0.05).3.Count the two groups from the start of radiotherapy to 2 weeks after the end of radiotherapy,and increase the number of patients and cumulative number every week.Through the generalize X2 group = 3.898,P value = 0.048,P <0.05;X2 time = 16.543,P value <0.001;Compared with week 1,the P values of the two groups at weeks 2,3,4,5,and 2 weeks after radiotherapy were 0.175,<0.001,<0.001,<0.001,0.003;it can be concluded that the incidence of the experimental group was lower than The control group,and compared with the first week,from the third week to two weeks after radiotherapy at each time point the difference in morbidity was statistically significant.4.The two groups of patients underwent LENT-SOMA symptom score and KPS function status score after radiotherapy.Through independent sample t test,the control group and experimental group LENT-SOMA score showed 1.40 ± 0.33 and 0.99 ± 0.30,P value <0.001;KPS The scores showed 79.50 ± 8.11 and 83.51 ± 6.94,P value <0.05,the experimental group was lower in symptom score than the control group,and the functional status score was higher than the control group,the difference was statistically significant.5.Detect the changes of IL-1?,IL-6,IL-10,TNF-? inflammatory factors before and after radiotherapy in two groups.The results show:(1)Comparison of four inflammatory factors in control group and experimental group before treatment.t test,P> 0.05,the difference was not statistically significant;(2)Compared with the inflammatory factors before and after treatment in the control group and the experimental group,IL-1?,IL-6 and TNF-? in both groups were higher than before treatment.-10 decreased compared with before treatment,by paired sample t test,P <0.05,the difference was statistically significant;(3)compared with the control group after treatment inflammatory factors in the experimental group after treatment,IL-1?,IL-6,TNF-? was lower than the control group,IL-10 was higher than the control group,and the independent sample t test,P <0.05,the difference was statistically significant.6.Before and after radiotherapy,all the bacteria were analyzed and tested.Aseptic disorder occurred before radiotherapy.Two groups of patients with bacterial disorder after radiotherapy were counted.The difference was not statistically significant(P> 0.05).Conclusion:1.The use of fucoidan for radiotherapy of pelvic tumors at the same time can reduce the incidence of radiation enteritis,and the incidence varies at different times.2.Fucoidan can improve the clinical symptoms of patients with pelvic tumors during radiotherapy,further improve the patients' quality of life and treatment compliance.3.Radiation therapy can increase the level of inflammatory factors in patients,the intervention of fucoidan can inhibit the expression of pro-inflammatory factors,stabilize the anti-inflammatory factors,thereby controlling the further development of inflammatory response and reducing the effect of inflammatory damage.4.Fucoidan has no obvious advantages in regulating intestinal flora. |
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