| Objective:1.Through the treatment of radioactive enteritis with Niruha therapy of Mongolian medicine modified Huanglian-5 powder,observe its clinical efficacy and safety,and demonstrate the therapeutic effect of Mongolian medicine modified Huanglian-5 powder Niruha therapy on radioactive enteritis.2.By using non-targeted metabolomics technology,the abnormal metabolites in the feces of patients with radiation enteritis after intervention with Mongolian medicine Jiawei Huanglian-Wuwei Niruha therapy were analyzed,and discuss their different metabolic characteristics.Methods:From November 2021 to December 2022,52 patients with radioactive enteritis who meets the admission criteria were randomly divided in to treatment group and control group,a total of 26 patients were enrolled in each group.The treatment group was treated with Mongolian medicine modified Huanglian-5 Weisan,and the control group was treated with medicated mesalazine enema.Treat once a day for seven consecutive days.The two groups took 7 days as a course of treatment.A total of 1course of treatment was observed.Observe and record the general conditions of the patients in the two groups,including the radiation intestinal injury grading table(RTOG/ECRTC grading table),the Mongolian medicine syndrome scoring table,and the functional status scoring table(KPS score);The stool samples of the two groups of patients before and after treatment were collected and analyzed by LC-MS metabolomics.Results:1.Comparison before treatment: the age of patients in the two groups,the stage distribution of radioactive enteritis,the classification of radioactive intestinal injury,the score of Mongolian medical syndrome,and KPS score were statistically analyzed,all P>0.05,differences between the two groups not significant and comparable.2.Comparison after treatment:(1)Comparison of radiation intestinal injury scores: The comparison between the two groups showed significant differences(P<0.05),and the improvement of radiation induced intestinal injury in the treatment group was better than control group.(2)Comparison of symptoms scores of Mongolian medicine syndromes:(1)The comparison of abdominal pain symptoms showed a significant difference between the two groups(P<0.05),and the treatment group was superior to the control group in improving abdominal pain symptoms.(2)The comparison of symptoms of anorexia showed no significant difference between the two groups.(P>0.05).(3)The comparison of characteristics and fecal quantity showed significant and statistically significant differences between the two groups(P<0.05).Compared with the control group,the treatment group improved stool characteristics and symptom frequency.(4)The comparison of mucosal symptoms and bloody stools showed significant and statistically significant differences between the two groups(P<0.05).The improvement of mucus and bloody stool symptoms in the treatment group was superior than control group.(5)There was no significant difference or statistical significance in tenedmus sympuoms in both groups(P>0.05).(6)The comparison of fatigue symptoms showed significant differences between the two groups(P<0.05).(3)Comparison of the total score of Mongolian medicine syndrome: comparing the total score of Mongolian medicine syndrome between two groups after treatment,significant differences between the two groups(P<0.05),indicating that the treatment group is superior to the control group in improving the clinical symptoms of radiation enteritis.(4)Comparison of KPS scores: The KPS score of the two groups after treatment was statistically significant(P<0.05),indicating that the KPS score of the treatment group was higher than that of the control group after treatment.3.Safety index results:The two groups of patients did not experience any significant adverse reactions during the treatment period.At the same time,the results of blood routine tests,liver and kidney functions,five items of ions,and electrocardiograms completed before and after treatment fluctuated,but both were within the normal range,with good safety.4.Metabolomics results:(1)Treatment group: The stool samples of the patients in the treatment group were analyzed by non-targeted metabonomics technology,and 11 different metabolites were found,mainly including deoxycholic acid,3,7-dihydroxy-5-chholesteroic acid,L-citrulline,glutamine,L-ornithine,glycerides,calcitriol,N-acetyl-D-glucosamine,vanillic acid,coumarinic acid,naphthalene,etc.Phenylalanine metabolism pathway with high enrichment was screened out through the enrichment of different metabolites.(2)Control group: The stool samples of the patients in the control group were analyzed by non-targeted metabolomics technology,and 10 different metabolites were found,mainly including 2-piperidine carboxylic acid,2,6-diethyl-acetylaniline,phosphatidylcholine,sinapine,N1-methyl-4-pyridine-3-formamide,21-hydroxyisovitreolactone,sphingolipids,Dictyoquinol B,3-O-ferulic acid,Bryononic acid,etc.Conclusion:1.The treatment of radioactive enteritis with Mongolian medicine modified Huanglian-5 Niruha can obviously relieve its clinical symptoms,and has a significant clinical effect.It can alleviate patients’ pain to a certain extent and improve their quality of life.It is a safe and reliable traditional treatment.2.Mongolian medicine modified Huanglian-5 Niruha therapy may play a role in treating radiation enteritis by regulating the metabolic level of amino acids,bile acids and lipids. |
