| Part Ⅰ Clinical observation of Tiaoqiyuchang Decoction in treating acute radiation enteritisObjective:To investigate the clinical efficacy and safety of Tiaoqiyuchang Decoction in the treatment of acute radiation enteritis.Methods:58 patients who met the inclusion criteria were randomly divided into control group and observation group,3 patients were removed or dropped during the study,and 27 patients were in the control group and 28 patients in the observation group.Control group was given berberine hydrochloride tablets 0.3g/time,3 times a day;Observation group was additionally given oral Tiaoqiyuchang Decoction granules,1 bag/time,2 times a day on the basis of the control group.Both groups took the drug for 2 weeks.The changes of RTOG grading,TCM syndrome score,fecal occult blood test and KPS score of the two groups were compared before and after treatment,and the clinical efficacy was evaluated.At the same time,the changes of blood routine,liver and kidney function and electrocardiogram of patients during this study were observed to evaluate the safety of Tiaoqiyuchang Decoction.Results:1 There were no statistically significant differences in the baseline data of gender,age,cancer type,tumor stage and concurrent chemoradiotherapy between the two groups(P>0.05),which could be compared between the two groups.2.In terms of RTOG grading,after treatment,there were 15,4 and 8 cases of grade 0,Grade 1 and grade 2 in the control group,and 20,5 and 3 cases in the observation group,with statistical significance(P=0.029<0.05).The total effective rate of the observation group was 85.7%,which was significantly higher than that of the control group(66.7%),with statistical significance(P=0.027<0.05).3.In terms of TCM symptoms,the diarrhea score of observation group after treatment was 0.93±0.663 lower than that of control group(1.37± 0.688),and the difference was statistically significant(P=0.023<0.05).After treatment,abdominal pain score of observation group was 0.71 ± 0.600 higher than that of control group(0.63 ± 0.629),and the difference was statistically insignificant(P=0.570>0.05).After treatment,the posterior weight score in the observation group(0.68±0.612)was lower than that in the control group(1.07±0.675),and the difference was statistically significant(P=0.030<0.05).After treatment,the mucus score of observation group was 0.89 ± 0.786,which was lower than that of control group(1.15±0.907),and the difference was statistically insignificant(P=0.309>0.05).After treatment,the Nater score of observation group was 0.86 ± 0.591,which was lower than that of control group(1.44 ± 0.892),and the difference was statistically significant(P=0.010<0.05).The fatigue score of the observation group was 0.82 ± 0.670,which was lower than that of the control group(1.85 ±0.718),and the difference was statistically significant(P=0.000<0.05).4.As for fecal occult blood test,after treatment,there were 14 negative and 13 positive patients in the control group,and 19 positive patients in the observation group,with statistical significance(P=0.022<0.05).5.In terms of KPS score,the increase rate,stabilization rate and decrease rate of KPS were 11.1%,55.6%and 33.3%in the control group after treatment,and 32.1%,60.7%and 7.1%in the observation group,respectively,with statistical significance(P=0.029<0.05).6.During the clinical trial,no obvious abnormalities were observed in blood routine,liver and kidney function and electrocardiogram in the two groups,and no serious adverse reactions were observed.Conclusions:1.In terms of clinical efficacy,Tiaoqiyuchang Decoction can reduce the RTOG grade of acute radiation enteritis,with significant clinical efficacy.2.In terms of relieving clinical symptoms,this decoction can effectively relieve the symptoms of diarrhea,abdominal pain,posterior tenesmus,phlegm and fatigue.3.In terms of improving fecal occult blood,this formula can inhibit intestinal bleeding and relieve the symptoms of hematochezia.4.In terms of KPS score,this formula can stabilize or even improve the KPS score.5.This formula has good safety,no obvious toxic side effects,and can be applied clinically.Part Ⅱ Study on network pharmacology and molecular docking of Tiaoqiyuchang Decoction for acute radiation enteritisObjective:To explore the mechanism of Tiaoqiyuchang Decoction in the treatment of acute radiation enteritis by using network pharmacology and molecular docking.Methods:The components and gene targets of Tiaoqiyuchang Decoction were obtained by TCMSP and UniProt databases.Gene targets of acute radiation enteritis were obtained by GeneCards and OMIM databases.Construct the Active Ingredients-Common Target network diagram by using Cytoscape 3.7.2 and analyze core components with NetworkAnalyzer plugin.The drug and disease intersection targets were submitted to STRING database to construct the PPI network and CytoNCA plug-in was run to screen core targets.GO and KEGG enrichment analysis was completed by Metascape.Finally,vina molecular docking was carried out through PubChem,RCSB PDB databases,ChemOffice and AutoDockTools softwares.Results:1.A total of 169 effective components and 307 gene targets were obtained from Tiaoqiyuchang Formula.1143 gene targets were obtained in acute radiation enteritis.The intersection targets of drugs and diseases were 142.2.The "active ingredient-common target"network analysis predicted quercetin,kaempferol,stigmasterol,isorhamnetin and taraxerol.3.Potential core targets such as AKT1,TP53,TNF,IL6 and IL1B were identified by PPI network topology analysis.4.GO enrichment results showed that the targets were mainly concentrated in biological processes such as response to lipopolysaccharide,organic matter,nutrient level,hormone and radiation,and cell components such as membrane raft,vesicle cavity,transcriptional regulatory complex,receptor complex,membrane side and bcl-2 family protein complex,and DNA binding,transcription factor binding,kinase binding,protein homologous dimerization activity,kinase regulatory activity,cytokine activity and other molecular functions.5.KEGG enrichment analysis suggested that the regulatory pathways included AGERAGE signaling pathway,PI3K-Akt signaling pathway,EGFR signaling pathway,NF-kB signaling pathway,JAK-STAT signaling pathway and PPAR signaling pathway.6.Molecular docking results showed that binding energies of potential core components and core targets were lower than-5 KJ.mol-1.Conclusions:In the treatment of acute radiation enteritis,the core components(quercetin kaempferol,stigmasterol,isorhamnetin,taraxerol)and core targets(AKT1,TP53,TNF,IL6,IL1B)of Tiaoqiyuchang Formula had strong binding force and stability.It may play a key therapeutic role by regulating AGE-RAGE signaling pathway,PI3K-Akt signaling pathway,EGFR signaling pathway,NF-kB signaling pathway,JAK-STAT signaling pathway and PPAR signaling pathway. |
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