| Objective:(1)Using the theory of treating different diseases in TCM,Simiao Powder,which has the effect of removing dampness and eliminating heat,is good at treating anal sinusitis of dampness-heat accumulation lower coke,is applied to anal sinusitis of dampness-heat injection type.The clinical efficacy of Simiao Powder is confirmed by observing the changes of various clinical scores and serum inflammatory index contents of patients.(2)To investigate the main active components,potential targets,biological processes and key signaling pathways of Simiao powder in the treatment of anal sinusitis with dampness-heat injection by network pharmacology and molecular docking,and then explain its molecular mechanism of action,and provide a scientific basis for the further study of rational drug use of Simiao powder in anal sinusitis.Methods:(1)Seventy eligible patients with dampness-heat injection anal sinusitis in the anorectal inpatient department and outpatient department of Jiangxi Provincial Hospital of Traditional Chinese Medicine from March 2022 to February 2023 were collected,and the chaos table was used to establish the treatment group and the control group according to the principle of "equal opportunity",with 35 cases in each group.The treatment group was treated with Simiao powder combined with metronidazole and sodium chloride solution retention enema,and the control group was treated with metronidazole and sodium chloride solution retention enema.Taking 1 week as a course of treatment,continuous treatment for 2 weeks,the scores of clinical symptoms(anal bulge,pain,burning)and signs(anal sinus congestion and edema)were recorded before treatment,after the first course of treatment,and after the second course of treatment in both groups;the changes in the contents of relevant inflammatory indicators before treatment and after 2 weeks of treatment were recorded,and safety assessment was performed(the vital signs and biochemical test indicators of the patients were unremarkable).The results were analyzed by SPSS 27.0 statistical software package.Patients in both groups were followed up 2 months after completion of all treatment.(2)All active ingredients related to traditional Chinese medicine in Simiao powder were searched in the Systematic Pharmacology Technology Database of Traditional Chinese Medicine(TCMSP).The related gene targets of anal sinusitis with hot and humid betting were obtained from Genecards,OMIM,Pharm Gkb and Drug Bank databases.Simiao powder drug targets were docked with anal sinusitis disease genes to take the intersection,and imported into STRING to make protein interaction maps and further construct subnetworks and network cores.The above network diagram was opened in Cytoscape 3.8.0 software,and the SMP– active ingredient – target – AS network model was established.The targets obtained after intersection were then subjected to KEGG and GO enrichment analysis.The core target TP53 was selected and molecular docking was run using Auto Dock Vina with the core active components Wogonin,quercetin,and baicalein in Simiao San,and the free energy of binding of protein receptors to small molecule ligands was calculated.Results:(1)(1)Some patients were excluded according to the exclusion criteria because they could not cooperate with the clinical treatment as required,and finally a total of 65 patients were included(control group: 32,treatment group: 33).(2)The general data of the two groups before treatment were compared;there was no significant difference in the symptom score,physical sign score and serum inflammatory index level,and subsequent comparison could be performed.(3)Comparison of symptoms: Compared with the group,the two groups of patients in the anal bulge,pain,burning were relieved to a certain extent.After 1 course of treatment,the treatment group and the control group opened a significant gap in anal pain(P < 0.05),and the treatment group had a better effect,but there was no significant difference in anal bulge and burning scores between the two groups(P > 0.05);after 2 weeks of treatment,the control group and the treatment group showed significant differences in symptom scores(P < 0.01),and the treatment group had a lower score.(4)Comparison of physical signs: The two groups of patients were compared within the group,and it was found that there was a certain degree of relief in the anal sinus congestion and edema scores.After 1 course of treatment,there was no significant difference in anal sinus congestion and edema between the two groups(P > 0.05);while after 2 courses of treatment,there was significant difference in symptom scores between the two groups(P < 0.05),and edema relief was more significant(P < 0.01);Moreover,the scores of anal sinus congestion and edema in the treatment group were lower than those in the control group regardless of 1 or 2 weeks of treatment.(5)Comparison of inflammatory parameters: The contents of TNF-α and IL-6 in the two groups were decreased to different extents after 2 weeks of treatment(P < 0.001),and the control group was higher than the treatment group.(6)Comparison of overall efficacy: after two courses of treatment,the total effective rates of the control group and the treatment group were 75.00% and 87.88% respectively(P<0.05).(7)Comparison of recurrence rate: 10 patients in the control group and 3 patients in the treatment group relapsed 2 months after the end of 2 weeks of treatment,and the recurrence rates were 34.48% and 9.68%,respectively(P < 0.05).(8)All safety indicators of patients in the two groups showed no abnormality during the treatment,and no adverse reactions occurred.(2)(1)Obtain 75 SMP active ingredients,916 active ingredient target genes,777 disease-related genes,and 65 SMP-AS intersection genes in the database;(2)Introduce the intersection genes into String to make a protein interaction network,and simplify the core protein network to obtain 10 core genes;(3)Using Cytoscape to draw the SMP-active component-target-AS network model,it can be seen that SMP contains 27 effective active ingredients and 174 targets involved in the treatment of damp-heat injection anal sinusitis;(4)GO enrichment functional analysis yielded a total of 2037 messages,of which 1878 were mainly enriched in biological processes,26 in cellular components(CC),and 133 in molecular functions(MF);KEGG signaling pathways were enriched in 148 pathways,of which key signaling pathways such as IL-17,HIF-1,TP53,tumor necrosis factor,and PI3K-Akt were associated with inflammatory responses and participated in the development of AS,and may be an important pathway for the treatment of AS.(5)Molecular docking results showed that baicalin,an effective active component,was most closely chimeric to TP53 and had the strongest structure.Conclusion:(1)It is clinically confirmed that Simiao Powder combined with metronidazole and sodium chloride solution enema has definite curative effect on anal sinusitis of damp-heat injection type,and compared with the control group,Simiao Powder is significantly superior to the control group in the treatment of various symptoms,physical sign scores and total effective rate of patients with damp-heat injection type anal sinusitis,highlighting the superiority of Simiao Powder,with obvious curative effect,safety and reliability and small probability of recurrence,with high patient acceptance,which is worthy of clinical application.(2)Based on the way of network pharmacology and molecular docking,it was found that Wogonin,quercetin,baicalein,etc.,which are effective active components in SMP,can play a role in multiple targets and proteins of multiple signaling pathways such as IL-17,HIF-1,P53,TNF,and PI3K-Akt,intervene inflammation and oxidative stress to delay the progression of anal sinusitis with hot and humid betting,relieve the symptoms and signs of patients,indicating that SMP has pharmacological effects such as good anti-inflammatory,bactericidal,and maintaining the physiological homeostasis of the body,theoretically confirming the effectiveness of Simiao Powder in the treatment of anal sinusitis with hot and humid betting,and providing theoretical guidance for the subsequent clinical application of Simiao Powder and the treatment of anal sinusitis related diseases. |
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