| Objective:To observe the clinical effectiveness and safety of Bi An Decoction com-bined with sulfasalazine in the treatment of damp-heat arthraltic ankylosing spondylitis(AS),and preliminarily discuss the mechanism of action of Bi An Decoction in the treatment of AS through network pharmacology,so as to provide clinical evidence and new ideas for traditional Chinese medical treatment of AS.Methods:1.Clinical study: 64 patients who met the inclusion criteria were random-ly divided into control group(n=32)and test group(n=32).The control group was given sulfasalazine,and the test group was additionally given Bi An Decoction.TCM symptom score,total clinical effectiveness,ESR,CRP,BASDAI,BASFI,VAS,PGA,ASAS20 and safety indexes of the two groups were compared before and after treatment,and analyzed by SPSS27.0software.2.Network pharmacology: TCMSP database was used to collect the active components and corresponding target proteins of Bi An Decoction,and the related targets of ankylosing spondylitis were searched in Gene Cards,OMIM and TTD databases.Protein interaction network was constructed with STRING11.0 database;Drug-disease intersection targets were conducted for GO enrichment analysis and KEGG signaling pathway analysis using DAVID6.8 database,and visualization processing was realized using R langua-ge.Establishment of Drug ingredient-Potential target network was used Cytoscape 3.8.0 software.Results:1.Clinical study1.1In this study,61 patients were eventually included,2 cases were lost in the control group,and 1 case was lost in the test group.Before treatment,the baseline data of the two groups were comparable,but there was no statistical significance between the two groups(P>0.05).1.2Comparison of indexes of clinical efficacy: After treatment,the TCM syndrome score decreased in both groups,with a extremely significant statistical difference(P<0.001);and the test group was superior to the control group,with a statistically difference(P<0.05).The total clinical effective rate of TCM syndrome score in the control group was 66.67%,while the total effective rate in the test group was 77.42%.The test group was superior to the control group,with a statistically difference(P<0.05).The ESR,CRP level,BASDAI,BASFI,VAS,and PGA scores of both groups decreased after treatment,with a extremely significant statistical difference(P<0.001),and the ASAS20 compliance rate increased,with a statistically difference(P<0.05).Moreover,the above indicators in the test group were better than those in the control group,with a statistically difference(P<0.05).1.3Comparison of safety indexes: No adverse reactions occurred in the two groups before and after treatment,and blood routine,liver and kidney functions were normal.WBC,ALT,Scr,BUN levels were not abnormal,there was no statistical significance in the two groups of data(P > 0.05).2.Network pharmacologyThe main effective ingredients of Bi An Decoction include quercetin,luteolin,kaempferol,etc.The protein targets for the treatment of ankylosing spondylitis mainly include RELA,IL-6,TNF,etc.Related pathways include TNF-α,NF-κB,IL-17 and other signaling pathways.Conclusion:1.Bi An Decoction combined with sulfasalazine can significantly reduce TCM syndrome scores of patients with ankylosing spondylitis of damp-heat obstruction type,and improve their clinical symptoms.2.Bi An Decoction combined with sulfasalazine can significantly reduce BASDAI,BASFI,VAS and PGA scores of patients with ankylosing spondylitis of damp-heat obstuction type,and the ASAS20 compliance rate can significantly increase.3.Bi An Decoction combined with sulfasalazine can significantly reduce CRP and ESR level of patients with ankylosing spondylitis of damp-heat obstuction type,and effectively control inflammation in the body.4.Bi An Decoction has good safety,with normal blood routine and live and kidney functions before and after treatment.There are no abnormalities in WBC,ALT,Scr,BUN levels,and no significant adverse reactions.5.The possible mechanism of Bi An Decoction in the treatment of AS is that the main active ingredients quercetin,luteolin and kaempferol interfere with the protein target RELA,IL-6 and TNF of AS and affect the signaling pathways of TNF-α,NF-κB and IL-17. |