| Objective:The pathogenesis of ankylosing spondylitis(AS)complicated,the biological agent is an important method of the treatment of AS,but the curative effect of biological agents alone cann’t meet the clinical needs,and TCM treatment of AS is proved curative effect,by clinical practice.Meta-analysis results showed that TCM combined with biological agents had significant efficacy and good safety in the treatment of AS,which may provide a better treatment of AS.This study conducted a randomized controlled trial to evaluate the clinical efficacy and safety of Wenshen Juanbi Decoction combined with Adamumab in the treatment of AS kidney deficiency and Du channel cold syndrome,and slso preliminarily explored the mechanism of Wenshen Juanbi Decoction in the treatment of AS through network pharmacology.Methods:1.Clinical study:Select 60 patients with AS who were treated in our hospital during the period from December 2019 to December 2020 and accorded with the inclusion criteria.These patients were randomly divided into the experimental group and the control group,each with 30 cases.The treatment plan:the experimental group was treated with Wenshen Juanbi Decoction combined with adalimumab,the control group was treated with adalimumab alone,and the two groups were treated with half a dose of adalimumab when it reached ASAS40.The treatment duration is 16 weeks,and The observation nodes were 0week,4week,8week,12week,16week.The observation items included spinal mobility,Pittsburgh sleep therapy index(PSQI),effectiveness index(ASDAS,BASDI,BASFI,ASAS,TCM syndrome score),and safety evaluation.2.Network Pharmacology:Obtain the chemical components of Wenshen Juanbi Decoction by searching the TCMSP database and reading related literatures,screening the effective chemical components through swissadme,and using STITCH database to obtain the compound targets of the decoction;by using the DRUGBANK and GENECARDS databases,we could get critical targets,use cytoscape 3.7.2 to screen the core targets of Wenshen Juanbi Decoction of AS;use TRING 11.0 to analyze the interactions between core target,and use metascape to analyze the GO and KEGG enrichment analysis of core targets.Results:1.Clinical research:1.1 Baseline:There was no significant difference in age,gender,schober test,distance between fingers and groud,distance between occiput and wall,thoracic expansion test,scoliosis test,PSQI,ASDAS,BASDI,BASFI,ASAS,TCM syndromes scores(P>0.05).1.2 ASAS40 rate(drug reduction time)and ASAS70 rate:At week 8,The total number of people who reduced biological agents reduction in the experimental group was significantly more than that of the control group(P=0.006),and at week 16,the AS AS 70 rate in the experimental group was significantly higher than that of the control group(P=0.020).1.3 Spinal mobility:The Schober test,distance between fingers and groud,distance between occiput and wall,and the scoliosis test of the two groups all had a significant time effect within 16 weeks(P<0.05),and the thoracic expansion of the experimental group also had more obvious time effect within 16 weeks than the control group(P=0.001,P=0.204);there was no significant difference in physical examination between the two groups at different observation nodes(P>0.05).1.4 PSQI:The PSQI of the two groups had a significant time effect within 16 weeks(P<0.001,P<0.001);the improvement of PSQI in the experimental group at 12 and 16 weeks was significantly better than that in the control group(P=0.001,P=0.002).1.5 ASDAS-CRP,ASDAS-ESR,BASDAI,BASFI:The ASDAS-CRP,ASDAS-ESR,BASDAI,BASFI of the two groups all had a significant time effect within 16 weeks(P<0.001);There was no significant difference between the two groups at different observation nodes(P>0.05).1.6 TCM syndrome scores:The TCM syndrome scores of the two groups of patients all had a significant time effect(P<0.001,P<0.001);The clinical remission rate of the experimental group was significantly higher than that of the control group at 16 weeks,(P=0.026);the improvement of the TCM syndrome scores of the experimental group at 12 and 16 weeks is better than that of the control group(P=0.004,P=0.006).In the control group,the time effect of the scores of ’frequent urination at night’within 16 weeks was not statistically significant(P=0.326),and the time effect of the item scores of the other TCM syndromes in the two groups was statistically significant(P<0.05);The improvement of’waist and knee soreness’,’chills’ at 8 weeks,12 weeks,16 weeks and the improvement of‘frequent night urination’ at 4,8,12,and 16 weeks in the experimental group were better than those in the control group(P<0.05).1.7 safety:There was no significant difference in the safety between the two groups(P=1.000).1.8 celecoxib dosage:There was no significant difference in the celecoxib dosage between the two groups(P=0.3 81).1.9 recurrence rate:There was no significant difference in recurrence rate between the two groups(P=0.112).2.Network pharmacology:The effective ingredients of Wenshen Juanbi Decoction mainly include beta-sitosterol,quercetin,kaempferol,etc.,The core targets of Wenshen Juanbi Decoction-AS included GAPDH,HSPA4,HSPA8,ACTB,EEF2,EEF1 A1,and the signaling pathways are mainly focused on viral carcinogenesis,Pathogenic Escherichia coli infection,proteoglycans in cancer,and neurotrophin.Conclusions:1.Wenshen Juanbi Decoction combined with adalimumab can significantly improve clinical symptoms,improve sleep quality,reduce disease activity,and have good safety in the treatment of AS kidney deficiency and Du channel cold syndrome;also,compared with adamumumab,Wenshen Juanbi Decoction combined with adalimumab achieved ASAS40 faster,achieved more ASAS70,didn’t increase the dosage of celecoxib and the recurrence rate after drug reduction.2.Wenshen Juanbi Decoction may adjust GAPDH,HSPA4,ACTB to affect signal pathways such as viral infection,Pathogenic Escherichia coli infection,proteoglycan and neurotrophin,so the decoction can produce certain clinical effects in the treatment of AS,Pathogenic Escherichia coli infection,proteoglycan and neurotrophin. |
PDF Full Text Request