Study On Bushen Shuji Granules Intervening Related Factors Of Ankylosing Spondylitis Heterotopic Ossification

Objective:(1)To observe the influence of Bushe Shuji Granule(BSG)to DKK-1?SOST and BMP-7,which are closely associated with heterotopic ossification?(2)To evaluate the efficacy and safety of Bushe Shuji Granule(BSG)in treating ankylosing spondylitis(AS)patients.Methods:A prospective randomized controlled clinical trial was carried out in 60 AS patients with Shen dificiency Du-channel cold syndrome(SDDCS),who were randomly assigned to the BSG group(treated with BSG)and the control group(treated with Celecoxib Capsules).Course of the treatment was 12 weeks,we evaluate the efficacy and safety indicators respectively at 4,12weeks.The targets include the level of serum DKK-1?SOST?BMP-7?erythrocyte sedimentation rate(ESR)and C-reactive protein(CRP),the spinal pain score,patient global assessment(PGA),the Bath AS Disease Activity Index(BASDAI),the Bath AS Fundation Index(BASFI),the Bath AS Metrology Index(BASMI),occiput to wall distance,jaw handle distance,finger to floor distance,activity of thoracic,TCM syndrome score,quality of life evaluation(ASQoL).We evaluated the therapeutic effects by ASAS20,ASAS40,ASAS5/6,BASDAI50 and traditional Chinese Medicine Syndrome Evaluation criteria.Safety index included blood and urine routine,liver and kidney functions,EKG.At the same time,we choosed forty healthy people as controls to detect the serum level of DKK-1?SOST and BMP-7.Results:Prior treatment,the serum level of DKK-1?SOST were significantly lower than the controls(P<0.001?P=0.003),while the level of BMP-7 was higher(P<0.001).Prior treatment,there were no statistical difference of the level of DKK-1/SOST/BMP-7 between Chinese and Western medicine group(P>0.05).After treatment of 12weeks,the level of DKK-1 of the BSG group and the control group increase than pre-treatment(P<0.05).The level of SOST in BSG group is higher than pre-treatment,while the level of BMP-7 lower of which(P<0.05).The level of CRP of the BSG group and control group are all decrease than pre-treatment(P<0.05).When treating for 4wekks,the activity of thoracic,PGA,BASDAI and ASQoL were improved compared with pre-treatment in BSG group(P<0.05).Activity of thoracic,PGA,BASFI,BASDAI,ASQoL were improved compared with pre-treatment in both groups(P<0.05?P<0.01).The score for TCM syndrome in the BSG group was lower than pre-treatment(P<0.05).The therapeutic effect of TCM in the BSG group was 70%higher than that in the control group(50%,P<0.05).The BSG group of ASAS20 standard rate was 53.33%higher than that in the control group(36.67%,P<0.05).There was no apparent difference in ASAS5/6?ASAS40?BASDAI50 between the two groups.The rate of incidence of adverse events in the BSG group was lower than that of the control group(3.33%vs6.67%,P>0.05).Conclusions:BSG can improve the level of the factors which are closely associated with heterotopic ossification,such as,raising the level of DKK-1 and SOST which are the inhibitors of the wnt/?-catenin pathway and lessening the level of BMP-7 which can promote osteogenesis.BSG can effectively control inflammation,improve symptoms,sign,joint function and the quality of life of AS patients.