The Clinical Efficacy Of Bushen Shuji Granules In The Treatment Of Ankylosing Spondylitis And The Study On Vertebral Body Structure Damage

Objective:(1)To evaluate the efficacy and safety of Bushe Shuji Granule(BSG)in treating ankylosing spondylitis(AS)patients.(2)To explore the influence of BSG on the injury of centrumstructureof the patients with AS.Methods:A prospective randomized controlled clinical trial was carried out in 64 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 treatment was 24 weeks,respectively4,12,24 weeks to evaluate the efficacy and safety indicators,before treatment and 24 weeks for radiological examination.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),erythrocyte sedimentation rate(ESR)and C-reactive protein(CRP)were observed before and after the treatment.Therapeutic effects were evaluated by ASAS20,ASAS40,ASAS5/6,BASDAI50(set by Assessments in Ankylosing Spondylitis working group,ASAS)and traditional Chinese Medicine Syndrome Evaluation criteria.The modified Stoke AS Spine Score(mSASSS)were evaluated by cervical vertebrae and lumbar vertebrae X-ray films before and 24 weeks of treatment.Safety index included hematuria,liver and kidney function,electrocardiogram.Results:Activity of thoracic,finger to floor distance,the spinal pain score,PGA,BASDAI,TCM syndrome score,ASQoL,CRP were improved compared with before treatment in both groups(P<0.05、P<0.01).In addition,before and after treatment of Chinese medicine group,occiput to wall distance and BASFI were improved compared with before treatment in the BSG group(P<0.05).After 24-weeks treatment,CRP,spinal pain score and ASQoL were improved more significantly in the BSG group than the control group(P<0.05).The efficacy for Chinese Medicine syndrome in the BSG group was 75%higher than that in the control group(50%,P<0.05).ASAS20 standard rate in the BSG group was 71.88%higher than that in the control group(48.88%,P<0.05).ASAS5/6 standard rate in the BSG group was 48.88%higher than that in the control group(18.75%,P<0.05).ASAS40 and BASDAI50 standard rate were no significant difference between the two groups(P>0.05).After treatment,mSASSS progress score was 0.28 + 0.37 of the BSG group and 0.41±0.21 of the control group.There were no significant differences between the groups and compared with the baseline(P>0.05).The incidence of adverse events in the BSG group was lower than that of the control group(6.25%vs18.75%,P>0.05).Conclusions:BSG can effectively control inflammation,improve symptoms,joint function and the quality of life of AS patients.Withing the advantages of lasting effect,stable function and convenient use,it had good clinical curative effect and safety in treating AS.However,no progress was made in mSASSS score by half-year treating.Larger samples and longer periods of randomized controlled studies are needed to further clarify.