Clinical Trial Of Traditional Chinese Medicine Fumigation In The Treatment Of Axial Spondyloarthritis

Objective: To investigate the clinical efficacy and safety of Traditional Chinese Medicine(TCM)fumigation in the treatment of axial spondyloarthritis.Method: In this prospective clinical study,all the patients with active axial spondyloarthritis in the Department of Rheumatology in The Second Hospital Of Dalian Medical University from January 2014 to December 2014 were included and randomized into 2 groups of the experimental group(n=40)and the control group(n=40),according to the predetermined inclusion and exclusion standards.The patients of the experimental group were treated with Loxoprofen(60mg,tid,per os)+ TCM fumigation,and the control group was given only Loxoprofen(60mg,tid,per os).During this study,all the patients of the both groups were treated with oral administration of Loxoprofen(60mg,tid),which were,Loxoprofen Sodium Tablets(product name: Loxonin)made by Daiichi Sankyo Pharmaceutical(Shanghai)Co.,Ltd(CFDA Registration No.H20030769,Batch No.SN097LA).There were 4 weeks of TCM fumigation treatment(30min/day),with the TCM fumigation device(model:SZ-88 I,product No.20130601)made by Dalian Pengda Medical Devices Co.,Ltd.The major indexes of clinical efficacy included the ratio of patients with ASAS20 and ASAS40 in week 4,8 and 12,and the minor indexes included Bath Ankylosing Spondylitis Disease Activity Index(the BASDAI),the spinal pain VAS,the patient's global assessment(PGA),Bath Ankylosing Spondylitis Function Index(BASFI),erythrocyte sedimentation rate(ESR)and C-reactive protein(CRP).The safety evaluation included: real-time record of the adverse events(AE)happening during the TCM fumigation treatment,the causal analysis on the relationship between the AEs and the TCM fumigation,and the medical examinations of routine blood test,liver biochemical test and renal function test of all patients in week 0,4,8 and 12.Results: 1).In week4,a total of 27 patients(67.5%)in the experimental group and18 patients(45%)in the control group achieved ASAS 20 improvement,with the results of the experimental group significantly better than the control group(P<0.05);and 13patients(32.5%)in the experimental group and 11 patients(27.5%)in the control group achieved ASAS 40 improvement,with the results of the experimental group better than the control group,but this difference was of no statistical significance(P>0.05).In week8 and 12,the differences of the numbers of patients reaching ASAS20 and ASAS40 improvement were not of statistical significance(P>0.05).2).In week 4,the results of BASFI were evidently lower than these of the control group with statistical significance(P<0.05),while the differences of the results of BASDAI,the spinal pain VAS,the PGA,ESR and CRP of the two groups were not statistically significant(P>0.05),and the results of BASFI and ESR were not evidently different.(P>0.05)In week 12,there were no statistically significant differences of the results of BASFI,BASDAI,the spinal pain VAS,the PGA-VAS,ESR and CRP between the two groups.(P>0.05)3).There was no AE happening during the TCM fumigation treatment.In week 8 of the follow-up,1 patient of the experimental group presented slight higher results of transaminases(ALT,AST)(40U/L< transaminases<80U/L),with the difference of no statistical significance compared with the control group.In week 12,all the patients of the two groups had normal results of routine blood test,liver biochemical test and renal function test.Conclusion: TCM fumigation in the treatment of axial spondyloarthritis can provide fast of symptoms and pain,lower the activity of the disease and reduce the inflammation markers with good safety with no SAE.