A Retrospective Observation In Efficacy, Safety And Pharmacoeconomic Of Low Dose Glucocorticoids In The Treatment Of Ankylosing Spondylitis

?Background?Ankylosing spondylitis(AS)is a chronic and progressive inflammatory diseases,usually involves the axial joints,peripheral joints and extra-articular organs.AS can cause disability in the late stage.Studies have shown that inflammatory factors play an important role in the pathogenesis of ankylosing spondylitis.At present,there is no radical method for AS.Control disease symptom and inflammation by non-steroidal anti-inflammatory drugs and/or biological disease-modifying antirheumatic drugs(b DMARDs)are the key treatment targets in AS according to ASAS/EULAR guidelines recommend.Glucocorticoid(GC)have been shown to be effective in reducing the inflammation,but their use is not recommended by Assessment of Spondyloarthritis International Society(ASAS)/European League Against Rheumatism(EULAR),which recommend NSAIDs as the first line treatment trategy in AS.A few studies shown that the use of low-dose GC does not bring about significant side effects,but the study about efficacy of low-dose GC in patients with AS is still rare.Therefore,the aim of this study was to assess the efficacy,safety and pharmacoeconomic of low-dose GC by retrospective observing the condition of before and after treatment in patients with AS.?Objective?To assess the efficacy,safety and pharmacoeconomic of low-dose GC in the treatment of ankylosing spondylitis ?Method?The present study was a retrospective and non-inferiority study.The patients with ankylosing spondylitis who were treated in Peking University Shenzhen Hospital from December 7,2004 to December 7,2013 were recruited in our study.All patients were fulfilled the 1984 revised New York Criterion of Ankylosing Spondylitis.According to whether glucocorticoids were used or not,patients were distributed into GC group and control group.GC group were given 10 mg Prednisone or 8mg Medrol after breakfast and NSAIDs after dinner,control group were only given NSAIDs after breakfast and dinner.All patients were also treated with sulfasalazine and anti-osteoporosis treatment.The data of ESR,hs-CRP,BASFI scores,BASDAI scores,ASDAS-ESR scores,ASDAS-CRP scores,ASAS20 and ASAS40 after treatment 0,3,6,9,and 12 months were studied.At the same time,the therapic adverse reactions and yearly cost-effectiveness of two groups were observed respectively.?Results?(1)245 patients with ankylosing spondylitis were recruited.145 patients treated by GC was distributed to studied group(GC group),while 100 patients treated only NSAIDs but no GC was distributed to control group.There was no significant difference between two groups in the data of age,disease duration,sex ratio,ESR,hs-CRP,BASFI score,BASDAI score,ASDAS-ESR score and ASDAS-CRP score in the baseline(p>0.05).After treatment,all two groups had significantly improvement in ESR,hs-CRP,BASFI score,BASDAI score,ASDAS-ESR score,and ASDAS-CRP score(p<0.05).(2)Compared with the control group,the data of ESR,hs-CRP,BASDAI score,ASDAS-ECR score,and ASDAS-CRP score of GC group after three months treated was more significantly improved(p<0.05).However,the data of the GC group included ESR,hs-CRP,BASFI score,BASDAI score,ASDAS-ESR score,ASDAS-CRP score had no significant difference with the control group after 6th month treated(p>0.05).(3)The most common adverse drug reactions in low-dose GC treatment group were upper abdominal discomfort,followed by infection,elevated blood sugar,acne,high blood pressure,and oral ulcers.The adverse drug reactions in NSAIDs treatment group were epigastric discomfort and infection.Most drug-related adverse reactions in both groups were mild and the symptoms could be relieved spontaneously or after symptomatic treatment.(4)The rate of ASAS20 at each stage(3thmonth,6thmonth,9thmonth and 12thmonth)in GC group were 74.48%,77.24%,79.31%,and 81.37% respectively,while that rate of control were72%,75%,82%,and 76% respectively.The rate of ASAS40 at each stage in GC groups were: 53.79%,54.48%,58.62% and 54.48% respectively,while that of control group were 55%,57%,61% and 56% respectively.There was no significantly difference between the two groups(p>0.05).A one-year cost-effectiveness analysis was performed on the yuan per year,and the cost of the control group was 6,946.59 yuan per year.Taking ASAS20 as an indicator of efficacy,the GC group effect was 81.37%,the cost-effectiveness ratio was 7280.85.the control group effect was 76%,and the cost-effectiveness ratio was 9123.49.Taking ASAS40 as an indicator of efficacy,the GC group effect was 54.48%,and the cost-effectiveness ratio was 10874.50.The control group effect was 56% and the cost-effectiveness ratio was 12394.09.Both results suggest that the cost-effect of low-dose GC treatment group was advantageous than control group.?Conclusions?(1)Compared with treatment of NSAIDs,short-term use of low-dose GC could relieve symptoms and disease activity more quickly in patients with ankylosing spondylitis.(2)There was not significantly difference in the improvement of symptoms and disease activity scores of the AS patients between the low-dose GC treatment group and the NSAIDs treatment group.(3)There was not significantly difference in efficacy after 6th months therapy between the low-dose GC treatment group and the NSAIDs treatment group.It was suggested that the optimal duration of treatment with low-dose of GC should be less than 6th months.(4)There was no serious adverse drug reaction found in low-dose GC treatment group.(5)The cost-effect of low-dose GC treatment group was advantageous than NSAIDs treatment group.