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  • 比较依那西普和塞来昔布单药或联用治疗活动性AS有效及安全性

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核心提示 A multi-center, open label, random clinical tries of etanercept and celecoxib alone/combined treatment in effectiveness
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A multi-center, open label, random clinical tries of etanercept and celecoxib alone/combined treatment in effectiveness and safety of ankylosing spondylitis  

Liudan Tu¹, Minjin Zhao¹,  Zhimin Lin¹, Zhizhong Ye², Qinghong Yu³,Zetao liao¹, Shuangyan Cao¹, JieruoGu¹

1. Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University
2. Department of Rheumatology, Fourth People’s Hospital of Shenzhen City, Xiangmi Lake branch
3.  Department of Rheumatology,ZhuJiang Hospital of Southern Medical University


Objectives: To compare the clinical、radiographic and magnatic resonance imaging change in active ankylosing spondylitis patients with etanercept and celecoxib alone/combined treatment,and to eva1uate the effectiveness and safety on clinical and structural change of AS patients with different treatments after 24 weeks.

Methods: A total of 92 active ankylosing spondylitis patients were included, disease activity was defined as the following three aspects: BASDAI ≥ 4 or ASDAS≥ 2.1;CRP>6 mg/L or ESR 28 mm/1st hour;more than 2 and less than 16 syndesmophyts between cervical spine and lumber spine detected by X-ray. All patients were randomly assigned (1:1:1)to one of the three treatment groups:celecoxib 200mg bid,etanercept 50mg qw and combined therapy for 24 weeks. Disease activity was assessed with BASDAI and ASDAS, ASAS response rate was used for the eva1uation of clinical efficacy. Structural change was detected using the mSASSS and SIJ SSS, and inflammation was assessed by SIJ SPARCC.

Results: A total of 92 active AS patients were included, the average age was 32.02 with mean disease duration of 9 years, the positive rate of HLA-B27 was 94.8%. The average syndesmophyts was 5.61 per patient, mSASSS and SIJ SPARCC score was 8.76 and 15.13 respectively in baseline. Erosion, fat me-taplasia, backfill and ankylosis score of SSS was 3.26, 5.26, 1.09 and 3.26. After completing 24 weeks’ treatment, the ASAS20 response in celecoxib, etanercept and combined group are 69.2%, 71.8% and 88.2% respectively. Of the three groups, 46.1%, 65.6% and 70.6% of patients fulfilled ASAS40 response, and almost half of patients acquired ASDAS major change. The back pain score, BASDAI, BASFI and ASDAS of three different treatment groups decreased as time extend, the combined therapy group obtained most significant change. After 24 weeks, SIJ and spine SPARCC inflammation score decreased sharply, and no statistical difference was found between three groups in four indexes of SSS. Adverse events such as upper respiration infection and slightly elevated ALT were more seen in the combined group and no SAE occurred during the research.

Conclusions
: Etanercept and celecoxib alone/combined treatment were efficacious and safe in improving the symptom and sign of active AS patients, combined therapy group had the best result. The use of etanercept can alleviate inflammation detected by MRI, there were no difference of structural change between the three groups.

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