Efficacy And Safety Of Bushen Tongluo Decoction Combinaed With Celecoxib Capsule In Patients With Ankylosing Spondylitis:A 12-weeks Randomized Single Blinded Clinical Observation

Objective:To observe the efficacy and safety of Bushen Tongluo Decoction combinaed with Celecoxib Capsule in patients with ankylosing spondylitis.Methods:Sixty in or outpatients with ankylosing spondylitis from the first Affiliated Hospital of TCM of GZU from June the 2015 to Dec the 2015, conforming to the diagnostic criteria, was randomly divided into the therapeutic group and the controlled group according to the SAS table of random numbers. Thirty cases in the control group received Celecoxib Caspule 0.2g twice a day, while the other thirty cases in the observation group received Celecoxib Caspule 0.2g per day, in combination with the Bushen Tongluo Decotion 250ml per day(included: Tuckahoe 30g, Fructu 20g, moutan 15g, rhizoma alismatis 30g,Yam 15g, cassia twig 10g, radices rehmanniae 20g, radix angelicae 10g, Tinospora sinensis 30g, lignum et folium trachelospermi 30g, scorpio 8g, Angelica dahurica Benthl5g).A course of either group costs 4 weeks and the observation lasts 12 weeks. The Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), the Bath Ankylosing Spondylitis Fuctional Index(BASFI),the Joint Axis Pain VAS score, the Patient Global Evaluation of VAS score, the Ankylosing Spondylitis Disease Activity Score depending on CRP(ASDAS-CRP) and the TCM symptom score were evaluated and compared in and between the groups in the 4th,8th and 12th week.Objection:1. The age, gender, acute phase reactants (CRP, ESR), BASDAI, BASFI, the Joint Axis Pain VAS score, the Patient Global Evaluation of VAS score, ASDAS-CRP, CRP, ESR of all the patients in both group before the observation.2. in the 4th,8th and 12th week of the treatment the acute phase reactants(CRP, ESR), BASDAI, BASFI, the Joint Axis Pain VAS score, the Patient Global Evaluation of VAS score, ASDAS-CRP of patients were compared between the two groups;and all the indexes above would be compared with the baseline in one group.3. The clinical chemistry measurements such as the hemanalysis, creatinine, urea, AST, ALT between the controlled and the therapeutic groups were evaluated and compared before and after the whole treatment, and the adverce reactions would be marked and compared between two groups after the treatment.Evaluation Criteria:The International Ankylosing Spondylitis Evaluation Team Recommended Standard ASAS20,50 reaction scheme for ankylosing spondylitis.The ASAS20 and ASAS50 responders between the control group and observation group would be compared.Results:After the 12 weeks observation, the acute phase reactants (CRP, ESR), BASDAI, BASFI, the Joint Axis Pain VAS score, the Patient Global Evaluation of VAS score, ASDAS-CRP of both grougs were declined significantly, compared with the baseline. Especially in the 8th and 12th week, all the indexes in the observation group had a more dramatic change than those in the control group (K0.01), and the therapeutic group showed the more stable and sustained effection on the patients. Compared with the controlled group, the therapeutic group had a dramtic decrease in the TCM symptom score, which recommended the Bushen Tongluo Decoction benifited the improvement in the overall symptom and the quality of life, as well as the anti-inflammatory and acesodyne.In the 12th week the ASAS20 responders were 80% in the observation group while 43.4% in the control group,which showed a significant variation (P<0.01). But the ASAS 50 responders and the activity score of AS showed no difference in two groups(P>0.05). The other clinical laboratory assessments such as hemanalysis, creatinine, urea, AST, ALT were shown no significantly difference between two groups before and after the treatment(P>0.05). And no drug adverce reactions appeared.Conclusion:Bushen Tongluo decotion in combination with Celecoxib Capsule showed prominent effect compared with the pure NSAIDs and was well tolerance and safe.