Clinical Study Of Terygium Wilfordii In Active Ankylosing Spondylitis

Objective:(1) To evaluate the efficacy of terygium wilfordii in ankylosing spondylitis (AS) of 12 weeks. (2) To evaluate the safety of terygium wilfordii in ankylosing spondylitis (AS) of 12 weeks..Methods:This was an open-labeled,1 center, phase I clinical trial. Patients eligible for this study were to be adults with a diagnosis of definite AS, as defined by the 1984 Modified New York Criteria. Active disease at the time of screening was a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score≥4 and a visual analogue scale (VAS) score for spinal pain of≥4, each on a scale of 0 to 12. terygium wilfordii 20 mg, 3/d was taken orally. To analyses parameters predicting the clinical response to terygium wilfordii in AS at weeks 0,2,6,12.Rusults:1.Efficacy Results:At week 12,42.11% of patients reached the primary end point of ASAS20. The percent of patients reaching the secondary endpoints of ASAS40 and BASDAI50 were 31.58% and 26.26% respectively. The improvements at week 12 of BASDAI, BASFI, ESR/CRP were statistically significant. There was no statistical difference in the improvement of BASMI and chest expansion (P>0.05).2.Safety Results:10(45.45%) patients reported 23 treatment related adverse events, the most frequently occurring were gastrointestinal tract reaction. The secondary occuring was abnormal liver enzyme levels. There were no serious adverse events. Most treatment-related adverse events were mild to moderate in severity。Conclusions:1. This study confirms the surely efficacy of terygium wilfordii in Active AS.2. Terygium wilfordii was safe and well tolerated, with no changes in the overall patterns.