Clinical Efficacy And The Safety Of BuShen QiangDuZhiWangTang(BST) For Treating Ankylosing Spondylitis(AS)

ObjectiveTo observe the clinical efficacy and the safety of BuShenQiangDuZhiWangTang(BST) for treating ankylosing spondylitis(AS) by which adopted the Angelicae Pubescentis and Loranthi Decoction(APD) as controlled trial.MethodsThe patients that were consistent with AS standard of diagnostic criteria in western medicine and Chinese medicine were divided into BST group and APD group in random. Chinese symptom(including waist-sacro-back ache,backache,arthrocele,fever,lumbar vertebrae limitation of activity,early morning stiffness,joint fever,hypodynamia,waista and knee ache,pricking pain,Dry mouth,yellow urine,limbs weary,muscle and skin dry,emissions and chilly 17 Chinese symptom),BS activity index number,BS function index,overall backache score,backache at night score and overall evaluation (VAS) score were observed and recorded both at after and before treatment time.Statistical methods:The classification data was observed using 2 test and the ranked data by Wilcoxon rank-sum test. T-test or Wilcoxon rank-sum test was applied for group comparison. Matched t-test or Wilcoxon matched-rank-sum test was applied for self-AP:PA comparison. The statistical analysis was used with the software of SPSS17.0.ResultsGeneral investigation data showed that the average of patients'age was 34.1±3.8years old and the course of disease was 4.8±2.5 months. Compared with the curative effect on symptom of Chinese medicine within two groups, it was showed that the clinical recovery rate of the treatment group was 40%, and the excellence rate was 27.5%, the effective rate was 25%, the total effective rate was 92.5%. While in the control group, the clinical recovery rate of the treatment group was 7.5%, and the excellence rate was 17.5%, the effective rate was 35%, the total effective rate was 60%. The total improvement rate of the symptom in Chinese medicine in both two groups were all above at 50%. To the secondary of curative effect index which including BS activity index number,BS function index,overall backache score,backache at night score and overall evaluation (VAS) score, both two groups had significant difference between before and after treatment, which all could decrease the score of the index. In the BST group, there was 7.5 percent of patients had alimentary canal complaint and 2.5 percent of patients had aleucocytosis. There was no abnormal change of liver enzyme. While in the control group, there was 12.5 percent of patients had alimentary canal complaint and 15 percent of patients had aleucocytosis. There was 5% of patients had abnormal change of liver enzyme. The adverse reaction rate of BST group was far lower than which of control group. And the adverse reaction would disappear after stopping medicine.ConelusionThere was significant difference between two groups (P<0.05). The BST group was better than the APD group on the total curative effect of the symptom in Chinese medicine for improving the waist-sacro-back ache,backache,arthrocele,lumbar vertebrae limitation of activity,early morning stiffness,joint cold,pricking pai,Dry mouth and limbs weary (P<0.05). To the secondary of curative effect index which including BS activity index number,BS function index,overall backache score,backache at night score and overall evaluation (VAS) score, both two groups had significant difference between before and after treatment, which all could decrease the score of the index. But the BST group was better than the APD group. The analysis of safety had presented that it had not abnormal change in blood routine test,urine and stool routine test,liver and renal function test and electrocardiogram test. The BST showed that it was safe in the clinical application.