Objective: Objective to evaluate the efficacy and adverse reactions of Bawei Shenqi Pill in the treatment of ankylosing spondylitis of kidney yang deficiency type by observing the symptoms,evaluation index and laboratory index changes of Bawei Shenqi Pill in the treatment of ankylosing spondylitis of kidney yang deficiency type,so as to provide clinical basis for Bawei Shenqi Pill in the treatment of ankylosing spondylitis.Methods: This study used a randomized,double-blind,placebo-controlled clinical trial to collect 80 patients with ankylosing spondylitis who met the inclusion criteria.The patients were randomly divided into Bawei Shenqi Pill combined with western medicine treatment group(Jingfang group)and Bawei Shenqi Pill combined with western medicine treatment group(control group)by SPSS software,the total course of treatment in both groups was 12 weeks.The efficacy of traditional chinese and western medicine,spinal activity,pain VAS score,BASDAI score,BASFI score,inflammatory index,TCM symptom score and quality of life were compared between the two groups.Results:(1)Evaluation of the curative effect of western medicine: The total clinical effective rate of the patients in the prescription group was 60.5%,the total clinical effective rate of the control group was 52.8%,and the curative effect was the same(P>0.05).(2)Evaluation of TCM curative effect: The total effective rate of the two groups was 92.1% in Jingfang group and 36.1% in control group respectively,and the curative effect of Jingfang group was better(P<0.01).(3)Single TCM clinical symptoms:The two groups of patients before and after the treatment of single clinical syndrome score significantly improved(P<0.01),the Jingfang group has more advantages in the pain of back and waist,the stiffness of back,morning stiffness,fatigue,facial color not good and the soreness and weakness of waist and knees(P<0.05).(4)Inflammatory index:The improvement of C reactive protein was obvious before and after treatment(P<0.01),but there was no significant difference between the two groups(P>0.05),and there was no significant difference in erythrocyte sedimentation rate(P>0.05).(5)Joint activity: In group comparison,Pillow wall distance,chest expansion,finger ground distance and Schober test improved before and after treatment(P<0.05).There was no significant difference in occipital wall distance and finger ground distance between the two groups(P>0.05),and the chest dilatation and Schober test group improved significantly compared with the control group(P>0.05).(6)Disease activity and functional evaluation index: Compared with the group,the pain VAS score,BASDAI score and BASFI score of the two groups were significantly improved before and after treatment(P<0.01).The scores of pain VAS,BASDAI and BASFI were better than those of control group(P<0.01).(7)SF-36 scale: Compared with the group,physiological function,physical pain,general health status,energy,social function,health changes and mental health of the Jingfang group were significantly improved(P<0.01).Compared with the control group,the general health status,energy and mental health improved more significantly(P<0.05).(8)Safety index and adverse reaction: 1 case of liver enzyme increased slightly,no special treatment was given,and then the liver function was normal.Conclusion: Bawei Shenqi Pill Combined with meloxicam tablets can improve the TCM curative effect of ankylosing spondylitis of kidney yang deficiency type.2.Bawei Shenqi Pill combined with meloxicam tablets can improve the quality of life of patients with ankylosing spondylitis of kidney yang deficiency type.3.Bawei Shenqi Pill combined with meloxicam tablets has no obvious adverse reactions in the treatment of ankylosing spondylitis of kidney yang deficiency type,so it can be safely used in clinic. |