Objective:By observing the traditional Chinese medicine(TCM)syndrome score,laboratory examination(ESR,CRP),spinal pain VAS score,BASDAI index,BASFI index,ASDAS-CRP before and after treatment,objective evaluation of the clinical efficacy and safety of wenshen jianpi dingji decoction in the treatment of ankylosing spondylitis with kidney deficiency and spleen disease,providing objective basis for the development of new drugs of wenshen jianpi dingji decoction.Methods:According to the method of randomized controlled trial,60 cases of ankylosing spondylitis with kidney deficiency and spleen disease were divided into treatment group and control group,30 cases each.The treatment group was treated with wenshen jianpi dingji decoction,while the control group was treated with celecxib capsule twice a day for 200mg each time.Both groups were treated for 3 months.TCM syndrome score,spinal pain VAS score,BASDAI index,BASFI index,ASDAS-CRP before and after treatment were analyzed to evaluate the efficacy of the two groups,and erythrocyte sedimentation rate,c-reactive protein were detected to understand the control of inflammation level.Blood routine examination and liver and kidney function evaluation were performed before and after treatment to evaluate the safety.Results:1.Group inclusionThere was no significant difference in gender,age,course of disease,TCM syndrome score,BASDAI,BASFI,ASDAS-CRP,spinal VAS score and laboratory index(ESR,CRP)between the two groups(P>0.05),indicating that the two groups were comparable.2.TCM syndrome scoreGroup comparison:two groups of treatment for the sacral,deadlocked of morning of back pain,lumbar spinal restricted movement,before the treatment had significant difference(P<0.01)in lumbar debility,abdominal distension,defecate is not trapped,body weight,limb tired fatigue,the treatment group with significant difference(P<0.01),limbs don't warm before the treatment is also statistically significant(P<0.05),the control group,no significant difference(P>0.05).Comparison between the two groups:there were significant differences between the two groups in the treatment of lumbar spondylosis,abdominal distension,irregular stool and limb fatigue(P<0.01),and there were statistically significant differences in limb fatigue(P<0.05),while there were no statistically significant differences in lumbosacral dorsal pain,lumbar spinal movement limitation,morning stiffness and limb imtemperability(P>0.05).3.ESR and CRPAfter treatment,ESR and CRP in the two groups were significantly lower than before treatment(P<0.01),but there was no significant difference in ESR and CRP between the two groups after treatment(P>0.05).4.BASDAI,BASFI,ASDAS-CRP,spinal VASBASDAI,BASFI,ASDAS-CRP and spinal VAS scores were significantly decreased in both groups after treatment(P<0.01),and there were statistically significant differences between the two groups after treatment(P<0.05).5.Comparison of efficacyThe total effective rates of TCM syndromes in the treatment group and the control group were 90%and 56.67%,respectively,and the overall efficacy of TCM in the treatment group was better than that in the control group(P<0.05).There was a statistical difference in ASAS20 and ASAS40 between the two groups(P<0.01,P<0.05).6.Safety analysisNo serious adverse events occurred in either group during the treatment period.Conclusions:Wenshen jianpi dingji decoction can significantly improve clinical symptoms,signs,and spinal function(BASFI)in patients with ankylosing spondylitis of kidney deficiency and spleen disease.and in reducing inflammation index(ESR,CRP)and disease activity index(BASDAI,ASDAS-CRP)curative effect,good security,speculated that wenshen jianpi dingji decoction may be through anti-inflammatory analgesic,immune regulation,regulating gastrointestinal function and play a role of the overall treatment,worth clinical promotion. |