The Observation Of Clinical Effect Of Qingre Shudu Decoction On Active Ankylosing Spondylitis And The Study Of Its Mechanism

Objective:To evaluate the clinical efficacy and safety of Qingre Shudu Decoction in the treatment of active Ankylosing Spondylitis through clinical randomized controlled trials,and explore its mechanism with detecting serum levels of inflammatory cytokines and bone metabolism-related factors.Methods:75 patients with active AS were randomly divided into 38 patients in the control group and 37 patients in the treatment group.The control group was treated with salazosulfopyridine(SASP)(0.25 g each time and 3 times a day in the first week,0.5g each time and 2 times a day in the second week,0.75 g each time and 2 times a day in the third week,1g each time and 2 times a day since the forth week).The treatment group was based on the treatment of the control group combined with Qingre Shudu Decoction(one dose per day,divided into 2 times orally),with 12 weeks of the course of treatment.Observe the patient’s global assessment,spinal pain score,nocturnal pain score,TCM syndrome score,BASFI,BASDAI,ASDAS score and erythrocyte sedimentation rate(ESR)before and after treatment in two groups of patients.ELISA was used to detect the serum levels of IL-23,IL-17,TNF-ɑ,RANKL,OPG,DKK-1 and SOST.The standard-reaching rates of BASDAI50 and ASAS20 and CM syndrome efficacy were used to evaluate the effectiveness.Results:(1)71 cases,containing 35 cases in the treatment group and 36 cases in the control group,were included finally in this study,with a total of 4 cases of loss(total loss rate of 5.3%).(2)The effective rate of CM syndrome and standard-reaching rates of BASDAI50 and ASAS20 in the treatment group were higher than the control group.(3)Compared before and after treatment,the patient’s global assessment,spinal pain score,nocturnal pain score,TCM syndrome score,BASFI,BASDAI,and ASDAS score of the two groups were significantly improved compared with before treatment.The levels of ESR,IL-23,IL-17,TNF-ɑ,RANKL and the ratio of RANKL/OPG were significantly lower than before treatment.The levels of DKK1 and OPG were significantly higher than before treatment.The SOST level in the treatment group increased,while in the control group not change significantly with an upward trend compared to before treatment.(4)Compared between the two groups after treatment,the decline in CM syndrome score,patient’s global assessment,spinal pain score,nocturnal pain score and ESR,and the improvement of BASFI,BASDAI,and ASDAS score in the treatment group,were significantly better than the control group.(5)Comparison between the two groups after treatment,the reduced levels of TNF-α,IL-23,IL-17,RANKL and ratio of RANKL/OPG,and the increased levels of DKK1 and OPG in the treatment group were more significant than the control group.There was no significant difference between the levels of SOST in two groups after treatment.Conclusion:Qingre Shudu Decoction can effectively alleviate the clinical symptoms and functional status of active AS,reduce inflammation indicators,decrease the disease activity,and improve clinical efficacy.Its mechanism might be to control inflammation by reducing TNF-α levels and down-regulating the IL-23/IL-17 axis,and could induce the expression of DKK1 and SOST,which are Osteogenesis pathway inhibitors,and regulate the RANKL/OPG system to reduce osteoclast activation and delay osteogenesis,through which of two pathways to regulate the state of bone metabolism,and thus may have a delaying effect on bone damage.