ABSTRACT
Objective:This study aims to investigate the clinical efficacy of modified Anshentang on the treatment of ankylosing spondylitis in early and middle stages with kidney deficiency and cold-governing syndrome and its effect on serum inflammatory factors， immune function， and bone metabolism indexes of patients. Method:In this study， 120 patients were randomly divided into control group and observation group， 60 cases in each group. On the basis of ethotrexate treatment， patients in control group took Bushen Shuji granule orally， while patients in observation group took modified Anshentang orally for 8 weeks. Before and after treatment， patients in two groups were observed for clinical symptoms ［ bath ankylosing spondylitis patient global score （BAS-G）， bath ankylosing spondylitis disease activity index （BASDAI）， spondyloarthritis research consortium of Canada （SPARCC）， traditional Chinese medicine symptoms （TCM symptoms）<italic> </italic>］， serum inflammatory factors ［ tumor necrosis factor-<italic>α </italic>（TNF-<italic>α</italic>）， macrophage migration inhibitory factor （MIF）， interleukin-23 （IL-23）］， immune function ［ immunoglobulin A（IgA）， immunoglobulin G（IgG）， immunoglobulin M（IgM）］， bone metabolic indicators ［osteocalcin （BGP）， bone morphogenetic protein-2 （BMP-2）， bonespecific alkaline phosphatase （BALP）］. The clinical efficacy， adverse reactions and recurrence rates of 12 months in two groups were observed. Result:During the study， 4 cases dropped out from control group and 2 cases from observation group. The total effective rate of 96.55% （56/58） in observation group was higher than 80.36% （45/56） in control group （<italic>χ</italic><sup>2</sup>=4.827，<italic>P</italic><0.05）. The recurrence rate of 5.17% （3/58） in observation group was lower than 19.64% （11/56） in control group （<italic>χ</italic><sup>2</sup>=5.187， <italic>P</italic><0.05）. Compare with control group after treatment， BAS-G，BASDAI， SPARCC， TCM symptoms， TNF-<italic>α</italic>， MIF and IL-23 in observation group were significantly decreased （<italic>P</italic><0.05）， while BGP， BMP-2， BALP， IgA， IgG and IgM were significantly increased （<italic>P</italic><0.05）. The incidence of adverse reactions was 12.07%（7/58） in observation group， which was lower than 32.14%（18/56） in control group （<italic>χ</italic><sup>2</sup>=4.826，<italic>P</italic><0.05）. Conclusion:Modified Anshentang is effective in the treatment of ankylosing spondylitis in early and middle stages with kidney deficiency and cold-governing syndrome， and the incidence of adverse reactions is low.