Clinical curative effcet observation on Bushen Qiangdu Formula combined with Secukinumab in ankylosing spondylitis with kidney vacuity and Du channel-cold syndrome
Objective:To observe the clinical efficacy of Bushen Qiangdu Formula combined with Secukinumab in ankylosing spondylitis(AS)patients with kidney vacuity and Du channel-cold syndrome.Methods:Thirty-six AS patients with kidney vacuity and Du channel-cold syndrome were enrolled.All patients have treated with Bushen Qiangdu Formula and subcutaneous injections of Secukinumab for 16 weeks.Efficacy and safety evaluations were conducted at the 4th and 16th weeks.The primary endpoint was the proportion of patients with at least 20％improvement in the assessment of ASAS5/6 response criteria at week 16.Spondyloarthritis International Society(ASAS20),ASAS40,TCM syndrome score,spinal pain score,PGA,BASDAI,BASFI,BASMI,ESR,CRP,ASDAS-CRP,SPARCC score of sacroiliac joint and whole spine MRI were used as the secondary efficacy indicators.Blood,urine,stool routine,liver and kidney function and electrocardiogram were used as safety indicators.Results:After 16 weeks treatment,among the total of 36 patients,ASAS5/6 response rate was 58.33％(21/36),ASAS20 and ASAS40 response rates were 72.22％(26/30),and 52.78％(19/36)respectively.After 16 weeks treatment,the total efficacy rate of TCMSS in 36 patients was 88.89％(32/36).Compared with before treatment,significant reductions were seen in BASFI,spinal pain score,PGA,BASDAI,ESR,CRP,ASDAS-CRP at the 4th week or 16th week(P＜0.05).Compared with before treatment,SPARCC SI joint scores and SPARCC spine scores decreased after 16 weeks of continuous treatment(P＜0.05).Conclusion:The efficacy of Bushen Qiangdu Formula combined with Secukinumab in AS patients was confirmed,accompanied by reduced inflammatory conditions in the SI joint and the spine,also improvement in clinical symptoms and signs.
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