六藤安脊汤联合柳氮磺吡啶治疗活动期肾虚瘀阻型强直性脊柱炎临床研究

Clinical Study on Liuteng Anji Decoction(六藤安脊汤)Combined with Sulfasalazine in Treatment of Active Ankylosing Spondylitis with Kidney Deficiency and Blood Stasis Syndrome

目的:观察六藤安脊汤联合柳氮磺吡啶治疗活动期肾虚瘀阻型强直性脊柱炎(AS)的临床疗效与安全性。方法:选择活动期肾虚瘀阻型AS患者66例,随机分为观察组和对照组各33例。观察组患者口服六藤安脊汤和柳氮磺吡啶,对照组患者口服模拟中药汤(焦糖)和柳氮磺吡啶,两组均治疗12周。比较两组患者主要疗效指标、次要疗效指标、西医AS评估工作组(ASAS)疗效、中医证候疗效及不良反应情况。结果:①治疗后,两组主要疗效指标水平较治疗前均明显改善(P<0.05或P<0.01),且观察组Bath强直性脊柱炎病情活动指数、Bath强直性脊柱炎功能指数、脊柱痛评分、夜间痛评分、患者对病情总体评分、中医证候积分均低于对照组(P<0.01)。②治疗后,两组次要疗效指标中的胸廓活动度、脊柱活动度、Schober试验体征、指地距及红细胞沉降率、C反应蛋白(CRP)水平较治疗前均明显改善(P<0.05或P<0.01),且观察组胸廓活动度、脊柱活动度、Schober试验体征、指地距、CRP水平均优于对照组(P<0.05或P<0.01)。③观察组ASAS疗效和中医证候疗效均优于对照组(P<0.05),且观察组未见不良反应。结论:六藤安脊汤联合柳氮磺吡啶治疗活动期肾虚瘀阻型AS疗效确切,安全性较高。

Objective:To observe the clinical efficacy and safety of Liuteng Anji Decoction(六藤安脊汤)combined with sulfasalazine in the treatment of active ankylosing spondylitis(AS)with kidney deficiency and blood stasis syndrome.Methods:A total of 66 patients with active AS with kidney deficiency and blood stasis syndrome were divided into observation group and control group,with 33 cases in each group. The patients in the observation group were treated with oral administration of Liuteng Anji Decoction and sulfasalazine,while the patients in the control group were treated with oral administration of simulated traditional Chinese medicine(TCM) decoction(caramel) and sulfasalazine. Both groups were treated for 12 weeks. The main efficacy indicators,secondary efficacy indicators,curative efficacy evaluated according to relative indicators of AS assessment association(ASAS),curative efficacy on TCM syndrome,and adverse reactions were compared between the two groups. Results:①After treatment,the levels of main efficacy indicators of both the two groups were significantly improved compared with those before treatment(P<0.05 or P<0.01),and the Bath ankylosing spondylitis disease activity index,Bath ankylosing spondylitis function index,spinal pain score,nocturnal pain score,overall score of the disease evaluated by the patients and TCM syndrome score of the observation group were lower than those of the control group(P<0.01). ②After treatment,the thoracic mobility,spinal mobility,Schober test sign,finger-to-floor distance,erythrocyte sedimentation rate and C-reactive protein(CRP) level of both the two groups were significantly improved compared with those before treatment(P<0.05 or P<0.01),and the thoracic mobility,spinal mobility,Schober test sign,finger-to-floor distance and CRP level of the observation group were better than those of the control group(P<0.05 or P<0.01). ③The curative efficacy evaluated according to relative indicators of ASAS and curative efficacy on TCM syndrome of the observation group were better than those of the control group(P<0.05),and there was no adverse reactions in the observation group. Conclusion:Liuteng Anji Decoction combined with sulfasalazine is safe and effective in the treatment of active AS with kidney deficiency and blood stasis syndrome.