补肾舒脊颗粒治疗肾虚督寒证强直性脊柱炎的临床疗效及对放射学进展的影响

Clinical efficacy of Bushen Shuji Granules in the treatment of kidney dificiency Du-channel cold syndrome ankylosing spondylitis and its influence on radiological progress

目的:评价中药补肾舒脊颗粒治疗肾虚督寒证强直性脊柱炎(AS)患者的近期疗效及安全性,探讨补肾舒脊颗粒对肾虚督寒证AS患者放射学进展的影响。方法:采用前瞻性随机对照临床试验,将120例肾虚督寒证AS患者随机分组,中药组服用补肾舒脊颗粒,西药组服用塞来昔布胶囊,疗程均为24周,分别于4、12、24周进行疗效评价及安全性指标评价,治疗前和治疗24周时行放射学检查。结果:治疗24周后,两组胸廓活动度、指地距、脊柱痛评分、患者总体评价(PGA)、强直性脊柱炎疾病活动指数(BASDAI)、强直性脊柱炎功能指数(BASFI)、中医证候评分、生活质量评价(ASQoL)、血沉(ESR)、C-反应蛋白(CRP)水平均较治疗前改善(P<0.05,P<0.01),中药组最大踝间距、颈椎活动度较治疗前好转(P<0.05)。治疗24周时,中医组的CRP、脊柱痛评分、中医证候评分与同期西药组相比改善更明显(P<0.05)。治疗12、24周时,中医证候疗效评价中药组总有效率均高于西药组(P<0.05);治疗24周时,中药组达到ASAS20的例数多于西药组(P<0.05)。治疗后两组mSASSS进展评分与基线相比及组间比较均无统计学意义。结论:补肾舒脊颗粒疗效持久、作用平稳、服用方便,具有良好的近期临床疗效及安全性。

Objective:To evaluate the efficacy and safety of Bushe Shuji Granules (BSG) in the treatment of kidney dificiency Du-channel cold syndrome ankylosing spondylitis (AS) patients.To explore the influence of BSG on the injury of centrum structure of the patients with AS.Methods:A prospective randomized controlled clinical trial was carried out in 120 AS patients with kidney dificiency Du-channel cold syndrome (SDDCS),who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsules).Course of treatment was 24 weeks,4,12,24 weeks to evaluate the efficacy and safety indicators respectively,before treatment and 24 weeks for radiological examination.Results:After 24 weeks treatment,the activity of thoracic,finger to floor distance,the spinal pain score,PGA,BASDAI,BASFI,TCM syndrome score,ASQoL,CRP were improved compared with before treatment in both groups (P<0.05,P<0.01),maximum ankle distance and cervical range of motion were improved compared with before treatment in BSG group (P<0.05).After 24 weeks treatment,CRP,spinal pain score and TCM syndrome score were improved more significantly in the BSG group than the control group (P<0.05).After 12 and 24 weeks treatment,the efficacy for Chinese Medicine syndrome in the BSG group was higher than that in the control group (P<0.05).After 24 weeks treatment,ASAS20 standard rate in the BSG group was higher than that in the control group (P<0.05).After treatment,there were no significant differences in mSASSS progress score between the two groups and compared with the baseline.Conclusion:Withing the advantages of lasting effect,stable function and convenient use,BSG has good clinical curative effect and safety in treating AS.