补肾壮骨方加减治疗强直性脊柱炎疗效观察

Treatment of Ankylosing Spondylitis by Modified Bushen Zhuanggu Recipe:a Clinical Observation

目的观察补肾壮骨方加减治疗强直性脊柱炎(ankylosing spondylitis,AS)的临床疗效及安全性。方法选择96例2010年5月—2011年5月中日友好医院门诊AS肾虚寒湿证或肾虚湿热证患者,按1∶1随机分中药组及西药组。中药组48例,按证型分为:肾虚寒湿证组(A组,22例,补肾壮骨祛寒汤+西药安慰剂)及肾虚湿热证组(B组,26例,补肾壮骨清化汤+西药安慰剂);西药组48例,按证型分为肾虚寒湿证组(C组,27例,SASP加中药安慰剂)及肾虚湿热证组(D组,21例,SASP+中药安慰剂)。各组均治疗12周。观察治疗前后AS患者总和指数(BAS-G)、AS功能指数(BASFI)、AS疾病活动指数(BASDAI)、脊柱痛、夜间痛、中医证候评分、枕墙距、指地距、胸廓活动度、脊柱活动度、Schober试验、ESR、CRP,以ASAS20、ASAS50、ASAS70、BASDAI50及中医疗效评价标准进行临床疗效评价。结果与本组治疗前比较,各组治疗后BAS-G、BASFI、BASDAI、脊柱痛、夜间痛、中医证候评分、指地距、Schober试验、ESR及CRP均改善(P<0.01,P<0.05),A、C两组治疗后胸廓活动度、脊柱活动度均改善(P<0.01,P<0.05);B组治疗后枕墙距、脊柱活动度均改善(P<0.01,P<0.05)。与C组比较,A组治疗后BAS-G、BASFI、BASDAI、脊柱痛、指地距、胸廓活动度、脊柱活动度、Schober试验、ESR、CRP均改善(P<0.01,P<0.05)。与D组比较,B组治疗后BASFI、BASDAI、脊柱痛、夜间痛、中医证候、指地距、枕墙距、脊柱活动度、Schober试验、ESR改善(P<0.01,P<0.05)。中药组总有效率、ASAS20、ASAS50、ASAS70及BASDAI50高于西药组(P<0.05)。结论运用补肾壮骨方加减治疗AS在改善AS患者的症状、体征、中医证候评分和实验室炎性活动指标方面疗效明显优于SASP。

Objective To observe the clinical effect and safety of modified Bushen Zhuanggu Recipe （BZR） in treating ankylosing spondylitis （AS）. Methods Recruited were 96 AS outpatients of Shen deficiency induced cold-dampness syndrome （SDCDS） or Shen deficiency dampness-heat syndrome （SDDHS） at clinics of China-Japan Friendship Hospital from May 2010 to May 2011. They were randomly assigned to the traditional Chinese medicine （TCM） treatment group and the Western medicine （WM） treatment group in the ratio of 1：1. Those in the TCM treatment group were syndrome typed as the SDCDS group （group A, 22 cases, treated by Bushen Zhuanggu Quhan Decoction ＋WM placebos） and the SDDHS group （group B, 26 cases, treated by Bushen Zhuanggu Qinghua Decoction ＋WM placebos）. Those in the WM treatment group were syndrome typed as SDCDS group （group C, 27 cases, treated by SASP＋TCM placebos） and the SDDHS group （group D, 21 cases, treated by SASP ＋TCM placebos）. Totally 12 weeks consisted of one therapeutic course. BAS-G, BASFI,BASDAI, spine pain, pain at night, TCM symptom score, distance between occipital and wall, distance between finger and ground, thoracic activity, spine activity, Schober test, ESR, CRP were observed as the observing indices ASAS20, ASAS50, ASAS70, BASDAI50, and criteria of TCM were explored for clinical evaluation and safety evaluation. Results In comparison with the same group before treatment,BAS-G,BASFI,BASDAI,spine pain, pain at night, TCM syndrome score, distance between finger and ground,Schober test,ESR, and CRP were improved after treatment （P 〈0.01 ,P 〈0.05）. In group A and C,thoracic activity and spine activity were getting better （P 〈0.01 ,P 〈0.05）. In group B distance between occipital and wall and spine activity were getting better （P 〈0.01 ,P 〈0.05）. In comparison with group C,BAS-G,BASFI,BASDAI,spine pain, distance between finger and ground,thoracic activity,spine activity, Schober test, ESR, CRP were getting better in group A after treatment （P 〈0.01 ,P 〈0.05）. In comparison with group D, BASFI,BASDAI, spine pain, pain at night,distance between finger and ground, distance between occipital and wall, spine activity, Schober test,and ESR were getting better in group B after treatment （P 〈0.01 ,P 〈0.05）. The total effective rate, ASAS20, ASAS50,ASAS70, and BASDAI50 were higher in the TCM treatment group than in the WM treatment group （P 〈 0.05）. Conclusion Modified BZR was more effective than SASP method in relieving clinical symptoms and signs, TCM syndrome scores, and inflammatory activity indi- cators of AS patients.