中医辨证治疗强直性脊柱炎的临床疗效评价

Clinical Effect Analysis of Ankylosing Spondylitis Treated by Chinese Medical Syndrome Differentiation

目的评价中药补肾强脊汤和清热强脊汤治疗强直性脊柱炎(ankylosing spondylitis,AS)的疗效及安全性。方法采用分层区组随机、阳性药、平行对照、优效性、多中心临床试验,将354例活动期肾虚瘀阻证和湿热瘀阻证AS患者随机分入中药组和西药组,中药组采取辨证论治,分别予补肾强脊汤和清热强脊汤加减,西药组予柳氮磺吡啶肠溶片口服,疗程24周,采用国际强直性脊柱炎评价(asessments in ankylosing spondylitis,ASAS)工作组制定的ASAS20标准、中医证候疗效评价标准,以及Bath强直性脊柱炎病情活动指数(BASDAI)、Bath强直性脊柱炎功能指数(BASFI)、Bath强直性脊柱炎测量学指数(BASMI)、脊柱痛评分、夜间痛评分、病人总体评价(PGA)、实验室指标C反应蛋白(CRP)及血沉(ESR)综合评价中医辨证治疗AS的临床疗效。结果补肾强脊汤和清热强脊汤治疗AS患者24周后,ASAS20的达标率为86.75%,中医证候疗效总有效率为85.47%,能够显著降低患者的中医证候积分、BASDAI、BASFI、BASMI、脊柱痛评分、夜间痛评分和PGA,与西药组比较,差异均有统计学意义(P<0.01)。结论以补肾活血、清热利湿活血立法处方的补肾强脊汤和清热强脊汤治疗AS有一定效果。

Objective To evaluate the curative effect and safety of Bushen Qiangji Decoction （BQD） and Qingre Qiangji Decoction （QQD） in treating ankylosing spondylitis （AS） patients, and to verify the clinical utility of AS syndrome differentiation and treatment scheme [ Shen-deficiency induced stasis obstruction syndrome （SDISOS） and dampness-heat obstruction syndrome （DHOS） being two basic syndrome types, Shen invigorating blood activating method （SIBAM） and heat clearing dampness resolving method （HCDRM） being two basic treatment methods l. Methods Totally 354 AS patients of SDISOS and DHOS were randomly assigned to the treatment group and the control group using a multi-center randomized, positive drug parallel-controlled clinical trail. Patients in treatment group were treated by BQD or QQD according to syndrome typing, while those in the control group took Sulfasalazine enteric- coated tablet （SECT）, 24 weeks as one therapeutic course. After treatment, the clinical efficacy was e- valuated by using ASAS20 standard （set by Asessment in Ankylosing Spondylitis working group）, Chi- nese medical efficacy evaluation standards, and BASDAI, BASFI, BASMI, night-pain index, spinal pain index, PGA, C-reactive protein （CRP）, and erythrocyte sedimentation rate （ESR）. Results After 24 weeks of treatment by BQD or QQD, ASAS20 standard rate was 86.75% in the treatment group, and the total effective rate of Chinese medical syndrome was 85.47%. They could significantly reduce patients＇ integrals of Chinese medical syndrome, BASDAI, BASFI, BASMI, night-pain index, spinal pain index, and PGA （all P 〈0.01 ）. Conclusions QQD and BQD got confirmable clinical effects in treating AS, providing strong evidence of evidence-based medicine for syndrome differentiation and treatment of AS.