补肾通督方治疗强直性脊柱炎临床研究

Clinical Study on Effects of "Bushen Tongdu Decoction" in Treating Ankylosing Spondylitis

目的观察补肾通督方治疗强直性脊柱炎(AS)的临床疗效及其安全性。方法将65例AS患者随机分为治疗组(35例,用补肾通督方治疗)和对照组(30例,用柳氮磺胺吡啶片治疗),连续用药24周;观察治疗前、治疗12周、治疗24周时BathAS病情活动指数、BathAS功能指数、BathAS计量指数及患者总体评价,脊柱疼痛、血沉、C反应蛋白,并评价两组达到ASAS20的患者比例。结果治疗组对上述指标均有显著改善(P<0.05,P<0.01),在12周、24周达到ASAS20分别为51.4%和77.1%;对照组在治疗12周、24周达到ASAS20分别为53.3%和66.7%,两组比较均无显著性差异(P>0.05);但治疗组在24周时达到ASAS20显著高于12周(P<0.05),即随治疗时间延长,疗效逐渐增强。结论补肾通督方治疗AS临床疗效好,安全性高,且具有明显的时效性。

Objective To evaluate the efficacy and safety of ＂Bushen Tongdu Decoction（BTD）＂ in treating ankylosing spondylitis（AS）. Methods A randomized controlled and single-blinded prospective clinical trial was carried out in 65 patients, who were randomly divided into treatment group in which 35 cases were treated with BTD and control group in which 30 cases were treated with Sulfasalazine, with a course of 24 weeks; the Bath AS disease activity index （BASDAI）, Bath AS functional index （BASFI）, Bath AS metrology index（BASMI）, global assessment （BAS-G） and spinal pain, erythrocyte sedimentation rate （ESR） and C-reactive protein （CRP） were measured before treatment and at the end of 12th and 24th weeks of treatment. The proportion of ASAS20 responders was calculated at 12, and 24 weeks. Results BASDA1, BASFI, BASMI, BAS-G, spinal pain, ESR and CRP in treatment group were improved remarkably（P〈0.05, P〈0.01）, the proportion of ASAS20 responders was 51.4% and 77.1% respectively in 12 and 24 weeks in the treatment group and were 53.3% and 66.7% respectively in 12 and 24 weeks in the control group, with no significant differences between the two groups （P〉0.05）, but it was higher in 24 weeks than in 12 weeks in the treatment group （P〈0.05）. The clinical efficacy improved increasingly with treatment courses. Conclusion ＂Bushen Tongdu Decoction＂ has excellent effects and safety on ankylosing spondylitis, with a marked time-dependant relation.