补肾强脊颗粒治疗强直性脊柱炎疗效与安全性评价

Clinical Study on Effect and Safety of Bushen Qiangji Granule in Treating Ankylosing Spondylitis Patients

目的评价补肾强脊颗粒治疗强直性脊柱炎(AS)肾虚血瘀证的疗效与安全性。方法采用随机、对照、单盲前瞻性研究,将68例AS肾虚血瘀证患者随机分为中药组和中西医结合组,中药组予以补肾强脊颗粒治疗,中西医结合组予以补肾强脊颗粒联合柳氮磺胺吡啶(SASP)治疗,连续用药6个月,选取治疗前、治疗1个月、治疗3个月、治疗6个月作为评价时点。结果中药组和中西医结合组总有效率分别为81·82%和86·82%,两组比较差异无显著性,但治疗第1个月,中药组和中西医结合组的总有效率分别为15·15%和27·59%,两组比较差异有显著性(P<0·01);两组患者Bath病情活动指数、Bath功能指数、疼痛、晨僵等临床症状均有明显的改善,Schober试验、胸廓活动度、指地距、ESR、CRP亦有改善;补肾强脊颗粒治疗AS疗效具有明显的时效性,随治疗时间延长,疗效逐渐增强(P<0·05或P<0·01);中西医结合组起效时间早于中药组。结论补肾强脊颗粒治疗AS临床疗效满意,安全性与依从性好,服用方便,具有广阔的应用前景和开发价值。

Objective To evaluate the efficacy and safety of Bushen Qiangji Granule （BQG） in treating ankylosing spondylitis （AS） patients with Sben-deficiency and blood-stasis syndrome. Methods A randomized controlled and single-blinded prospective clinical trial was carried out on 68 patients, who were randomly as- signed into the BQG group treated with BQG alone and the combined treated （CT） group treated with BQG and sulfasalazine, six-month medication was successively applied to both groups. The therapeutic effects were evaluated before treatment and at the end of the 1st, 3rd and 6th month of the treatment. Results The total effective rate was 81.82% in the BQG group and 86.82% in the CT group after 6 months of treatment, showing no significant difference between the two groups, but that after 1 months of treatment in the BQG group was lower than that in the combined group （ 15.15 % vs 27.59 % , P 〈 0.01）. Bath AS disease activity index （BASDAI）, Bath AS function index （BASFI）, and clinical symptoms such as ache and morning stiffness, as well as indexes of Scbober test, activity of thoracic cage, finger-ground distance, erytbrocyte sedimentation rate （ESR） and Creactive protein （CRP） in both groups were improved remarkably. BQG showed a time-dependant effect, the therapeutic effect intensified as the time went by （P〈0.05 or P〈0.01）. Moreover, the effect initiating time was earlier in the CT group than that in the BQG group. Conclusion BQG has satisfactory efficacy, good safety and compliance, and is convenient for administering, therefore, it has broad applying prospect with high exploiting value.