目的 观察痹祺胶囊对强直性脊柱炎患者疗效及细胞因子的影响。方法 将120例强直性脊柱炎患者随机分为对照组和治疗组，每组各60例。对照组口服柳氮磺吡啶片，2次/d，4片/次。治疗组口服痹祺胶囊，1.2 g/次，3次/d。4周为1个疗程，两组均连服3个疗程。比较两组的疗效，并观察治疗前后视觉模拟评分（VAS）、Bath强直脊柱炎疾病活动指数（BASDAI）、Bath强直脊柱炎功能指数（BASFI）和Bath强直性脊柱炎计量学指数（BASMI），并采用ELISA法检测白介素-1β（IL-1β）、肿瘤坏死因子-α（TNF-α）、白介素-4（IL-4）、白介素-10（IL-10），仪器法测定血沉（ESR），全自动生化仪分析仪检测超敏C反应蛋白（hs-CRP）。结果 治疗后，治疗组达AS疗效评价标准20%（ASAS20）、BASDAI改善50%（BASDAI50）达标率高于对照组，但差异无统计学意义；治疗后，两组VAS、BASDAI、BASFI、BASMI、ESR、hs-CRP均明显下降，同组治疗前后差异具有统计学意义（P<0.01）；且治疗后治疗组BASDAI和hs-CRP明显低于对照组（P<0.05）。治疗后，两组IL-4、IL-10水平明显升高，TNF-α、IL-1β明显降低，同组治疗前后比较差异具有统计学意义（P<0.01）；且治疗后治疗组IL-10明显高于对照组（P<0.05）。结论 痹祺胶囊对强直性脊柱炎有一定治疗作用，可能与升高抗炎因子，降低致炎因子，调节炎症免疫有关。

Objective To observe the effects of Biqi Capsules on clinical efficacy and cytokines of patients with ankylosing spondylitis. Methods Patients (120 cases) with ankylosing spondylitis were randomly divided into control group and treatment group for 60 cases in each group. Patients in the control group were po administered with Sulfasalazine Tablets, four tablets twice a day. Patients in the treatment group were po administered with Biqi Capsules, 1.2 g for each time, three times daily. Four weeks were a course. Patients in two groups were treated for three courses. After treatment, the clinical efficacy was evaluated, and visual analog scales (VAS), Bath ankylosing spondylitis disease active index (BASDAI), Bath ankylosing spondylitis functional index (BASFI), and Bath ankylosing spondylitis metrological index (BASMI) in two groups before and after treatment were compared. Enzyme linked immunosorbent assay (ELISA) were employed to measure the expression levels of cytokines IL-1β, TNF-α, IL-4, and IL-10. Erythrocyte sedimentation rate (ESR) was detected by instrument method and hs-CRP was detected by automatic biochemical analyzer. Results After treatment, the compliance rate of ASAS20 (20%) and BASDAI50 (50%) in the treatment group was higher than that in the control group, but the difference was not statistically significant. After treatment, VAS, BASDAI, BASFI, BASMI, ESR, and hs-CRP in two groups were significantly decreased, with significantly difference between two groups before and after treatment (P<0.01). And BASDAI and hs-CRP were significantly lower than those in the control group (P<0.05). After treatment, IL-4 and IL-10 were significantly increased, but TNF-α and IL-1β were significantly decreased, with significantly difference between two groups before and after treatment (P<0.01). And IL-10 was significantly higher than that in the control group (P<0.05). Conclusion Biqi Capsules has certain therapeutic effect on ankylosing spondylitis, and it may be associated with increasing anti-inflammatory factors, decreasing inflammatory factors and regulating inflammatory immunity.

R285.64

国家临床重点专科中医风湿病科建设项目（财社[2013]239号）；国家临床重点专科中医适宜技术临床应用开放基金项目（2015ZKJJ003）；安徽省重点实验室建设项目（1306c083035）