目的 观察痹祺胶囊联合依那西普注射液治疗强直性脊柱炎的临床疗效。方法 选择2017年7月—2020年6月天津市北辰医院接收的120例强直性脊柱炎患者，根据信封抽签法将患者分为对照组和治疗组，每组各60例。对照组皮下注射依那西普注射液，25 mg/（kg·d），2次/周。治疗组在对照组的基础上口服痹祺胶囊，1.2 g/次，3次/d。两组均连续治疗12周。观察两组的临床疗效，比较两组的症状量表评分、血清因子。结果 治疗后，治疗组的总有效率（85.00%）高于对照组（63.33%）（P<0.05）。治疗后，两组视觉模拟评分法（VAS）、Bath强直性脊柱炎计量学指数（BASMI）、巴氏强直性脊柱炎功能指数评分（BASFI）、巴氏强直性脊柱炎活动指数评分（BASDAI）评分均下降（P<0.05），且治疗组VAS、BASMI、BASFI、BASDAI评分低于对照组（P<0.05）。治疗后，两组血沉（ESR）、超敏C反应蛋白（hs-CRP）、肿瘤坏死因子-α（TNF-α）、白细胞介素-1β（IL-1β）、干扰素-γ（IFN-γ）水平均下降（P<0.05），且治疗组ESR、hs-CRP、TNF-α、IL-1β、IFN-γ水平低于对照组（P<0.05）。结论 痹祺胶囊联合依那西普注射液治疗强直性脊柱炎可有效改善患者临床症状，安全有效，可改善疾病活动指标和血清因子水平，其主要作用机制可能与调节炎症反应有关。

Objective To observe the clinical effect of Biqi Capsules combined with Etanercept Solution for injection in treatment of ankylosing spondylitis. Methods Patients (120 cases) with ankylosing spondylitis in Tianjin Beichen Hospital from July 2017 to June 2020 were randomly divided into control and treatment groups, and each group had 60 cases. Patients in the control group were sc administered with Etanercept Solution for injection, 25 mg/(kg·d), twice weekly. Patients in the treatment group were po administered with Biqi Capsules on the basis of the control group, 1.2 g/time, three times daily. Patients in two groups were treated for 12 weeks. After treatment, the clinical efficacies were evaluated, and the symptom scale score and the serum factor in two groups were compared. Results After treatment, the total effective rate of the treatment group (85.00%) was higher than that of the control group (63.33%) (P<0.05). After treatment, the scores of VAS, BASMI, BASFI, and BASDAI in two groups were decreased (P<0.05), and the scores of VAS, BASMI, BASFI, and BASDAI in the treatment group were lower than those in the control group (P<0.05). After treatment, the levels of ESR, hs-CRP, TNF-α, IL-1β, and IFN-γ in two groups were decreased (P<0.05), and the levels of ESR, hs-CRP, TNF-α, IL-1β, and IFN-γ in the treatment group were lower than those in the control group (P<0.05). Conclusion Biqi Capsules combined with Etanercept Solution for injection can effectively improve the clinical symptoms of patients with ankylosing spondylitis, which is safe and effective. Its main mechanism of action may be related to the regulation of inflammatory response.

R977

天津市滨海新区卫生局科研项目（2014BWKY013）