目的 探讨正清风痛宁注射液局部封闭联合依那西普注射液治疗强直性脊柱炎患者的临床疗效。方法 纳入2023年1月—2024年12月武汉市中医医院收治的60例强直性脊柱炎患者，经随机数字表法将其分为对照组和治疗组，各30例。对照组皮下注射依那西普注射液，25 mg/次，2次/周。治疗组在对照组治疗基础上给予正清风痛宁注射液局部封闭，单次最大注射量≤3 mL，每日总剂量≤100 mg。两组均连续治疗12周。观察两组的治疗效果，对比两组炎症因子、视觉模拟评分法（VAS）、Bath强直性脊柱炎计量学指数（BASMI）、Bath强直性脊柱炎功能指数（BASFI）、Bath强直性脊柱炎疾病活动指数（BASDAI）。结果 治疗后，治疗组总有效率是93.33%，显著高于对照组的60.00%（P＜0.05）。治疗后，两组血清肿瘤坏死因子α（TNF-α）、γ-干扰素（IFN-γ）、超敏C反应蛋白（hs-CRP）较同组治疗前显著降低（P＜0.05）；治疗后，治疗组血清TNF-α、IFN-γ、hs-CRP水平均低于对照组（P＜0.05）。治疗后，两组VAS评分、BASMI评分、BASFI评分、BASDAI评分均较同组治疗前显著降低（P＜0.05）；治疗后，与对照组比较，治疗组VAS评分、BASMI评分、BASFI评分、BASDAI评分均更低（P＜0.05）。结论 正清风痛宁注射液局部封闭联合依那西普注射液治疗强直性脊柱炎患者利于提高治疗效果，纠正炎症状态，改善疼痛程度，增强脊柱相关功能，且安全性尚可。

Objective To explore the effect of Zhengqing Fengtongning Injection combined with etanercept in treatment of ankylosing spondylitis. Methods A total of 60 patients with ankylosing spondylitis who were admitted to Wuhan Hospital of Traditional Chinese Medicine from January 2023 to December 2024 were included. They were divided into control group and treatment group using a random number table, with 30 cases in each group. Patients in control group were given subcutaneous injection of Etanercept Solution for injection at a dose of 25 mg each time, twice weekly. Patients in treatment group were given local block with Zhengqing Fengtonging Injection on basis of control group, with the maximum single injection volume not exceeding 3 mL and the total daily dose not exceeding 100 mg. Both groups were treated continuously for 12 weeks. The therapeutic effects of two groups were observed, and the inflammatory factors, Visual Analogue Scale (VAS), Bath Ankylosing Spondylitis Metrics Index (BASMI), Bath Ankylosing Spondylitis Functional Index (BASFI), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of two groups were compared. Results After treatment, the total effective rate of the treatment group was 93.33%, significantly higher than that of control group (60.00%), (P < 0.05). After treatment, the serum levels of tumor necrosis factor α (TNF-α), γ-interferon (IFN-γ), and high-sensitivity C-reactive protein (hs-CRP) in both groups were significantly lower than those before treatment in the same group (P < 0.05). After treatment, the serum levels of TNF-α, IFN-γ, and hs-CRP in treatment group were all lower than those in control group (P < 0.05). After treatment, the VAS scores, BASMI scores, BASFI scores, and BASDAI scores of both groups were significantly lower than those before treatment in the same group (P < 0.05). After treatment, compared with control group, the VAS scores, BASMI scores, BASFI scores, and BASDAI scores of treatment group were all lower (P < 0.05). Conclusion The combination of Zhengqingfeng Tongning Injection for local block and Etanercept Solution for injection in treatment of patients with ankylosing spondylitis is beneficial for improving the therapeutic effect, correcting the inflammatory state, alleviating the pain level, enhancing the spinal-related functions, and the safety is acceptable.

R982

湖北中医药管理局中医药科研项目（ZY2025M061）