目的 探讨尪痹胶囊联合玻璃酸钠治疗踝关节创伤性关节炎的临床疗效。方法 选择2021年10月—2022年4月海南省中医院收治的90例踝关节创伤性关节炎患者，按照数字随机法分为对照组和治疗组，每组各45例。对照组关节囊内注射玻璃酸钠注射液，20 mg/次，1次/周。在对照组的基础上，治疗组口服尪痹胶囊，5粒/次，3次/d。两组治疗12周。观察两组患者临床疗效，比较治疗前后两组患者临床症状缓解时间，视觉模拟评分法（VAS）和Mcguire踝关节功能评分，血清肿瘤坏死因子-α（TNF-α）、干扰素诱生蛋白-10（IP-10）、白细胞介素-1β（IL-1β）和白细胞介素-6（IL-6）水平，及不良反应。结果 治疗后，治疗组患者临床有效率为97.78%，明显高于对照组有效率（82.22%，P＜0.05）。治疗后，治疗组症状缓解时间均早于对照组（P＜0.05）。治疗后，两组VAS评分明显低于治疗前，而Mcguire踝关节功能评分明显高于治疗前（P＜0.05），且治疗组评分明显好于对照组（P＜0.05）。治疗后，两组患者血清炎性因子IL-1β、IL-6、IP-10、TNF-α水平较治疗前明显降低（P＜0.05），且治疗组明显均低于对照组（P＜0.05）。治疗后，治疗组不良反应总发生率为8.89%，明显低于对照组（15.56%，P＜0.05）。结论 尪痹胶囊联合玻璃酸钠注射液治疗踝关节创伤性关节炎效果确切，能有效缓解踝关节功能，有效减弱关节炎性反应，促进疼痛状态好转，且安全可靠。

Objective To investigate the effect of Wangbi Capsules combined with intra-articular injection of sodium hyaluronate in treatment of traumatic arthritis of ankle joint. Methods Patients (90 cases) with traumatic arthritis of ankle joint in Hainan Traditional Chinese Medicine Hospital from October 2021 to April 2022 were divided into control and treatment group by the random number table method, and each group had 45 cases. Patients in the control group was intra-articular injection administered with Sodium Hyaluronate Injection, 20 mg/time, once weekly. Patients in the treatment group were po administered with Wangbi Capsules on the basis of the control group, 5 grains/time, three times daily. Patients in two groups were treated for 12 weeks. After treatment, the clinical evaluation was evaluated, and the symptom relief time, the scores of VAS and McGuire ankle function, the levels of serum factor IL-1β, IL-6, IP-10 and TNF-α, and adverse reaction in two groups before and after treatment were compared. Results After treatment, the clinical effective rate of the treatment group was 97.78%, which was significantly higher than that of the control group (82.22%, P < 0.05). After treatment, the time of symptom relief in the treatment group was earlier than that in the control group (P < 0.05). After treatment, the VAS score in two groups was significantly lower than that before treatment, while the Mcguire ankle function score was significantly higher than that before treatment (P < 0.05), and the scores of the treatment group were significantly better than that of the control group (P < 0.05). After treatment, the levels of serum inflammatory factors IL-1β, IL-6, IP-10, and TNF-α in two groups were significantly lower than those before treatment (P < 0.05), and which in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, the total incidence of adverse reactions in the treatment group was 8.89%, which was significantly lower than that in the control group (15.56%, P < 0.05). Conclusion Wangbi Capsules combined with intra-articular injection of sodium hyaluronate have definite therapeutic effect in treatment of traumatic arthritis of ankle joint, can effectively relieve the ankle function, effectively weaken the joint inflammatory reaction, and promote the improvement of pain state, and which is safe and reliable.

R977

海南省临床医学中心建设项目（21A200188）