目的 探讨复方南星止痛膏联合依托考昔治疗寒湿痹阻型膝骨关节炎的临床疗效。方法 选取2022年3月—2024年5月南京中医药大学附属医院收治的80例寒湿痹阻型膝骨关节炎患者，按照随机数字表法分为对照组和治疗组，每组40例。对照组口服依托考昔片，60 mg/次，1次/d。治疗组在对照组的治疗基础上给予复方南星止痛膏，选最痛部位，1贴/次，1次/隔日。两组用药28 d。观察两组临床疗效，比较两组治疗前后骨关节炎指数（WOMAC）评分、视觉模拟疼痛评分（VAS）、12条目简短生命质量评分量表（SF 12）评分、中医症状评分、骨转换标志物和血清炎症因子水平的变化情况。结果 治疗后，治疗组总有效率为95.00%，明显高于对照组的77.50%（P＜0.05）。治疗后，两组患者WOMAC评分、VAS评分明显低于治疗前，而SF-12生活质量评分高于治疗前（P＜0.05）；治疗后，治疗组WOMAC评分、VAS评分低于对照组，SF-12生活质量评分高于对照组（P＜0.05）。治疗后，两组患者关节疼痛、局部肿胀、关节活动度、腰膝酸软、关节重着、遇寒加重和僵硬体评分明显低于治疗前（P＜0.05），且治疗组患者中医症状评分明显低于对照组（P＜0.05）。治疗后，两组患者总I型胶原氨基端延长肽（TPINP）、I型胶原羧基端肽B特殊序列（β-CTX）、骨钙素N端中分子（N-MID）水平明显低于治疗前（P＜0.05）；且治疗组患者TPINP、β-CTX及N-MID水平明显低于对照组（P＜0.05）。治疗后，两组肿瘤坏死因子（TNF-α）、白细胞介素-1（IL-1）、转化生长因子-β（TGF-β1）、基质金属蛋白酶13（MMP13）水平明显低于治疗前（P＜0.05）；且治疗组患者TNF-α、IL-1、TGF-β1及MMP13水平明显低于对照组（P＜0.05）。结论 复方南星止痛膏联合依托考昔治疗寒湿痹阻型膝骨关节炎患者效果明显，能够明显改善患者的关节功能，缓解疼痛，提高患者生活质量，改善骨代谢和降低炎症反应，值得借鉴与应用。

Objective To explore the therapeutic effect of Compound Nanxing Zhitong Ointment combined with etoricoxib in treatment of cold-dampness arthralgia type knee osteoarthritis. Methods A total of 80 patients with cold-dampness arthralgia type knee osteoarthritis admitted to the Affiliated Hospital of Nanjing University of Chinese Medicine from March 2022 to May 2024 were selected and divided into control group and treatment group according to random number table method, with 40 cases in each group. Patients in control group were po administered with Etoricoxib Tablets, 60 mg/time, once daily. Patients in treatment group were given Compound Nanxing Zhitong Ointment on basis of the control group, selected the most painful part, 1 patch/time, 1 time/every other day. Both groups were treated for 28 d. The clinical effects of two groups were observed, and the changes of WOMAC score, VAS score, SF 12 score, TCM symptom score, bone turnover markers and serum inflammatory factors before and after treatment were compared between two groups. Results After treatment, the total effective rate of treatment group was 95.00%, which was significantly higher than that of control group (77.50%, P < 0.05). After treatment, WOMAC scores and VAS scores were significantly lower than before treatment, but SF-12 quality of life scores were higher than that before treatment (P < 0.05). After treatment, WOMAC scores and VAS scores in treatment group were lower than those in control group, and SF-12 quality of life scores were higher than those in control group (P < 0.05). After treatment, the scores of joint pain, local swelling, joint range of motion, waist and knee tenderness, joint heavy, cold aggravation, and stiffness in two groups were significantly lower than those before treatment (P < 0.05), and the scores of TCM symptoms in treatment group were significantly lower than those in control group (P < 0.05). After treatment, the levels of TPINP, β-CTX, and N-MID in two groups were significantly lower than those before treatment (P < 0.05). The levels of TPINP, β-CTX, and N-MID in treatment group were significantly lower than those in control group (P < 0.05). After treatment, the levels of TNF-α, IL-1, TGF-β1, and MMP13 in two groups were significantly lower than those before treatment (P < 0.05). The levels of TNF-α, IL-1, TGF-β1, and MMP13 in treatment group were significantly lower than those in control group (P < 0.05). Conclusion Compound Nanxing Zhitong Ointment combined with etoricoxib has obvious effect in treatment of cold-dampness arthralgia type knee osteoarthritis, and can significantly improve the joint function of patients, relieve pain, improve the life quality and bone metabolism of patients, and reduce inflammatory response, which is worth learning and applying.

R977

江苏省自然科学基金面上项目（BK20181501）