目的 探讨通迪胶囊联合双氯芬酸二乙胺乳胶剂治疗膝关节软组织损伤的临床疗效。方法 选取2019年3月—2021年7月在河南省洛阳正骨医院就诊的68例膝关节软组织损伤患者，按照随机数字表法将全部患者分为对照组和治疗组，每组各有34例。对照组患处根据受损面积涂抹双氯芬酸二乙胺乳胶剂，3次/d。治疗组患者在对照组基础上口服通迪胶囊，6粒/次，3次/d。两组患者连续治疗14 d。观察两组的疗效，比较两组的视觉模拟评分法（VAS）评分、膝关节功能量表（Lysholm）评分、WHO生活质量量表（WHOQOL-BREF）评分以及血清中白细胞介素-6（IL-6）、C-反应蛋白（CRP）水平。结果 治疗后，治疗组的总有效率为94.12%，比对照组总有效率（76.47%）高，差异有统计学意义（P<0.05）。治疗后，两组的VAS评分显著降低，Lysholm评分、WHOQOL-BREF评分显著提高（P<0.05），治疗组VAS评分低于对照组，Lysholm评分、WHOQOL-BREF评分高于对照组（P<0.05）。治疗后，两组的血清IL-6、CRP水平明显减少，差异有统计学意义（P<0.05）；治疗组的IL-6、CRP水平明显低于对照组，差异有统计学意义（P<0.05）。结论 通迪胶囊联合双氯芬酸二乙胺乳胶剂治疗膝关节软组织损伤具有较好的疗效，能减轻疼痛程度，改善患者的关节功能和生活质量，调节炎症因子水平，安全性良好。

Objective To investigate the clinical study of Tongdi Capsules combined with Diclofenac Diethylamine Emulgel in treatment of knee soft tissue injury. Methods Patients (68 cases) with knee soft tissue injury in Luoyang Orthopedic-Traumatological Hospital of Henan Province from March 2019 to July 2021 were randomly divided into control and treatment groups, and each group had 34 cases. Patients in the control group were given administered with Diclofenac Diethylamine Emulgel according to the damaged area, three times daily. Patients in the treatment group were po administered with Tongdi Capsules on the basis of the control group, 6 grains/time, three times daily. Patients in two groups were treated for 14 d. After treatment, the clinical efficacies were evaluated, and VAS scores, Lysholm scores, WHOQOL-BREF scores, and the levels of IL-6 and CRP in two groups were compared. Results After treatment, the total effective rate of the treatment group (94.12%) was higher than that of the control group (76.47%) (P < 0.05). After treatment, the VAS score of two groups were significantly decreased, but the Lysholm scores and WHOQOL-BREF scores of two groups were significantly increased (P < 0.05). The VAS score of the treatment group was lower than that of the control group, but the Lysholm score and WHOQOL-BREF score of the treatment group were higher than those of the control group (P < 0.05). After treatment, the levels of IL-6 and CRP in two groups were significantly decreased (P < 0.05), and the levels of IL-6 and CRP in the treatment group were significantly lower than those in the control group (P < 0.05). Conclusion Tongdi Capsules combined with Diclofenac Diethylamine Emulgel has clinical curative effect in treatment of knee soft tissue injury, can reduce the degree of pain, improve the joint function and quality of life of patients, regulate the level of inflammatory factors, with good safety.

R977

河南省中医药科学研究专项课题（20-21ZY1059）