【目的】观察补肾强筋胶囊联合抗阻训练对肾虚血瘀型早中期膝骨关节炎（KOA）患者临床症状、关节功能、生活质量 及下肢肌肉质量的影响，并评价其安全性及临床价值。【方法】选取2025 年2 月至2025 年8 月于广东省第二中医院骨科门诊 就诊的肾虚血瘀型早中期KOA 患者84 例，采用随机数字表法将患者随机分为观察组和对照组，每组各42 例。2 组患者均予 以健康教育、生活方式干预等常规基础治疗，在此基础上，对照组给予抗阻训练治疗，观察组在对照组基础上给予口服补 肾强筋胶囊治疗，2 组疗程均为8 周。观察2 组患者治疗前后疼痛视觉模拟量表（VAS）评分、西安大略与麦克马斯特大学骨关 节炎指数（WOMAC）评分、中文版36 条目简明健康量表（SF-36v2）生理功能评分及下肢肌肉质量的变化情况，并评价2 组患 者的临床疗效及治疗方案的安全性。【结果】（1）疗效方面，治疗8 周后，观察组的总有效率为90.48%（38/42），对照组为 76.19%（32/42）；组间比较（秩和检验），观察组的整体疗效明显优于对照组（P＜0.05）。（2）膝关节疼痛方面，治疗后，2 组患 者的疼痛VAS 评分均较治疗前明显降低（P＜0.01），且观察组的降低幅度明显优于对照组（P＜0.01）。（3）膝关节功能方面，治 疗后，2 组患者的WOMAC 评分均较治疗前明显降低（P＜0.01），且观察组的降低幅度明显优于对照组（P＜0.05）。（4）生活基 本能力方面，治疗后，2 组患者的SF-36v2 生理功能评分均较治疗前明显升高（P＜0.01），且观察组的升高幅度明显优于对照 组（P＜0.05）。（5）下肢肌肉质量方面，治疗后，2 组患者的患侧下肢肌肉质量均较治疗前明显升高（P＜0.01），且观察组的升 高幅度明显优于对照组（P＜0.05）。（6）安全性方面，治疗期间，2 组患者均无明显不良反应发生，且2 组患者在治疗4 周和8 周后 的血常规、相关生化指标及肝功能指标均未见异常。【结论】针对肾虚血瘀型早中期KOA 患者，补肾强筋胶囊联合抗阻训练 能够在缓解疼痛、改善关节功能及生活质量的同时，显著提升下肢肌肉质量，其临床疗效优于单纯抗阻训练，且安全性良 好。说明联合干预方案对肾虚血瘀型早中期KOA 患者具有积极的临床作用。

Objective To observe the effects of Bushen Qiangjin Capsules combined with resistance training on clinical symptoms，joint function，quality of life，and lower limb muscle mass in patients with early-to-mid stage knee osteoarthritis（KOA）of kidney deficiency and blood stasis type，and to evaluate its safety and clinical value. Methods A total of 84 patients with early-to-mid-stage KOA of kidney deficiency and blood stasis type who attended the Orthopedics Outpatient Department of Guangdong Second Traditional Chinese Medicine Hospital from February 2025 to August 2025 were enrolled. A random number table was adopted，and the patients were randomly divided into an observation group and a control group，with 42 cases in each group. Both groups received routine basic treatments including health education and lifestyle intervention. On this basis，the control group was treated with resistance training，while the observation group was treated with oral use of Bushen Qiangjin Capsules in addition to the resistance training. The treatment course for both groups was 8 weeks. The changes in pain Visual Analogue Scale（VAS）score，Western Ontario and McMaster Universities Osteoarthritis Index（WOMAC）score， Chinese version of the 36-Item Short Form Health Survey（SF-36v2）physical function score，and lower limb muscle mass were observed before and after treatment in both groups. The clinical efficacy and safety of the treatment protocols were evaluated. Results（1）Regarding efficacy，after 8 weeks of treatment，the total effective rate was 90.48%（38/42）in the observation group and 76.19%（32/42）in the control group；intergroup comparison（by rank-sum test）showed that the efficacy in the observation group was significantly superior to that in the control group（P＜0.05）.（2）Regarding knee pain，after treatment，the pain VAS scores in both groups were significantly decreased compared with those before treatment（P＜0.01），and the reduction in the observation group was significantly greater than that in the control group（P＜0.01）.（3）Regarding knee function，after treatment，the WOMAC scores in both groups were significantly decreased compared with those before treatment （P＜0.01），and the reduction in the observation group was significantly greater than that in the control group（P＜ 0.05）.（4）Regarding basic living ability，after treatment，the SF-36v2 physical function scores in both groups were significantly increased compared with those before treatment（P＜0.01），and the increase in the observation group was significantly greater than that in the control group（P＜0.05）.（5）Regarding lower limb muscle mass， after treatment，the muscle mass of the affected lower limb in both groups was significantly increased compared with that before treatment（P＜0.01），and the increase in the observation group was significantly greater than that in the control group（P＜0.05）.（6）Regarding safety，during the treatment period，no significant adverse reactions occurred in either group，no abnormalities were observed in blood routine tests，related biochemical indicators，or liver function indicators after 4 and 8 weeks of treatment in both groups，either. Conclusion For patients with early-to-mid-stage KOA of kidney deficiency and blood stasis type，Bushen Qiangjin Capsules combined with resistance training can alleviate pain，improve joint function and quality of life，and also significantly increase lower limb muscle mass. Its clinical efficacy is superior to resistance training alone，with a good safety profile. This indicates that the combined intervention has positive clinical value for these patients.

R274.9

广州市科技局重点研发计划项目（编号：202206010048）；“广东特支计划”省卫生健康委领军人才项目（粤卫人函〔2024〕54 号）； 广州地区中西医协同临床重大创新技术建设项目（穗卫函〔2023〕2318 号）