Abstract:

Objective　To observe the efficacy of Zhuanggu Chubi pill combined with isokinetic strength training for early-mid knee osteoarthritis (cold-dampness obstructive type). Methods　A total of 120 outpatients with early and mid-stage knee osteoarthritis (cold and dampness obstructive type) were selected from Department of Sports Medicine of Yan'an Traditional Chinese Medicine Hospital from January 2024 to October 2024. Patients were randomly divided into four groups: control group, experimental group A, experimental group B, and experimental group C, with 30 patients in each group. The control group included 15 males and 15 females, aged (55.81±4.96) years; group A included 12 males and 18 females, aged (56.28±5.25) years; group B included 13 males and 17 females, aged (55.70±5.03) years; and group C included 10 males and 20 females, aged (56.15±5.37) years. The control group received celecoxib and functional exercise; group A received celecoxib, functional exercise, and Zhuanggu Chubi pills; group B received celecoxib, functional exercise, and isokinetic strength training; and group C received celecoxib, functional exercise, Zhuanggu Chubi pills, and isokinetic strength training. All groups were treated continuously for 4 weeks and followed up for 12 weeks. Clinical efficacy, traditional Chinese medicine (TCM) symptom grading scores, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, peak torque (PT) and total work (TW) at a quadriceps flexion/extension speed of 60°/s, and safety evaluations were compared among the four groups. Statistical methods included χ² test, rank-sum test, and analysis of variance. Results　The total effective rate in experimental group C was higher than that in the control group [93.33% (28/30) vs. 70.00% (21/30)], with a statistically significant difference (χ²=5.455, P=0.038). After 4 weeks of treatment and 12 weeks of follow-up, the traditional Chinese medicine symptom grading scores decreased in all four groups. The scores for experimental group A [(13.63±3.17) points, (10.13±2.73) points], group B [(12.57±2.77) points, (10.27±2.63) points], and group C [(10.33±2.80) points, (8.37±2.20) points] were all lower than those in the control group [(15.40±3.07) points, (12.07±2.57) points], with group C having the lowest scores (all P<0.05). WOMAC scores also decreased in all groups, with experimental group A [(22.47±7.67) points, (20.17±5.67) points], group B [(23.53±7.97) points, (20.37±5.77) points], and group C [(16.53±5.47) points, (13.30±4.27) points] being lower than the control group [(29.17±9.73) points, (26.13±7.37) points], and group C having the lowest scores (all P<0.05). Peak torque (PT) and total work (TW) increased in all groups, with experimental group C [(72.56±13.77) N·m, (74.86±12.93) N·m and (79.78±8.63) J, (80.83±8.42) J] being higher than the control group [(65.46±12.95) N·m, (66.71±13.06) N·m and (74.48±10.61) J, (75.01±9.54) J] (all P<0.05). During treatment, all four groups experienced mild adverse reactions that were self-limiting, and no significant abnormalities were observed in any indicators during follow-up. Conclusion　Zhuanggu Chubi Pills combined with isokinetic strength training is effective for early-mid knee osteoarthritis (cold-dampness obstructive type), improving knee function, reducing symptoms and pain, enhancing muscle strength, and maintaining advantages during follow-up.

Key words: Knee osteoarthritis,  , cold and dampness obstructive type,  , Zhuanggu Chubi , pills,  , Isokinetic muscle strength training

摘要：

目的　观察壮骨除痹丸联合等速肌力训练治疗早中期寒湿痹阻型膝骨关节炎的疗效。方法　选取2024年1—10月延安市中医院运动医学科收治的早中期寒湿痹阻型膝骨关节炎门诊患者120例，采用随机数表法分为对照组、试验A组、试验B组、试验C组，各30例。对照组男15例、女15例，年龄（55.81±4.96）岁；试验A组男12例、女18例，年龄（56.28±5.25）岁；试验B组男13例、女17例，年龄（55.70±5.03）岁；试验C组男10例、女20例，年龄（56.15±5.37）岁。对照组给予塞来昔布+功能锻炼治疗，试验A组给予塞来昔布+功能锻炼+壮骨除痹丸治疗，试验B组给予塞来昔布+功能锻炼+等速肌力训练，试验C组给予塞来昔布+功能锻炼+壮骨除痹丸+等速肌力训练。4组均连续治疗4周，均随访12周。比较4组临床疗效、中医症状分级量化积分、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分、股四头肌伸屈肌角速度60°/s时峰值力矩（PT）和总功（TW）及安全性评价。统计学方法采用χ²检验、秩和检验、方差分析。结果　试验C组治疗总有效率高于对照组［93.33%（28/30）比70.00%（21/30）］，差异有统计学意义（χ²=5.455，P=0.038）；治疗4周、随访12周后，4组中医症状分级量化积分均降低，试验A组［（13.63±3.17）分、（10.13±2.73）分］、B组［（12.57±2.77）分、（10.27±2.63）分］、C组［（10.33±2.80）分、（8.37±2.20）分］均低于对照组［（15.40±3.07）分、（12.07±2.57）分］，且试验C组最低（均P<0.05）；4组WOMAC评分均降低，试验A组［（22.47±7.67）分、（20.17±5.67）分］、B组［（23.53±7.97）分、（20.37±5.77）分］、C组［（16.53±5.47）分、（13.30±4.27）分］均低于对照组［（29.17±9.73）分、（26.13±7.37）分］，且试验C组最低（均P<0.05）；4组PT和TW均升高，试验C组［（72.56±13.77）N·m、（74.86±12.93）N·m和（79.78±8.63）J、（80.83±8.42）J］均高于对照组［（65.46±12.95）N·m、（66.71±13.06）N·m和（74.48±10.61）J、（75.01±9.54）J］（均P<0.05）。治疗期间，4组患者出现轻微可自行缓解的不良反应，随访期间各项指标均无明显异常。结论　壮骨除痹丸联合等速肌力训练治疗早中期寒湿痹阻型膝骨关节炎患者疗效较高，能在保证安全的前提下提高患者膝功能，改善临床症状，降低疼痛程度，提升肌力，且在随访期间能持续保持优势。

关键词: 膝骨关节炎, 寒湿痹阻型, 壮骨除痹丸, 等速肌力训练