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刘顺超, 石昆, 陈绍华.基于“肝主筋，肾主骨”理论辨证取穴温针灸联合膝痹方治疗膝骨关节炎的临床研究及模型化评价[J].湖南中医药大学学报英文版,2025,45(5):883-890.[Click to copy
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| 基于“肝主筋，肾主骨”理论辨证取穴温针灸联合膝痹方治疗膝骨关节炎的临床研究及模型化评价 |
| 刘顺超,石昆,陈绍华 |
| (上海市长宁区天山中医医院, 上海200051c) |
| 摘要: |
| 目的 探究基于“肝主筋，肾主骨”理论辨证取穴温针灸联合膝痹方治疗膝骨关节炎（KOA）的临床疗效及其对血清炎症因子的影响，并构建药效模型化评价。方法 选取2022年9月至2024年9月上海市长宁区天山中医医院收治KOA患者97例，随机分为对照组（温针灸治疗，n=49）和研究组（温针灸联合膝痹方治疗，n=48），基线资料均衡。比较两组治疗前后西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分、奎森功能演算指数（Lequesne）评分、中医证候积分、血清肿瘤坏死因子-α（TNF-α）、白细胞介素（IL）水平。采用非线性混合效应模型建立温针灸联合膝痹方治疗KOA的时间效应模型，检验模型的拟合效果和参数稳定性，可视化预测评估模型性能。基于最终模型模拟各基线下中医证候积分的典型时间效应曲线。结果 治疗后，研究组WOMAC痊愈率、Lequesne显效率、Lequesne总有效率均高于对照组（P＜0.05）。治疗后，与治疗前相比，对照组神疲乏力评分差异无统计学意义（P＞0.05），研究组神疲乏力评分下降（P＜0.05），两组患者中医证候积分、膝骨关节疼痛、活动受限、腰膝酸软无力、舌红少苔、脉细数评分以及血清TNF-α、IL-1β、IL-6水平均下降（P＜0.05）；且研究组中医证候积分、膝骨关节疼痛、活动受限、腰膝酸软无力、神疲乏力、舌红少苔、脉细数和血清TNF-α、IL-1β、IL-6水平均低于对照组（P＜0.05）。中医证候积分随时间增加而减少，最终达到药效平台，符合经典的Emax模型。逐步筛选协变量后，最终药效模型为Emax,i=15.48+1.35×（Baselinei-27.89）。模型拟合效果较好，参数估算稳健，中医证候积分基线值越高则降幅越大，治疗42 d均降低至8分以下。结论 基于“肝主筋，肾主骨”理论辨证取穴温针灸联合膝痹方可有效降低KOA患者血清炎症因子水平，显著改善患者膝骨关节疼痛、活动受限、腰膝酸软无力、神疲乏力、舌红少苔、脉细数的临床症状。 |
| 关键词: 膝骨关节炎 肝主筋 肾主骨 温针灸 膝痹方 炎症反应 药效模型 |
| DOI：10.3969/j.issn.1674-070X.2025.05.014 |
| Received:April 28, 2025 |
| 基金项目:上海市长宁区卫生健康委员会课题项目（20234z009）。 |
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| Clinical study and model-based evaluation on the treatment of knee osteoarthritis with warm needle moxibustion at selected acupoints from pattern identification based on the theory of "liver governs sinews and kidney governs bones" combined with the Xibi Formula |
| LIU Shunchao, SHI Kun, CHEN Shaohua |
| (Shanghai Changning Tianshan Traditional Chinese Medicine Hospital, Shanghai 200051, China) |
| Abstract: |
| Objective To investigate the clinical efficacy of warm needle moxibustion at selected acupoints from pattern identification based on the theory of "liver governs sinews and kidney governs bones" combined with the Xibi Formula in the treatment of knee osteoarthritis (KOA), as well as its impact on serum inflammatory factors, and to construct a pharmacodynamic model-based evaluation. Methods A total of 97 patients with knee osteoarthritis (KOA) admitted to Shanghai Changning Tianshan Traditional Chinese Medicine Hospital from September 2022 to September 2024 were enrolled in this study. The patients were randomly divided into control group (treated with warm needle moxibustion alone, n=49) and study group (treated with a combination of warm needle moxibustion and the Xibi Formula, n=48), with balanced baseline characteristics between the two groups. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, Lequesne Functional Algorithm Index scores, TCM pattern scores, as well as serum levels of tumor necrosis factor-α (TNF-α) and interleukins (IL), were compared between the two groups before and after treatment. A nonlinear mixed-effects model was utilized to establish a time-effect model for the combined treatment of warm needle moxibustion and Xibi Formula in KOA. The model's goodness-of-fit and parameter stability were evaluated, and its predictive performance was assessed through visualization and analysis. Based on the final model, typical time-effect curves for TCM pattern scores under various baseline conditions were simulated. Results After treatment, the study group exhibited significantly higher cure rates based on the WOMAC scores, marked effectiveness rates, and overall effectiveness rates based on the Lequesne scores compared to the control group (P<0.05). After treatment, compared with the pre-treatment status, there was no statistically significant difference in fatigue and lassitude score in the control group (P＞0.05), while the scores of the study group decreased (P<0.05). Both groups showed significant decreases in TCM pattern scores, as well as scores for knee joint pain, restricted mobility, soreness and weakness of the waist and knees, red tongue with scanty coating, and thready and rapid pulse, along with reduced serum levels of TNF-α, IL-1β, and IL-6 (P<0.05). Moreover, the study group had significantly lower scores for TCM patterns, knee joint pain, restricted mobility, soreness and weakness of the waist and knees, fatigue and lassitude, red tongue with scanty coating, thready and rapid pulse, as well as lower serum levels of TNF-α, IL-1β, and IL-6 compared to the control group (P<0.05). The TCM pattern scores decreased over time and eventually reached a plateau, consistent with the classic Emax model. After stepwise covariate screening, the final pharmacodynamic model was established as. The model demonstrated good goodness-of-fit and robust parameter estimation. A higher baseline value of the TCM pattern scores indicated a greater magnitude of reduction, and after 42 d of treatment, the scores all decreased to below 8 points. Conclusion The treatment of warm needle moxibustion at selected acupoints from pattern identification based on the theory of "liver governs sinews and kidney governs bones" combined with Xibi Formula, can effectively reduce serum inflammatory factor levels in KOA patients and significantly alleviate their clinical symptoms, including knee joint pain, restricted mobility, soreness and weakness of the waist and knees, fatigue and lassitude, red tongue with scanty coating, and thready and rapid pulse. |
| Key words: knee osteoarthritis liver governs sinews kidney governs bones warm needle moxibustion Xibi Formula inflammation response pharmacodynamic model |
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