Retrospective analysis of the clinical efficacy of Wumen Qiteng decoction in the treatment of 100 cases of knee osteoarthritis of damp-heat obstruction type
吴门芪藤汤治疗湿热痹阻型膝骨关节炎100例临床疗效回顾性分析

摘要

目的 基于“人用经验”角度，回顾性分析苏州市中医医院吴门医派研究院资深中医药专家龚正丰教授经验方吴门芪芪藤汤治疗湿热痹阻型膝骨关节炎（Knee Osteoarthritis, KOA）的临床疗效及安全性。方法 选取2021年1月至2025年10月苏州市中医医院收治的200例KOA患者，分为暴露组（吴门芪芪藤汤干预，100例）和非暴露组（西医对症干预，100例），比较两组治疗前后中医证候积分、骨关节炎指数量表（Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC）评分、视觉模拟评分法（Visual Analogue Scale, VAS）疼痛评分、炎症因子白介素-1（Interleukin-1, IL-1）和白介素-6（Interleukin-6, IL-6）、骨关节炎生物标志物软骨寡聚基质蛋白（Cartilage Oligomeric Matrix Protein, COMP）、血清骨钙素（Osteocalcin, BGP）、骨特异性碱性磷酸酶（Bone Alkaline Phosphatase, BLAP）、抗酒石酸酸性磷酸酶5b（Tartrate Resistant Acid Phosphatase-5b, TRAP-5b）及患者关节液基质金属蛋白酶-3（Matrix Metalloproteinase-3, MMP-3）和MMP-13检测水平及临床疗效和安全性。结果 治疗后，暴露组在中医证候积分、WOMAC评分、VAS评分改善方面均优于非暴露组（P<0.05），总有效率暴露组为95.00%，非暴露组为92.00%（P<0.05）。暴露组在降低血清IL-1、IL-6、COMP水平，调节骨代谢标志物（升高BGP、BLAP，降低TRAP-5b），以及抑制关节液MMP-3、MMP-13水平方面均显著优于非暴露组（P<0.05）。两组不良反应发生率无显著差异（暴露组4.00% vs 非暴露组6.00%，P>0.05）。结论 基于真实世界“人用经验”的初步总结，吴门芪藤汤治疗KOA疗效确切，明显缓解KOA患者膝关节疼痛、改善膝关节功能，其作用可能与抑制患者血清炎症因子和关节炎标志物水平相关，具有良好的临床应用价值，也为进一步的高级别临床真实世界研究提供了重要的人用经验部分依据。

Abstract

Objective Based on the perspective of ' human experience ', the clinical efficacy and safety of Wumen Qiteng Decoction, an empirical prescription of Professor Gong Zhengfeng, a senior Chinese medicine expert of Wumen Medical School Research Institute of Suzhou Hospital of Traditional Chinese Medicine, in the treatment of Knee Osteoarthritis (KOA) of damp-heat obstruction type were retrospectively analyzed.
Methods A total of 200 patients with KOA admitted to Suzhou Hospital of Traditional Chinese Medicine from January 2021 to October 2025 were selected and divided into exposure group (Wumen Qiteng Decoction intervention, 100 cases) and non-exposure group (western medicine symptomatic intervention, 100 cases). The TCM syndrome score, Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) score, Visual Analogue Scale ( VAS ) pain score, inflammatory factors interleukin-1 ( IL-1 ) and interleukin-6 ( IL-6 ), osteoarthritis biomarkers Cartilage Oligomeric Matrix Protein ( COMP ), serum osteocalcin ( BGP ), Bone Alkaline Phosphatase ( BLAP ), Tartrate Resistant Acid Phosphatase-5b ( TRAP-5b ) and joint fluid Matrix Metalloproteinase-3 ( MMP-3 ) and MMP-13 detection levels and clinical efficacy and safety were compared between the two groups before and after treatment.
Results After treatment, the improvement of TCM syndrome score, WOMAC score and VAS score in the exposed group was better than that in the non-exposed group (P < 0.05). The total effective rate was 95.00 % in the exposed group and 92.00 % in the non-exposed group (P< 0.05). The exposure group was significantly better than the non-exposure group in reducing serum IL-1, IL-6, COMP levels, regulating bone metabolism markers (increasing BGP and BLAP, reducing TRAP-5b), and inhibiting MMP-3 and MMP-13 levels in synovial fluid (P< 0.05). There was no significant difference in the incidence of adverse reactions between the two groups (4.00 % in the exposed group vs 6.00 % in the non-exposed group, P > 0.05).
Conclusion   Based on the preliminary summary of ' human experience ' in the real world, Wumen Qiteng Decoction is effective in the treatment of KOA, which can significantly relieve knee pain and improve knee function in KOA patients. Its effect may be related to the inhibition of serum inflammatory factors and arthritis markers in patients. It has good clinical application value and provides an important part of human experience for further high-level clinical real world research.