目的 探討羅浮山風濕膏藥聯合硫酸氨基葡萄糖治療風寒濕痹型膝骨關節(jié)炎臨床療效。方法 選擇中國中醫(yī)科學院廣安門醫(yī)院2021年9月—2022年5月收治的膝骨關節(jié)炎（風寒濕痹型）患者122例，依照隨機數字表法分為對照組、試驗組，每組61例，對照組采用硫酸氨基葡萄糖，試驗組聯合羅浮山風濕膏藥治療，比較兩組臨床療效，比較兩組治療前后中醫(yī)證候積分，病情嚴重程度［骨關節(jié)炎指數（WOMAC）］、膝關節(jié)功能［Lysholm膝關節(jié)評分表（LKSS）］、生活質量［日常生活活動能力（ADL）］，骨代謝指標［骨鈣素（BGP）、骨保護素（OPG）、血清I型膠原交聯C末端肽（CTX-I）、CTX-II］，疼痛相關介質［血清P物質（SP）、前列腺素E₂（PGE₂）、5-羥色胺（5-HT）］，炎癥因子水平［白細胞介素-1β（IL-1β）、白細胞介素-6（IL-6）、腫瘤壞死因子-α（TNF-α）、C反應蛋白（CRP）］，并統(tǒng)計不良反應發(fā)生率。結果 兩組的總有效率相比，試驗組更高（P＜0.05）。治療前兩組中醫(yī)證候積分，病情嚴重程度、骨代謝指標、疼痛相關介質、炎癥因子水平比較差異均無統(tǒng)計學意義（P＞0.05）。治療后，兩組患者中醫(yī)證候各項積分均較本組治療前顯著降低（P＜0.05），且治療后試驗組顯著低于對照組（P＜0.05）。治療后，兩組WOMAC評分均較本組治療前顯著降低（P＜0.05），兩組LKSS、ADL評分均較本組治療前顯著升高（P＜0.05），且試驗組WOMAC評分較對照組低，LKSS、ADL評分較對照組高（P＜0.05）；兩組骨代謝指標組間比較差異無統(tǒng)計學意義（P＞0.05）；兩組疼痛相關介質SP、PGE₂、5-HT均較本組治療前顯著降低（P＜0.05），且試驗組SP、PGE2、5-HT水平顯著低于對照組（P＜0.05）；兩組疼痛相關介質SP、PGE₂、5-HT均較本組治療前顯著降低（P＜0.05），且試驗組SP、PGE₂、5-HT水平顯著低于對照組（P＜0.05）；兩組炎癥因子IL-1β、IL-6、TNF-α、CRP水平均較本組治療前顯著降低（P＜0.05），且試驗組IL-1β、IL-6、TNF-α、CRP水平均較對照組低（P＜0.05）；試驗組疼痛緩解時間、疼痛消失時間以及關節(jié)活動度復常時間均短于對照組（P＜0.05）。兩組不良反應發(fā)生率無統(tǒng)計學意義（P＞0.05）。結論 羅浮山風濕膏藥聯合硫酸氨基葡萄糖治療風寒濕痹型膝骨關節(jié)炎患者的效果明顯，可減輕病情、改善膝關節(jié)功能、提高生活質量，還可減少疼痛介質，減輕炎癥反應，且安全性高。

Objective To explore the clinical efficacy of Luofushan Fengshi Gao combined with glucosamine sulfate in the treatment of knee osteoarthritis with wind cold dampness type. Method A total of 122 patients with knee osteoarthritis (wind cold dampness bi type) admitted to Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine from September 2021 to May 2022 were selected. They were randomly divided into a control group and an experimental group, with 61 cases in each group. The control group was treated with glucosamine sulfate, while the experimental group was treated with Luofushan Fengshi Gao. The clinical efficacy of the two groups was compared, and the TCM syndrome scores before and after treatment were compared between the two groups, severity of the condition [McMaster University (WOMAC)], knee function [Lysholm Knee Score (LKSS)], quality of life [Activity of Daily Living (ADL)], bone metabolism indicators [BGP, OPG, CTX-I, CTX-II], pain related mediators [serum substance P (SP), prostaglandin E2 (PGE₂), serotonin (5-HT)], Inflammatory cytokine levels [interleukin-1β (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor- α (TNF- α), C-reactive protein (CRP) ] and the incidence of adverse reactions were calculated. Results The total effective rate of the two groups was higher in the experimental group (P < 0.05). There was no statistically significant difference in the scores of traditional Chinese medicine syndromes, severity of the condition, bone metabolism indicators, pain related mediators, and levels of inflammatory factors between the two groups before treatment (p > 0.05). After treatment, the TCM syndrome scores of both groups of patients were significantly reduced compared to before treatment (P < 0.05), and the experimental group was significantly lower than the control group after treatment (P < 0.05). After treatment, the WOMAC scores of both groups were significantly reduced compared to before treatment in same group (P < 0.05), while the LKSS and ADL scores of both groups were significantly increased compared to before treatment in same group (P < 0.05). Moreover, the WOMAC scores of the experimental group were lower than those of the control group, while the LKSS and ADL scores were higher than those of the control group (P < 0.05). There was no statistically significant difference in bone metabolism indicators between the two groups (p > 0.05), pain related mediators SP, PGE₂, and 5-HT in both groups were significantly reduced compared to before treatment in same group (P < 0.05), and the levels of SP, PGE₂, and 5-HT in the experimental group were significantly lower than those in the control group (P < 0.05). Two groups of inflammatory cytokine IL-1 β, IL-6, TNF-α, CRP levels were significantly reduced compared to before treatment in same group (P < 0.05), and IL-1β, IL-6, TNF-α, and CRP levels in the experimental group were also significantly reduced than those of the control group (P < 0.05). The time for pain relief, pain disappearance, and joint range of motion normalization in the experimental group were all shorter than those in the control group (P < 0.05). The incidence of adverse reactions in both groups was not statistically significant (p > 0.05). Conclusion The combination of Luofushan Fengshi Gao and glucosamine sulfate has a significant effect on the treatment of patients with wind cold dampness type knee osteoarthritis. It can alleviate the condition, improve knee joint function, improve quality of life, reduce pain mediators, alleviate inflammatory reactions, and has high safety.

R982