罗浮山风湿膏药联合硫酸氨基葡萄糖治疗风寒湿痹型膝骨关节炎临床观察

目的 探讨罗浮山风湿膏药联合硫酸氨基葡萄糖治疗风寒湿痹型膝骨关节炎临床疗效。方法 选择中国中医科学院广安门医院2021年9月—2022年5月收治的膝骨关节炎（风寒湿痹型）患者122例，依照随机数字表法分为对照组、试验组，每组61例，对照组采用硫酸氨基葡萄糖，试验组联合罗浮山风湿膏药治疗，比较两组临床疗效，比较两组治疗前后中医证候积分，病情严重程度［骨关节炎指数（WOMAC）］、膝关节功能［Lysholm膝关节评分表（LKSS）］、生活质量［日常生活活动能力（ADL）］，骨代谢指标［骨钙素（BGP）、骨保护素（OPG）、血清I型胶原交联C末端肽（CTX-I）、CTX-II］，疼痛相关介质［血清P物质（SP）、前列腺素E₂（PGE₂）、5-羟色胺（5-HT）］，炎症因子水平［白细胞介素-1β（IL-1β）、白细胞介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）、C反应蛋白（CRP）］，并统计不良反应发生率。结果 两组的总有效率相比，试验组更高（P＜0.05）。治疗前两组中医证候积分，病情严重程度、骨代谢指标、疼痛相关介质、炎症因子水平比较差异均无统计学意义（P＞0.05）。治疗后，两组患者中医证候各项积分均较本组治疗前显著降低（P＜0.05），且治疗后试验组显著低于对照组（P＜0.05）。治疗后，两组WOMAC评分均较本组治疗前显著降低（P＜0.05），两组LKSS、ADL评分均较本组治疗前显著升高（P＜0.05），且试验组WOMAC评分较对照组低，LKSS、ADL评分较对照组高（P＜0.05）；两组骨代谢指标组间比较差异无统计学意义（P＞0.05）；两组疼痛相关介质SP、PGE₂、5-HT均较本组治疗前显著降低（P＜0.05），且试验组SP、PGE2、5-HT水平显著低于对照组（P＜0.05）；两组疼痛相关介质SP、PGE₂、5-HT均较本组治疗前显著降低（P＜0.05），且试验组SP、PGE₂、5-HT水平显著低于对照组（P＜0.05）；两组炎症因子IL-1β、IL-6、TNF-α、CRP水平均较本组治疗前显著降低（P＜0.05），且试验组IL-1β、IL-6、TNF-α、CRP水平均较对照组低（P＜0.05）；试验组疼痛缓解时间、疼痛消失时间以及关节活动度复常时间均短于对照组（P＜0.05）。两组不良反应发生率无统计学意义（P＞0.05）。结论 罗浮山风湿膏药联合硫酸氨基葡萄糖治疗风寒湿痹型膝骨关节炎患者的效果明显，可减轻病情、改善膝关节功能、提高生活质量，还可减少疼痛介质，减轻炎症反应，且安全性高。

Clinical observation of Luofushan Fengshi Gao combined with glucosamine sulfate in treating knee osteoarthritis of wind cold and damp bi type

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.