通经蠲痹胶囊治疗肝肾亏虚型膝关节骨性关节炎的临床疗效及对膝关节功能与骨代谢的影响

Clinical Efficacy of Tongjing Juanbi Capsules in the Treatment of Knee Osteoarthritis of the Liver-Kidney Deficiency Pattern and Their Effects on Knee Joint Function and Bone Metabolism

摘要

目的 分析通经蠲痹胶囊治疗肝肾亏虚型膝关节骨性关节炎（knee osteoarthritis，KOA）的疗效及对患者膝关节功能与骨代谢指标的影响。方法 选取秦皇岛市中医医院于2021年1月至2024年6月收治的216例肝肾亏虚型KOA患者，以随机数字表法分组，对照组（n=108）予以硫酸氨基葡萄糖胶囊与美洛昔康治疗，研究组（n=108）在对照组治疗方案基础上联用通经蠲痹胶囊治疗，对比2组临床疗效、中医证候积分、疼痛程度、膝关节功能、骨代谢指标及不良反应发生情况。结果 研究组总有效率较对照组更高（94.44% vs85.19%）（P＜0.05）；研究组治疗1个月后、3个月后Lysholm膝关节评分较同组治疗前及对照组均更高，中医证候积分、西安大略和麦克马斯特大学骨关节炎指数（Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC）、Lequesne指数评分较同组治疗前及对照组均更低（P＜0.05）；研究组治疗1个月后、2个月后、3个月后视觉模拟评分法（Visual Analogue Scale，VAS）评分较同组治疗前及对照组均更低（P＜0.05）；研究组治疗1个月后、3个月后骨保护素（osteoprotegerin，OPG）、骨钙素（osteocalcin，OC）水平较同组治疗前及对照组均更高，Ⅰ型胶原交联C-端肽（C-terminal cross-linked telopeptide of type I collagen，CTX-Ⅰ）水平较同组治疗前及对照组均更低（P＜0.05）；2组不良反应的发生率差异无统计学意义（P＞0.05）。结论 联用通经蠲痹胶囊治疗肝肾亏虚型KOA可明显提高临床总有效率，促进膝关节功能改善，减轻患者疼痛，改善骨代谢，且安全性良好。

Abstract

Objective To analyze the clinical efficacy of Tongjing Juanbi Capsules in the treatment of knee osteoarthritis (KOA) of the Liver-Kidney Deficiency Pattern and to investigate their effects on knee joint function and bone metabolism markers. Methods A total of 216 KOA patients with Liver-Kidney Deficiency Pattern admitted to Qinhuangdao Hospital of Traditional Chinese Medicine from January 2021 to June 2024 were enrolled. They were randomly divided into two groups, using a random number table. The control group (n=108) received glucosamine sulfate capsules and meloxicam, while the intervention group (n=108) received Tongjing Juanbi Capsules in addition to the same treatment. Clinical efficacy, traditional Chinese medicine (TCM) syndrome scores, pain intensity, knee joint function, bone metabolism markers, and adverse reactions were compared between the two groups. Results The total effective rate was significantly higher in the intervention group than in the control group (94.44% vs85.19%, P＜0.05). At 1 and 3 months of treatment, the intervention group showed higher Lysholm knee scores and lower TCM syndrome scores, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, and Lequesne index scores compared with both baseline values in the same group and those in the control group (P＜0.05). At 1, 2, and 3 months of treatment, the Visual Analogue Scale (VAS) score in the intervention group was lower than that before treatment in the same group and that in the control group (P＜0.05). At 1 and 3 months, the intervention group exhibited higher levels of osteoprotegerin (OPG) and osteocalcin (OC), and lower levels of C-terminal cross-linked telopeptide of type I collagen (CTX-I), compared with both baseline values in the same group and those in the control group (P＜0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P＞0.05). Conclusion Tongjing Juanbi Capsules can significantly increase the total clinical effective rate, improve knee joint function, alleviate pain, improve bone metabolism, and exhibit a favorable safety profile in the KOA patients with Liver-Kidney Deficiency Pattern.

关键词

通经蠲痹胶囊 / 膝关节骨性关节炎 / 肝肾亏虚型 / 膝关节功能 / 骨代谢

Key words

Tongjing Juanbi Capsule / knee osteoarthritis / Liver-Kidney Deficiency Pattern / knee joint function / bone metabolism

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基金资助

秦皇岛市重点研发计划科技支撑项目(202301A057)