肾气丸对阳虚寒凝型膝关节骨关节炎骨代谢指标的临床研究

Clinical study of the effects of Shenqi Pill on bone metabolism indicators in patients with yang-deficiency and cold-coagulation-type osteoarthritis

摘要:

目的 探讨肾气丸对阳虚寒凝型膝关节骨关节炎（KOA）患者骨代谢异常的临床疗效，并与活性维生素D制剂α-骨化醇进行对照观察。方法 选取2024年1月—2025年10月在重庆市铜梁区中医院确诊的KOA患者100例，并随机分为肾气丸组与α-骨化醇组，各50例，连续治疗3个月。比较两组治疗前后骨代谢指标［骨钙素（BGP）、Ⅰ型前胶原氨基端前肽（PINP）、Ⅰ型胶原交联C端肽（β-CTX）］、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分、膝关节红外皮温及中医证候评分的变化。结果 两组治疗前BGP、PINP及β-CTX水平比较，差异均无统计学意义（P >0.05）。肾气丸组治疗后BGP、PINP水平均高于α-骨化醇组（P <0.05），β-CTX水平低于α-骨化醇组（P <0.05）。肾气丸组治疗前后BGP、PINP及β-CTX水平的差值均大于α-骨化醇组（P <0.05）。两组治疗前WOMAC评分比较，差异无统计学意义（P >0.05）。肾气丸组治疗后WOMAC评分低于α-骨化醇组（P <0.05）。肾气丸组治疗前后WOMAC评分下降幅度大于α-骨化醇组（P <0.05）。两组治疗前膝关节皮温比较，差异无统计学意义（P >0.05）。肾气丸组治疗后膝关节皮温高于α-骨化醇组（P <0.05）。肾气丸组治疗前后皮温的差值大于α-骨化醇组（P <0.05）。两组治疗前中医证候评分比较，差异无统计学意义（P >0.05）。肾气丸组治疗后中医证候评分低于α-骨化醇组（P <0.05）。肾气丸组治疗前后中医证候评分的差值大于α-骨化醇组（P <0.05）。两组不良反应发生率比较，差异无统计学意义（P >0.05）。结论 肾气丸可改善阳虚寒凝型KOA患者骨代谢指标、关节功能及中医证候表现，并在提升局部皮温方面优于α-骨化醇，为中西医结合治疗提供参考。

Abstract:

Objective This study aimed to investigate the clinical efficacy of Shenqi Pill in improving abnormal bone metabolism in patients with knee osteoarthritis (KOA) of the Yang-deficiency and cold-coagulation type, in comparison with the active vitamin D preparation alfacalcidol.Methods A total of 100 patients with knee osteoarthritis diagnosed at Chongqing Tongliang District Hospital of Traditional Chinese Medicine between January 2024 and October 2025 were randomly assigned to the Shenqi Pill group or the alfacalcidol group (n = 50 each) and treated for 3 months. Changes in bone metabolism markers [bone Gla protein (BGP), procollagen type I N-terminal propeptide (PINP), and β-cross-linked C-terminal telopeptide of type I collagen (β-CTX) ], Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, infrared knee skin temperature, and traditional Chinese medicine (TCM) syndrome scores were compared between the groups.Results Before treatment, BGP, PINP, β-CTX, WOMAC score, knee skin temperature, and TCM syndrome score did not differ significantly between the two groups (P > 0.05). After treatment, BGP and PINP levels were higher and β-CTX levels were lower in the Shenqi Pill group than in the alfacalcidol group; the pre-to-post-treatment changes in all three markers were also greater in the Shenqi Pill group (P < 0.05). The WOMAC and TCM syndrome scores were lower and knee skin temperature was higher in the Shenqi Pill group than in the alfacalcidol group; the changes in these measures were also greater in the Shenqi Pill group (P < 0.05). The incidence of adverse reactions did not differ significantly between the groups (P > 0.05).Conclusion Shenqi Pill improves bone metabolism markers, joint function, and TCM syndrome manifestations in patients with knee osteoarthritis of the Yang-deficiency and cold-coagulation type and is superior to alfacalcidol in increasing local skin temperature, providing a reference for integrated traditional Chinese and Western medicine treatment.