首页|期刊导航|亚太传统医药|骨坏死康复丸治疗股骨头坏死临床疗效研究

骨坏死康复丸治疗股骨头坏死临床疗效研究OA

Clinical Investigation of the Hospital-Prepared Formulation Guhuaisi Kangfu Pill as an Intervention for Osteonecrosis of the Femoral Head

中文摘要英文摘要

目的:探究院内制剂骨坏死康复丸治疗股骨头坏死的临床效果.方法:选取2019年7月-2019年12月郑州某三甲医院收治的84例股骨头坏死患者的临床资料作为实验组,所有患者均接受骨坏死康复丸治疗(口服,3次/d,9g/次,连续24周);随机选取院内检验科体检健康人员84例作为对照组(因实验研究过程中有3例受试者选择退出研究,实际对照组人员为81例).采集对照组、实验组治疗前后的静脉血,进行酶联免疫吸附测定和血液检查,比较分析治疗前后患者血清 OPG、RANK、RANKL指标,血液学指标(血脂、凝血四项)的变化;比较 Harris髋关节功能评分、视觉模拟评分法(VAS)评分的变化;分析年龄段(青年、中年、老年)、病因(激素性、酒精性、创伤性)、中医证型(肝肾亏虚型、湿热蕴结型)不同因素治疗后的疗效差异.结果:与对照组比较,实验组 OPG水平显著降低(P<0.05),RANK水平、RANKL水平和RANKL·OPG-1比值显著增加(P<0.05),血脂代谢和凝血功能异常;治疗后实验组,RANK水平、RANKL水平和RANKL·OPG-1比值显著降低(P<0.05),血脂代谢和凝血功能有所调节;Harris评分显著升高(P<0.05),VAS评分显著降低(P<0.05);中年组RANKL·OPG-1升高幅度显著高于老年组(P<0.05),而老年组LDL、ApoB和APTT显著高于青年组和中年组(P<0.05),表明老年人的影响较大;激素性、酒精性和特发性血液学指标改善明显高于外伤组(P<0.001);RANKL指标湿热蕴结证高于肝肾亏虚(P<0.05);所有患者均未出现不良反应.结论:骨坏死康复丸能够改善骨代谢标志物RANKL、OPG、RANK、血脂代谢、凝血功能等指标的水平,改善髋关节的功能,有效缓解股骨头坏死患者的疼痛症状,且在老年、酒精性病因患者中的疗效更突出,安全性良好.

Objective:To investigate the clinical efficacy of the hospital-prepared formulation Guhuaisi Kangfu Pill(Os-teonecrosis Rehabilitation Pill)in the treatment of osteonecrosis of the femoral head(ONFH).Methods:Clinical data from 84 patients with ONFH admitted to our hospital between July and December 2019 were selected as the experi-mental group.All patients received Guhuaisi Kangfu Pill treatment(9g orally,three times daily for 24 weeks).Eighty-one individuals undergoing routine physical examinations were included as the control group(Three subjects withdrew from the study during the course of the experiment).Venous blood samples were collected from both groups before and after treatment.Enzyme-linked immunosorbent assay(ELISA)and hematological tests were performed to compare se-rum levels of OPG,RANK,RANKL,as well as hematological parameters(lipid profile and coagulation).Changes in Harris Hip Score and Visual Analog Scale(VAS)score were evaluated.Therapeutic efficacy was analyzed across dif-ferent age groups(young,middle-aged,elderly),etiologies(steroid-induced,alcohol-induced,traumatic),and traditional Chinese medicine(TCM)syndrome types(liver-kidney deficiency,damp-heat accumulation).Results:Compared with the control group,the ONFH group showed significantly lower OPG levels(P<0.05),and significantly higher RANK levels,RANKL levels,and RANKL·OPG-1 ratio(P<0.05),along with abnormal lipid metabolism and coagulation function.After treatment,the ONFH group exhibited significantly reduced RANK levels,RANKL levels,and RANKL·OPG-1 ratio(P<0.05),improved lipid metabolism and coagulation function,significantly increased Harris scores(P<0.05),and significantly decreased VAS scores(P<0.05).The middle-aged group showed a significantly greater increase in RANKL·OPG-1 than the elderly group(P<0.05),while the elderly group had significantly higher LDL,ApoB,and APTT levels than the young and middle-aged groups(P<0.05),indicating a more pronounced effect in the elderly.Improvements in hematological indicators were significantly greater in the steroid-induced,alcohol-induced,and idiopathic groups than in the traumatic group(P<0.001).RANKL levels were higher in the damp-heat accumulation syndrome group than in the liver-kidney deficiency syndrome group(P<0.05).No adverse reactions were observed in any patients.Conclusion:Guhuaisi Kangfu Pill can improve the levels of bone metabolism markers(RANKL,OPG,RANK),lipid metabolism,and coagulation function,enhance hip joint function,and effectively alleviate pain in patients with ONFH.The therapeutic effect is more prominent in elderly patients,those with alcohol-induced ONFH,with a fa-vorable safety profile.

田亮玉;贾永涛;赵高亮;贾红政;曹玉举;李文茜

郑州中医骨伤病医院,河南 郑州 450000郑州中医骨伤病医院,河南 郑州 450000郑州中医骨伤病医院,河南 郑州 450000郑州中医骨伤病医院,河南 郑州 450000郑州中医骨伤病医院,河南 郑州 450000郑州中医骨伤病医院,河南 郑州 450000

医药卫生

骨坏死康复丸股骨头坏死临床效果血液指标Harris评分中医证型

Guhuaisi Kangfu PillOsteonecrosis of the Femoral HeadClinical EfficacyBlood ParametersHarris Hip ScoreSyndrome Pattern of Traditional Chinese Medicine

《亚太传统医药》 2026 (4)

59-64,6

郑州市中医药青苗人才培养项目(郑卫中管函[2024]7号)河南省自然科学基金(242300420446)

10.11954/ytctyy.202604011

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