亚太传统医药2026，Vol.22Issue(4)：59-64,6.DOI:10.11954/ytctyy.202604011
骨坏死康复丸治疗股骨头坏死临床疗效研究
Clinical Investigation of the Hospital-Prepared Formulation Guhuaisi Kangfu Pill as an Intervention for Osteonecrosis of the Femoral Head
摘要
Abstract
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.关键词
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Key words
Guhuaisi Kangfu Pill/Osteonecrosis of the Femoral Head/Clinical Efficacy/Blood Parameters/Harris Hip Score/Syndrome Pattern of Traditional Chinese Medicine分类
医药卫生引用本文复制引用
田亮玉,贾永涛,赵高亮,贾红政,曹玉举,李文茜..骨坏死康复丸治疗股骨头坏死临床疗效研究[J].亚太传统医药,2026,22(4):59-64,6.基金项目
郑州市中医药青苗人才培养项目(郑卫中管函[2024]7号) （郑卫中管函[2024]7号）
河南省自然科学基金(242300420446) （242300420446）
