Clinical Observation Of Shock Wave Combined With Gushi Capsule In The Treatment Of Early Steroid-induced Osteonecrosis Of The Femoral Head

Steroid-induced femoral head necrosis(SANFH),as a difficult disease,is mostly caused by patients’ long-term use of hormones.It is not easy to be found in the early stage,and the treatment effect in the later stage is poor.In the end,patients can only undergo hip replacement or femoral head replacement,which not only brings great burden to patients’ life,but also reduces their quality of life after operation.At present,there are many theories about the pathogenesis of SANFH,but the pathogenesis is not yet clear.Studies have shown that with the increasing application of hormones in clinic,the incidence of SANFH has increased year by year,ranking first in non-traumatic femoral head necrosis.Therefore,it is one of the main problems faced by doctors at present that the treatment of SANFH should focus on early prevention and cure,and finding effective treatment methods to prevent and cure SANFH in early stage and slow down its progress.The purpose of this study is to provide a clinical prevention and treatment method for early SANFH,and to explore the possible mechanism in the treatment of early SANFH.This clinical study was examined and approved by the Ethics Committee of the first affiliated Hospital of Heilongjiang University of traditional Chinese Medicine(Ethical Review approval No.:HZYLLKT202 1 0470 1).All clinical research processes strictly follow the ethical principles of the Ministry of Health’s measures for Ethical Review of Biomedical Research involving people(2016),the CFDA Code for quality Management of Drug Clinical Trials(2020),the Code for quality Management of Clinical Trials of Medical Devices(2016),the WMA Declaration of Helsinki(2013)and the CIOMS International Ethics Guide for Biomedical Research in Human bodies(2002).The source of funds used in this clinical study:Postdoctoral Research Foundation of Heilongjiang Province(LBH-Q 19182).Objective:1.To explore the clinical efficacy of extracorporeal shock wave combined with bone erosion capsule in the treatment of early SANFH.2.To investigate the effect of this method on the expression of serum Toll-like receptor-4(TLR-4)and Nuclear transcription factor-κB(NF-κB)in early treatment of SANFH.3.The purpose of this study is to explore a safe and reliable method for early prevention and treatment of SANFH,and to provide a reference for clinical delay,control and treatment of SANFHMethods:According to the inclusion and exclusion criteria,75 patients with SANFH from November 2020 to Jaunary 2022 were randomly divided into three groups:drug treatment group(n=25),physiotherapy group(n=25)and comprehensive treatment group(n=25).The drug treatment group was treated with bone erosion capsule,the physical treatment group was treated with simple extracorporeal shock wave therapy,the comprehensive treatment group was treated with bone erosion capsule and extracorporeal shock wave therapy.The patients were treated for 90 days.After treatment,Visual analogue scale(VAS),Harris and the levels of serum TLR-4 and NFκB in the three groups were statistically analyzed.Results:There was no significant difference in age,sex,VAS score,Harris score and serum levels of TLR-4 and NF-κB among the three groups before treatment.After 3 months of treatment,the observation index statistics of the three groups before and after treatment and the comparative statistical analysis between the two groups showed that the symptoms of the three groups were improved after treatment,and the changes of VAS score,Harris score and the levels of TLR-4 and NF-κB in serum were significantly different from those before treatment.After treatment,there was no significant difference in VAS score,Harris score,serum TLR-4 and NF-κB between drug treatment group and physical treatment group.Compared with drug treatment group and physical treatment group,the therapeutic effect of comprehensive treatment group was significantly better than that of drug treatment group and physical treatment group,and the difference was statistically significant(P<0.05).Conclusion:Gushi capsule combined with shock wave therapy is effective in the treatment of early steroid-induced osteonecrosis of the femoral head,which is superior to Gushi capsule alone and shock wave therapy alone.The possible mechanism of this treatment is related to its regulation of the expression of TLR-4 and NF-κB.