Connotation analysis and clinical verification of efficacy of Bushen Zhuanggu Fang(补肾壮骨方)against non-traumatic osteonecrosis of the femoral head with syndrome of liver-kidney deficiency
Objective:To investigate the efficacy connotation of Bushen Zhuanggu Fang(补肾壮骨方,BSZGF)in treating non-trauma-tic osteonecrosis of the femoral head(NONFH)with syndrome of liver-kidney deficiency(LKD).Methods:①The network pharmacology-based research.The candidate target genes of BSZGF were screened and collected by retrieving the TCMIP v2.0,ETCM2.0 and HERB da-tabases.The differentially expressed genes(DEGs)related to LKD syndrome of NONFH were extracted from the previous research performed by the project team,and the typical symptom-related genes of LKD syndrome of NONFH were searched in the HPO database by taking the typical symptoms of LKD syndrome of NONFH as keywords.The aforementioned genes were merged as the target gene sets to build the pro-tein-protein interaction(PPI)network of BSZGF against the LKD syndrome of NONFH,from which the key target genes were screened and then subjected to KEGG signaling pathway enrichment analysis,furthermore,the pharmacological actions of the related signaling pathways were analyzed based on the relevant articles.After that,an association network of Chinese herb-key target-signaling pathway-efficacy-phar-macological action-clinical symptom for BSZGF against the LKD syndrome of NONFH was constructed based on the mapping relationships between target genes and signaling pathways as well as between signaling pathways and pharmacological actions,and the reports in the rele-vant articles.②Clinical research.Seventy-seven NONFH patients(120 hips)with LKD syndrome were selected and treated with oral appli-cation of BSZGF for 6 months.After that,the clinical outcomes and radiological outcomes were assessed by using the evaluation criteria for clinical efficacy of femoral head necrosis and the X-ray evaluation system of Beijing University of Chinese Medicine,respectively.Results:①The results of network pharmacology-based research.Five hundred and fifty-six key target genes were screened out from the constructed PPI network of BSZGF against the LKD syndrome of NONFH.The results of KEGG signaling pathway enrichment analysis and the reports of relevant articles suggested that the 556 key target genes participated in 39 LKD syndrome of NONFH-related signaling pathways,mainly in-volved in rectifying the bone metabolism disorder(183 target genes),rectifying the lipid metabolism disorder(176 target genes),rectifying the immune-inflammatory imbalance(171 target genes),and improving the blood circulation obstruction(125 target genes).The established association network diagram of Chinese herb-key target-signaling pathway-efficacy-pharmacological action-clinical symptom intuitively illus-trated the efficacy connotation of BSZGF in treating the LKD syndrome of NONFH.②The results of clinical research.The results of evalu-ation on clinical outcomes showed that the scores for hip pain intensity,hip flexion function,walking distance,and total clinical efficacy all decreased after 6-month treatment compared to pre-treatment(5.86±1.96 vs 2.26±1.84 points,t=25.672,P=0.000;5.76±1.62 vs 3.46±1.68 points,t=38.411,P=0.000;6.31±1.41 vs 0.78±0.74 points,t=46.771,P=0.000;5.92±1.18 vs 2.32±1.06 points,t=48.263,P=0.000).The clinical outcome was excellent in 88 hips,good in 28 hips,fair in 2 hips,and poor in 2 hips.The results of evaluation on radiological outcomes showed that,at 3 years after the treatment,the radiological outcome was excellent in 17 hips,good in 25 hips,fair in 67 hips,and poor in 11 hips;the morphology of the femoral head was stable in 109 hips,and progressed in 11 hips;the necrotic foci was improved in 67 hips,stabilized in 34 hips,and progressed in 19 hips;and the osteoarthritis was stable in 100 hips,and progressed in 20 hips.Conclusion:The BSZGF exerts the effects by rectifying the disorders of bone metabolism and lipid metabolism,rectif-ying the imbalance of immune-inflammation,and improving the obstruction of blood circulation in treatment of NONFH with LKD syndrome,among which rectifying the disorder of bone metabolism may be the most primary mechanism.
femur head necrosisdeficiency of liver and kidneyBushen Zhuanggu Fangnetwork pharmacologyclinical trial
万方数据
维普
