Clinical Observation And Network Pharmacological Study Of Gusongkang Ointment In Treating Senile Osteoporosis With Kidney-yang Deficiency

Objective:(1)To observe the clinical efficacy and safety of Gusongkang Ointment in the treatment of senile osteoporosis with kidney-yang deficiency.(2)Effective Components and Mechanisms of Gusongkang Ointment Anti-osteoporosis Based on Network Pharmacology.Method:(1)From December 2018 to September 2019,72 patients with osteoporosis due to kidney-yang deficiency were selected from outpatients or inpatients in the second area of bone and spine of Ruikang Hospital affiliated to Guangxi University of Traditional Chinese Medicine and randomly divided into control groups And treatment group,36 cases in each group.The treatment group was given oral calcitriol gum pills + traditional Chinese medicine "Gusongkang" ointment;the control group was given oral calcitriol gum pills + Xianling Gu Bao capsule.The treatment period was 3 months.After the treatment period,statistical analysis and comparison of TCM symptom scores,clinical efficacy of TCM,bone metabolism indexes(blood calcium,bone alkaline phosphatase),and bone mineral density were performed.(2)Screening of the main active ingredients and target targets of Gusongkang Ointment prescription through the Chinese Medicine System Pharmacology Database and Analysis Platform(TCMSP);Screening of osteoporosis disease targets through Gene Cards and OMIM databases;R software Find common targets for drugs and diseases;build a common targetPPI network through the STRING online platform;build a drug-active ingredient-disease-target interaction network through Cytoscape software;apply R code to R Gene function(GO)analysis and Kyoto Encyclopedia of Genes and Genomes(KEGG)enrichment pathway analysis.Results:(1)This clinical observational study showed that both Gusongkang cream and Xianling Guzhen capsule can effectively reduce the TCM symptom score of senile osteoporosis with kidney-yang deficiency syndrome.There is no significant difference between the two(P> 0.05).In terms of clinical efficacy of traditional Chinese medicine,both of them have good treatment effects,the difference is not statistically significant(P> 0.05);in terms of bone metabolism,neither can effectively increase the blood calcium level of patients,the difference is not statistically significant(P> 0.05));Gusongkang Ointment can effectively increase bone alkaline phosphatase levels in patients compared with Xianling Gufu Capsule,the difference is statistically significant(P <0.05);in terms of bone density,neither can improve the lumbar spine of patients in the short term There was no significant difference in bone mineral density(P> 0.05).In terms of safety,no significant liver and kidney damage occurred in the two groups after 3 months of treatment,and there were no significant toxic or side effects.(2)(1)A total of 86 active bioactive components and 935 targets of Gongsongkang Formula prescription were screened out from TCMSP.(2)1026 osteoporosis-related targets were screened from the Gene Cards and OMIM databases,and 63 common targets for Gusongkang drugs and diseases were obtained through the Wayne diagram.These targets mainly include interleukin-6(IL-6),Transcription factor(JUN),protein kinase(AKT1),mitogen-activated protein kinase(MAPK1),estrogen receptor gene(ESR1),etc.(3)GO function enrichment analysis shows that biological processesmainly involve responses to steroid hormones and reactive oxygen species;molecular functions mainly involve nuclear receptor activity,transcription factor activity,steroid hormone receptor activity,and cytokine receptor binding;cell groups It mainly involves extracellular matrix,collagen,nuclear chromatin,etc.;KEGG pathway enrichment analysis,a total of 119 signal pathways were enriched,and the pathways with more genes were mainly AGE-RAGE signal pathway and IL-17 signal pathway.,TNF signaling pathway,estrogen signaling pathway,HIF-1 signaling pathway,relaxin signaling pathway,PI3K-Akt signaling pathway,etc.Conclusions:(1)Gusongkang ointment has good therapeutic effect on senile osteoporosis of kidney-yang deficiency type,and its clinical effect is equivalent to Xianling Gubao capsule after 3 months of treatment,and it can effectively improve the bone alkaline phosphate of patients The enzyme level has the function of promoting the differentiation of osteoblasts,is safe and has no obvious adverse reactions,and can be further clinically applied.In the short term,there was no significant change in the bone mineral density of the two groups of patients.Long-term follow-up is needed to further observe the study.(2)The preliminary verification of this study through the method of network pharmacology showed that Gusongkang ointment has multi-component,multi-target and multi-channel action characteristics in the treatment of osteoporosis,and predicted its possible target and mechanism of action.Provide a theoretical basis for further experimental research.