The Clinical Research On Treatment Of Perimenopausal Syndrome(Syndrome Of Disharmony Between Heart And Kidney) By Qingxin Zishen Prescription And And Network Pharmacology Research

Research purpose:To evaluate the clinical efficacy of Qingxin Zishen Prescription in treating perimenopausal syndrome with syndrome of disharmony between heart and kidney.The LC/Q-TOF-MS technology and network pharmacology methods were established to analyze the specific chemical components,targets and curative effects of Qingxin ZishenPrescription in the prevention and treatment of perimenopausal syndrome.Research method:Clinical study:Select 60 patients who were treated in the gynecological clinic of Jiangsu Provincial Hospital of Traditional Chinese Medicine from January 2020 to December 2020.This patients who met the diagnostic criteria of this study were divided into experimental group and control group according to the principle of randomization,with 30 in each one.The experimental group was taken orally with Qingxin Zishen Prescription,and the control group was taken orally with Kuntai Capsule.The clinical efficacy,Traditional Chinese medicine（TCM）syndrome score and modified Kupperman score,basic serum sex hormones E₂,FSH and LH level changes and safety evaluation were analyzed in the two groups of patients before and after treatment.Network pharmacology study:With the help of LC/Q-TOF-MS technology combined with Peakview data processing platform to quickly analyze and construct the mass spectrum database of the water extra of Qingxin Zishen Prescription,and preliminary identification of the chemical components of Qingxin Zishen Prescription,using network pharmacology methods to identify the effective active ingredients and targets of Qingxin Zishen Prescription and to obtain disease targets related to perimenopausal syndrome,and the intersection of the two to obtain potential targets,using network topology Relationship and signal pathway analysis to determine the effective active components,core targets and mechanism of Qingxin Zishen Prescription for preventing and treating perimenopausal syndrome,and the molecular docking was used to test the bind energy of the effective active components and core targets.Research result:Clinical study:（1）Total clinical effective rate:The total clinical effective rate of the experimental group and the control group were 86.67%and 70.0%,respectively.Comparison between groups:the total clinical effective rate of the experimental group is better than that of the control group（P<0.05）;（2）TCM syndrome scores:Before treatment,the score of the experimental group and the control group were 19.73±4.71 and 19.37±4.31,respectively.After treatment,the score of the experimental group and the control group were 6.80 ± 4.16 and 9.40±4.90,respectively.Intra-group comparison:after treatment,the scores of TCM syndrome of the two groups of patients decreased significantly（P<0.01）.Comparison between groups:after treatment,the scores of TCM syndromes in the experimental group were lower than those in the control group（P<0.05）;（3）Modified Kupperman score:Before treatment,the score of the experimental group and the control group were 28.13±6.21 and 27.50±5.30,respectively.After treatment,the score of the experimental group and the control group were 12.13 ±3.42 and 15.33±4.51,respectively.Intra-group comparison:after treatment,the scores of modified Kupperman of the two groups of patients decreased significantly（P<0.01）.Comparison between groups:after treatment,the scores of modified Kupperman of the experimental group was lower than that in control group（P<0.05）;（4）E2 value:the value of E2 in the experimental group is 24.00±9.78 and the value of E2 in the control group is 25.74± 11.91 before treatment,the value of E2 in the experimental group is 38.43±6.93 and the value of E2 in the control group is 41.61± 13.47 after treatment.Intra-group comparison:after treatment,the value of E2 of the two groups of patients increased significantly（P<0.01）.Comparison between groups:The E2 value of the two groups improved to the same degree after treatment（P>0.05）;（5）FSH value:Before treatment,the value of FSH in the experimental group was 61.82±18.03 and the value of FSH in the control group was 62.75±28.86.the value of FSH in the experimental group was 33.70± 11.20 and the value of FSH in the control group was 43.28±22.98 after treatment.Intra-group comparison:after treatment,the value of FSH of the two groups of patients decreased significantly（P<0.01）.Comparison between groups:after treatment,the value of FSH in the experimental group was lower than that of the control group（P<0.05）;（6）LH value:Before treatment,the value of LH in the experimental group was 34.34±21.10 and the value of LH in the control group was 33.06±21.58,the value of LH in the experimental group was 15.58±8.01 and the value of LH in the control group was 20.59± 10.17 after treatment.Intra-group comparison:after treatment,the value of LH of the two groups of patients decreased significantly（P<0.01）.Comparison between groups:after treatment,the value of LH in the experimental group was lower than the control group（P<0.05）.（7）Safety analysis:There were no obvious adverse events during the treatment of the two groups,and there were no obvious abnormalities in the safety indicators before and after treatment.Network pharmacology study:（1）The LC/Q-TOF-MS technology was established to analyze the chemical compnents of the water extra of Qingxin Zishen Prescription and construct a mass spectrometry database.A total of 83 chemical composition in Qingxin Zishen Prescription were identified by comparison and analysis with standard products,mass spectrometry cracking rules,and literature information;（2）Use database search to obtain the relevant targets of the active components of Qingxin Zishen Prescription and the disease-related targets of perimenopausal syndrome.The intersection of the two will determine the potential targets of this study;（3）Construct a network topology map and Perform pathway enrichment analysis.From the 155 disease-related pathways,19 pathways were screened which have been confirmed Significantly related pathways for the disease including MAPK,PI3K-Akt,TGF-β,Wnt,NF-κB,Toll-like receptors,etc.identified as berberine,epiberberine,palmatine,berberine,liensinine,quercetin and other 23 effective active components,as well as MAPK1,SRC,TP53,MAPK3,AKT1,CASP3 After waiting for 13 key targets,the reliability of network pharmacology predicted targets was verified by molecular docking.Research conclusions:Clinical studies have shown that Qingxin Zishen Prescription is effective for the clinical effectiveness of perimenopausal syndrome with syndrome of disharmony between heart and kidney,has advantages in improving the clinical syndromes of traditional Chinese medicine and serum sex hormone levels,and has no obvious adverse events.Treatment options for patients with perimenopausal syndrome with cardiorenal incompatibility in the onset period.Network pharmacology studies have shown that Qingxin Zishen Prescription has the characteristics of multiple components,multiple targets,and multiple pathways in the prevention and treatment of perimenopausal syndrome.This is consistent with the therapeutic mechanism of Qingxin Zishen Prescription explained by TCM theory,which Provide scientific basis for further research and clinical application promotion of Qingxin Zishen Prescription.