| Objective:Based on data mining technology,this study analyzes the drug use characteristics of Professor Wu Quansheng’s treatment of perimenopausal syndrome,summarizes the core drugs,and summarizes the common patterns.On this basis,network pharmacology was applied to predict the possible mechanisms of action and targets of core drugs on the drug group,aiming to provide new ideas for clinical drug using and lay the scientific foundation for experimental and drug mechanism research.We also set up a clinical control trial to verify the clinical efficacy of core prescriptions for the treatment of this disease.Method:1.The clinical cases of Prof.Wu Quansheng in the treatment of perimenopausal syndrome were collected,and the data set was established by using SPSS Statistics 22.0 and IBM SPSS Modeler 18.Statistical methods were used to analyze the characteristics of medication patterns,to derive the core drugs of TCM for perimenopausal syndrome,and to analyze the clinical experience.2.Based on the data mining results,we established"Huang Lian,Ban Xia,Fu Ling,Hovenia and Hou Pu"as the core drug pair for the treatment of PMS,and used them to predict their possible targets and mechanisms of action based on the network pharmacology.Based on the TCMSP,we searched the active ingredients of Huang Lian,Ban Xia,Fu Ling,Hovenia,Hou Pu and their corresponding targets,and used Genecards and OMIM databases to search the disease targets of menopausal syndrome.We also used Genecards and OMIM databases to search for"perimenopausal syndrome"disease targets,and to identify"drug-disease"common targets,and explored the possible molecular biological mechanisms of action of the core drugs for PMS treatment through PPI analysis,GO functional enrichment analysis,and KEGG signaling pathway analysis.3.According to the instructor’s clinical experience,the core drugs were added and subtracted to form a new prescription named"Qing Xin Ping Liver Formula",and clinical observation was conducted 120 patients who met the criteria for nadir were randomly divided into a control group of 60 cases of Anjin Yi(estradiol drospirenone tablets)and a treatment group("Qing Xin Ping Liver Formula"combined with Anjingyi)in 60 cases,to observe the changes of FSH,LH,E2levels,the improvement of total TCM evidence score,Kupperman score,MENQOL score,PSQI score,HAMA score,the difference of TCM evidence efficiency,the recurrence rate at 3 months after stopping the drug and the complications and side effects after treatment,to evaluate The effectiveness and safety of"Qingxinping Liver Formula"in the treatment of PMS were evaluated.Results:1.The results of data mining show that 143 prescriptions involving 93 Chinese medicines were included,with a total frequency of 2650 times.High-frequency drug combinations include"Huanglian-Banxia","Citrus aurantium-Houpu","Chenpi-Banxia","Oyster-Mother of Pearl"Tribulus terrestris-Xia Kucao"and so on.Using systematic clustering,high-frequency herbal medicines were clustered into three categories:Class I for Huanglian,Banxia,Poria,Citrus aurantium,and Houpu;Class II for Oyster,Mother of Pearl,Tribulus terrestris,Xiaku cao,Chenpi,and Chuanmutong;and Class III for Salvia miltiorrhiza.2.The network pharmacology study showed that there are 66 active ingredients,194potential drug targets and 77 common targets with PMS,and the strongest associations are with NOS2,ESR1,AR,CHRM3,SLC6A3,EGFR,AKT1,etc,CHRM3,SLC6A3,EGFR,AKT1,etc,which are mainly involved in inflammatory response process,signaling,transcriptional activation,immune response,apoptosis,etc,suggesting that the core drug may achieve the effect of treating PMS by participating in the regulation of MAPK,PI3K-Akt,endocrine resistance,cellular senescence and other signaling pathways.3.Clinical observation results showed that:(1)The overall effective rate of TCM syndrome:the effective rate of the treatment group and the control group were 91.67%and 78.33%,respectively.The effective rate of the treatment group was better than that of the control group,and the difference was statistically significant(P<0.05).(2)The total score of TCM syndrome,Kupperman score,PSQI score,MENQOL score and HAMA score of the two groups were decreased compared with that before treatment,and the difference between the two groups was statistically significant(P<0.05),while the difference between the two groups was statistically significant(P<0.05).(3)The level of E2in both groups increased after treatment,and the difference was statistically significant(P<0.05).There was no significant difference between the two groups(P>0.05).Both the treatment group and the control group could increase E2level,and the effect was similar.The levels of FSH and LH in both groups decreased after treatment,with statistical significance in intra-group comparison(P<0.05)and inter-group comparison(P<0.05).(4)During the treatment,no serious adverse events occurred in both groups.The follow-up showed that the recurrence rate of 3 months after drug withdrawal was 1.67%in the treatment group and 11.67%in the control group,P<0.05 for comparison between groups,indicating that the treatment group could prevent relapse more effectively.Conclusion:1.Through data mining technology,we studied the prescriptions of our supervisor,Professor Wu Quansheng,for the treatment of perimenopausal syndrome,and summarized the characteristics of the prescriptions,and concluded that the core drugs are"Huang Lian,Ban Xia,Hovenia,Hou Pu,Dan Shen,Poria,Chen Pi,Oyster,Tribulus terrestris,Mother of Pearl,Chuan Mu tong,Xia Kucao".Based on the instructor’s clinical experience,the core drugs were added and subtracted to form a new prescription,named:"Qing Xin Ping Liver Formula".2.The results of network pharmacology confirmed that the core drug pair"Huang Lian,Ban Xia,Fu Ling,Hovenia and Hou Pu"can be used as a multi-component,multi-target and multi-pathway to treat PMS.3.The clinical observation found that"Qing Xin Ping Liver Formula"combined with Anjin Yi(Estradiol Drospirenone Tablets)has significant advantages over the control group in the treatment of PMS,and its overall efficacy in improving the symptoms of PMS,Chinese medicine symptoms,and sex hormone improvement are better than the oral Western medicine treatment alone,with no significant adverse effects,high safety and low recurrence rate.It is worthy of clinical reference and application. |