| Objective(1)This study systematically and objectively analyzed the effectiveness and safety of Shenqi pill in treating kidney-yang deficiency type polycystic ovary syndrome combined with infertility by using literature Mata analysis and network pharmacological analysis combined with kidney tonifying method.(2)To predict the target of kidney-yang-deficiency polycystic ovary syndrome by using network pharmacology,and to preliminatively explore the potential mechanism of action of Shenqi pills on kidney-yang-deficiency polycystic ovary syndrome.(3)To observe and evaluate the clinical effect of Shenqi pills on infertility caused by kidney-yang deficiency type polycystic ovary syndrome,and provide a clinical idea for the treatment of infertility caused by polycystic ovary syndrome.Methods(1)The search was conducted on CNKI,Wanfang,VIP and China Biomedical Literature Database(SinoMed).The search period was from 2023-10-21.The search was constructed with the keywords "kidney tonifying","polycystic ovary syndrome" and"infertility".Review Manager 5.4 software was used to complete the data analysis of the included literature..(2)A total of 60 patients who were diagnosed with PCOS and infertility in the gynecological clinic of Zhenguan Traditional Chinese Medicine Clinic in Yonghe District,Taiwan from April 2019 to December 2019,and who were diagnosed as kidney-yang deficiency in TCM syndrome,were selected according to random numbers.Table,according to the order in which patients go to see a doctor,they are randomly divided into treatment group and control group,with 30 patients in each group.Patients in the treatment group started to take Shenqi Pills(Beijing Tongrentang Co.,Ltd.Tongrentang Pharmaceutical Factory,National Medicine Zhunzi Z11020996)after menstruation was clear,orally,2 times a day,4g each time,for a total of 3 menstrual cycles,treatment period or treatment After successful pregnancy,the traditional Chinese medicine Shoutaiwan will be added or subtracted until the 12th week of pregnancy.The control group received oral clomiphene treatment.The menstrual cramp patients started to take the drug on the 5th day of the menstrual cycle for a total of 5 days,once a day,50 mg each time,for a total of 3 menstrual cycles.If the two groups of patients had amenorrhea and cycle disorders,after excluding pregnancy,they were given progesterone 20 mg intramuscularly for 5 days.The treatment was started on the 5th day of withdrawal bleeding,and a total of 3 menstrual cycles were treated.It is to observe the two groups of patients before and after treatment:menstruation and kidney-yang deficiency related symptoms and signs;body mass index measurement(BMI);basal body temperature;clinical pregnancy rate;ovulation rate;Sex hormone levels;and Clinical efficacy.(3)To study the efficacy mechanism of Shenqi pill in the treatment of PCOS based on network pharmacology:Bioavailability and drug properties were selected as screening conditions.The active ingredients of Yijing Decoction were collected from TCMSP,and the target information of effective active compounds was collected from STRING database and Uniprot database.Disease targets of PCOS were collected in GeneCard Disease database.The intersection targets of disease targets and kidney Qi pill targets were used as data sets and imported into Cytoscape3.9.1 to construct the network of "target-active ingredientYijing Decoction",and the intersection targets were imported into STRING database to construct the protein-protein interaction network.According to the degree value results of STRING,the top 20 degree values were taken as core genes to enrich biological process,cell composition,molecular function and signal pathway.Results1.Meta analysis resultsA total of 21 RCTS were included in this study.The control group was treated with conventional western medicine,and the sample size was 790.The observation group was treated with conventional western medicine combined with proprietary Chinese medicine,traditional Chinese medicine decoction,or pure Chinese medicine.The results showed that tonifying kidney could increase the number of follicles,increase follicle diameter and improve serum E2 in PCOS patients with infertility.Secondly,tonifying kidney can increase endometrial thickness,so it can be seen that tonifying kidney in treating kidneyyang deficiency type PCOS with infertility may promote the number of follicles in patients with this disease,promote follicle development,improve endometrial thickness,and assist in conception.;2.Network pharmacological resultsNetwork pharmacological study of Shenqi pills in treating PCOS:112 kinds of active ingredients of Shenqi pills were obtained.There were 97 intersection targets of Shenqi pills and PCOS.The PPI network with 211 nodes and 951 connections is constructed by importing the target points of STRING into Cytoscape3.9.1 for topological analysis.Screening key genes such as AKT1,TP53,TNF,VEGFA,IL1B and CASP3 according to Degree value are potential targets for Shenqi pills to treat PCOS.Finally,a total of 2772 GO items were enriched.A total of 208 enrichment results were obtained by KEGG pathway enrichment analysis.It is associated with Pathways in cancer pathway,Lipid and atherosclerosis pathway,Fluid shear stress and atherosclerosis pathway,PI3K-Akt signaling pathway and so on.3.Clinical research results(1)Main clinical outcome measures:After treatment,the pregnancy rate was 23.3%in the control group and 40%in the treatment group,and there was a statistical difference between the two groups(P<0.05).(2)Secondary clinical outcome measures:① Ovulation rate was 61.6%in the control group and 75.5%in the treatment group after treatment,and there was a statistically significant difference in ovulation rate between the two groups(P<0.05).②After treatment,the number of patients with bipolar BBT in the treatment group was higher than that in the control group,and the difference was statistically significant(P<0.05).(3)Comparison of other laboratory observation indicators:① Intra-group comparison between the two groups after treatment found that the improvement of body mass index in the treatment group and the control group was better than before treatment,and the difference was statistically significant(P<0.05).② The comparison between the two groups after treatment showed that the improvement of body mass index in the treatment group was better than that in the control group,and the difference was statistically significant(P<0.05).③After treatment,there were statistically significant differences in fasting blood glucose and fasting insulin levels between and within the two groups(P<0.0001),suggesting that both Western medicine and Chinese medicine intervention in this study could improve fasting blood glucose and insulin resistance.④(6)After treatment,AMH improvement in the treatment group was better than that in the control group,and the difference was statistically significant(P<0.05),suggesting that Shenqi pill could improve the hormone level of patients.(4)TCM symptom score results:Before treatment,there was no statistical significance in menstrual cycle,menstrual volume color,waist and knee tenderness,cold fear,fatigue,dizziness,tinnitus,frequent nocturnal urination,thin lax stool and total score of TCM symptoms between the two groups(P>0.05).After the end of treatment,the comparison before and after treatment in the two groups found that the scores of TCM symptoms in the two groups were significantly improved compared with those before treatment.The comparison between the two groups showed that the improvement of symptoms such as waist and knee weakness and cold fear in the treatment group was better than that in the control group,with statistical significance(P<0.05),but there was no statistical significance in the improvement of symptoms such as menstrual cycle,menstrual volume and color,fatigue,frequent nocturnal urination,loose stool and dizziness and tinnitus between the two groups(P>0.05).(5)Analysis of total effective rate of treatment:In the treatment group,12 patients were cured,7 patients with obvious effect,7 patients with effective effect,and 4 patients with ineffective effect;in the control group,7 patients were cured,5 patients with obvious effect,8 patients with effective effect,and 10 patients with ineffective effect.The clinical efficacy of the two groups was tested by non-parametric test,and the results indicated that there was no statistical significance in the distribution of clinical efficacy between the two groups(P>0.05).Conclusion(1)kidney-tonifying therapy for kidney-yang deficiency polycystic ovary syndrome complicated with infertility can increase follicle diameter,promote follicle development,increase the number of mature follicles,promote ovulation,improve endometrial thickness and hormone levels,improve glucose and lipid metabolism,and increase pregnancy rate.(2)Shenqi pills can improve the clinical symptoms of kidney-yang deficiency.(3)The mechanism of Shenqi pills in the treatment of PCOS may be that quercetin,β-sitosterol,stigasterol and other active ingredients participate in cancer signaling pathway and insulin resistance through PTGS2,FGFR4,PIM1,RXRA and other targets,improve ovarian cell apoptosis and carcinogenesis,regulate energy metabolism disorders,and thus play an ovarian protective role. |
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