| Objective:1.Observe the clinical efficacy of Jianwei Ermiao Granules on patients with HR-HPV persistent infection and the changes of vaginal microecology before and after treatment,so as to provide evidence-based basis for clinical promotion of Jianwei Ermiao Granules,and provide new traditional Chinese medicine ideas for prevention and treatment of HR-HPV persistent infection and cervical cancer prelesion;2.To further analyze the bacterial flora and its metabolites in the vaginal lavage fluid of patients with HR-HPV continuous infection,to study the relationship between HR-HPV continuous infection and vaginal bacterial flora and its metabolites,and to explore the pathogenesis of HR-HPV continuous infection,so as to provide a theoretical basis for expanding the clinical application range of Jiaweiermiao Granules.Method:1.A total of 80 patients with HR-HPV infection who came to gynecological outpatient department of Jiangsu Hospital of Traditional Chinese Medicine from November 2019 to December 2019 and who were in line with the TCM syndrome type of wet heat injection syndrome were selected.They were divided into treatment group(Jiawei Ermiao Granules treatment)and control group(40 cases in each case)by random number method.The treatment group was treated with Jiawei Ermiao granules,and the control group was followed up and observed.Routine leucorrhea,HPV and TCT were rechecked 6 months later to evaluate the clinical efficacy and vaginal microecology.2.A total of 156 women who requested colposcopy and cervical biopsy due to HR-HPV infection and(or)ASCUS and above lesions indicated by TCT in gynecology department of Jiangsu Hospital of Traditional Chinese Medicine from May 2020 to July 2020 were selected.According to the pathological results of cervical biopsy,the patients were divided into the following groups:In the NILM group(78 cases),LSIL group(52 cases),and HSIL group(26 cases)without intraepithelial cell lesion(NILM group),vaginal lavage fluid was collected for 16S rRNA gene sequencing and metabolomics analysis.Results:1.(1)The clinical efficacy of the two groups was compared.The number of cases of negative conversion in the treatment group and the control group was 33 and 24,and the total effective rate was 82.5%and 60%,respectively,with statistical significance between the groups(P<0.05).(2)The vaginal microecological changes between the two groups were compared.The abnormal detection rate of vaginal cleanliness,the positive expression rate of H202,the positive expression rate of leucocyte esterase and the positive expression rate of sialidase in the treatment group were significantly lower than those in the control group(x 2 test was 5.165,6.765 and 5.591,respectively,the differences were statistically significant(P<0.05).Vaginal cleanliness,H2O2,leucocyte esterase and sialidase were related factors affecting HR-HPV negative turn,with correlation coefficients of 0.254,0.453,0.391 and 0.330,respectively,and the differences were statistically significant(P<0.05).(3)In the treatment group,there was no adverse reaction during medication,and no obvious abnormality in blood routine and liver and kidney function was observed,indicating that Jiawei Ermiao Granules was safe.2.(1)The species and diversity of vaginal micro flora in patients infected with HR-HPV decreased with the occurrence and development of SIL,and the cleanliness of the vaginal microenvironment of patients decreased accordingly,and the imbalance of bacterial flora may be related to the increase of pathogenic anaerobic bacteria,the abundance of Chia bacteria,Ciliomycetes and other miscellany bacteria increased,and the abundance of Streptococcus decreased.(2)A total of 164 known metabolites were detected in the three groups of vaginal lavage fluids.Metabolites such as amino acids,purines and uric acid in the cervix vagina microenvironment changed significantly with the deepening of cervical lesions.(3)Significant separation trends were observed between the NILM group and the HSIL group,and between the LSIL group and the HSIL group,indicating significant differences in secretion metabolic patterns between HSIL patients and other patients.The metabolic pathways that affect the occurrence of SIL are mainly carbamyl-tRNA biosynthesis pathway,phenylalanine and tyrosine and tryptophan pathway,alanine and aspartate and glutamate metabolic pathway.(4)Various metabolites were significantly associated with vaginal flora.Taurine was positively correlated with the intestinal group of Weisella,Porphyromonas and RC9,and negatively correlated with Corynebacterium,Rhodococcus and Rblight.Hydroxyl products such as hydroxylamine and hydroxyurea were positively correlated with various vaginal microflora,but negatively correlated with lactobacillus.The opposite is true for mannitol,glycerol,guanine,adenine,etc.(5)The initial progression of cervical lesions will lead to the consumption of large amounts of amino acids,purines and so on in the cervix-vagina environment.As the disease intensifies,amino acids,purines,and other metabolites may be compensatory upregulated and involved in the immune defense of cervical and vaginal epithelial cells.Conclusion:(1)Vaginal lavage fluid is easy to obtain and non-invasive,and has the potential to be used as a diagnostic tool to assist in determining the pathogenesis of HPV and the progression of SIL,and to promote the prevention of cervical cancer.(2)Jiawei Ermiao Granules showed significant clinical efficacy in patients with persistent infection of HR-HPV induced by dampness-heat injection,and could also significantly improve the vaginal microecology of patients.There were no abnormal safety indicators rechecked after the drug,which was safe and effective,and worthy of further clinical promotion and application.(3)The vaginal flora of HPV-infected women was still composed of Lactobacillus and Gardnella,but the abundance and diversity of microorganisms contained in lavage fluid changed with the progression of SIL.The cervix vaginal flora may play an important role in the activation of inflammation and immune system by regulating the synthesis and decomposition of amino acids,purines,uric acid and other metabolites. |
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