| Pur Pose:In this study,by observing the clinical efficacy of Ha’s No.2 Stop Leucorrhea Prescription in the treatment of damp invasion of lower energizer on Bacterial vaginosis(BV),changes in the number of vaginal lactobacilli,vaginal microenvironment and local vaginal immunity,and explore its mechanism,this study provide theoretical and scientific basis for Ha’s No.2 Stop Leucorrhea Prescription in the treatment of BV.Method:48 patients with damp invasion of lower energizer BV who met the inclusion and exclusion criteria were selected from the gynecological clinic of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 2020 to December 2020.The patients were divided into a treatment group and a control group by a randomized controlled research method,with 24 cases in each group.The control group was given tinidazole suppository vaginally,1 capsule at a time,once every other day,6 capsules for a course of treatment(stopped during menstruation).On the basis of the control group,the treatment group took Ha’s No.2 Stop Leucorrhea Prescription orally,1 pair a day,decocted in water(without the menstrual period),a total of 14 prescriptions.Observe the Nugent scores,the number of vaginal lactobacilli,vaginal microenvironment,local symptoms and signs scores,and TCM syndrome scores of the two groups before and after treatment.The vaginal lavage fluids of the two groups were collected and tested by enzyme-linked immunosorbent assay(ELISA).The levels of IL-1β,IL-6 and TNF-α in the vagina before and after treatment.Patients with a Nugent score of less than 7 after treatment were followed up for observation at1,2,and 3 months after treatment.Use SPSS22.0 for statistics and draw conclusions.Result:1 Baseline comparison:The two groups’ age,pregnancy history,course of disease,Nugent score,number of lactobacilli in vagina,vaginal microecology,local symptoms,physical sign score,TCM syndrome score,and vaginal local immunity were compared.The difference was not statistically significant in the baseline coditions(P>0.05),and they were comparable.2 Efficacy evaluation results:2.1 BV clinical efficacy:Treatment group,the clinical efficacy of the control group,the total efficiency of 91.67%,70.83% respectively,the total effective rate difference was statistically significant(P<0.05).Comparison of clinical efficacy,the clinical efficacy of the treatment described group than the control group.2.2 Comparison of the number of lactobacilli in the vagina:The number of lactobacilli in the vagina before and after treatment in the treatment group was statistically significant(P<0.05);the number of lactobacilli in the vagina before and after treatment in the control group was not statistically significant(P>0.05).After treatment,the number of lactobacilli in the vagina was compared between the two groups.The difference was statistically significant(P<0.05),indicating that the treatment group can increase the number of lactobacilli and the treatment group is better than the control group.2.3 Comparison of the Nugent scores:The Nugent scores of the two groups before and after treatment were compared within the group,and the differences between the two groups before and after treatment were statistically significant(P<0.05).The Nugent scores of the two groups after treatment were tested by rank sum,P > 0.05,the difference was not statistically significant.2.4 Comparison of vaginal microecology:Treatment of vaginal flora group density,diversity,vaginal p H,vaginal comparing white blood cell count in the group,the vaginal flora intensive treatment group,compared with vaginal p H values before treatment to improve,the differences were statistically significant(P < 0.05),there was no significant difference in vaginal flora diversity and vaginal white blood cell count before and after treatment(P>0.05);after treatment in the control group,the vaginal flora density and vaginal flora diversity were improved compared with before treatment.statistically significant(P < 0.05),vaginal p H,white blood cell counts were not significantly different(P before and after treatment>0.05);after treatment,vaginal flora density,diversity,vaginal p H,vaginal white blood cell count,respectively for comparison between groups,vaginal flora intensity,vaginal interleukin count groups no significant(P>0.05),vaginal flora diversity,inter vaginal p H group,the difference was statistically significant(P<0.05),indicating that the treatment group is better than the control group in improving the diversity of vaginal flora and vaginal p H.2.5 Comparison of local symptoms and signs scores:T Treatment group,local symptoms and signs score of the control group total efficiency of 87.50% and 75.00%,respectively,the difference was significant(P<0.05),treatment group than the control group.The total scores of local symptoms and signs were compared between the two groups before and after treatment,and the differences between the two groups were statistically significant(P<0.05).Two groups of local symptoms and signs total score points for comparison between groups,P<0.05,statistically significant difference,indicating that the treatment group is better than the control group in improving the local symptoms and signs.2.6 Comparison of TCM syndrome scores:Treatment group and the control group TCM syndrome total efficiency of 91.67% and 79.17%,respectively,the difference was statistically significant(P<0.05),improvement of the treatment group than the control group Syndrome.Main symptoms TCM treatment group,the total effective rate secondary symptoms 87.50%,95.83%,79.17% in the control group,62.50%,two main symptoms,time differences between disease groups were statistically significant(P<0.05),it shows that the treatment group is better than the control group in improving the primary and secondary symptoms.2.7 Vaginal local immunity:IL-1β for the intravaginal two groups before and after treatment,IL-6,TNF-α levels are compared,P<0.05,statistically significant differences were;between the two groups to be compared after treatment,P < 0.05,the differences are statistically significant,indicating that the treatment group increased intravaginal IL-1β,IL-6,TNF-α levels and better than the control group.2.8 Follow-up:The Nugent scores of the treatment group were not statistically different in the first,second,and third months after treatment with the previous one month(P>0.05);the Nugent scores of the control group were significantly different in the first month after treatment than those after treatment(P<0.05),there was no statistically significant difference in the second and third months after treatment compared with the previous one month(P>0.05).The comparison between the treatment group and the control group in the first 1,2,and3 months after treatment,the difference was statistically significant(P≤0.05),indicating that the treatment group was better than the control group in reducing the Nugent score in the first,second,and third months.Combining the two groups of Nugent score change trend graphs,it is found that the Nugent scores of the two groups decreased after treatment,and the decrease of the treatment group was larger.The Nugent scores of the first,second,and third months after treatment had an upward trend,but the rising trend of the treatment group was slow.The number of lactobacilli in the vagina in the first month after treatment in the treatment group increased compared with before treatment,and the difference was statistically significant(P < 0.05);the number of lactobacilli in the vagina in the first month after treatment in the control group was not statistically significant(P>0.05).In the first month after treatment,the treatment group increased the number of vaginal lactobacilli better than the control group,and the difference was statistically significant(P<0.05).Conclusion:1 Ha’s No.2 Stop Leucorrhea Prescription has obvious clinical effect in treating damp-heat betting type BV,which can improve local symptoms,signs and TCM syndromes;2 Ha’s No.2 Stop Leucorrhea Prescription can increase the number of lactobacilli in the vagina,maintain the vaginal microecological balance and Prevent recurrence.3 Ha’s No.2 Stop Leucorrhea Prescription may inhibit IL-1β,IL-6,TNF-α to treat damp-heat betting type BV. |
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