The Clinical Observation Of Modified Ermiao Formula Combined With JinShuxi In The Treatment Of Spleen Deficiency And Damp-heat Type CIN1 With HPV16/18 Infection

Objective:To observe the clinical efficacy of Modified Ermiao Formula combined with recombinant human ?-2b interferon vaginal effervescent tablets(Jinshuxi)in the treatment of CIN1 with HPV16/18 infection,and to evaluate the efficacy and safety of this empirical formula In eliminating 16/18 HPV and reversing CIN1,so as to provide a new Chinese medicine Idea for follow-up treatment of CIN1 and improve the accuracy of antiviral use of traditional Chinese medicine.Methods:64 patients with HPV 16 and/or HPV18 infection and CIN1 diagnosed by cervical biopsy under colposcopy were selected from gynecological clinic from June 2016 to June 2018.The patients were randomly divided into two groups according to the order of visits:the treatment group was treated with modified Ermiaofang for 6 months and recombinant human-2b interferon(Jinshuxi)for 3 months,while the control group was treated with recombinant human-2b interferon(Jinshuxi)for 3 months.The clinical efficacy was evaluated 6 months after treatment.Results:(1)There were 19 cases of CIN1 reversal in the treatment group,the reversal rate was 59.3 8%,and 10 cases in the control group,the reversal rate was 31.25%.The data of the two groups were P=0.024<0.05.The difference was statistically significant.The treatment group was significantly better than the control group in reversing CIN1.(2)Comparing the total negative conversion rate of HPV 16/18 between the two groups,9 cases in the control group turned negative,the total negative conversion rate was 28.13%,15 cases in the treatment group turned negative,the total negative conversion rate was 46.88%.?2=2.400,P=0.121>0.05,there was no significant difference between the two groups,but the total negative conversion rate in the treatment group was significantly higher than that in the control group.(3)There was no significant difference in the negative conversion rate of HPV 16 single infection and mixed infection between the control group and the treatment group(P>0.05),and there was no significant difference in the negative conversion rate of HPV 18 single infection and mixed infection between the control group and the treatment group(P>0.05).The total negative conversion rates of HPV type 16 in treatment group and control group were 34.78%,25.00%,P?0.486>0.05,respectively,with no statistical significance,but the negative conversion rates in treatment group were higher than those in control group;the total negative conversion rates of HPV type 18 in treatment group and control group were 72.73%,28.57%,P=0.047<0.05,respectively,with statistical differences between the two groups.(4)By comparison,the scores of TCM syndromes in the control group and the treatment group decreased significantly before and after treatment,and the treatment group P=0.000<0.01,with significant statistical difference.Compared with the control group,the improvement of syndrome in the treatment group was significantly better than that in the control group,the difference was statistically significant(P?0.003<0.05).(5)In the treatment group,12 cases were cured,3 cases were markedly effective and 5 cases were effective.The total effective rate was 62.50%.In the control group,6 cases were cured,1 case was markedly effective and 5 cases were effective.The total effective rate was 37.50%.The rank sum test showed that P=0.035<0.05.There was significant difference between the two groups.Conclusions:(1)Modified Ermiao Formula combined with interferon is safe and effective for CIN1 with HPV16/18 infection.It can accelerate the reversion of CIN1 and significantly reduce the TCM syndrome score of patients,especially for patients with obvious clinical symptoms at the time of consultation.It is the advantage of TCM and is suitable for clinical application.(2)The negative conversion rate of Modified Ermiao Formula combined with IFN in the treatment of 16-type HPV infection was higher than that of IFN alone,but the ideal clearance rate was not yet achieved.The negative conversion rate of 18-type HPV infection was 72.73%after 6 months of treatment,which was significantly better than IFN alone.This conclusion is helpful to guide clinical precise drug use.For patients with HPV 18 infection,the combination of oral medication is more recommended in clinic.