| Background:Cervical cancer(CC)is the number one malignant tumor in female reproductive tract in terms of incidence,which is a serious threat to women’s life and health Human papilloma virus(HPV)infection is the main cause of cervical cancer and has a correlation with recurrence,metastasis and survival of cervical cancer,and numerous studies have proved that Chinese medicine is safe and effective in the treatment of cervical cancer and HPV.After preliminary clinical observation,it was found that Purple Snake Richong Tang has good clinical effect in the treatment of cervical cancer,and it is necessary to further study it.Objectives.1.To clarify the effect and influence of the treatment with Zi Shi Li Chong Tang combined with external cleansing formula on HPV conversion and on PFS by observing the HPV conversion rate,survival and quality of life of patients with HR-HPV infection stage IIb-IIIc cervical cancer.2.To observe the changes of peripheral blood T cells and NK cells levels before and after treatment of patients,analyze the correlation between cellular immunity level and HPV infection status,and investigate the mechanism of action of Chinese medicine in the treatment of HPV infection.3.To investigate the relationship between Chinese herbal medicine intervention,HPV infection status and PFS through survival analysis by Kaplan-Meier curve,univariate and multifactorial analysis of factors affecting progression-free survival by COX proportional risk model,and to clarify whether HPV infection status and Purple Snake Reechong Tang combined with external cleansing formula were independent correlated factors affecting PFS.METHODS:A controlled study was conducted to include 60 patients with moderately advanced cervical cancer(stage Ⅱb-Ⅲ)who achieved CR or PR after standard Western medical treatment and still had HR-HPV infection with clear HR-HPV positive subtypes,and the subjects were divided into a treatment group(Chinese herbal medicine group)and a control group(recombinant human interferon α-2b vaginal effervescent capsules)according to the treatment drugs received.The treatment group was given Zixie Li Chong Tang orally and combined with external bath fumigation,and the Chinese herbal medicine was used continuously for at least 6 months.The control group was administered vaginally with human interferon α-2b vaginal effervescent capsule,and the control group was administered continuously for 3 months according to the western clinical standard.The patients in both groups were monitored for HPV conversion rate,progression-free survival,and monitored for peripheral blood CD3+,CD3+CD4+,CD3+CD8+,CD3+CD4+/CD3+CD8+,CD4+CD25+CD127-and NK cell changes(during which HPV tests were negative for more than 2 consecutive times could be changed to 1 year).RESULTS:A total of 62 patients with postmenstrual cervical cancer with HR-HPV infection in stage Ⅱb-Ⅲc were included in this study.The two groups were not statistically significant(P>0.05)in terms of age,pregnancy and delivery,whether they were menopausal,size of primary tumor,evaluation of tumor efficacy,pathological type,pathological stage and disease duration,and were comparable.A total of 60 patients completed the 2-year follow-up and shed 2 cases(3.33%).1.1 month after the end of treatment,11 cases(36.67%)of HR-HPV subtypes in the treatment group were all converted to negative and 7 cases(23.33%)were partially converted,with a total effective rate of 60%;6 cases(20%)in the control group were all converted to negative and 4 cases(13.33%)were partially converted,with statistically significant differences in the total effective rate between the two groups(P<0.05);the conversion rate in the treatment group vs.the control group within 1 year The rate of conversion within 1 year was 86.67%vs.70%in the treatment group vs.the control group,and the difference was statistically significant(P<0.05);by the end of the study follow-up period,the total effective rate of HR-HPV conversion in the treatment group and the control group was 93.33%(28/30)and 73.33%(22/30),respectively,and the results showed that both groups promoted the conversion of HR-HPV,but the efficacy of the treatment group was better than that of the control group,and the The results were statistically significant(P=<0.05).The results showed that the combination of Zi Shi Li Chong Tang and topical formula could promote the clearance of virus,and the efficacy was greater than that of treatment with interferon in this experiment.2.The two groups in the TCM symptom scores were analyzed by descriptive statistics and conformed to normal distribution,and the result was t=-1.459 by t-test,P=0.15>0.05,which were not statistically significant,indicating that the two groups were comparable in the TCM symptom scores before treatment.According to the results of statistical analysis,the P between the two groups on the TCM symptom score before treatment was>0.05,which was not statistically significant.Statistical analysis of the results of reducing TCM symptom scores showed that;after treatment,the differences between and within the two groups were statistically significant(all P<0.05),indicating that both groups were able to reduce TCM symptom scores,and the efficacy of the treatment group was significantly greater than that of the control group.3.In the treatment group,there was one case(3.33%)of local recurrence and one case(3.33%)of distant metastasis in the first year after the end of treatment;one case(3.33%)of local recurrence and one case(3.33%)of distant metastasis in the second year,with PFS of 10,11,20 and 19 months,respectively.In the control group,3 cases(10%)of local recurrence and 3 cases(10%)of distant metastases were found in the first year after the course of treatment,with PFS of 11,8,10.5,9,6.5,and 11 months,respectively;2 cases(6.67%)of local recurrence and 3 cases(10%)of distant metastases in the second year,of which 1 case(3.33%)of distant metastases died,with PFS of 14,14.5,12.5,and 19 months,respectively.14.5,12.5,13,and 15 months,respectively.The 1-year/2-year recurrence metastasis rate and 1-year/2-year survival rate in both groups were 6.67%/13.33%and 100%/100%in the treatment group,respectively.In the control group,they were 20%/16.67%and 100%/96.67%.It can be seen that the treatment group outperformed the control group in terms of 1-year/2-year recurrence metastasis rate and overall survival,but none of them was statistically significant(P>0.05).The distribution of progression-free survival time in the two groups did not conform to a normal distribution curve,and the difference was statistically significant using a nonparametric test with P=0.028<0.05.The 1-year/2-year progression-free survival rates were 93.33%and 86.67%in the treatment group and 80%and 63.33%in the control group,respectively,and the 2-year median PFS was 24 months in both the treatment and control groups,with statistically significant differences in the 2-year overall PFS survival curves(PFS:logrank x2=4.647,P=0.031).survival time curves for HPV infection status versus PFS were statistically significant for HPV negative and HPV positive(PFS:logrank x2=7.618,P=0.006).The difference between elevated and normal levels of regulatory T cells and PFS survival curves was statistically significant(PFS:logrank x2=12.276,P=0.00).4.Before treatment in both groups in CD3+,CD3+CD4+,CD3+CD8+,CD3+CD4+/CD3+CD8+ratio,CD4+CD25+CD127-%,and NK cell level ratio by descriptive statistical analysis,all conformed to normal distribution,and by t-test,all P values were>0.05,which were not statistically significant and comparable.At the end of treatment,CD3+,CD3+CD4+,CD3+CD4+/CD3+CD8+ratio,and NK cell ratio in the treatment group were all higher than before,and the differences were all statistically significant(P<0.05),while CD3+,CD3+CD4+,CD3+CD4+/CD3+CD8+ ratio,and NK cell level in the control group were also higher than before,but the results were not statistically significant(P>0.05).Both groups showed a decrease in CD4+CD25+CD127-%and there was a statistically significant(P<0.05)comparison within and between groups.There were statistically significant differences between the two groups in CD3+,CD3+CD4+,CD3+CD4+/CD3+CD8+ratio,and NK cell changes(P<0.05).There was no statistically significant difference in CD3+CD8+before and after comparison between the two groups(P>0.05).5.By COX regression analysis,the intervention mode,HPV infection status,tumor efficacy evaluation,and regulatory T cells after enrollment were independent factors affecting PFS in cervical cancer patients(P<0.05).6.The scores in four dimensions(somatic,psychological,social,and disease)were higher between the two groups after treatment than before treatment,and were more significant in the treatment group than in the control group,with statistically significant differences(all P=0.038<0.05).CONCLUSION.1.Zi Shi Li Chong Tang combined with external washing formula is effective in treating HR-HPV-positive cervical cancer companion,which can promote HPV virus clearance and increase the conversion rate,and overall not only can reduce disease symptoms,improve patients’ quality of life and promote psychological health,but also can reduce disease recurrence and metastasis rate and prolong progression-free survival time of cervical cancer patients.2.The ratio of peripheral blood immune cells in patients with positive HPV infection before and after treatment is more imbalanced than that in negative patients,and the immune function of the body is suppressed.Purple Snake Reechong Tang combined with External Washing Formula can regulate the imbalance of peripheral blood immune cell ratio,which has different regulatory effects on the levels of CD4+,CD8+ and Treg cells,which are representative of T cell subpopulation,by upregulating CD4+level and coordinating CD4+/CD8+ratio balance,and down-regulating Treg cell levels to promote the restoration of immune function.So the possible mechanism of its exerting its role is to restore the body’s immunity by regulating the cellular immunity level to reach a balance,help anti-viral and anti-tumor,and try to eliminate the risk factors affecting the prognosis of cervical cancer.3.After COX regression analysis,HPV-negative,normal regulatory T-cell level,tumor efficacy evaluation of CR,and treatment with traditional Chinese medicine after enrollment were the protective factors affecting progression-free survival of cervical cancer. |
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