Clinical Research On Chinese Medicine Verruca Clean Praeparatum To Treat Cervix Pathological Changes Infected By HR-HPV

Research purposeCervix pathological changes is women' s common disease, frequently-occurring disease,including inflammation,cervix condyloma acuminatum,cervix endometriosis,cervix precancerous lesion,cervical cancer.But in the worldwide scale,cervical cancer is still the woman's main murderer.The prevention and cure is the momentous topic to ensure women' s health and lives.It's worth attention that the youth tendency of cervical cancer occurrence become very obvious in the recent years.Therefore to cut down cervical cancer's incidence rate is very important.Among of the total, the treatment of cervix precancerous lesion is the key point.The cause of cervical cancerr is due to multiple factors' mutual functions.It correlats to the coition for the first time too earlier,many sex partner,male partner' s sexual behavior,smoking,birth control method, and herper virus type 2 affection.Now nearly all the epidemiologic survey and laboratory research data show that HR-HPV persistent infection is the main cause of cervical cancer.How to clear HR-HPV is the key point to stop the course of disease and to prevent cervical cancer from hanppening.Now the hot spot of the research is the development of Prophylactic vaccine and Remedial vaccine also to try to use Chinese medicine to clear HPV.But now chinese medicine clinical research which specially aim directly at HR-HPV infection and which has scientific and reasonable design and strong persuasion is very few.The Verruca Clean Mistura and Verruca Clean Cpot Apply Cremor created by our hospital dermatology departmrnt have a good therapeutic effect in curing the genitals' condyloma acuminatum.The research indicates it has the function to kill the local HPV and to make local lesion tissue regain the normal function.According to our gynecology department' s clinic initial observation,this series of medicine has a better therapeutical effect to cervix pathological changes affected by HR-HPV and it has a reverse effect to cervix local tissue pathological changes.In order to validate its therapeutic effect and the possible mechanism of action,we design and enforce the research.Based on the present research,we aim to observe Chinese medicine' s intervention to HPV virus load changes and reverse influence to cervix pathological changes in order to approach traditional Chinese medicine' s function in curing cervix HR-HPV infection and cervix pathological changes as well as to know its' possible mechanism of action.Research method1.The research is a prospective and single blind controlled clinical trial. We set up Chinese medicine treatment group and placebo control group.The research includes treatment group 42 persons,placebo control group 11 persons. The treatment group use chinese medicine Verruca Clean Praeparatum for external application while control group use isotonic Na chloride.Twice to three times a week and three menstrual cycles,totally 19 times.Follow up and recheck every index when the 4^thtimes period is over.2.Monitor index:includes general index:main clinical symptoms,physical sign improving condition in prior-treatment post-treatment;therapeutic effect index:TCT, HC2,Reid score under vaginoscopy,cervical biopsy,;therapeutic effect assessment index:HC2 difference,Reid score therapeutic effect index, pathology results.Research resultsThe comparison of two groups' baseline index befor treatment in the research have no statistically significance(P＞0.05),it hints two groups have comparability.As a result,the positive changement index are the control of prior and post HC₂ itself and the treatment group' s advantage in changing TCT ' s grades(P＜0.01).The treatment group' s several aspects like:semiology,etiology(HC₂),cervix superficial shape and Reid score under endoscope and pathology result which is as the final result index dose not show an advantage than control group(P＞0.05).It indicates that traditonal chinese medicine Verruca Clean Praeparatum' therapeutical effect to this desease is to improve the cell pathology grade directly rather than clear HR-HPV.But because the sample is few and there is no further information,so it still hasn't reflect the influence to the final pathology result.That needs our further follow-up to make a approach.conclusion1 The research creative point:It is the first time to use placebo control.The current situation of the disease is that there haven' t a generally accepted effective curative yet, which makes the placebo become possible.It is the first time to use single blind design,the medicine used in the disease are all in charge of andenforced to treatment by the researcher.Subjects dosenn' t know that,so it overcomes the bias from the subjects' subjective factor.2 problem and solution needs further discussiona)whether it has the function to improve pathology result or not ---to enlarge the sample quantity,to finish the 7^th,13^thmonth follow-up plan,to know the final pathology results,to make sure the therapeutic effect in the near future and long term.b)whether it has the function to clear HR-HPV or not ---to enlarge the placebo control sample quantity,to overcome bias,to gain scientific conclusion.c)whether it surpass western medicine and natural turnover or not---to set up Chinese medicine group,western medicine group,blank control group and placebo control group at the same time,to add the life quality measuring scale evaluation to control group,to know mental intervention' s influence to disease.d)whether there is any difference between Chinese medicine oral application and external application these two ways or not --- to set Chinese medicine oral application,external application,oral application + external applicatione)How to increase sample quantity---(1)to strengthen cases management, follow up positively,build a good relationship with patients(2)to improve the form of medication and improve the medication' s convenience,to increase patients' compliancef)How to carry out higher level research ---The existing research is doing the preliminary work in the cell,tissue,morphology level.The research after should collect the disease case,at the same time pay more attention to collect molecular biology index,such as cervix tissue telomerase activation,the changement of HPV16 / 18 DNA and carcinogene E6,E7 expression,so as to further evaluate Chinese medicine' s clinical therapeutic effect to cure cervix pathological changes infected by HR-HPV.To elucidate its possible mechanism of action,to supply scientific evidence to new medicine development that Chinese medicine prevent and cure cervix cancer precancerous lesiong)How to do the random,double-blind clinical control research --- the existing condition and treatment are in the charge of the third person who can be completely do the random and double-blind control trial, but with regard to the specific enforcement,it needs to throw greater manpower and resources into the researchers' strict training and quality control during the process.