A Clinical Trial About Treatment With Nr-CWS For Cervical High-risk HPV Infection

Objective:To seek the clearance effect of Nocardia Rubra Cell Wall Skeleton (Nr-CWS) for treating the high-risk HPV infection of the lower female genital tract.Methods:Select 144 cases of those who do not have clinical symptoms,and the test results of HPV subtypes testing by HybriMax are positive(including single high-risk HPV positive,mixed high-risk HPV positive,and both high-risk & low-risk HPV positive),all cases are excluded high grade cervical lesions by colposcopy and cervical biopsy.All cases were random divided into 4 groups:the first group was treated with Nocardia Rubra Cell Wall Skeleton(Nr-CWS)(n=39) every other day, 120μg a time,10 times a procedure;the second group was treated with 50% trichloroacetic acid(n=38),one time per week,about 8～10 times a procedure, according to the disappearance of acetic white epithelium;the third group was treated with microwave therapy apparatus(n=46) to contact treat on the surface of cervix for 2～3 minutes in orde to make the cervical surface tissue solidified and turned into yellow or white after menses clean and without acute inflammation of intemal or external genitals;and the patients without any trerapy as control group(n=21).All patients get HPV subtypes testing by Hybribio flow-through hybridization(short for HybriMax) before and 6 months after treatment.Compare the negative conversion ratio of high-risk HPV of each group and roughly analyse the clearance effect for HPV subtypes.Result:The negative conversion ratio of Groupl,Group2,Group3 and control group are 71.8%,63.2%,60.9%and 28.6%.The negative conversion ratio between groupl and control group is significant difference(χ~2=10.385,P=0.001),the conversion ratio of groupl is higher than that of control group;the negative conversion ratio between group2 and control group is significant difference(χ~2=6.474,P=0.011),the conversion ratio of group2 is higher than that of control group;the negative conversion ratio between group3 and control group is significant difference(χ~2=6.017,P=0.014),the conversion ratio of group3 is higher than that of control group.No statistical significance of negative conversion ratio in 3 treatment groups(χ~2=1.197, P=0.551),and we do not think there is difference among the negative conversion ratio of the 3 groups.There is no statistical significance of negative conversion ratio between single HPV subtype positive and mixed HPV subtypes positive(P=0.731).There is also no statistical significance of negative conversion ratio among single HPV-16 subtype,HPV-16 mixed other HPV subtype and non-HPV-16 subtype(P=0.682).Conclusion:This clinical research proves that there is clearance effect of Nocardia Rubra Cell Wall Skeleton(Nr-CWS) in clearing the high-risk HPV infection of the lower female genital tract.Nr-CWS has pharmaclolgical action on HPV without selectivity to its subtype.Compare with the clearance effect of 50%trichloroacetic acid and microwave therapy,there is clearance effect of all these 3 therapy methods to clear the high-risk HPV infection.But Nocardia Rubra Cell Wall Skeleton(Nr-CWS) is more simple,convenient,safe and effective without any side effects,and is easy to accepted by the patients.It has very important clinical applied cost.