CN111358841A

CN111358841A - Traditional Chinese medicine composition for treating high-risk subtype cervical HPV persistent infection and application thereof

Info

Publication number: CN111358841A
Application number: CN202010275400.9A
Authority: CN
Inventors: 沈明洁; 蒋国静; 顾翠峰; 张俞莹
Original assignee: Shuguang Hospital Affiliated to Shanghai University of TCM
Current assignee: Shuguang Hospital Affiliated to Shanghai University of TCM
Priority date: 2020-04-09
Filing date: 2020-04-09
Publication date: 2020-07-03

Abstract

The invention relates to a traditional Chinese medicine composition for treating high-risk subtype cervical HPV persistent infection, which consists of antibacterial liquid of a blue leather excellent and water for injection, wherein the volume ratio of the antibacterial liquid of the blue leather excellent to the water for injection is 2: 0.8-1.1, wherein the antibacterial liquid of the blue leather excellent contains 0.12-0.15% (w/w) of chlorhexidine acetate, dandelion, purslane, isatis root, folium isatidis, fructus cnidii, scouring rush, safflower, rhubarb, radix sophorae flavescentis and brucea javanica. The invention also provides application of the traditional Chinese medicine composition for treating high-risk subtype cervical HPV persistent infection. The invention has the advantages that: can rapidly and effectively eliminate cervical HPV virus and rapidly turn negative. The treatment of the invention can quickly reverse the pathological result and avoid the progress to the canceration direction of the patient with the cervical and vaginal low-grade squamous epithelial lesion. After the treatment, patients with high-risk subtype HPV after cervical high-grade squamous epithelial lesion surgery can quickly clear and turn negative HPV, and the cervical lesion recurrence or canceration risk is obviously reduced.

Description

Traditional Chinese medicine composition for treating high-risk subtype cervical HPV persistent infection and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating high-risk subtype cervical HPV persistent infection and application thereof.

Background

Persistent infection with HPV of the high-risk cervical subtypes (16,18 and 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73) is the leading cause of cervical cancer and cervical intraepithelial neoplasia. At present, modern medicine lacks an effective treatment means for cervical HPV persistent infection, the 9-valent cervical cancer vaccine is only suitable for women under the age of 26 years, and has no treatment effect on patients infected with high-risk HPV, while the persistently infected patients have cervical intraepithelial neoplasia and cervical cancer lesion risks.

The blue leather excellent antibacterial liquid (Suwei Xiao (2017) No. 32010008) is a skin antibacterial external disinfectant for pudendum and the like developed by Nanjing Tenasi biotechnology development Limited company, and comprises the following main components: "Chlorhexidine acetate 0.12% -0.15% (w/w)"; dandelion, purslane, isatis root, dyers woad leaf, common cnidium fruit, scouring rush, safflower, rhubarb, lightyellow sophora root, brucea javanica and other more than ten traditional Chinese medicines. Is mainly used for vulvar skin disinfection, and has clinical reports of effective treatment of condyloma acuminatum. However, the persistent infection of the cervical high-risk subtype HPV by the blue leather is not reported at present.

Disclosure of Invention

The first purpose of the present invention is to provide a Chinese medicine composition for treating high risk subtype cervical HPV persistent infection, aiming at the defects in the prior art.

The second purpose of the invention is to provide the application of the traditional Chinese medicine composition for treating the high-risk subtype cervical HPV persistent infection.

In order to achieve the first purpose, the invention adopts the technical scheme that:

a traditional Chinese medicine composition for treating high-risk subtype cervical HPV persistent infection comprises antibacterial liquid of a blue family leather excellent and water for injection, wherein the volume ratio of the antibacterial liquid of the blue family leather excellent to the water for injection is 2: 0.8-1.1, wherein the antibacterial liquid of the blue leather excellent contains 0.12-0.15% (w/w) of chlorhexidine acetate, dandelion, purslane, isatis root, folium isatidis, fructus cnidii, scouring rush, safflower, rhubarb, radix sophorae flavescentis and brucea javanica.

Further preference is given to: the volume ratio of the antibacterial liquid of the blue leather excellent to the water for injection is 2: 0.9.

in order to achieve the second object, the invention adopts the technical scheme that:

the traditional Chinese medicine composition is applied to the preparation of medicines for treating high-risk subtype cervical HPV persistent infection diseases.

Further preference is given to: the traditional Chinese medicine composition is applied to the preparation of medicines for treating high-risk subtype 16,18 and 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 and 73 cervical HPV persistent infection diseases.

The blue leather excellent antibacterial liquid is only used for disinfecting skin parts such as vulva, vagina and the like, and has not been applied to the treatment of high-risk subtype cervical HPV persistent infection. The invention adopts the 'Lanzhou leather excellent' antibacterial liquid cervical vagina plugging method, and the gauze containing the 'Lanzhou leather excellent' antibacterial liquid is placed in the cervical canal for 6 to 12 hours with the length of 0.5 to 1cm and on the surface of the cervix and the position of the vaginal fornix, which is completely different from the prior art which is only used for skin surface disinfection.

The invention has the advantages that:

(1) can rapidly and effectively eliminate cervical HPV virus and rapidly convert negative (patients with high-risk subtype HPV persistent infection often cannot eliminate the virus by themselves or the negative conversion process is slow for 1 year or even years, and precancerous lesion or even canceration risk exists in the process)

(2) The treatment of the invention can quickly reverse the pathological result and avoid the progress to the canceration direction of the patient with the cervical and vaginal low-grade squamous epithelial lesion.

(3) After the treatment, patients with high-risk subtype HPV after cervical high-grade squamous epithelial lesion surgery can quickly clear and turn negative HPV, and the cervical lesion recurrence or canceration risk is obviously reduced.

(4) Social and economic benefits:

compared with the existing physical and pharmaceutical treatment aiming at the persistent infection of the high-risk subtype cervical HPV, the cervical and vaginal tamponade method of the antibacterial liquid has the advantages of simple operation, short treatment time, low cost, obvious reduction of cervical canceration risk of patients and great social and economic benefits.

Detailed Description

The following examples are provided to illustrate specific embodiments of the present invention.

Example 1

Traditional Chinese medicine composition for treating high-risk subtype cervical HPV persistent infection

The blue family leather excellent antibacterial liquid stock solution is diluted by adding water for injection (2 parts of blue family leather excellent, 0.9 part of water for injection), (blue family leather excellent antibacterial liquid: Suwei Xiao (2017) No. 32010008 is a pudendum and other skin antibacterial external disinfectant developed by Nanjing Tena biotechnology development Limited) (the water for injection is water which is specified under the Chinese pharmacopoeia water for injection, and the water for injection is distilled water or deionized water and is obtained by distilling) and is uniformly dripped into sterilized gauze.

Example 2

Traditional Chinese medicine composition (II) for treating high-risk subtype cervical HPV persistent infection

The blue family leather excellent antibacterial liquid stock solution is diluted by adding water for injection (2 parts of blue family leather excellent, 0.8 part of water for injection, (blue family leather excellent antibacterial liquid: Suwei Xiao (2017) No. 32010008 is a pudendum and other skin antibacterial external disinfectant developed by Nanjing Tena biotechnology development Limited) (the water for injection is water according to the specification of the Chinese pharmacopoeia water for injection, and the water for injection is distilled water or water obtained by distilling deionized water) and is uniformly dripped into sterilized gauze.

Example 3

Traditional Chinese medicine composition (III) for treating high-risk subtype cervical HPV persistent infection

The blue family leather excellent antibacterial liquid stock solution is diluted by adding water for injection (2 parts of blue family leather excellent, 1.1 parts of water for injection, (blue family leather excellent antibacterial liquid: Suwei Xiao (2017) No. 32010008 is a pudendum and other skin antibacterial external disinfectant developed by Nanjing Tena biotechnology development Limited) (the water for injection is water which is specified under the term of water for injection in Chinese pharmacopoeia, and the water for injection is distilled water or water obtained by distilling deionized water) and is uniformly dripped into sterilized gauze.

Example 4

Traditional Chinese medicine composition (IV) for treating high-risk subtype cervical HPV persistent infection

The blue family leather excellent antibacterial liquid stock solution is diluted by adding water for injection (2 parts of blue family leather excellent, 0.95 part of water for injection), (blue family leather excellent antibacterial liquid: Suwei Xiao (2017) No. 32010008 is a pudendum and other skin antibacterial external disinfectant developed by Nanjing Tena biotechnology development Limited) (the water for injection is water which is specified under the Chinese pharmacopoeia water for injection, and the water for injection is distilled water or deionized water and is obtained by distilling) and is uniformly dripped into sterilized gauze.

Example 5

Traditional Chinese medicine composition (V) for treating high-risk subtype cervical HPV persistent infection

The blue family leather excellent antibacterial liquid stock solution is diluted by adding water for injection (2 parts of blue family leather excellent, 1 part of water for injection, (blue family leather excellent antibacterial liquid: Suwei Xiao (2017) No. 32010008 is a private part and other skin antibacterial external disinfectant developed by Nanjing Tennes biotechnology development Limited) (the water for injection is water according with the specification of Chinese pharmacopoeia water for injection, and the water for injection is distilled water or water obtained by distilling deionized water) and is uniformly dripped into sterilized gauze.

Example 6

Control group Chinese medicinal composition 1

The blue family leather excellent antibacterial liquid stock solution is diluted by adding water for injection (2 parts of blue family leather excellent, 0.7 part of water for injection), (blue family leather excellent antibacterial liquid: Suwei Xiao (2017) No. 32010008 is a pudendum and other skin antibacterial external disinfectant developed by Nanjing Tena biotechnology development Limited) (the water for injection is water which is specified under the Chinese pharmacopoeia water for injection, and the water for injection is distilled water or deionized water and is obtained by distilling) and is uniformly dripped into sterilized gauze.

Example 7

Control group Chinese medicinal composition

The blue family leather excellent antibacterial liquid stock solution is diluted by adding water for injection (2 parts of blue family leather excellent, 1.15 parts of water for injection, the blue family leather excellent antibacterial liquid is a private part skin antibacterial external disinfectant developed by Nanjing Tennes biotechnology development limited company of Suwei Xiao (2017) No. 32010008) (the water for injection is water which is specified under the Chinese pharmacopoeia water for injection, and the water for injection is distilled water or deionized water and is obtained by distilling) and is uniformly dripped into sterilized gauze.

Example 8 effective experiment

1. Materials: examples 1 to 7 of the "Lanzuo" antibacterial liquid and water for injection

2. The application object is:

(1) patients with persistent infection of the cervical high risk subtype HPV for more than half a year (16,18 and 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73). Cervical biopsy prompting: low grade squamous epithelial lesion (LSIL) or cervical intraepithelial neoplasia grade I (CIN grade I) or chronic cervicitis. Exclusion criteria: patients with cervical high-grade squamous epithelial lesion (HSIL) or cervical epitheliomatous lesion II to III or cervical cancer are not treated by operation.

(2) The cervical high-grade squamous epithelial lesion or cervical canceration is treated by operation (LEEP operation and the like reserve cervical operation and have negative incisal margin), and the HPV is continuously positive after the reexamination for 4-6 months after the operation.

(3) Vaginal high-risk type HPV persistent infection, vaginal biopsy suggesting low grade squamous epithelial lesions of the vagina, or grade I vaginal intraepithelial neoplasia (grade VIN I). Exclusion criteria: high grade squamous epithelial lesion of vagina or grade II to III intraepithelial neoplasia of vagina or vaginal cancer.

3. The method comprises the following steps:

(1) grouping:

treatment group 1 patient baseline: the number of patients (16,18 and 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73) with the high-risk cervical subtype HPV infection is 70 in total, wherein the cervical biopsy indicates 5 LSIL, 2 low-grade squamous epithelial lesions of vaginal epithelium, 1 HPV-positive patients after cervical in-situ cancer operation, 5 HPV-positive patients after LEEP (cervical high-grade squamous epithelial lesion) operation, and 67 chronic cervicitis and other lesions. Treatment group 1. gauze with the antibacterial solution of example 1 was used.

Treatment group 2 patient baseline: the number of patients (16,18 and 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 and 73) with the high-risk cervical subtype HPV infection is 70 in total, wherein the cervical biopsy indicates that the number of LSIL is 4, the number of low-grade squamous epithelial lesions in vaginal epithelium is 1, the number of patients with HPV positive after cervical in situ cancer operation is 1, the number of patients with HPV positive after LEEP operation is 5, and the number of lesions such as chronic cervicitis is 65. Treatment group 1. gauze with the antibacterial solution of example 2 was used.

Treatment group 3 patient baseline: the number of patients (16,18 and 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 and 73) with the high-risk cervical subtype HPV infection lasting more than half year is 70, wherein the cervical biopsy indicates 5 patients with LSIL, 1 patient with low-grade squamous epithelial lesion of vaginal epithelium, 1 patient with HPV positive after cervical in-situ cancer operation, 3 patients with HPV positive after LEEP operation of high-grade squamous epithelial lesion of cervix, and 63 patients with chronic cervicitis and other lesions. Treatment group 1. gauze with the antibacterial solution of example 3 was used.

Control group 1 patient baseline: the number of patients (16,18 and 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73) with the high-risk cervical subtype HPV infection is 70 in total, wherein the cervical biopsy indicates that the number of LSIL is 3, the number of low-grade squamous epithelial lesions in vaginal epithelium is 2, the number of patients with HPV positive after cervical in situ cancer operation is 1, the number of patients with HPV positive after LEEP operation is 3, and the number of lesions such as chronic cervicitis is 66. Treatment group 1. gauze with the antibacterial solution of example 6 was used.

Control group 2 patient baseline: the number of patients (16,18 and 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73) with the high-risk cervical subtype HPV infection is 70 in total, wherein the cervical biopsy indicates 2 LSIL, 2 vaginal epithelial low-grade squamous epithelial lesions, 1 patient with HPV positive after cervical in situ cancer operation, 3 patients with HPV positive after LEEP operation of cervical high-grade squamous epithelial lesions, and 63 patients with chronic cervicitis. Treatment group 1. gauze of the antibacterial solution of example 7 was used.

(2) The vagina speculum opens the vagina to expose the cervix, the painless iodine disinfects the cervix, and the dry yarn ball is wiped clean.

(3) The long forceps clamp the gauze added with the antibacterial liquid, the gauze is inserted into the cervical canal from the cervix by the depth of 0.5-1cm, other parts of the gauze cover the surface of the cervix, the vagina and the fornix vaginae, and the vaginal speculum is slowly taken out after the gauze is filled, so that the gauze is positioned on the cervical canal, the surface of the cervix and the fornix vaginae.

(4) The gauze containing the blue leather excellent antibacterial liquid is placed in the cervix and vagina for 6 to 12 hours and then taken out.

(5) The blue leather excellent antibacterial liquid is used for 2-3 times per week according to the method, the medicine is stopped in the menstrual period, the medicine is applied again after the menstrual period is clean, and the antibacterial liquid is used for 50-60ml (the period is 6-8 weeks).

(6) The test was repeated 2 months after withdrawal and cervical/vaginal sampling was used to screen for HPV. If cervical low-grade squamous epithelial lesion (LSIL) exists before treatment

4. As a result:

as a result: the HPV is rechecked 2-3 months after the treatment,

as shown in table 1: five groups of cure rate and effective rate

The cure rate and the effective rate of the treatment group 1, the treatment group 2 and the treatment group 3 are better than those of the control group 2. The cure rate and the effective rate of the treatment group 1, the treatment group 2 and the treatment group 3 are equal to or close to those of the control group 1. However, as analyzed from the side effect (scar left) perspective, the side effects of the treatment group 1, the treatment group 2 and the treatment group 3 were significantly smaller than those of the control group 1.

In the treatment group 1, 66 persons all turn negative, 2 persons have partial subtype turn negative (3 subtype virus positive is screened for the first time, 2 subtypes turn negative is rechecked, 1 subtype is continuously positive), 2 persons have the subtype turn negative, and a new subtype infection appears in the rechecking (sexual life during the treatment period, considering the reinfection). Cervical biopsy was only suggestive of chronic cervicitis in 5 patients 6 months after treatment with LSIL. Patients after cervical in situ cancer operation turn negative by HPV after 4 months of treatment, chronic cervicitis is prompted by rechecking cervical biopsy after 6 months of treatment, and chronic cervicitis and HPV negativity are prompted by secondary biopsy after 1 year of treatment. The pelvic cavity magnetic resonance enhancement is not abnormal. Vaginal biopsy after 6 months of treatment in 2 patients with low grade squamous epithelial lesions of vaginal epithelium only suggested chronic inflammation.

64 persons in the treatment group 2 all turn negative, and 3 persons partially turn negative (wherein 1 person primarily screens 3 subtype virus positives, rechecks 2 subtype turn negative, and 1 subtype continuously positive; wherein 1 person primarily screens 4 subtype virus positives, rechecks 2 subtype turn negative, and 2 subtype continuously positive; wherein 1 person primarily screens 4 subtype virus positives, rechecks 3 subtype turn negative, and 1 subtype continuously positive). Cervical biopsies were only suggestive of chronic cervicitis in 4 patients reviewing 6 months after treatment. Patients after cervical in situ cancer operation turn negative by HPV after 4 months of treatment, chronic cervicitis is prompted by rechecking cervical biopsy after 6 months of treatment, and chronic cervicitis and HPV negativity are prompted by secondary biopsy after 1 year of treatment. The pelvic cavity magnetic resonance enhancement is not abnormal. Vaginal biopsy after 6 months after treatment of 1 person with low grade squamous epithelial lesions of vaginal epithelium only suggested chronic inflammation.

In the treatment group 3, all 60 persons turn negative, and partial 5 persons turn negative (wherein 1 person primarily screens 4 subtype virus positives, rechecks 3 subtype turns negative, 1 subtype continuously positive, wherein 3 persons primarily screen 3 subtype virus positives, rechecks 1 subtype continuously positive, and a new subtype infection appears in the rechecks, wherein 1 person primarily screens 3 subtype virus positives, rechecks 2 subtype turns negative, and 1 subtype continuously positive), and cervical biopsy after 6 months of treatment of 5 LSIL patients only indicates chronic cervicitis. After 1 cervical in situ cancer postoperative patient is treated for 4 months, HPV turns negative, after 6 months, cervical biopsy is rechecked to prompt chronic cervicitis, and biopsy is carried out again 1 year after treatment to prompt chronic cervicitis and HPV negativity. The pelvic cavity magnetic resonance enhancement is not abnormal.

The antibacterial liquid cervical and vaginal tamponade method for treating cervical high-risk subtype HPV persistent infection can enable cervical HPV to turn negative rapidly, change cervical and vaginal low-level squamous epithelial diseases to benign directions, and block the cervical HPV from turning to high-level squamous epithelial diseases and canceration directions. And can effectively and rapidly intervene the continuous HPV infection after cervical high-grade squamous epithelial lesion remaining cervical surgery (LEEP), so that the virus is rapidly cleared, and the recurrence and the progression risk of the postoperative cervical lesion of a patient are reduced.

The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating high-risk subtype cervical HPV persistent infection is characterized by consisting of antibacterial liquid of Yaaniou and water for injection, wherein the volume ratio of the antibacterial liquid of Yaaniou to the water for injection is 2: 0.8-1.1, wherein the antibacterial liquid of the blue leather excellent contains 0.12-0.15% (w/w) of chlorhexidine acetate, dandelion, purslane, isatis root, folium isatidis, fructus cnidii, scouring rush, safflower, rhubarb, radix sophorae flavescentis and brucea javanica.

2. The traditional Chinese medicine composition of claim 1, wherein the volume ratio of the antibacterial liquid of the Lanzhou leather to the water for injection is 2: 0.9.

3. the use of the Chinese medicinal composition according to claim 1 or 2 in the preparation of a medicament for treating high risk subtype cervical HPV persistent infection.

4. The use of claim 3, wherein the Chinese medicinal composition is used for treating high risk subtypes 16,18 and 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73 cervical HPV persistent infection.