The effectiveness of the use of API-NORM® vaginal suppositories by the patients after surgical treatment

Chaika G.V., Kucherenko O.M., Strichenko L.D

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Vinnytsia National Medical University named after E. Pirogov

Department of Obstetrics and Gynecology No. 1 (56 Pyrogova St., Vinnytsia, Ukraine, 21018)

Annotation

To increase the effectiveness of rehabilitation measures after surgical treatment, 70 women of reproductive age with ectopy of the cylindrical epithelium of the cervix associated with HPV were examined. According to rehabilitation measures after surgical treatment, they were divided into two groups.

The main group included 52 women who, after surgical rehabilitation treatment, received API-NORM® vaginal suppositories containing activated propolis extract, beeswax, St. John's wort extract, calendula, and sea buckthorn oil, once a day for 10 days. The comparison group included 28 women who were treated with suppositories containing methyluracil in a dose of 500 mg.

The analysis of the obtained data was carried out with the help of the program "STATISTICA 5.5" (belongs to the Center for Scientific Research of Vinnytsia National Medical University named after M.I. Pirogov, license #AXXR910A374605FA) using non-parametric methods of evaluating the obtained results.

It was determined that the use of this method of rehabilitation after electro-excision treatment of cervical pathology made it possible to reduce the regeneration period of the wound surface by 2.4 times and reduce the frequency of bleeding to 1.9% in the postoperative period. The appointment of API-NORM vaginal suppositories for postoperative rehabilitation helps to reduce the frequency of recurrence of the disease and the syndrome of the coagulated cervix to 3.8% and 1.9%, respectively, and promotes full epithelization of the cervix in 94.2% of cases. This testifies to the high effectiveness of the recommended method of rehabilitation.

Introduction

Diseases of the cervix are one of the most acute and urgent medical and social problems of modern gynecology, the frequency of which in the structure of gynecological pathology reaches 40.0 - 61.5%.

Despite the number of scientific discoveries, the frequency of cervical pathologies tends to increase, which negatively affects reproductive health and prompts the search for new strategies for diagnosis, treatment, and rehabilitation of this pathological condition.

Given the clear tendency to increase the frequency of cervical pathologies in young women, as well as to increase the age restrictions of the reproductive period, the priority is to adhere to an organ-preserving approach in the treatment of the cervix.

Timely diagnosis and the use of effective methods of treatment of cervical pathology are reliable guarantees of the prevention of benign and precancerous diseases of the cervix. In addition to conservative methods of treatment of cervical pathology, a surgical approach using modern methods (radio wave, cryo-destruction, laser, and argon plasma coagulation) is often used. The choice of a specific method of treatment depends on the age of the patient, the clinical form of the detected pathology, her intentions regarding reproduction in the future, and the presence of previous surgical interventions on the cervix. Undoubtedly, the first question that arises in the case of surgical treatment of cervical pathology is the question of the risk of complications and the possibility of recurrence, which prompts the search for new effective methods of rehabilitation in the postoperative period.

A decrease in the intensity of the regenerative processes of the epithelium of the cervix after surgery increases the risk of postoperative complications, leads to a violation of the processes of epithelialization and deformation of the tissues of the cervix, and as a result - to a relapse of the disease. To improve the course of treatment of the disease, it is necessary to create favorable conditions for the regenerative processes of the epithelium precisely at the stage of rehabilitation, after surgical intervention on the cervix.

Thus, the use of the above measures after surgical treatment on the cervix is an important and necessary step in the treatment of cervical pathology to improve the reproductive health of women.

The purpose of the study is to improve the effectiveness of rehabilitation measures after surgical treatment of ectopy of the cylindrical epithelium of the cervix in women of reproductive age associated with HPV.

Materials and methods

70 women of reproductive age with ectopy of the cylindrical epithelium of the cervix associated with HPV were examined and were divided into two groups according to the rehabilitation measures taken after the main treatment. The main group consisted of 52 patients who, from the fifth day after surgery, received API-NORM® vaginal suppositories for rehabilitation purposes, containing activated propolis extract, beeswax, St. John's wort extract, calendula oil, and sea buckthorn, once a day for 10 days. The comparison group included 28 women who were treated with suppositories containing methyluracil in a dose of 500 mg.

All patients underwent a comprehensive clinical and laboratory examination.

The analysis of the obtained data was carried out with the help of the program "STATISTICA 5.5" (belongs to the Center for Scientific Research of Vinnytsia National Medical University named after M.I. Pirogov, license #AXXR910A374605FA) using non-parametric methods for evaluating the obtained results.

The results. Discussion

The groups of examined patients were representative in terms of age. The average age of women in the main group was 31.7±3.2 years, the comparison group was 32.4±4.1 years.

In 22 (42.3%) patients from the main group with ectopy of the cylindrical epithelium associated with HPV, the main complaint was long-term discharge from the genital tract, which created unpleasant sensations and irritation in the area of the external genitalia. In the comparison group, the number of such women was 12 (42.8%).

Sexual disorders in the form of dyspareunia were indicated by 8 (15.4%) women in the main group and 6 (21.4%) patients in the control group.

Analyzing the anamnesis data, we established a high frequency of concomitant gynecological pathology in patients with ectopy of the cylindrical epithelium of the cervix associated with HPV, primarily inflammatory diseases of the genital organs. In particular, vaginitis was noted in 34 (65.4%) subjects from the main group and in 18 (64.3%) patients from the control group. Chronic salpingo-oophoritis occurred in 14 (27.0%) and 10 (35.7%) women of the main group and patients of the comparison group, respectively.

During the cytological examination on the 10-20th day of the menstrual cycle, the II (inflammatory) smear type (according to the Papanicolaou classification) was established in the vast majority of patients, namely in 48 (92.3%) patients of the main group and 25 (89.3%) ) patients of the comparison group. The present squamous intraepithelial changes of mild degree (LSIL) occurred in 4 (7.7%) patients of the main group and 3 (10.7%) patients of the control group.

It should be noted that the final diagnosis was made based on an extended colposcopy with a targeted biopsy.

Extended colposcopy confirmed the presence of ectopy of the cylindrical epithelium of the cervix in 48 (92.3%) women of the main group and 24 (85.7%) women of the comparison group. The presence of mild dysplastic changes in the epithelium of the cervix was established in 4 (7.7%) women of the main group and 4 (14.3%) women of the comparison group.

The results of the colposcopic examination and pathomorphological examination of the tissues of the cervix were the same.

It should be noted that at the preoperative stage, patients of both studied groups received complex isotropic anti-inflammatory therapy. In particular, women of the main group received API-NORM® vaginal suppositories as preoperative preparation according to the scheme: 1 suppository once a day for 10 days in the II phase of the menstrual cycle.

In the absence of an effect from conservative therapy, the next stage of treatment in these patients was loop excision of the cervix. The method is applied using an electrosurgical device that generates a constant low voltage that is transmitted to a loop designed to remove the altered tissue. There is simultaneous removal and coagulation of tissues. The technique makes it possible to obtain a fragment of tissue with a minimal burn surface area, which can be sent for histological examination to determine the degree of damage to the cervix and exclude undetected invasion, thanks to which both treatment and diagnosis are carried out. Operative intervention was carried out in an outpatient setting under local anesthesia, in the first phase of the menstrual cycle using the device "Nadia-4, model 300".

For rehabilitation in the postoperative period, from the fifth day after electro-excision treatment, the women of the main group were offered suppositories API-NORM® for vaginal administration, containing activated propolis extract, beeswax, St. John's wort extract, calendula, and sea buckthorn oil, once a day for 10 days. Women in the comparison group were offered suppositories containing methyluracil in a dose of 500 mg according to a similar scheme.

It should be noted that the main active substances of the API-NORM® drug, which was used by patients of the main group for rehabilitation, are activated propolis extract, beeswax, St. John's wort extract, calendula, and sea buckthorn oil. Therefore, due to the above-mentioned active substances included in the composition of API-NORM® suppositories, the drug has a pronounced anti-inflammatory, cytoprotective, reparative, antioxidant, and immunomodulatory effect, which is extremely appropriate and necessary in the postoperative period. The effect of this drug is aimed at improving the trophic and restorative processes of the epithelium of the cervix, which, in turn, minimizes the risk of postoperative complications in the future.

The only contraindication to the use of this drug is increased individual intolerance to beekeeping products.

When observed in dynamics, for 3 months, the proposed method of rehabilitation after surgical treatment of ectopy of the cylindrical epithelium of the cervix made it possible to reduce the regeneration period of the wound surface by 2.4 times, reduce the probability of bleeding to 1.9% in the postoperative period, compared to women in the comparison group, which received treatment with the drug with methyluracil, this indicator was 17.8%.

Complications such as coagulated cervix syndrome and cervical endometriosis were 1.9% and 1.9% of women in the main group, compared with 10.7% and 7.1% of women in the control group, respectively.

The frequency of recurrence of the disease in the postoperative period after using the rehabilitation method chosen by us was 3.8% and 25.0%, respectively. Full epithelization of the cervix was established in 94.2% of cases.

Summarizing the results of our research, we found that to increase the effectiveness of the treatment of cervical pathology and prevent early and long-term postoperative complications, this method of rehabilitation in women of reproductive age with ectopy of the cylindrical epithelium of the cervix associated with HPV is highly effective and can be recommended for widespread implementation in health care institutions of the obstetric and gynecological profile.

Conclusions and prospects for further development

The results of the conducted studies prove that the use of API-NORM® vaginal suppositories in women of reproductive age with the presence of ectopy of the cylindrical epithelium of the cervix associated with HPV at the stage of rehabilitation after surgical treatment made it possible to reduce the regeneration time of the postoperative wound surface by 2.4 times, as well as reduce the frequency of bleeding and the syndrome of coagulated cervix up to 1.9%, recurrences of the disease - up to 3.8%, which contributed to full epithelization of the cervix in 94.2% of cases.

To consolidate the results, patients are given recommendations regarding sexual rest limitation of physical activity for 4 weeks, and a ban on thermal procedures for 14 days after surgical treatment. It is also recommended to use API-NORM® vaginal suppositories from the fifth day after surgery, one suppository per night for 10 days.

The next follow-up examination is recommended after 4–6 weeks, with colposcopic and cytomorphological examinations followed by monitoring once every three months for one year.