Vaginal Suppositories Research Articles

The Efficacy of Vaginal Suppository Based on Alcea angulata Freyn & Sint. (A Persian Medicine Product) in Patients with Vaginal Atrophy: A Randomized, Double-Blind, Placebo-Controlled Trial

Vaginal atrophy is one of the most common complaints in postmenopausal women. Symptoms of vaginal atrophy include dryness, itching, bleeding, and dyspareunia. According to Traditional Persian Medicine (TPM), the using of moisturizing plants can treat dry mucous membranes. TPM suggests the use of marshmallow (Alcea angulata) to moisturize dry mucus with its mucilage. The aim of this study was to evaluate the effect of Alcea on the treatment of vaginal atrophy. This double-blind, clinical trial was conducted on 60 postmenopausal women with vaginal atrophy (40 – 65 years of age). The patients were randomly assigned into two groups of treatment and control (n = 30). The treatment group received Alcea vaginal suppository 5% (125 mg), and the control group received placebo. Both groups used suppositories every night for two weeks and every other night for six weeks. Vaginal Maturation Value (VMV), symptoms of vaginal atrophy, and pH were compared before and after the intervention. Data were analyzed using SPSS 16. VMV was increased in the treatment group, from 40.30 ±13.27 to 46.40 ± 11.27, (p ˂ 0.0001) compared to the control group, in which the change of VMV was not significant (p ˂ 0.122). The vaginal pH was significantly decreased in the treatment group, from 6.45 ± 0.92 to 5.52 ± 0.62, (p ˂ 0.0001) compared to the control group, in which the change of pH was not significant (p ˂ 0.257). The symptoms were significantly reduced in the treatment group. It seems that Alcea vaginal suppository can be useful as a natural product to relieve the symptoms of vaginal atrophy.

Subcutaneous progesterone (Prolutex) versus vaginal (Cyclogest) for luteal phase support in IVF/ICSI cycles: a randomized controlled clinical trial

BackgroundTo compare the safety, efficacy, and tolerability of subcutaneous vaginal progesterone suppository for luteal phase support (LPS) in assisted reproduction technology (ART) cycles in patients referred to the Royan Institute.MethodsThis randomized clinical trial was conducted from August 2016 to March 2018. The infertile patients undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) were evaluated. The controlled ovarian stimulation (COH) was performed in all of the patients with standard long GnRH agonist protocol. After ovum pickup, eligible women were randomly allocated into two groups. In group A, since oocyte retrieval day, subcutaneous injections of progesterone (50 mg) (Prolutex®) were used daily, and in group B, two vaginal suppositories (Cyclogest ®) were administrated for LPS. The clinical pregnancy and miscarriage rates and the drug’s side effect were compared between two groups by appropriate statistical tests.ResultsFinally, 40 patients in each group were enrolled, and the IVF/ICSI outcomes were compared between groups. The data analysis showed that no significant differences were found between groups in terms of the demographic, infertility characteristics, and the COH outcome between groups. The chemical and clinical pregnancy rates (CPR) in group A were significantly higher than those of group B (P = 0.04, P = 0.02, respectively). The implantation and twin pregnancy rates in group B were significantly higher than those in group A (P = 0.009, P = 0.02, respectively).ConclusionThe subcutaneous administration of progesterone 25 mg twice daily for LPS was associated with higher CPR versus vaginal progesterone, and it was safe and well-tolerated in the follow-up. In addition, it can be a suitable replacement in cases of allergic reactions to vaginal suppositories. However, further study is required to compare the cost-effectiveness of these medications.Trial registrationThe study was also registered in the Iranian Registry of Clinical Trials on February 19, 2015 (IRCT201402191141N18 at www.irct.ir, registered prospectively).

Effect of Dual Trigger with Follicle Stimulating Hormone and Chorionic Gonadotropin Hormone on Ovulation Rate in Infertile Women received Aromatase Inhibitor Superovulation in Kirkuk City, Iraq

A prospective during the period October 2020 to April 2021, a comparative study was conducted at the Al-Nahrain University’s High Institute for Infertility Diagnosis and Assisted Reproductive Technologies (HIIDART). The study’s primary goal was to determine whether using a dual trigger (FSH and hCG) could increase the likelihood of achieving pregnancy. The participants in this study totaled one hundred women. Before taking part in the study, each participant signed a written informed consent form that was approved by the Al-Nahrain University’s Ethics Committee before participating. A total of one hundred and one women participated in the study, who were chosen from among those who attended the consultant clinic of the High Institute for Infertility Diagnosis and Assisted Reproductive Technologies in New York City. On the day of the IUI An ultrasound scan of the vaginal cavity was performed after 36 to 48 hours of trigger ovulation to confirm ovulation, measure, and evaluate the endometrial pattern, and assess sub endometrial blood flow. FSH, LH, Progesterone, and E2 levels were determined in a blood sample drawn on the same day for hormonal testing. Luteal phase support was initiated on the day of the IUI and continued for two weeks by administering 400 mg of progesterone vaginal suppository daily to the patient. Estimation of Beta human chorionic gonadotropins 14 days after IUI. The distribution of study groups by general characteristics is shown in Table 1. Study patients’ age was ranging from 19 to 39 years with a mean of 29.98 years and a standard deviation (SD) of ± 5.3 years. The highest proportion of study patients in all groups was aged between 25–34 years, overweighed, and complained from infertility for less than five years’ duration. The comparison in hormonal parameters between study groups at day of IUI is shown in Table 4.5. Mean of FSH level was significantly lower (p = 0.031) in group C than that in groups A and B (6.98 versus 9.06 and 9.3 IU/L respectively). Mean of E2 level was significantly higher (p = 0.001) in-group A than that in groups B and C (69.62 versus 53.32 and 36.65 pg/mL, respectively). The comparison in percentage of change in hormonal parameters at day of IUI compared to that at day of trigger according pregnancy outcome is shown in table (4.16). No significant differences between women who get pregnant than that in those who didn’t, in percentage of change of all other hormonal parameters at day of IUI (p ≥ 0.05) compared to that at day of trigger.

Innovative Earth-Friendly UV-Spectrophotometric Technique for In Vitro Dissolution Testing of Miconazole Nitrate and Nystatin in Their Vaginal Suppositories: Greenness Assessment.

The combined mixture of miconazole nitrate (MIC) and nystatin (NYS) has proven its efficiency as a prodigious remedy to cure women's frequent infections: vaginal mycosis and vaginal candidiasis. A novel green spectrophotometric technique, namely the Fourier self-deconvolution method (FSD), was employed for the quantitative determination of MIC and NYS in their pure and pharmaceutical forms without prior separation. Moreover, the proposed technique was first employed to study the dissolution profile of the cited drugs in their pharmaceutical formulation according to FDA recommendations without excipient interference. The FSD method is based on a simple mathematical manipulation of zero-order spectra of the cited drugs, which suffered from severe overlapping, so zero-order spectra of the cited drugs were deconvoluted using the Fourier wavelet function in spectrophotometer software. The deconvoluted amplitudes for MIC and NYS were measured at 255 nm and 320 nm, respectively. Linearity ranges were 70-700 µg/mL for MIC and 1-25 µg/mL for NYS. The greenness of the proposed technique was assessed using two assessment tools, namely eco-scale scoring and green analytical procedure index (GAPI), revealing the excellent greenness of this technique. The proposed technique was validated consistent with ICH guidelines and statistically compared to the reported method with no significant differences between them. The proposed technique has advantages of being simple, time-saving, and noting need any modification to be suitable for quantitative analysis of MIC and NYS in both pharmaceutical and laboratory mixtures. An innovative FSD method was developed for quantitative analysis of MIC and NYS in their synthetic and pharmaceutical mixtures and applied for in vitro dissolution testing of their pharmaceutical mixture, producing satisfactory results.

Preliminary Data from Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent BV [A80

INTRODUCTION: Bacterial vaginosis (BV) is a vaginal dysbiosis causing pain, irritation, discharge, odor, and itching. Antibiotic treatment is standard of care, but BV recurs in up to 50% of patients in 1 year. We hypothesized that using the Flourish Vaginal Care (FVC) system (an over-the-counter kit by Good Clean Love), with iso-osmotic components to optimize vaginal pH and Lactobacillus levels would reduce BV recurrence. METHODS: Ten women with two or more BV episodes within the past 2 years were enrolled in the pilot study for 11 weeks. Participants were treated with metronidazole and simultaneously started on a daily external wash with pH<4.4; iso-osmolar intravaginal lactic acid-containing gel every other day, and vaginal homeopathic suppository in a probiotic base every 3 days. Outcomes were vaginal pH, BV, and yeast occurrence tested biweekly. Participants journaled associated symptoms daily. Patient satisfaction was determined via telephone interview 10-12 months post trial. RESULTS: During the trial, no participants had BV recurrence. Mean vaginal pH decreased from 4.54 to 4.08 at baseline to study end. Journals showed decreased frequencies of pain and irritation (∼2-fold) and itching (∼4-fold). All (100%) of subjects participating in telephone interviews were satisfied with their symptom resolution 10-12 months post trial. CONCLUSION: Our pilot study shows that consistent use of vaginal products that are iso-osmotic and support optimal vaginal pH with bio-matched lactic acid prevents BV recurrence and alleviates associated symptoms. This work has important implications for prevention of recurrent BV and is evidence for the importance of maintaining the vaginal microbiome.

Evaluation of biomarkers in the studies of keloid tissue after laser therapy

The main metabolite of lactobacilli, regulating their anti-inflammatory functions, is lactic acid (LA), which maintains the physiological state of the microbiocenosis of the vagina of women of reproductive age. Normocenosis of the vagina is based on a combination of acidic environment and colonization resistance. Pathogenic and conditionally pathogenic pathogens are colonized mainly in an alkaline environment. LA is an important biological substrate that supports the vaginal microbiota. Normally, the reaction of the vaginal contents is a pH of 3.8 to 4.5, and only in this case lactobacilli predominate in the biotope, which are able to unite into special communities – biofilms, forming the most powerful factor in protecting the vagina from adhesion and invasion of pathogens: a full-fledged lactobacillary biofilm is often able to prevent adhesion of even STI pathogens. Disruption of the functioning of each of the links of protection of the vaginal microbiome leads to a change in the pH of the habitat and excessive reproduction of conditionally pathogenic microorganisms. A frequent infectious syndrome, accompanied by an imbalance of the vaginal microbiota and the replacement of lactoflora with various types of anaerobic microorganisms (Gardnerella vaginalis, Ureaplasma urealyticum, Mycoplasma hominis, Mobiluncus, Prevotella), is bacterial vaginosis. When prescribing antibacterial treatment, side effects are possible: allergic reactions, hepatotoxic, nephrotoxic, candidiasis. The review presents the possibility of using LA, which is a basis in the composition of the drug Lactodepantol (Femilex®) – vaginal suppositories containing 100 mg of LA, as the main factor regulating the natural composition of the vaginal microbiota and the possibility of using vaginal suppositories based on LA (lactodepantol) for the prevention and treatment of bacterial vaginosis in the form of monotherapy and in combination with antimicrobials.

Comparative Study of the Therapeutic Effect of Nigella Sativa Vaginal Suppository against Clotrimazole Vaginal Cream among Women with Candida Albicans Infection

Objective and Background: Candida Albicans is responsible for 90% of vaginal fungal infections. This study aimed at comparison of the therapeutic effect of Nigella Sativa vaginal suppository against Clotrimazole vaginal cream among women with Candida Allicans vaginal infection. Materials and Methods: This interventional study is an analysis performed on 68 non-pregnant women suffering from Candida Albicans infection who referred to Alavi Hospital in Ardabil. They were divided into two equal groups of 34 people including Nigella Sativa (intervention group) and Clotrimazole vaginal cream (control group). Clinical and experimental symptoms and signs were observed and recorded by a questionnaire and form at the beginning of the study and after treatment. Treatment was performed in both groups for 7 nights. Data was analyzed by one-way ANOVA, t-test and McNemar Test. Results: The results of the study showed that the rate of improvement and treatment failure in the intervention and control groups was 86.30%-14.70% and 58.82%-41.18%, respectively. There was a significant difference between the two groups (p<0.002). Conclusion: The present study showed that Nigella Sativa vaginal suppository provides a more effective therapeutic effect on Candida Albicans vaginal infection compared to Clotrimazole vaginal cream.

Study on the Application Value of Fluconazole Combined with Clotrimazole Vaginal Suppository in the Treatment of Mycotic Vaginitis

Study on the Application Value of Fluconazole Combined with Clotrimazole Vaginal Suppository in the Treatment of Mycotic Vaginitis

Development and Evaluation of Vaginal Suppository Containing Althaea officinalis L. Polysaccharide Extract

Intrauterine adhesions cause several gynecological problems. Althaea officinalis L. roots known as marshmallows contain polysaccharides (M.P.) which possess anti-inflammatory and anti-ulcerogenic activities also can form a bio-adhesive layer on damaged epithelial membranes prompting healing processes. Vaginal formulations of herbal origin are commonly applied to relieve cervico-uterine inflammation. Herein, we aim to develop and evaluate vaginal suppositories containing polysaccharides isolated from the A. officinalis root. Six formulations (four P.E.G.-based and two lipid-based suppositories containing 25% and 50% M.P.) met standard requirements, which were then subjected to qualitative and quantitative evaluation. All suppositories exhibited acceptable weights, hardness, content uniformity, melting point, and disintegration time, which fall within the acceptable recommended limits. Higher concentrations of M.P. in PEG-bases moderately increased the hardness (p<0.05). PEG-formulations showed content uniformity>90% of the average content while it was 75-83% for suppocire formulations. All formulations disintegrated in<30minutes. In-vitro release test revealed that M.P. release from 25%-MP formulations was higher than that of 50%-M.P. suppositories. Overall, results revealed the feasibility of preparing P.E.G.-or lipid-based suppositories containing M.P., which met the B.P. quality requirement.

Vaginal Vitamin E for Treatment of Genitourinary Syndrome of Menopause: A Systematic Review of Randomized Controlled Trials.

Genitourinary syndrome of menopause significantly affects the quality of life in postmenopausal women with few evidence-based alternatives to vaginal estrogen for women with contraindications. This systematic review evaluates the evidence for vaginal vitamin E efficacy in reducing patient-reported genitourinary symptoms in healthy postmenopausal women compared to placebo or vaginal control therapy. This systematic review evaluated randomized controlled trials before October 2020 that assessed the efficacy of vitamin E vaginal suppositories in reducing genitourinary symptoms in postmenopausal women compared with a control group of healthy postmenopausal women. Outcomes included patient-perceived genitourinary symptoms. Of the 31 studies, four met the inclusion criteria. One 8-week trial (n = 42) found a significant reduction in vaginal symptoms in the 1 mg vitamin E group than the placebo group (difference in means, 5.3; 95% confidence interval [CI], 4.4 to 6.2). Another 8-week trial (n = 40) found 5 mg vaginal hyaluronic acid superior to 1 mg vitamin E (difference in means -0.50, 95% CI, -0.95 to -0.05). Two 12-week trials (n = 52 in each) found no difference between 0.5 g vaginal estrogen and 100 IU vaginal vitamin E in healthy postmenopausal women (difference in means: -0.19, 95% CI, -4.4 to 4.0, and -3.47, 95% CI, -13.8 to 6.8). Evidence from small, limited studies suggests that vaginal vitamin E may be effective in alleviating symptoms of genitourinary syndrome of menopause; however, additional high-quality studies are needed to determine efficacy, ideal dosing, and long-term safety.

The role of vaginal progesterone in established pre-term labor: A randomized controlled trial.

Pre-term birth (PTB) is the leading cause of mortality and morbidity in newborn and infants. One of the proposed theories is the withdrawal of progesterone, either actual or functional, to be an antecedent to the onset of labor. The aim of the study is to evaluate the role of vaginal progesterone in delaying delivery following an episode of arrested pre-term labor. This is a pragmatic open-label randomized controlled trial that was conducted in the Department of Obstetrics and Gynecology at All India Institute of Medical Sciences, Jodhpur. Hundred patients with singleton pregnancies presenting with pre-term labor between 24 and 34 weeks of gestation and treated successfully with acute tocolysis for 48 hours and steroids covered were randomized to receive either progesterone 400 mg vaginal suppository or no treatment. The primary outcome was the duration of randomization to delivery interval, which was significantly higher in the study than in the control group (28 days versus 10 days). The secondary outcomes such as gestational age at delivery was also higher in the study group compared to the control group (82% versus 60% delivered after 37 weeks in the study group and control group, respectively). The neo-natal outcomes such as birth weight (2802 grams versus 2324 grams), incidence of respiratory distress syndrome (RDS) (13% versus 26%), and newborn intensive care unit (NICU) admission (17% versus 31%) were lower in the study group, which signifies decreased neo-natal morbidities and mortalities in pre-term labor treated with maintenance tocolysis in the form of vaginal progesterone. Administration of vaginal progesterone (400 mg, daily) following an episode of arrested pre-term labor significantly increased the duration to delivery interval; that is, it reduced the rate of PTB before 37, 32, and 28 weeks of gestation among women. It further reduced the neo-natal morbidities such as RDS and NICU admission and increased the birth weight among infants of women assigned to progesterone treatment.

Экофуцин® как профилактика развития кандидозно- бактериального дисбиоза влагалища на фоне применения системной антибактериальной терапии

Aim: to assess the efficacy and safety of Ecofucin® in patients after performing planned gynecologic surgery procedures based on the changes in vaginal microbiota over time amid the use of systemic antimicrobial therapy (AMT). Patients and Methods: this prospective open randomized comparative parallel-group clinical study involved patients without signs of vaginal microbiota dysbiosis — bacterial vaginosis or candidiasis, who were hospitalized for planned surgery procedures. The group 1 patients (n=39) received systemic AMT and Ecofucin® for intravaginal application once a day at the bedtime for 12 days, starting 6 days before the planned surgery and AMT initiation, while the group 2 patients (n=40) received only systemic AMT. The efficacy was assessed a day after the completion of AMT and the use of the tested medication (i.e. on day 13 after the initiation of Ecofucin application) and 30±2 days after the initiation of using the tested drug. Clinical, microbiological and molecular genetic methods were used for the assessment. Results: symptoms common for vaginal microbiota dysbiosis — bacterial vaginosis and candidiasis were reported by 18% and 21% of the group 2 patients at days 13 and 30±2 after the initiation of AMT, while such symptoms were not recorded in any of the group 1 patients (F=0,107, р=0,007). In 100% of the group 1 patients both lactobacilli and bifidobacteria were detected at all endpoints. In group 2, lactobacilli were found at days 13 and 30±2 in 93.8% and 97% of patients, respectively (F=0.035, p=0.2; F=0.017, p=0.458), bifidobacteria — in 84.4% and 81.1% of patients, respectively (F=0.092, р=0.016; F=0.107, р=0,007, respectively). At the baseline, the groups had similar results of the vaginal discharge culture tests. In the group 1 patients, Candida spp. were not identified at any of the endpoints, in group 2 — Candida spp. were found in 22.5% of patients, starting from day 13 (F=0,125, р=0,002). No adverse events were reported. Conclusion: the administration of Ecofucin® vaginal suppositories containing natamycin 100 mg and excipient lactulose is effective for preventing microbiota dysbiosis — bacterial vaginosis and candidiasis in patients receiving antimicrobial therapy. KEYWORDS: vagina, microbiocenosis, antimicrobial therapy, lactobacilli, bifidobacteria, candidiasis, natamycin, lactulose. FOR CITATION: Kuzmin V.N. Ecofucin® for the prevention of vaginal microbiota dysbiosis — bacterial vaginosis and candidiasis amid the use of systemic antimicrobial therapy. Russian Journal of Woman and Child Health. 2022;5(4):292–296 (in Russ.). DOI: 10.32364/2618-8430- 2022-5-4-292-296.

Luteal Phase Support in Intrauterine Insemination Cycles: A Randomized Clinical Trial of Vaginal Versus Intramuscular Progesterone Administration.

Background:Different progesterone doses and routes are used for luteal phase support in stimulated intrauterine insemination (IUI) cycles, but the optimal supplementation scheme has not yet been determined. Therefore, our aim was to compare the administration of two different doses of vaginal progesterone with two doses of intramuscular (IM) progesterone for luteal phase support in patients undergoing IUI cycles.Methods:In this randomized clinical trial, 312 women with unexplained or malefactor infertility intending to start IUI cycles between April 2015 and January 2018 were included. They were randomized into four groups (n=78/each) including group 1 who received IM progesterone in oil (25 mg daily), group 2 who received IM progesterone in oil (50 mg daily), group 3 who received progesterone suppository (400 mg daily), and group 4 who received progesterone suppository (800 mg daily; 400 mg twice daily). The primary outcome was the clinical pregnancy rate. The ongoing pregnancy rate, abortion rate, and patients’ satisfaction, and convenience the secondary outcomes.Results:In our study, the overall clinical and ongoing pregnancy rates per cycle with COS and IUI were 16.02% and 12.8%, respectively. There were no significant differences in clinical pregnancy, ongoing pregnancy, and abortion rates among groups (p=0.84). The overall patients’ satisfaction and convenience was significantly higher in the vaginal progesterone suppository groups than the IM progesterone groups (p=0.001).Conclusion:The results of this study showed that vaginal progesterone administration provides a more easy-to-use and convenient method than IM progesterone administration for luteal phase support in IUI cycles with comparable pregnancy rates.

Preliminary Studies on the Formulation of Vaginal Suppositories with Liposomal Oregano Oil

Infections with Candida species represent a large percentage of the total number of fungal infections in the vaginal mucosa. Conventional treatments with antifungal medicinal substances have proven to be low in efficiency, so we are currently looking for alternative products based on plant extracts (these being more effective according to existing studies but also non-toxic). Our study aimed to obtain the oil of Origanum vulgare L. and its characterization from the point of view of antimicrobial

Dependence of the dynamics of changes in the quality of life of patients with bacterial vaginosis on local levels of TNF-α and IL-1β.

Background and aim:Bacterial vaginosis is among serious health problem for women of reproductive age commonly associated with aberrant changes in the vaginal microbiome that influences on their local changes in inflammatory mediators and quality of life. The aim was to assess the dependence of the dynamics of changes in the quality of life of patients with bacterial vaginosis on local levels of TNF-α and IL-1β.Methods:In the prospective study 37 women aged 19-40 years with bacterial vaginosis were treated according to the Centres for Disease Control and Prevention. Patients received vaginal suppositories of clindamycin phosphate (100 mg) once daily for 3 days before bedtime. TNF-α, IL-1β levels in vaginal secretions by means of ELISA test), as well as the quality of life according to the RAND 36-Item Health Survey 1.0 were studied as in control group (once - to determine the reference values) and in the dynamics (the 1st day – before treatment, on the 7th day – after treatment) in the main group.Results:After the treatment microscopy of smears-imprints of vaginal secretions showed the complete absence of pathological microflora. The treatment was well tolerated by all patients. In the result there was proved the role of bacterial vaginosis in a violation of the quality of life of patients mainly due to the mental component of health, even after clinical and laboratory recovery.Conclusions:There was proved the relation of vaginal TNF-α and IL-1β with physical and mental health in patients with bacterial vaginosis which can have a prognostic significance of the disease. (www.actabiomedica.it)

Снижение частоты рецидивов бактериального вагиноза. Комплексное решение

Objective. To reduce the recurrence rates of bacterial vaginosis by applying a complex two-stage approach to its treatment. Patients and methods. Patients with bacterial vaginosis were divided into three groups. Group 1 (n = 30) received treatment with Metronidazole (vaginal) 500 mg 2 times a day for 7 days; group 2 (n = 30) was treated with Lactobacillus casei rhamnosus Doderleini (1 vaginal capsule daily for 14 days); in group 3 (n = 29), patients received Acylact DUO (1 vaginal suppository daily for 10 days) at the second stage of treatment. Patient age in group 1 was 30.7 ± 4.4 years, in group 2 – 29.7 ± 4.3 years, in group 3 – 27.1 ± 2.4 years. Results. The qualitative and quantitative composition of the vaginal microbiota one month after treatment showed that patients in group 1 had the lowest level of Lactobacilli and the highest titers and diversity of microflora, while patients in group 3 had the highest level of Lactobacilli. Three months after the end of treatment, the level of bacterial contamination remained within the range of 5 lg in patients in groups 2 and 3, while patients in group 1 had it higher than 106 Ge/mL. The level of Lactobacilli in group 3 was higher than in groups 1 and 2. Absolute normocenosis of the vaginal microbiota was revealed in 56.7% of patients in group 1, in 80% of patients in group 2, and in 82.7% of patients in group 3 six months after the end of treatment. Conclusion. The use of a two-stage approach to bacterial vaginosis treatment is effective and reduces recurrence rates with a six-month follow-up. Key words: bacterial vaginosis, Acylact DUO, Lactobacillus crispatus

Отдаленные результаты цитокинотерапии у беременных с дисплазией шейки матки

Aim: to assess long-term outcomes of exogenous cytokine therapy in pregnant women with cervical intraepithelial neoplasia (CIN). Patients and Methods: this prospective study included 50 pregnant women with CIN. Women were randomized into two groups. Group 1 women (n=30, mean age 31.6±1.7 years) received vaginal suppositories with Superlymph 25 U. Group 2 women (n=20, mean age 29.8±1.4 years) received rectal suppositories with Superlymph 25 U. Cervical smear cytology (at baseline, 22 days after starting treatment, and 6 weeks after delivery), colposcopy, and cervical biopsy (at baseline and 6 weeks after delivery) were performed. Results: in group 1, cytology revealed high-grade squamous intraepithelial lesion (HSIL) in 43.3%, atypical squamous cells-cannot exclude a high-grade lesion (ASC-H) in 6.7%, and atypical squamous cells of undetermined significance (ASCUS) in 10%. In group 2, cytology revealed low-grade squamous intraepithelial lesion (LSIL) in 25%, HSIL in 45%, ASC-H in 10%, and ASCUS in 20%. After the treatment course, in group 1, a regress from HSIL to LSIL was detected in 6.7%, regress from LSIL to ASCUS in 3.3%, and regress from HSIL to ASC-H in 3.3%. In group 2, NILM was detected in 5%, a regress from HSIL to LSIL in 5%, and regress from LSIL to ASCUS in 5%. Histologically, LSIL was verified in 50% of women of both groups, CIN grade 2 in 36.7% (group 1) and 40% (group 2), CIN grade 3 in 13.3% (group 1) and 10% (group 2). Six weeks after delivery, cytological abnormalities were identified in 30 women of both groups (HSIL in 56.7% and LSIL in 43.3%). Histology detected carcinoma in situ in 3.3% and CIN grade 2–3 in 53.3%. Delivery in time (on average, at 38.4±1.1 weeks of gestation) occurred in all women. Conclusion: trend toward the improvement of cytological parameters irrespective of the mode of drug administration is reported after finishing cytokine therapy. Normalization of cytological findings was reported in 3.3% (group 1) and 5% (group 2), while improvement was reported in 6.6% (group 1) and 10% (group 2). No worsening was reported.

The role of non-hormonal methods in treatment of urogenital menopausal syndrome: modern views

The article is devoted to a review of the literature on the problem of overcoming the negative outcomes of the genitourinary syndrome of menopause (GSM). It is known that a woman is in menopause almost 30–40% of her life, and according to WHO, by 2030, 1.2 billion women will be in postmenopause. At the same time, there is an increase in life expectancy in developed countries, which also leads to an increase in the number of women with GSM. The article presents the pathogenetic mechanisms of the development of GSM, in particular, it is indicated that the occurrence and degree of manifestations of this pathology are proportional to the decrease in estrogens level and their metabolism in the organism. The prevalence of GSM symptoms among menopausal women has been shown in the article. The negative impact of the GSM outcomes on the quality of life of patients is described. Women who are sexually active during menopause are more likely to have the manifestations of this pathology and consult with the doctor, but sexually inactive women can also benefit from awareness of the manifestations and the treatment of GSM. Unlike vasomotor symptoms, which may become less pronounced over time, the manifestations of GSM progress if not to treat them, tend to more severe course, and almost never disappear spontaneously.Modern approaches to the treatment of this pathology are also given. In particular, the possibility of prescribing plant therapy as an alternative to menopausal hormone therapy is considered. Herbal medicines can be used for a long time and without health risks. A range of vaginal oils, vaginal moisturizers with hyaluronic acid, isoflavones (a medicine with fennel, chamomile and saffron) are commonly used to treat women with GSM.The article discusses the issues of recommendations for the prescription of herbal therapy, its advantages and features of use. The possibility of treating the symptoms of GSM for sexually active and inactive women with vaginal suppositories, which include hyaluronic acid (in the form of sodium salt), tocopherol acetate, Asian centella extract, chamomile flower extract, calendula officinalis flower extract, which have a moisturizing, regenerative effect, antiseptic, anti-inflammatory action for the rapid restoration of the vaginal mucosa. The effectiveness and safety of such therapy was established.

Biological Evaluation of Medical Devices in the Form of Suppositories for Rectal and Vaginal Use

Background. Programs of preclinical safety studies of the health care products depend on the regulatory status of the investigated products. The classification of such products, in particular suppositories for rectal and vaginal use, is a critical step of developing tactics for their biological evaluation. Adaptation of biological evaluation methods for the medical devices based on the combination of biologically active substances, as well as evaluation of the results of such studies is urgent task of biomedicine. Objective. To substantiate the regulatory status and to carry out a biological evaluation of medical devices in the form of vaginal suppositories based on octenidine dihydrochloride ("Prodexyn") and in the form of rectal suppositories based on Saw palmetto, Levisticum officinale and Calendula officinalis extracts ("Pravenor"). Methods. Biological evaluation was conducted according to the requirements of ISO 10993 standards using in vitro and in vivo biological test systems (cytotoxicity in cell culture and the MTT test, sensitizing and irritating effect in guinea pigs). Results. The cytotoxicity (СС50) of the medical device "Prodexyn" extract in Vero cell culture was 8.35 μg/ml calculated as octenidine dihydrochloride and 416.65 μg/ml calculated as dexpanthenol. "Pravenor" medical device was found to be non-toxic in Vero cell culture. According to the results of MMT assay CC50 for octenidine dihydrochloride was 1.67 μg/ml, and 83.33 μg/ml – for dexpanthenol. CC50 indicators calculated for the different active ingredients of the medical device "Pravenor" were the following: 50 mg/ml for the dwarf palm berries extract (Saw palmetto), 16.67 mg/ml for the lovage roots extract (Levisticum officinale), and 16.67 mg/ml for the calendula flowers extract (Calendula officinalis). No sensitizing or skin irritating effects were observed in guinea pigs. Conclusions. Biological evaluation of medical devices in the form of rectal suppositories "Pravenor" and vaginal suppositories "Prodexyn" performed using in vitro and in vivo biological systems. It was demonstrated an acceptable level of safety of the products. The MTT test was 5 times more sensitive than the Vero cell culture method in determination of cytotoxicity.

The Outpatient Prescribing of Miconazole in a Tertiary Hospital in Riyadh Region

Aim: The present study aimed to describe the use of miconazole in the outpatient setting of a tertiary hospital in Riyadh Region.&#x0D; Methodology: This was a retrospective study that included reviewing the electronic prescriptions that contained miconazole among patients in a public hospital in Riyadh Region.&#x0D; Results: Most of the patients who received miconazole were females (89.29%) and the age of 51.79% of them was between 30 and 39 years. Most of the prescriptions were written by residents (96.43%) and most of the prescriptions were prescribed by emergency department (66.07%). Most of the patients received miconazole as vaginal suppository (50.00%) or as cream (39.29%).&#x0D; Conclusion: The present study showed that miconazole was uncommonly prescribed in in Riyadh Region. Further studies are needed to explore the frequency and pattern of miconazole use as well as to explore the frequency of prescribing other antifungal medications in different settings.