Vaginitis Research Articles

Assessment of Pregnant Women’s knowledge about Vaginal Yeast Infection in Woman's Health Hospital, Assuit University

Assessment of Pregnant Women’s knowledge about Vaginal Yeast Infection in Woman's Health Hospital, Assuit University

The Role of Prevotella Species in Female Genital Tract Infections.

Female genital tract infections (FGTIs) include vaginal infections (e.g., bacterial vaginosis [BV]), endometritis, pelvic inflammatory disease [PID], and chorioamnionitis [amniotic fluid infection]. They commonly occur in women of reproductive age and are strongly associated with multiple adverse health outcomes including increased risk of HIV/sexually transmitted infection acquisition and transmission, infertility, and adverse birth outcomes such as preterm birth. These FGTIs are characterized by a disruption of the cervicovaginal microbiota which largely affects host immunity through the loss of protective, lactic acid-producing Lactobacillus spp. and the overgrowth of facultative and strict anaerobic bacteria. Prevotella species (spp.), anaerobic Gram-negative rods, are implicated in the pathogenesis of multiple bacterial FGTIs. Specifically, P. bivia, P. amnii, and P. timonensis have unique virulence factors in this setting, including resistance to antibiotics commonly used in treatment. Additionally, evidence suggests that the presence of Prevotella spp. in untreated BV cases can lead to infections of the upper female genital tract by ascension into the uterus. This narrative review aims to explore the most common Prevotella spp. in FGTIs, highlight their important role in the pathogenesis of FGTIs, and propose future research in this area.

Socio-demographic, obstetric characteristics and molecular confirmation of <i>Trichomonas vaginalis</i> detected from pregnant women attending Kawo General Hospital, Kaduna, Nigeria

Trichomoniasis is a widespread Sexually Transmitted Infections (STIs) that can have detrimental consequences, including infection of the skin, endometrium, Bartholin glands, and fallopian tubes and ovaries (the adnexa of the uterus). This study was conducted to assess the prevalence of Trichomonas vaginalis (T. vaginalis) and T. vaginalis from vaginal swabs of pregnant patients attending Kawo general hospital in Kaduna state. A total of 250 high vaginal swab samples were randomly taken from consenting pregnant women attending antenatal. Structured questionnaires were used to collect participant demographic and medical data. Samples were analysed by wet mount preparation and T. vaginalis positive samples were confirmed using Polymerase Chains Reaction (PCR). Out of the 250 pregnant women that were examined, 24 (9.6%) were positive for T. vaginalis infection. T. vaginalis was detected more in age group 20-25 (9.4%), and among women of third trimester stage (11.4%). T. vaginalis infection was significantly associated with age, gravidation, education and occupation. Among the 24 pregnant women that tested positive for T. vaginalis infection, only 2 (8.0%) were without symptoms associated with vaginal trichomoniasis, while the remaining 22 (92.0%) presented symptoms such as vaginal odour (20%), itching and discomfort (32%) and greenish yellow vaginal discharge (92%). Molecular analysis confirmed 1 positive case out of the 5 samples randomly analysed. Trichomoniasis transmission to newborn infants could be avoided with better personal cleanliness, screening, and treatment for pregnant women who are affected.

Cracking the Code: Investigating the Correlation between Aerobic Vaginitis and Preterm Labor.

Aerobic vaginitis (AV) is a distinct clinical entity characterized by inflammation and abnormal vaginal microflora. Often mistaken for bacterial vaginosis, AV remains relatively unknown and underdiagnosed. AV's understanding is evolving, with some experts suggesting it may primarily be an immunological disorder, the prevalence of which has a range of 7-13% in non-pregnant women and 4.1-8.3% during pregnancy. Pregnancy can affect susceptibility to vaginal infections, leading to adverse outcomes for the woman and the newborn. This review summarizes the correlation between AV and adverse pregnancy outcomes, particularly preterm birth, the leading cause of morbidity and mortality among neonates. An improved understanding of AV's impact on pregnancy outcomes can lead to early recognition, proper management, and effective interventions. While some studies support an association between AV and preterm labor, the existing knowledge of this relationship remains limited. The evidence suggests that AV may contribute to adverse pregnancy outcomes, mainly preterm birth, but further research is needed to establish a definitive link. Further studies are needed to investigate the underlying mechanisms and clarify AV's role in premature labor. A comprehensive understanding of AV's impact on pregnancy outcomes is crucial for early recognition, appropriate management, and effective interventions.

Correlation between Indicators of Vaginal Microbiota and Human Papillomavirus Infection: A Retrospective Study

Background: Increasing evidence suggests that both the vaginal microbiota and human papillomavirus (HPV) may play a role in the development of cervical intraepithelial neoplasia (CIN) and cervical cancer. However, the relationship between the vaginal microbiome and HPV infection remains poorly understood. The objective of this study was to investigate the association between indicators of the vaginal microbiota and HPV infection. Methods: From January 2020 to June 2022, clinical data were collected from 5099 outpatients at Beijing Friendship Hospital. These patients underwent simultaneous testing for vaginal microecology and HPV type. A statistical analysis was conducted to examine the relationship between indicators of the vaginal microbiota and HPV infection. Results: HPV infections were detected in 12.47% (636/5099) of the subjects. Single, double, triple, quadruple, and quintuple infections accounted for 81.29%, 14.62%, 3.14%, 0.94%, and 0.15% of all infections, respectively. A significant disparity in HPV infection prevalence was observed between the vaginitis group and the general population. However, no variation was found among different vaginitis groups. The data indicated that individuals with clue cells and sialidase were more susceptible to HPV infection. Sialidase was identified as an independent risk factor for HPV infection in a multivariable logistic regression model. The most prevalent HPV subtypes were 16 and 52, representing 2.10% and 2.86%, 3.14% and 2.86%, 1.78% and 2.16% in the normal, bacterial vaginitis, and other groups, respectively. Conclusions: Our findings demonstrate the presence of clue cells and sialidase, which are two diagnostic criteria for bacterial vaginitis, in association with HPV infection. Furthermore, our results suggest that sialidase could potentially serve as a valuable predictor of HPV infection.

Efficacy of Intravaginal Lactic Acid Bacteria, Cell-Free Supernatant, or Enrofloxacin on Vaginitis and Fertility in Ewes Synchronized with Progesterone-Based Protocol

An intravaginal sponge impregnated with progesterone is commonly used for estrus induction and synchronization in ewes. Although using an intravaginal sponge containing progesterone positively affects the synchronization rate, varying degrees of vaginitis occur during its application. This study aimed to investigate the impacts of various intravaginal treatment options on the vaginitis severity and pregnancy rate in Merino ewes synchronized with intravaginal sponges impregnated with progesterone. During the breeding period, 589 ewes, aged 2–6, received intravaginal sponges for 14 days. The control group (CON) received no treatment, whereas vaginal sponges absorbed with enrofloxacin (ENR), Lactobacillus plantarum (LAC), or Lactobacillus plantarum supernatant (CFS) were applied in the treatment groups. All groups received 500 IU of equine chorionic gonadotropin intramuscularly. The ENR group showed lower scores in vaginal discharge and sponge odor compared with the CON, LAC, and CFS groups. Although estrus responses did not differ between groups, the pregnancy rate tended to be higher in the ENR group. In conclusion, intravaginal ENR application, but not LAC or CFS, reduced vaginitis severity and tended to increase pregnancy rates in ewes synchronized with intravaginal sponges impregnated with progesterone.

Does vaginal bacterial colonization contribute to preterm birth in women with asymptomatic shortened cervix?

PurposeThe aim of this study is to describe the typical microbial spectrum and the influence of distinct vaginal infections on preterm birth in pregnancies affected by cervical incompetence.Methods327 patients were admitted because of asymptomatic shortening of the cervix in the second and third trimester of pregnancy. Clinical data such as age, cervical length, gestational age at admission and at delivery and vaginal microbiologic findings were collected and analyzed.ResultsThe spectrum of germs in the vagina revealed seven different distinct species; the most common bacteria were Ureaplasma spp. and E. coli. In 327 included patients, 217 revealed a bacterial colonization, 110 did not. Most common bacteria in women with preterm birth before 34 weeks were Ureaplasma spp., while E. coli was most common in women undergoing preterm birth after 34 weeks. Nevertheless, the rates of occurrence of these bacterial taxa were not significantly different between who underwent preterm birth to those who did not.ConclusionsThis study gives an overview over the vaginal bacterial colonization in pregnant women with cervical incompetence. The clinical relevance of vaginal bacterial colonization remains unclear.

Comprehensive Review of Kaphaja Yonivyapath: Etiology, Diagnosis and Management Strategies

A family's health is guaranteed by a healthy woman. Ayurveda and contemporary medicine have both discussed the idea of a healthy yoni at various stages of a woman's life, from adolescence to menopause. These days, vaginal infections are a major concern for people of all ages and socioeconomic backgrounds. Because women have a special role of giving birth, gynecological illnesses have gained enormous relevance in the medical field. The majority of gynecological problems are included under the word "Yonivyapad," which is used in Ayurveda to refer to women's health care. Among 20 Yoni Vyapath’s Kaphaja yonivyapath is the one which is due to vitiation of Kapha, this vitiated Kapha reaches the Yoni Pradesha causes signs and symptoms like Kandu, Picchila Srava and Alpa Vedana as well as Sthanika and Sarvadaihika Kapha Prakopa Laxana. The treatment of Kaphaja Yonivyapath explained in classic as Kapha hara Dravyas and Shodhana Chikitsa mainly Vamana is indicated. This can be correlated with vulvovaginitis which is caused due to bacterial vaginosis, moniliasis and trichomans vaginalis. In this review an attempt has been made in this work to provide a conceptual analysis that covers nearly all of the Nidana, Samprapti and Chikitsa of Kaphaja Yoni Vyapad according to both Ayurveda and modern.

Transition of the genital mollicutes from the second to the third trimester of pregnancy and its association with adverse pregnancy outcomes in GDM women: a prospective, single-center cohort study from China

BackgroundThe association of genital Mollicutes infection transition with adverse pregnancy outcomes was insignificant among general pregnant women, but there remains a paucity of evidence linking this relationship in gestational diabetes mellitus (GDM) women. The aim was to investigate the association between genital Mollicutes infection and transition and adverse pregnancy outcomes in GDM women, and to explore whether this association still exist when Mollicutes load varied.MethodsWe involved pregnant women who attended antenatal care in Chongqing, China. After inclusion and exclusion criteria, we conducted a single-center cohort study of 432 GDM women with pregnancy outcomes from January 1, 2018 to December 31, 2021. The main outcome was adverse pregnancy outcomes, including premature rupture of membrane (PROM), fetal distress, macrosomia and others. The exposure was Mollicutes infection, including Ureaplasma urealyticum (Uu) and Mycoplasma hominis (Mh) collected in both the second and the third trimesters, and testing with polymerase chain reaction method. The logistic regression models were used to estimate the relationship between Mollicutes infection and adverse pregnancy outcomes.ResultsAmong 432 GDM women, 241 (55.79%) were infected with genital Mollicutes in either the second or third trimester of pregnancy. At the end of the pregnancy follow-up, 158 (36.57%) participants had adverse pregnancy outcomes, in which PROM, fetal distress and macrosomia were the most commonly observed adverse outcomes. Compared with the uninfected group, the Mollicutes (+/-) group showed no statistical significant increase in PROM (OR = 1.05, 95% CI:0.51 ∼ 2.08) and fetal distress (OR = 1.21, 95% CI: 0.31 ∼ 3.91). Among the 77 participants who were both Uu positive in the second and third trimesters, 38 participants presented a declined Uu load and 39 presented an increased Uu load. The Uu increased group had a 2.95 odds ratio (95% CI: 1.10~8.44) for adverse pregnancy outcomes.ConclusionMollicutes infection and transition during trimesters were not statistically associated with adverse pregnancy outcomes in GDM women. However, among those consistent infections, women with increasing Uu loads showed increased risks of adverse pregnancy outcomes. For GDM women with certain Mollicutes infection and colonization status, quantitative screening for vaginal infection at different weeks of pregnancy was recommended to provide personalized fertility treatment.

Use of Antibiotics and Probiotic Lactobacilli in the Treatment of Preterm Premature Rupture of Membranes: a Review

ABSTRACT To review the current evidence of the potential use of antibiotics and probiotics Lactobacillus in preterm premature rupture of membranes cases and to see the effect on microorganism concentrations especially Streptococcus agalatiae and Lactobacillus. This review used several databases (Google Scholar, Pubmed, and Science Direct) and searched for English and Indonesian articles in the last ten years. Articles were received in the form of case reports, observational studies and clinical trials that discussed the use of antibiotics and probiotic Lactobacillus in premature rupture of membranes especially in preterm pregnancy. After searching the database and eliminating duplicates and articles unrelated to the topic, we included some articles in this review. Prophylactic antibiotics are also expected to prolong the latent phase, thereby reducing the risk of fetomaternal morbidity and mortality. Penicillin is often recommended in preterm PROM, because broad-spectrum antibiotics are better as infection prophylaxis. Providing alternative therapy with lactobacillus probiotics is believed to prevent preterm birth and has the benefit of being a safe and effective therapy in restoring normal vaginal microflora and preventing vaginal infections during pregnancy. However, further research is needed to see the effectiveness of lactobacillus probiotics and look at the concentration of microbes, especially Streptococcus agalctiae and Lactobacillus. Keywords: Preterm Premature Rupture of Membranes, Antibiotics, Probiotics Lactobacillus, Streptococcus Agalactiae

The effect of interleukin-10 gene polymorphism in the formation of deep disorders of vaginal microbiocenosis in bacterial vaginosis

Background: Bacterial vaginosis (BV) is a common vaginal infection that causes significant gynecological and obstetric morbidity. Despite modern methods and treatment regimens, BV therapy remains a difficult task due to high rates of relapses, which amount to 60% within a year after treatment. This problem, in part, can be solved by assessing the individual genetic characteristics of the organism associated with the presence of allelic variants of the immune system genes that determine the constitutional possibility of a high or low level of synthesis of the corresponding immunocompetent molecules (cytokines, pattern-recognition receptors, etc.). The aim of the study: To determine the significance of the polymorphism -1082 G/A (rs1800896) of the gene IL-10 in the formation of various molecular biological profiles of vaginal microbiocenosis in bacterial vaginosis. Materials and methods: 195 women of reproductive age were examined, including 100 patients with bacterial vaginosis and 95 conditionally healthy women with vaginal normocenosis. The state of vaginal microbiocenosis was assessed by microscopic and molecular biological methods. The polymorphism -1082 G/A (rs1800896) of the IL-10 gene was genotyped using polymerase chain reaction and detection of amplification products on an electrophoresis gel. Results: Genotype G/G was more common in women with the prevalence of obligate-anaerobic microorganisms in the microbiocenosis (21.2%, p=0.046), genotype G/A – in women with severe mixed dysbiosis (61.3%, p=0.023). In women with a predominance of facultative anaerobes Gardnerella vaginalis and Atopobium vaginae in the microbiocenosis, there was no significant difference in the distribution of genotypes (p>0.05). Conclusion: The carriage of allelic variants -1082G (rs1800896) of the gene IL-10 is associated with deeper disorders of vaginal microbiocenosis, which suggests their use as markers that increase the effectiveness of the diagnosis of recurrent forms of bacterial vaginosis.

Identification of gynecological pathologies by applying classification algorithms: Results of a local study

Purpose: Vaginal infections are prevalent causes of gynecological consultations. This study introduces and evaluates the efficacy of four Machine Learning algorithms in detecting vaginitis cases in southern Mexico. Methods: Utilizing Simple Perceptron, Naïve Bayes, CART, and AdaBoost, we conducted classification experiments to identify four vaginitis subtypes (gardnerella, candidiasis, trichomoniasis, and chlamydia) in 600 patient cases. Results: The outcomes are promising, with a majority achieving 100% accuracy in vaginitis identification. Conclusion: The successful implementation and high accuracy of these algorithms demonstrate their potential as valuable diagnostic tools for vaginal infections, particularly in southern Mexico. It is crucial in a region where health technology adoption lags behind, and intelligent software support is limited in gynecological diagnoses.

The Use of Carbon Dioxide (Co2) Lasers in the Treatment of Vulvovaginal Atrophy Symptoms in Perimenopausal and Postmenopausal Women

This study explores the efficacy of pixelated carbon dioxide (CO2) laser treatment in mitigating vulvovaginal atrophy symptoms among perimenopausal and postmenopausal women. This study examines the effectiveness of CO2 laser treatment in reducing vaginal discomfort for women experiencing menopause. With a cohort of 127 participants (mean age 47 ± 5 years), the researchers administered three sessions of vaginal CO2 laser treatment over three months. The primary evaluation metric was patient-reported satisfaction levels, aiming to assess the treatment's impact on alleviating symptoms associated with vulvovaginal atrophy, such as dryness, burning, and discomfort during intercourse. The findings revealed that 98% of the patients experienced significant symptom improvement three months post-treatment. Notably, 89% reported a resolution of sexual dysfunction due to vaginal dryness, and 96% indicated an end to discomfort and burning sensations. The satisfaction of the patients is extremely high, with 98% of the participants being satisfied with the results, and this satisfaction has persisted even after some time following the treatment. Furthermore, 95% of the women encountered no discomfort during the procedure, and any post-treatment complaints were mild and temporary, with a watery discharge being the most common. The study concludes that pixel CO2 laser treatment is a practical, painless, and efficient approach for addressing vulvovaginal atrophy symptoms, yielding high patient satisfaction rates. The study finds that using pixel CO2 laser treatment is a practical and painless way to help with symptoms of vaginal discomfort, and most patients are satisfied with the results.

An Untargeted Metabolomic Analysis of Lacticaseibacillus (L.) rhamnosus, Lactobacillus (L.) acidophilus, Lactiplantibacillus (L.) plantarum and Limosilactobacillus (L.) reuteri Reveals an Upregulated Production of Inosine from L. rhamnosus.

Lactic acid bacteria are considered an inexhaustible source of bioactive compounds; indeed, products from their metabolism are known to have immunomodulatory and anti-inflammatory activity. Recently, we demonstrated that Cell-Free Supernatants (CFS) obtained from Lactobacillus (L.) acidophilus, Lactiplantibacillus (L.) plantarum, Lacticaseibacillus (L.) rhamnosus, and Limosilactobacillus (L.) reuteri can impair Candida pathogenic potential in an in vitro model of epithelial vaginal infection. This effect could be ascribed to a direct effect of living lactic acid bacteria on Candida virulence and to the production of metabolites that are able to impair fungal virulence. In the present work, stemming from these data, we deepened our knowledge of CFS from these four lactic acid bacteria by performing a metabolomic analysis to better characterize their composition. By using an untargeted metabolomic approach, we detected consistent differences in the metabolites produced by these four different lactic acid bacteria. Interestingly, L. rhamnosus and L. acidophilus showed the most peculiar metabolic profiles. Specifically, after a hierarchical clustering analysis, L. rhamnosus and L. acidophilus showed specific areas of significantly overexpressed metabolites that strongly differed from the same areas in other lactic acid bacteria. From the overexpressed compounds in these areas, inosine from L. rhamnosus returned with the best identification profile. This molecule has been described as having antioxidant, anti-inflammatory, anti-infective, and neuroprotective properties. The biological significance of its overproduction by L. rhamnosus might be important in its probiotic and/or postbiotic activity.

Weissella sp. SNUL2 as potential probiotics with broad-spectrum antimicrobial activities

Probiotics have been applied to a wide range of bacteria, causing gastrointestinal and vaginal infections. However, probiotics generally possess limited antimicrobial spectra and are primarily utilized as dietary supplements. Recognizing the need for more versatile probiotics, this study focuses on isolating and characterizing strains suitable for antibiotic replacement. Among these strains, Weissella sp. SNUL2, derived from a traditional fermented food in Korea (i.e., Sikhae), emerged as a promising candidate. The correlation between optical density at 600 nm and colony-forming units was verified and applied in subsequent experiments. To assess the therapeutic potential of probiotics, antibacterial tests were conducted using a microplate reader to evaluate the inhibition of 60 bacterial strains (including common foodborne pathogens) induced by Weissella sp. SNUL2 cell-free supernatant (CFS). The results confirmed its broad-spectrum antibacterial properties compared to previously known probiotics. Furthermore, enzymatic treatment with proteinases (trypsin and pepsin) and a time-kill assay were conducted to elucidate the nature of the antibacterial substance in Weissella sp. SNUL2 CFS. Through sequential chromatography involving gel filtration and ion-exchange chromatography, specific fractions with enhanced antibacterial properties were identified. LC-MS/MS analysis of the secretome fraction revealed the presence of various proteins from the C39 family, peptidoglycan endopeptidases, and N-acetylmuramoyl-l-alanine amidase domain-containing protein precursors. Hence, the combined action of these proteins may contribute to Weissella sp. SNUL2's broad antimicrobial activity.

Study of The Prevalence of Trichomonas Vaginalis Parasite in Females Suffering from Vaginal Inflammations

Background & Objective: Infection of trichomoniasis is accountable for disease transmitted by sex (non-virally), called trichomoniasis or vaginitis the most popular disease worldwide. The goal of current research was to determining spread rate of Trichomonas vaginalis among females suffering from genital inflammation in Najaf city of Iraq. Methods: Two hundred and sixty four of the participating women were included in our current study, They were going to Al-Manathra Hospital, Al-Najaf Hospital, Al-Furat Hospital, and a few outpatient clinics between January and June of 2023. One hundred and thirty two were included as a control group and one hundred and thirty two were included as patients (they were suffering from vaginal inflammation). All participants in the study underwent direct microscopic examination and then immediately cultured in diamond culture media by taking a swab from the vagina to confirm the presence of the parasite Trichomonas Vaginalis. Results: Out of (264) swab samples that which examined microscopically for T. vaginalis by using light microscope under (40x), Trichomoniasis infection detected in 70 (53.03%) out of 132 women undergoing from vaginal inflammation while there was 62 (46.97%) of women negative for T.vaginalis, and this difference was statistically non-significant (Chi-square=0.618, P-value=0.432), while in the control subjects 116 (91.67%) of (132) were negative for Trichomoniasis infection, except 11 women (8.33%) were positive for T.vaginalis, but not suffered from any symptoms, this difference was significant in statistic (Chi-square = 86.811, P-value = 0.000). Out of (264) swab samples that which cultured on diamond liquid media, Trichomoniasis infection detected in 74 (56.07%) out of 132 women undergoing from vaginal inflammation while there was 58 (43.93%) of these women were negative for T.vaginalis parasite, and this difference according to Chi-square value (2.206) and p-value (0.137), it was statistically non-significant. regarding the control subjects, 112 (88.64%) of (132) were negative for Trichomoniasis infection, and 15 women (11.36%) were positive for T.vaginalis, but not suffered from any symptoms. This difference was statistically significant according to the Chi-Square (74.087) and P value (0.000). Conclusions: The prevalence of the Trichomonas vaginalis parasite in Najaf Governorate, according to the results of the current study, is 56%, and this is considered a high and interesting percentage.

Caregivers’ concerns about the sexual and reproductive health of women with intellectual disability in Iran: a qualitative study

BackgroundWomen with intellectual disability (ID) have many sexual and reproductive problems. This study was conducted to explain the sexual and reproductive health considerations of women with ID from the perspective of their caregivers in a qualitative approach.MethodsThis study was a qualitative research conducted with a content analysis approach in Iran. The sampling method used was targeted sampling with maximum possible variation, which was continued until data saturation. For data collection, in-depth and semi-structured interviews were conducted with 21 participants, including 8 mothers, 6 caregivers, and 7 specialist caregivers who had experience working with women with intellectual disabilities. Data analysis was conducted using the conventional content analysis method proposed by Zhang and Wildemuth.ResultsTwo main themes, four categories and 12 subcategories emerged from the data analysis. The themes include “Reproductive health concerns” and” "Sexual health concerns”. This means that this group of women has many problems with menstrual hygiene and vaginal infections. On the other hand, caregivers were concerned about the manifestations of unconventional sexual behaviors and difficulties in controlling sexual behaviors as well as the risk of sexual abuse.ConclusionThe results of the present study show that it is not only necessary to provide women with ID with practical instructions on menstrual hygiene and sexual self-care, but also that regular examinations of the reproductive system by obstetricians or midwives, especially in care centers, seem essential.

Hydrogel- and Nanocomposite-Based Drug-Delivery Strategies in the Treatment of Vaginal Infections.

The reproductive health of women is governed by an optimal balance in the host-microbiota interaction. Depletion of the beneficial vaginal microflora caused by depletion of Lactobacillus species and increased proliferation of pathogens results in gynaecological infections. Among women of reproductive age, vaginal infections are increasingly prevalent. Attaining therapeutic efficacy using conventional formulations remains a challenge as vaginal fluids quickly remove or dilute the therapeutic formulations. Hydrogels have been widely exploited for targeted delivery of therapeutics directly into the vaginal mucus. With a careful choice of polymers (natural, synthetic, or semisynthetic), hydrogels with specific properties, such as stimuli responsiveness, antimicrobial, and muco-adhesiveness, can be tailored for higher therapeutic efficacy. In this review, the advances in hydrogel strategies for the treatment of vaginal infections are presented with emphasis on the types and properties that play a significant role in vaginal drug delivery systems.

Weekly Oral Tenofovir Alafenamide Protects Macaques from Vaginal and Rectal Simian HIV Infection.

Pre-exposure prophylaxis (PrEP) with a weekly oral regimen of antiretroviral drugs could be a suitable preventative option for individuals who struggle with daily PrEP or prefer not to use long-acting injectables. We assessed in macaques the efficacy of weekly oral tenofovir alafenamide (TAF) at doses of 13.7 or 27.4 mg/kg. Macaques received weekly oral TAF for six weeks and were exposed twice-weekly to SHIV vaginally or rectally on day 3 and 6 after each dose. Median TFV-DP levels in PBMCs following the 13.7 mg/kg dose were 3110 and 1137 fmols/106 cells on day 3 and 6, respectively. With the 27.4 mg/kg dose, TFV-DP levels were increased (~2-fold) on day 3 and 6 (6095 and 3290 fmols/106 cells, respectively). Both TAF doses (13.7 and 27.4 mg/kg) conferred high efficacy (94.1% and 93.9%, respectively) against vaginal SHIV infection. Efficacy of the 27.4 mg/kg dose against rectal SHIV infection was 80.7%. We estimate that macaque doses of 13.7 and 27.4 mg/kg are equivalent to approximately 230 and 450 mg of TAF in humans, respectively. Our findings demonstrate the effectiveness of a weekly oral PrEP regimen and suggest that a clinically achievable oral TAF dose could be a promising option for non-daily PrEP.

A 52-week efficacy and safety study of enavogliflozin versus dapagliflozin as an add-on to metformin in patients with type 2 diabetes mellitus: ENHANCE-M extension study.

To evaluate the long-term safety and efficacy of enavogliflozin 0.3 mg/day added to metformin in patients with type 2 diabetes mellitus. After 24 weeks of a randomized, double-blind treatment period with enavogliflozin 0.3 mg/day (n = 101) or dapagliflozin 10 mg/day (n = 99) added to metformin, all patients received enavogliflozin 0.3 mg/day plus metformin for an additional 28 weeks during the open-label extension period. Eighty-two patients continued enavogliflozin (maintenance group), and 77 were switched from dapagliflozin to enavogliflozin (switch group). All adverse drug reactions (ADR) were mild in severity. In the maintenance group, ADRs (cystitis and vaginal infection) were reported in two patients (2.44%) during 52 weeks. In the switch group, ADR (hypoglycaemia) was reported in one patient (1.30%) during a 28-week open-label extension period. At week 52, glycated haemoglobin and fasting plasma glucose were significantly lower than at the baseline, by 0.85% and 29.08 mg/dl, respectively, in the maintenance group (p < .0001 for both), and by 0.81% and 32.77 mg/dl, respectively, in the switch group (p < .0001 for both). At week 52, 68.92% of patients from the maintenance group and 64.29% from the switch group achieved glycated haemoglobin <7%. A significant increase in the urine glucose-creatinine ratio was observed at week 52, by 58.81 g/g and 63.77 g/g in the maintenance and switch groups, respectively (p < .0001). Enavogliflozin added to metformin was tolerated well for up to 52 weeks and provided continual glycaemic control in type 2 diabetes mellitus, along with a significant increase in the urine glucose-creatinine ratio.