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Infectious Diseases in Obstetrics and... 2020A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind,... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind, four-parallel group, tolerability, and pharmacokinetic Phase I study in healthy women.
METHODS
The fixed-dose combination was compared to econazole and benzydamine single-drug formulations and with placebo after daily applications for 3 consecutive days. Safety and tolerability were evaluated recording the adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs. Econazole, benzydamine, and its metabolite benzydamine N-oxide pharmacokinetics were investigated after single and multiple applications.
RESULTS
Local reactions were generally absent. Pruritus and pain at the application site were infrequently reported. According to the subjects' evaluations, the overall tolerability of the ovules was rated as excellent or good. No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed. Very low econazole, benzydamine, and benzydamine-N-oxide concentrations were measured in plasma, though quantifiable in almost all samples.
CONCLUSION
The tested fixed-dose combination showed a good safety profile consistently with the known tolerability of both active substances. In addition, the confirmed low bioavailability of the drugs excludes the possibility of any accumulation effects and limits the risk of undesired systemic effects. This trial is registered at ClinicalTrials.gov with the identifier NCT02720783 last updated on 07 February 2017.
Topics: Administration, Oral; Adult; Antifungal Agents; Area Under Curve; Benzydamine; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Delivery Systems; Econazole; Female; Healthy Volunteers; Humans; Middle Aged; Vagina; Young Adult
PubMed: 32410819
DOI: 10.1155/2020/7201840 -
Deutsches Arzteblatt International Feb 2020In Germany, 17-23% of the population suffers from chronic itching of the skin; in 5-10% of cases, the female genitalia are affected, specifically, the vulva. Vulvar... (Review)
Review
BACKGROUND
In Germany, 17-23% of the population suffers from chronic itching of the skin; in 5-10% of cases, the female genitalia are affected, specifically, the vulva. Vulvar pruritus is thus a common symptom that often markedly impairs the affected women's quality of life.
METHODS
This review is based on pertinent publications that were retrieved by a selective search in MEDLINE/PubMed for articles on the pathogenesis, diagnosis, and treatment of vul- var pruritus. The search terms were (in German and English) "vulvärer Juckreiz," "pruritus vulvae," and "genital itch," alone and in combination with "Behandlung," "Therapie," or "treat- ment."
RESULTS
The most common cause of vulvar pruritus is vulvo- vaginal candidiasis followed by chronic dermatoses, such as lichen sclerosus and vulvar eczema. Especially in refractory cases, an invasive or preinvasive lesion such as squamous epithelial dysplasia (VIN, vulvar intraepithelial neoplasia) should be borne in mind in the differential diagnosis. Rarer causes include infection, atrophy, and vulvodynia. The essen- tial elements of treatment are topical/oral antimycotic drugs and high-potency glucocorticoids, along with consistently ap- plied, basic moisturizing care and the avoidance of potential triggering factors.
CONCLUSION
As vulvar pruritus has multiple causes, standard- ization of its diagnostic evaluation and treatment would be l efficacy and to meet the diverse needs of women who suffer from this condition.
Topics: Female; Germany; Humans; Pruritus Vulvae
PubMed: 32181734
DOI: 10.3238/arztebl.2020.0126 -
Anaesthesia Sep 2019Patient-centred care and factors associated with patient satisfaction with anaesthesia have been widely studied. However, the most important considerations in the... (Observational Study)
Observational Study
Patient-centred care and factors associated with patient satisfaction with anaesthesia have been widely studied. However, the most important considerations in the setting of obstetric anaesthesia are uncertain. Identification of, and addressing, factors that contribute to patient dissatisfaction may improve quality of care. We sought to identify factors associated with < 100% satisfaction with obstetric anaesthesia care. At total of 4297 women treated by anaesthetists provided satisfaction data 24 h after vaginal and 48 h after caesarean delivery. As 78% of women were 100% satisfied, we studied factors associated with the dichotomous variable, 100% satisfied vs. < 100% satisfied. We evaluated patient characteristics and peripartum factors using multivariable sequential logistic regression. The following factors were strongly associated with maternal dissatisfaction after vaginal delivery: pain intensity during the first stage of labour; pain intensity during the second stage of labour; postpartum pain intensity; delay > 15 min in providing epidural analgesia and postpartum headache (all p < 0.0001). Pruritus (p = 0.005) also contributed to dissatisfaction after vaginal delivery, whereas non-Hispanic ethnicity was negatively associated with dissatisfaction (p = 0.01). After caesarean delivery, the intensity of postpartum pain (p < 0.0001), headache (p = 0.001) and pruritus (p = 0.001) were linked to dissatisfaction. Hispanic ethnicity also had a negative relationship with dissatisfaction after caesarean delivery (p = 0.005). Thus, inadequate or delayed analgesia and treatment-related side-effects are associated with maternal dissatisfaction with obstetric anaesthesia care. Development of protocols to facilitate identification of ineffective analgesia and provide an appropriate balance between efficacy and side-effects, are important goals to optimise maternal satisfaction.
Topics: Adult; Anesthesia, Obstetrical; Delivery, Obstetric; Female; Humans; Labor Pain; Labor, Obstetric; Patient Satisfaction; Pregnancy; Retrospective Studies
PubMed: 31264207
DOI: 10.1111/anae.14756 -
Prevalence and cervical organism burden among Louisiana women with Trichomonas vaginalis infections.PloS One 2019Trichomonas vaginalis is the most common curable sexually transmitted infection (STI) worldwide. Although predominately asymptomatic, the disease spectrum of...
Trichomonas vaginalis is the most common curable sexually transmitted infection (STI) worldwide. Although predominately asymptomatic, the disease spectrum of trichomoniasis in women is characterized primarily by signs and symptoms of vaginitis, including purulent discharge and localized vulvar pruritus and erythema. Several FDA-cleared nucleic acid amplification tests (NAATs) are available for the diagnosis of T. vaginalis infections, but laboratory developed tests (LDTs) are widely utilized and cost-effective solutions in both the research and clinical diagnostic settings. LDT diagnosis of T. vaginalis is particularly appealing since it can be performed using remnant specimens collected for other STI testing. Using a LDT implemented as part of this study, T. vaginalis was detected in 7% of participating Louisiana women (14/199). The mean T. vaginalis organism burden was 1.0x106 ± 4.5x105 organisms per mL of ThinPrep PreservCyt. Using DNA eluates obtained after HPV testing on the cobas 4800 system, the T. vaginalis LDT was characterized by excellent intra- and interassay reproducibility (coefficient of variation values all <3.5%). Compared with two commercially available NAATs from TIB MOLBIOL, the sensitivity and specificity of the LDT was 92.9 and 99.5%, respectively. Collectively, this study details the diagnostic and quantitative utility of a LDT for T. vaginalis. When applied in the clinical research setting, we confirmed the high prevalence of T. vaginalis, but also observed extraordinarily high organism burdens in the cervix. These findings highlight the unique host-pathogen relationship of T. vaginalis with lower reproductive tract tissues, and substantiate the need for continued investigation of this highly prevalent STI.
Topics: Adult; Cervix Uteri; Female; Humans; Louisiana; Mass Screening; Middle Aged; Prevalence; Trichomonas Vaginitis; Trichomonas vaginalis; Workflow
PubMed: 31220094
DOI: 10.1371/journal.pone.0217041 -
The Journal of International Medical... Jun 2019To evaluate the acceptability, tolerability, and effects on vulvovaginitis symptoms and signs of a non-soap, herbal-based intimate solution (Zelesse®). (Observational Study)
Observational Study
OBJECTIVE
To evaluate the acceptability, tolerability, and effects on vulvovaginitis symptoms and signs of a non-soap, herbal-based intimate solution (Zelesse®).
METHODS
We conducted a prospective, observational, multicenter study including adult women with symptoms and signs of vulvovaginitis with various etiologies, including candidiasis, trichomoniasis, bacterial vaginosis, and atrophic and irritative vaginitis. The presence and intensity of signs (edema, erythema, vaginal discharge) and symptoms (pruritus) of vulvovaginitis were evaluated before and after 5-15 days of daily use of Zelesse® alone or as a coadjuvant in antimicrobial therapy. Variables following a normal distribution and categorical variables were analyzed using the Student t-test and chi-square or Fisher's exact test, respectively.
RESULTS
A total 137 women were enrolled in the study; 87 (63.5%) women received concomitant antimicrobials and 50 (36.5%) used Zelesse® only. Global symptom scores and frequency of patients with vulvovaginitis signs and symptoms, and their mean intensity, decreased after treatment in both patient groups. Vaginal pH and (in the Zelesse®-only group) vaginal flora remained unaltered. The product was safe, well tolerated, and highly accepted by patients.
CONCLUSIONS
Zelesse®, the non-soap herbal-based solution in this study, may represent a safe and effective option for symptomatic relief of vulvovaginitis.
Topics: Adult; Anti-Bacterial Agents; Female; Follow-Up Studies; Humans; Hygiene; Male; Maximum Tolerated Dose; Phytotherapy; Prognosis; Prospective Studies; Severity of Illness Index; Solutions; Spain; Vulvovaginitis
PubMed: 31088247
DOI: 10.1177/0300060519837820 -
Journal of Clinical Laboratory Analysis Jan 2019Cytolytic vaginosis (CV) is a common disease that results in pruritus, dyspareunia, and vulvar dysuria. However, the pathological mechanisms of the disease are still...
BACKGROUND
Cytolytic vaginosis (CV) is a common disease that results in pruritus, dyspareunia, and vulvar dysuria. However, the pathological mechanisms of the disease are still unclear. Compared to traditional methods, high-throughput sequencing can obtain more accurate qualitative and quantitative information on the microbiome.
METHODS
We collected 75 samples from 32 healthy women (average age 44 ± 8) and 43 patients with CV (average age 38 ± 8). We used high-throughput sequencing of the 16S rRNA V3-V4 region to characterize and compare the vaginal microbiota of patients with CV and healthy women and to identify potential biomarkers for CV.
RESULTS
The vaginal pH of patients with CV was ≤3.8, and the vaginal concentration of H O was ≥2 μmol/L. Colony densities of Lactobacillus spp. in patients with CV ranged from +++ (5-30) to ++++ (>30) and were significantly higher than those in healthy women. High-throughput sequencing showed that Lactobacillus was the most prominent genus both in patients with CV and in healthy women, with abundances of 83.8% and 97.2%, respectively (P < 0.001). Lactobacillus crispatus was more abundant in patients with CV, whereas Lactobacillus sp. L-YJ was more abundant in healthy women, with area under the curve (AUC) values of 0.9375 and 0.8379, respectively.
CONCLUSION
The abundance of Lactobacillus spp. in CV patients was significantly different from that of healthy patients. Two suitable biomarkers, L. crispatus and Lactobacillus sp. L-YJ, were identified. These results will be useful for the identification of women at risk of serious illness before they develop obvious symptoms.
Topics: Adult; Bacteria; DNA, Bacterial; Female; High-Throughput Nucleotide Sequencing; Humans; Microbiota; Sequence Analysis, DNA; Vagina; Vaginosis, Bacterial
PubMed: 30203607
DOI: 10.1002/jcla.22653 -
Current Medical Mycology Mar 2018is a non- species isolated from certain plants, soil, air, and arctic glaciers.
BACKGROUND AND PURPOSE
is a non- species isolated from certain plants, soil, air, and arctic glaciers.
CASE REPORT
This report describes a case of a 23-year-old Iranian female with pruritus and vaginal irritation. Conventional tests and molecular analysis of the samples of vaginal discharge were performed. The mentioned analyses revealed as the causative agent of vaginal infection. The minimum inhibitory concentration analysis revealed that this species is susceptible to itraconazole, fluconazole, ketoconazole, and amphotericin B. The patient received 200 mg of oral ketoconazole once daily for 10 days. The patient did not show any clinical signs of vaginal infection after six months.
CONCLUSION
was found to have the ability to cause vulvovaginitis This is the first report of successful detection and treatment of vulvovaginal infection with .
PubMed: 30186991
DOI: 10.18502/cmm.4.1.32 -
The Journal of International Medical... Sep 2018Objective To evaluate the efficacy, tolerability and acceptability of Zelesse®, an intimate hygiene wash solution, in the relief of the symptoms and signs of... (Observational Study)
Observational Study
Objective To evaluate the efficacy, tolerability and acceptability of Zelesse®, an intimate hygiene wash solution, in the relief of the symptoms and signs of non-specific vulvovaginitis in paediatric patients. Methods The NINESSE Study was a prospective, observational, multicentre study involving females aged 2-8 years who attended paediatric offices with symptoms suggestive of non-specific vulvovaginitis. They were administered Zelesse® as a single treatment for 15 ± 5 days. Pruritus, burning, dysuria, erythema, leucorrhoea and oedema were evaluated before and after treatment. Results A total of 71 paediatric patients were enrolled in the study (mean ± SD age, 4.5 ± 1.9 years). The most significant effects were observed for pruritus and burning, where 98.4% (62 of 63) and 96.9% (63 of 65) of the patients improved after treatment, respectively. Zelesse® demonstrated a beneficial effect on dysuria, erythema, leucorrhoea and oedema. The effects on the symptoms and signs were observed within the first week of treatment; although 44.9% (31 of 69) of patients experienced improvements after 2-3 days. Zelesse® was well accepted and tolerated by most patients. No serious adverse events were reported. Conclusions Zelesse® was very effective for the relief of the symptoms and signs of non-specific vulvovaginitis, in particular pruritus, burning and erythema, in females aged 2-8 years.
Topics: Child; Child, Preschool; Female; Humans; Prospective Studies; Skin Care; Solutions; Treatment Outcome; Vulvovaginitis
PubMed: 29877120
DOI: 10.1177/0300060518775566 -
The New Microbiologica Jul 2018The aim of this non-interventional, observational, multicentre, open-label study was to assess the effectiveness of a vaginal gel containing extracts of Thymus vulgaris... (Clinical Trial)
Clinical Trial
The aim of this non-interventional, observational, multicentre, open-label study was to assess the effectiveness of a vaginal gel containing extracts of Thymus vulgaris and Eugenia caryophyllus in conjunction with two specific lactobacilli strains (Lactobacillus fermentum LF10 and Lactobacillus plantarum LP02) specifically formulated in slow-release vaginal capsules, in treating bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) or recurrent vulvovaginal candidiasis disease (RVVC) [Estromineral Probiogel (EPB) in Italy, or Saugella Probiogel; Meda Pharma - Mylan Group]. There was a statistically significant improvement in pruritus, burning, vulvovaginal oedema and erythema, dyspareunia and vaginal secretions in all diagnostic groups. At the end of the study, the microbiological evaluation was normal in 80.0% of cases with BV, 62.5% of cases with VVC and 100.0% with RVVC. The clinical data allow EPB to be recommended in the acute treatment of VVC and BV, suggesting that EPB is a useful maintenance treatment if there are recurrent episodes. Controlled studies are needed to confirm the efficacy of EPB in the treatment of recurrences and to identify the most appropriate dosage regimen.
Topics: Administration, Intravaginal; Adult; Candidiasis, Vulvovaginal; Drug Combinations; Eugenol; Female; Humans; Limosilactobacillus fermentum; Lactobacillus plantarum; Middle Aged; Thymol; Vagina; Vaginosis, Bacterial
PubMed: 29874389
DOI: No ID Found -
Facts, Views & Vision in ObGyn Sep 2017Lichen sclerosus most commonly affects the genital area. Contrarily to lichen planus, the involvement of the oral or vaginal mucosa is rare. Only four cases of vaginal...
BACKGROUND
Lichen sclerosus most commonly affects the genital area. Contrarily to lichen planus, the involvement of the oral or vaginal mucosa is rare. Only four cases of vaginal lichen sclerosus have been described in the literature.
CASE REPORT
The authors report two cases of postmenopausal women with a history of vulvar pruritus and burning. Both presented with lesions of the vaginal mucosa compatible with lichen sclerosus, and genital prolapse. Vaginal biopsies confirmed the diagnosis. Initial treatment with topical clobetasol was effective in one of the patients, but in the other patient line therapy with pimecrolimus, triamcinolone, and retinoids was needed.
CONCLUSION
Vaginal lichen sclerosus may be underdiagnosed and genital prolapse may favour the development of vaginal lesions.
PubMed: 29479404
DOI: No ID Found