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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