Tag: statistics

Drug Deliv. 2021 Dec;28(1):1877-1889. doi: 10.1080/10717544.2021.1974608.

ABSTRACT

Vulvovaginal candidiasis is a pervasive gynecological condition among women worldwide due to infection recurrence and resistance to conventional drugs. This calls for a novel formulation of alternative medication and with enhanced efficacy. This study aimed to fabricate mixed-lipid nanoconstructs (MLNCs) of voriconazole (VCZ) with a low concentration of lipids applying high shear homogenization and ultrasonication to form a semisolid formulation. Tefose 63 and Gelot 64 were employed as emulsifiers that are specified for vaginal preparations; as per their mucoadhesive properties and their texture enhancing characters, although usually used as lipids in different lipid carriers. A 2⁴ factorial design was established and the optimized formulation was prepared using 10% total lipids, in which solid lipids (Sterotex NF: Glyceryl monostearate) ratio was 1.92:1 and the oils percentage was 30% (Maisine: Glyceryl monooleate, in the ratio of 1:1), and the emulsifiers mixture (Tefose 63: Gelot 64) ratio was 1:1, as 10% of total formulation weight. The optimized formulation with a viscosity of 964.49 ± 57.99 cp showed spherical nanoparticles (322.72 ± 15.11 nm) that entrapped 67.16 ± 3.45% of VCZ and exhibited release of 70.08 ± 2.87% in 8 h. The optimized formulation with high bioadhesive potentials significantly reduced the fungal burden in female Wistar rats infected with vaginal candidiasis, compared to the aqueous VCZ suspension (p < .05). Furthermore, in vivo histopathological findings proved the effectiveness and the safety of the optimized MLNCs formulation after vaginal application. Inclusively, MLNCs formulation could be a promising vaginal delivery system of VCZ for the treatment of vulvovaginal candidiasis.

PMID:34519230 | DOI:10.1080/10717544.2021.1974608

Eur J Neurol. 2021 Sep 14. doi: 10.1111/ene.15103. Online ahead of print.

ABSTRACT

AIM: Many migraine patients rely on over-the-counter (OTC) analgesics for the treatment of migraine attacks. Fixed-dose combinations of aspirin, paracetamol and caffeine (APC) are used for treating migraine in many countries for a long time. We performed a meta-analysis for the comparison of APC vs placebo, which has not been done so far.

METHODS: Randomised, blinded, placebo-controlled, parallel-group studies using APC to treat a migraine attack were included in a meta-analysis. We calculated relative rates (RR) for APC compared with placebo.

RESULTS: Seven studies were included, with 3,306 participants (2,147 with APC and 1,159 with placebo). For the primary efficacy outcome pain-free at 2 h, APC was superior to placebo (19.6% vs. 9.0%, and RR = 2.2; 95%-confidence interval (CI): 1.4-3.3). For the co-primary efficacy outcome pain relief at 2 h, APC was superior to placebo (54.3% vs. 31.2%, and RR = 1.7; 95% CI: 1.6-1.9). Adverse event (AE) rates were more frequent for APC than for placebo (10.9% vs. 7.8%, and RR = 1.7, 95%-CI: 1.3-2.2).

CONCLUSIONS: APC is superior to placebo in the treatment of acute migraine attacks. The efficacy for a pain-free response and for pain relief at 2 h is clinically relevant.

PMID:34519136 | DOI:10.1111/ene.15103

Pain Pract. 2021 Sep 14. doi: 10.1111/papr.13076. Online ahead of print.

ABSTRACT

BACKGROUND: As a new technology, electronic wrist-ankle acupuncture (E-WAA) combines the advantages of wrist-ankle acupuncture and transcutaneous electrical nerve stimulation, but the analgesic effect and mechanism need to be clarified. The purpose of this study was to identify the pain modulation caused by electronic wrist-ankle acupuncture by evaluating the response of prefrontal cortex (PFC) from the perspective of neurophysiology.

METHODS: 50 male volunteers (age 25.00±1.05 years) with trapezius myofascial pain syndrome were randomly allocated into intervention group (E-WAA treatment)or sham control group at a 1:1 ratio. An outcome evaluation system was used to induce tenderness on the Jianjing point and record the pain value. A multichannel functional near-infrared spectroscope was used to detect the prefrontal cortex activation during tenderness before and after treatment to demonstrate the neuromodulation mechanism. A general linear model and t-test (p<0.05) were used to analyze the difference in the oxyhemoglobin (HbO) concentration and pain value.

RESULTS: In the intervention group, the pain value of volunteers decreased significantly (p=0.017) after E-WAA treatment, while there was no statistical difference(p=0.082) in the sham group. Before treatment, the frontopolar (FP) and dorsolateral prefrontal cortex (DLPFC)were the activation areas of the PFC. The E-WAA treatment then suppressed the activation of the two areas. The HbO concentration of the FP and DLPFC changed from a sharp rise during tenderness to not changing with tenderness stimulation.

CONCLUSION: The results demonstrated that the E-WAA have a great analgesic effect. The FP and DLPFC were relative to the analgesia neuromodulation induced by the E-WAA.

PMID:34519161 | DOI:10.1111/papr.13076

Head Neck. 2021 Sep 14. doi: 10.1002/hed.26872. Online ahead of print.

ABSTRACT

BACKGROUND: The aim was to analyze the frequency, clinical and demographic features of solitary and multiple/diffuse oral pigmented lesions submitted to histopathological examination, and to summarize the features that guide the clinical differential diagnosis.

METHODS: Clinical and demographic data were retrieved from biopsy records and descriptive statistics were performed.

RESULTS: Nine hundred and five (0.51%) oral pigmented lesions were retrieved among 177 356 specimens, being 95.9% solitary and 4.1% multiple/diffuse lesions. Regardless the overlapping clinical presentation, age, site, association with amalgam restoration, and a nodular appearance may help in the clinical differential diagnosis of solitary oral pigmentations. Patient’s habits, site, and systemic signs and symptoms are helpful in the clinical differential diagnosis of multiple/diffuse lesions.

CONCLUSIONS: Oral pigmented lesions are a rare diagnosis in oral pathology and solitary lesions are more commonly submitted to biopsy. Some key features help in the differential diagnosis, though biopsy can be warranted in doubtful cases.

PMID:34519124 | DOI:10.1002/hed.26872

Eur J Neurol. 2021 Sep 14. doi: 10.1111/ene.15102. Online ahead of print.

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) often remains undiagnosed in cryptogenic stroke (CS), mostly because of limited availability of cardiac long-term rhythm monitoring. There is an unmet need for a pre-selection of CS patients benefiting from such work-up. We therefore developed a clinical risk score for the prediction of AF after CS and evaluated its performance over one year of follow-up.

METHODS: Our proposed risk score ranges from 0 to 16 points and comprises variables known to be associated with occult AF in CS patients including age, NT-proBNP, electro- and echocardiographic features (supraventricular premature beats, atrial runs, atrial enlargement, left ventricular ejection fraction) and brain imaging markers (multi-territory/prior cortical infarction). We prospectively followed all CS patients admitted to our Stroke Unit between March 2018 to August 2019 for AF detection over one year after discharge.

RESULTS: During the one-year follow-up, we diagnosed 24 (16%) out of 150 CS patients with AF (detected via ECG-controls, n=18; loop recorder-monitoring, n=6). Our predefined AF risk score (cutoff ≥4 points; highest Youden’s Index) had a sensitivity of 92% and a specificity of 67% for one-year prediction of AF. Notably, only two CS patients with <4 score points were diagnosed with AF later on (negative predictive value: 98%).

CONCLUSIONS: We here present a clinical risk score for one-year prediction of AF in CS with high sensitivity, reasonable specificity, and excellent negative predictive value. Generalizability of our score needs to be tested in external cohorts with continuous cardiac rhythm monitoring.

PMID:34519135 | DOI:10.1111/ene.15102

Histopathology. 2021 Sep 14. doi: 10.1111/his.14566. Online ahead of print.

ABSTRACT

AIMS: Emerging data support that submucosa-invasive (pT1b) esophageal adenocarcinomas are cured via endoscopic resection provided that invasion measures ≤500 microns (μm), they lack other histologic features predictive of nodal metastasis, and have negative margins. Hence, pathologists’ measurement of depth of submucosal invasion in endoscopic resections may dictate further management (i.e. endoscopic follow-up vs. esophagectomy). In this study, we assessed the interobserver agreement in measuring the depth of submucosal invasion in esophageal endoscopic resections.

METHODS AND RESULTS: Six subspecialized gastrointestinal (GI) pathologists from 5 academic centers independently measured the depth of submucosal invasion in μm from the deepest muscularis mucosae on 37 esophageal endoscopic resection slides (Round 1 scoring). A consensus meeting with a systematic approach for measuring and discussion of pitfalls was undertaken and re-measuring (Round 2 scoring) was done. Interobserver agreement was assessed by the `intraclass correlation coefficient (ICC) and Cohen’s kappa statistics. A lack of agreement was seen amongst the six reviewers with a poor ICC for both rounds: 1 [0.40, 95% CI 0.26-0.56]; 2 [ 0.49 ,95%CI 0.34-0.63]. When measurements were categorized as < or >500 μm, the overall agreement amongst the 6 reviewers was only fair for both rounds: 1[Kappa 0.37, 95% CI 0.22-0.53]; 2 [Kappa 0.29, 95%CI 0.12- 0.46].

CONCLUSIONS: Our study shows a lack of agreement among GI pathologists in measuring depth of submucosal invasion in esophageal endoscopic resections despite formulating a consensus approach for scoring. If important management decisions continue to be based upon this parameter, more reproducible and concrete guidelines are needed.

PMID:34519098 | DOI:10.1111/his.14566

Vet Dermatol. 2021 Sep 14. doi: 10.1111/vde.13022. Online ahead of print.

ABSTRACT

BACKGROUND: The pathogenesis of feline allergic dermatitis (FAD) is unclear, with several differences from allergic dermatitis in dogs and humans.

HYPOTHESIS/OBJECTIVES: To survey cytokine expression levels in healthy cats and cats affected with allergic dermatitis or asthma.

ANIMALS: Formalin-fixed, paraffin-embedded skin biopsies from 22 cats with allergic dermatitis and 21 cats without allergic dermatitis were used for cutaneous assays. Serum was obtained from 17 healthy cats, 18 cats with allergic dermatitis, and 18 cats with a presumptive diagnosis of asthma.

METHODS AND MATERIALS: Cutaneous mRNA expression was evaluated with quantitative PCR [interleukin (IL)-31 and IL-31 Receptor A] and RNA in situ hybridisation (ISH) [IL-5, IL-31, IL-31RA, IL-33 and Oncostatin M receptor (OSMR)-β]. IL-31 protein concentrations were evaluated in serum with an enzyme-linked immunosorbent assay. Serum levels of 19 additional cytokines were evaluated using a Luminex panel.

RESULTS: IL-31, IL-31RA, IL-5 and IL-33 mRNA expression were either expressed in low quantities or undetectable in most samples. By contrast, OSMR-β expression was significantly higher in the skin of allergic versus healthy cats (P < 0.0001). Although serum IL-31 was detected in a larger number of cats with allergic dermatitis than healthy cats, and concentrations appeared to be higher in cats with allergies, this difference was not statistically significant. Cats affected by asthma also exhibited insignificantly higher concentrations of IL-31 in the serum.

CONCLUSIONS AND CLINICAL RELEVANCE: Our results suggest that feline allergic diseases may exhibit different pathomechanisms from allergic diseases affecting other species. These findings are useful in guiding further therapeutic development toward targets that may have a role in the pathogenesis of feline allergic skin disease.

PMID:34519120 | DOI:10.1111/vde.13022

Kidney Blood Press Res. 2021 Sep 10:1-11. doi: 10.1159/000518768. Online ahead of print.

ABSTRACT

INTRODUCTION: Serum uric acid (SUA) has been found correlated with an increased risk of hypertension, but evidence is sparse regarding the association in Gansu Province, especially in Yugur people. This study aimed to explore the nonlinear relationship between SUA levels and hypertension in Han and Yugur people in China.

METHODS: The cross-sectional study samples (n = 5,327) were from the China National Health Survey (CNHS) in Gansu Province. Participants were selected using a multistage stratified cluster sampling method. SUA was measured by enzymatic methods. The restricted cubic spline regression was performed to evaluate the shape of the association.

RESULTS: The overall prevalence of hypertension and hyperuricemia was 28.4% and 17.0%, respectively, in this study. Comparing the highest (>416.4 μmol/L) to the lowest (<254.1 μmol/L) SUA level groups, the multivariable adjusted differences and 95% confidence intervals (CIs) in blood pressure (BP) were 6.15 (4.22, 8.08) mm Hg and 4.87 (3.51, 6.23) mm Hg for SBP and DBP in Han, and 2.22 (-0.73, 5.18) mm Hg and 2.56 (0.38, 4.75) mm Hg for SBP and DBP in Yugur people, respectively. The corresponding odds ratios (95% CIs) for hypertension were 3.16 (2.26, 4.43) and 2.37 (1.46, 3.89) in Han and Yugur people, respectively. The restricted cubic spline regression models illustrated that both BP level and the risk of hypertension increased with elevated SUA levels in Han and Yugur people.

CONCLUSIONS: SUA was significantly and independently associated with an increased risk of hypertension in Han and Yugur people. Prospective studies are needed to confirm these findings.

PMID:34518473 | DOI:10.1159/000518768

ORL J Otorhinolaryngol Relat Spec. 2021 Sep 10:1-7. doi: 10.1159/000518366. Online ahead of print.

ABSTRACT

INTRODUCTION: The anterosuperior portion of the bulla lamella can extend into the frontal sinus and form the supra bulla frontal cell (SBFC) and supraorbital ethmoid cell (SOEC). This can affect the frontal drainage pathway and make surgery more challenging.

OBJECTIVES: The aim of the study was to compare the anatomical characteristics of SBFC and SOEC in Chinese chronic rhinosinusitis (CRS) patients and explore the relationship between the cells and frontal sinusitis (FS). The surgical skills in dealing with these cells were also studied.

METHODS: We prospectively identified SBFC and SOEC in 114 patients with CRS by computed tomography (CT). The sides of the patients were divided into groups A (with FS) and B (without FS). CT scans were analyzed to distinguish the SBFC, SOEC, and the drainage pathway. Statistical analysis was conducted to determine whether the cells were associated with the occurrence of FS.

RESULTS: The prevalence of frontal cells was as follows: SBFC: 9.65%, SOEC: 21.93%. There was an association between the presence of SBFC and FS (p < 0.05). The anterior drainage pathway was present in patients with SBFC and SOEC, anterolateral pathway in those with SBFC/SOEC coexisting with the frontal septal cell, and anteromedial pathway in those with SBFC/SOEC coexisting with the supra agger frontal cell.

CONCLUSIONS: There was an association between the presence of SBFC and the occurrence of FS. Extension of the anterosuperior portion of the bulla lamella into the frontal sinus obstructed the drainage pathway posteriorly. Understanding the anatomy may help surgeons thoroughly dissect the bulla lamella.

PMID:34518488 | DOI:10.1159/000518366

Ann Nutr Metab. 2021 Sep 10:1-9. doi: 10.1159/000518675. Online ahead of print.

ABSTRACT

INTRODUCTION: Obesity and overweight are important public health problems. Mindfulness can promote healthier living and dietary habits, which might support weight loss. This study aimed to evaluate the relationship between eating awareness and body mass index (BMI) and body composition in adults.

METHODS: This cross-sectional analytical study was conducted with 446 volunteers. The heights, weights, and waist circumferences of the participants were measured, and bioelectrical impedance analyses were performed. A sociodemographic information form prepared by the researchers and the Turkish version of the Mindful Eating Questionnaire (MEQ) were administered to the volunteers.

RESULTS: In this study, 31.2% (n = 139) of the participants were overweight and 46.9% (n = 209) were obese. There was no statistically significant relationship between gender and BMI. The total mean MEQ score was found to be 88.26 ± 13.3 (53-144). The awareness scores of women of normal weight were statistically significantly higher than those of women with obesity (p = 0.001). There was no difference between BMI categories and awareness scores among male participants. While participants with obesity had higher scores for eating disinhibition, their eating control, eating discipline, and interference scores were lower than those of participants with normal weight (p < 0.001). A weak statistically significant correlation was found between the awareness subdimension of the scale and the ages, BMIs, waist circumferences, and body fat rates of the participants.

CONCLUSION: It was observed that mindful eating was lower in women with overweight and obesity than that in women with normal weight. We believe that it is important to increase awareness of eating in order to protect against the diseases caused by obesity and for a healthy life.

PMID:34518446 | DOI:10.1159/000518675