Lymphedema self-care in patients with head and neck cancer: a qualitative study

Purpose

Lymphedema is a frequent side effect from head and neck cancer and/or its treatment. As a chronic and progressive condition, it requires an individual’s long-term involvement in self-care for management of lymphedema. This study aimed to report head and neck cancer patients’ perceived lymphedema education, self-care practices, and suggestions related to self-care of head and neck lymphedema.

Methods

Twenty head and neck cancer patients who completed lymphedema therapy participated in semi-structured face-to-face interviews. Interviews were audio-recorded and transcribed. Content analysis was used to analyze the interview data.

Results

All participants reported that they were educated about self-care activities for lymphedema management by their lymphedema therapists. Although most participants (n = 16, 80 %) expressed positive comments about lymphedema self-care education, some participants (n = 7, 35 %) described issues related to lymphedema self-care education. A majority of the participants (n = 17, 85 %) reported that they were conducting some lymphedema self-care activities; nonetheless, more than half of the participants (n = 11, 55 %) delineated barriers for diminished lymphedema self-care activities over time. Participants further indicated suggestions for improving and ensuring consistency of lymphedema self-care.

Conclusions

Opportunities exist to improve lymphedema self-care in head and neck cancer patients. Healthcare professionals should focus on delivering high quality and targeted information about self-care for management of head and neck lymphedema. Interventional research is warranted to address gaps in long-term self-care of head and neck lymphedema.

     

Peritumoral Brain Edema in Meningiomas Depends on Aquaporin-4 Expression and Not on Tumor Grade,Tumor Volume,Cell Count,or Ki-67 Labeling Index

Purpose

The aim of this study was to investigate to which degree the peritumoral brain edema in patients with meningiomas depends on aquaporin-4 (AQP4) expression, tumor grade, tumor volume, Ki-67 expression, and cell count.

Procedures

Thirty-three patients (25 women, 8 men; mean age 56.6 ± 16.0 years) with an intracranial meningioma underwent a standardized magnetic resonance (MR) examination prior to surgical resection. Edema indices (EIs) and tumor volumes were measured on the MR images. Tumor grade was classified according to the World Health Organization, and the proliferation index was estimated on Ki-67 antigen-stained specimens. Tumor cell count was evaluated. Eighteen specimens were stained for AQP4 expressioon.

Results

Significant intergroup differences between AQP4 expression grades and EIs were observed (P = 0.03), and a positive correlation was detected between EIs and AQP4 expression grades (r = 0.54; P < 0.05). A ROC analysis with EI as a test variable revealed an AUC of 0.77 (95 % CI 0.55–0.99) for the prediction of a moderate-to-strong AQP4 expression. An EI ≥1.5 predicted a moderate-to-high AQP4 expression with a sensitivity of 77 % and a specificity of 60 %. EI values of 2.2 and 3.5 reached sensitivity/specificity values of 69/80 % and 54/100 %, respectively. The AQP4 expression did not show any significant correlations with tumor grading, tumor volume, Ki-67 expression, or cell count. Moreover, we observed no significant positive or negative correlations between the EI and tumor grading (P = 0.7), tumor volume (P = 0.19), Ki-67 index (P = 0.9), and cell count (P = 0.34).

Conclusion

Peritumoral brain edema in patients with meningiomas may depend on AQP4 expression grades and not on tumor grade, tumor volume, Ki-67 expression, and cell count. The amount of edema predicted AQP4 expressions with moderate-to-good sensitivity and specificity.

     

Effect of available intravenous access on accuracy and timeliness of epinephrine administration

Purpose

To evaluate the effect of available intravenous (IV) access on the accuracy and timeliness of epinephrine administration during a surprise mock severe contrast reaction.

Methods

Informed consent was waived for this prospective randomized IRB-approved study. Radiology trainees with previous annual hands-on contrast reaction training (n = 46) were randomized to one of two surprise mock contrast reactions over a 23-month period: Group 1—severe laryngeal edema with IV access present (n = 27) or Group 2—severe laryngeal edema without IV access present (n = 19). Both intramuscular (IM, Epi-Pen^®) and IV epinephrine were available in both scenarios. Time-to-treat and epinephrine administration error rates were compared by study group and by route of administration using two-tailed Student’s t test or χ ² test. Epinephrine administration errors were correlated with training experience using Pearson’s correlation.

Results

Mean time to epinephrine administration was significantly faster for scenarios without IV access (Group 2: 35 ± 16 s vs. Group 1: 62 ± 49 s, p = 0.03), and for intramuscular administrations overall (IM: 42 ± 34 s vs. IV: 98 ± 46 s, p < 0.001). Epinephrine administration errors were common: (63% [17/27, Group 1] vs. 61% [11/18, Group 2], p = 1.00), had no relationship with time to most recent hands-on training (r = 0.24, p = 0.11), and were not predicted by year of post-graduate training (r = 0.04, p = 0.79).

Conclusions

Lack of IV access is associated with a faster epinephrine administration time but no improvement in epinephrine administration error rate among radiology trainees responding to a surprise mock severe contrast reaction. Annual hands-on training appears to have little effect on epinephrine administration accuracy.

     

Complementary and Alternative Medicine Treatments for Generalized Anxiety Disorder: Systematic Review and Meta-analysis of Randomized Controlled Trials

Introduction

The objective was to evaluate efficacy/safety of complementary and alternative medicine (CAM) methods for generalized anxiety disorder (GAD) based on randomized controlled trials in adults.

Methods

Data sources. Six electronic databases (“generalized anxiety (disorder)” and “randomized trial”) and reference lists of identified publications were searched to March 2017. Study selection. Eligibility: full-text publications (English, German language); CAM versus conventional treatment, placebo/sham or no treatment; GAD diagnosed according to standard criteria; and a validated scale for disease severity. Of the 6693 screened records, 32 were included (18 on biologically-based therapies, exclusively herbal preparations; eight on manipulative and body-based therapies; and three on alternative medical systems and three on mind–body therapies). Data extraction. Cochrane Collaboration methodology was used for quality assessment and data extraction.

Results

Direct comparisons of Kava Kava (Piper methysticum) extracts to placebo (4 quality trials, n = 233) were highly heterogeneous. Network meta-regression reduced heterogeneity and suggested a modest Kava effect [end-of-treatment Hamilton Anxiety scale score difference adjusted for baseline scores and trial duration: ? 3.24 (95% CI ? 6.65, 0.17; P = 0.059), Kava Kava 4 arms, n = 139; placebo 5 arms, n = 359]. Lavender (Lavandula angustifolia) extract (1 quality trial, 10 weeks, n = 523) and a combination of extracts of C. oxycantha, E. californica and magnesium (1 quality trial, 12 weeks, n = 264) were superior to placebo and balneotherapy was superior to paroxetine (1 quality trial, 8 weeks, n = 237) indicating efficacy. All other trials were small and/or of modest/low quality and/or lacked assay sensitivity. Safety reporting was poor.

Conclusion

Evidence about efficacy/safety of most CAM methods in GAD is limited. Apparent efficacy of certain herbal preparations and body-based therapies requires further confirmation.

     

Value of diffusion-weighted MR imaging in the diagnosis of lymph node metastases in patients with cholangiocarcinoma

Purpose

To evaluate diffusion-weighted MR imaging (DWI) in the diagnosis of lymph node metastases in patients with cholangiocarcinoma.

Methods

In 24 patients with cholangiocarcinoma, MR imaging of the upper abdomen was performed prior to surgery at 1.5 T using a respiratory-triggered single-shot echo-planar imaging (SSEPI) sequence (b values: 50, 300, and 600 s/mm²). ADC (apparent diffusion coefficient) values and diameters of regional lymph nodes (LN) were determined. Subsequently, in all patients, surgical exploration and/or resection of the primary tumor and regional LN dissection were performed. Imaging results were correlated with results of histopathologic analysis. ADC values and diameters of benign and malignant LN were compared using the Mann–Whitney U test. In addition, a ROC (receiver operating characteristic curve) analysis was performed.

Results

The mean ADC value (×10^?3 mm²/s) of metastatic LN (1.21 ± 0.15) was significantly lower than that of benign LN (1.62 ± 0.33, p < 0.001) while there was no significant difference in the mean diameter of malignant (16.8 ± 5.4 mm) and benign LN (14.1 ± 4.0 mm; p = 0.09). Using an ADC value of 1.25 × 10^?3 mm²/s as threshold, 91.4% of LN were correctly classified as benign or malignant with a sensitivity/specificity of 83.3%/92.8% and a positive/negative predictive value of 66.7%/96.7%. The area under the ROC curve was 0.93.

Conclusion

DWI using a respiratory-triggered SSEPI sequence, according to our preliminary experience, is a promising imaging modality in the differentiation of benign and malignant LN in patients with cholangiocarcinoma.

     

[<Superscript>68</Superscript>Ga]PSMA-HBED-CC Uptake in Osteolytic,Osteoblastic, and Bone Marrow Metastases of Prostate Cancer Patients

Purpose

The aim of this study was to evaluate potential differences in “Glu-NH-CO-NH-Lys” radio-labeled with [⁶⁸Ga]gallium N,N-bis[2-hydroxy-5-(carboxyethyl)benzyl]ethylenediamine-N,N-diacetic acid ([⁶⁸Ga]PSMA-HBED-CC) uptake in osteolytic, osteoblastic, mixed, and bone marrow metastases in prostate cancer (PC) patients.

Procedures

This retrospective study was approved by the local ethics committee. Patients who received [⁶⁸Ga]PSMA-HBED-CC positron emission tomography/computed tomography ([⁶⁸Ga]PSMA-PET/CT) with at least one positive bone metastasis were included in this study. Only patients who have not received systemic therapy for their PC were included. Bone metastases had to be confirmed by at least one other imaging modality or follow-up investigation. The maximum standardized uptake value (SUV_max) and mean Hounsfield units (HU_mean) of each metastasis were measured. Based on CT, each metastasis was classified as osteolytic (OL), osteoblastic (OB), bone marrow (BM), or mixed (M).

Results

One hundred fifty-four bone metastases in 30 patients were evaluated. Eighty out of 154 (51.9%) metastases were classified as OB, 21/154 (13.6%) as OL, 23/154 (14.9%) as M, and 30/154 (19.5%) as BM. The SUV_max for the different types of metastases were 10.6 ± 7.07 (OB), 24.0 ± 19.3 (OL), 16.0 ± 21.0 (M), and 14.7 ± 9.9 (BM). The SUV_max of OB vs. OL and OB vs. BM metastases differed significantly (p ≤ 0.025). A significant negative correlation between HU_mean and SUV_max (r = ?0.23, p < 0.05) was measured.

Conclusions

[⁶⁸Ga]PSMA-HBED-CC uptake is higher in osteolytic and bone marrow metastases compared to osteoblastic metastases. Information derived from [⁶⁸Ga]PSMA-PET and CT complement each other for the reliable diagnosis of the different types of bone metastases in PC patients.

     

Evaluation of the impact of computed high <Emphasis Type="Italic">b</Emphasis>-value diffusion-weighted imaging on prostate cancer detection

Purpose

The purpose of this study was to compare high b-value (b = 2000 s/mm²) acquired diffusion-weighted imaging (aDWI) with computed DWI (cDWI) obtained using four diffusion models—mono-exponential (ME), intra-voxel incoherent motion (IVIM), stretched exponential (SE), and diffusional kurtosis (DK)—with respect to lesion visibility, conspicuity, contrast, and ability to predict significant prostate cancer (PCa).

Methods

Ninety four patients underwent 3 T MRI including acquisition of b = 2000 s/mm² aDWI and low b-value DWI. High b = 2000 s/mm² cDWI was obtained using ME, IVIM, SE, and DK models. All images were scored on quality independently by three radiologists. Lesions were identified on all images and graded for lesion conspicuity. For a subset of lesions for which pathological truth was established, lesion-to-background contrast ratios (LBCRs) were computed and binomial generalized linear mixed model analysis was conducted to compare clinically significant PCa predictive capabilities of all DWI.

Results

For all readers and all models, cDWI demonstrated higher ratings for image quality and lesion conspicuity than aDWI except DK (p < 0.001). The LBCRs of ME, IVIM, and SE were significantly higher than LBCR of aDWI (p < 0.001). Receiver Operating Characteristic curves obtained from binomial generalized linear mixed model analysis demonstrated higher Area Under the Curves for ME, SE, IVIM, and aDWI compared to DK or PSAD alone in predicting significant PCa.

Conclusion

High b-value cDWI using ME, IVIM, and SE diffusion models provide better image quality, lesion conspicuity, and increased LBCR than high b-value aDWI. Using cDWI can potentially provide comparable sensitivity and specificity for detecting significant PCa as high b-value aDWI without increased scan times and image degradation artifacts.

     

Characterization and Mosquitocidal Potential of the Soil Bacteria <Emphasis Type="Italic">Aneurinibacillus aneurinilyticus</Emphasis> Isolated from Burdwan,West Bengal,India

Aedes aegypti, Anopheles subpictus and Culex quinquefasciatus are the principal vector mosquitoes globally, especially in tropical and subtropical countries. It is very essential to control the mosquito population to prevent mosquito-borne disease transmission. The major goal of the present study was to isolate an alternative for the microbial mosquito control agents like Bacillus thuringiensis and Bacillus sphaericus. The spore forming soil bacteria isolated from Burdwan, West Bengal, India were assessed for mosquitocidal potential. One potent mosquitocidal isolate was characterized by phenotypic, biochemical and 16S rDNA sequence (GU244410) analysis. The isolate was identified as Aneurinibacillus aneurinilyticus. Five ml bacterial suspension of A. aneurinilyticus (22 × 10⁹ colony forming unit/milliliter)/100 ml water resulted in 34, 59.6 and 100 % mortality of Ae. aegypti, Cx. quinquefasciatus and An. subpictus larvae respectively within 72 h, whereas, 10 ml suspension having same concentration showed 95 and 97 % death of Ae. aegypti and Cx. quinquefasciatus larvae respectively within the same time period.     

Effects of a physical therapy program combined with manual lymphatic drainage on shoulder function,quality of life,lymphedema incidence,and pain in breast cancer patients with axillary web syndrome following axillary dissection

Purpose

The aim of this study was to evaluate the effects of physical therapy (PT) combined with manual lymphatic drainage (MLD) on shoulder function, pain, lymphedema, visible cords, and quality of life (QOL) in breast cancer patients with axillary web syndrome (AWS).

Methods

In this prospective, randomized trial, 41 breast cancer patients with visible and palpable cords on the arm and axilla and a numeric rating scale (NRS) pain score of >3 were randomly assigned to PT (3 times/week for 4 weeks; n?=?20) and PT combined with MLD (5 times/week for 4 weeks; PTMLD; n?=?21) groups. MLD was performed by a physical therapist and the patients themselves during week 1 and weeks 2–4, respectively. Arm volume, shoulder function (muscular strength; active range of motion; and disabilities of the arm, shoulder, and hand [DASH]); QOL (European Organization for Research and Treatment of Cancer Core and Breast Cancer‐Specific QOL questionnaires), and pain (NRS) were assessed at baseline and after 4 weeks of treatment.

Results

QOL including functional and symptom aspects, shoulder flexor strength, DASH, and NRS scores were significantly improved in both groups after the 4-week intervention (P?<?0.05). NRS score and arm volume were significantly lower in the PTMLD group than in the PT group (P?<?0.05). Lymphedema was observed in the PT (n?=?6), but not PTMLD, group (P?<?0.05).

Conclusions

PT improves shoulder function, pain, and QOL in breast cancer patients with AWS and combined with MLD decreases arm lymphedema.

     

Protein and Amino Acid Composition of Indian Himalayan Snow Trout and Their Dietary Significance

Seven species of snow trout (Schizothorax spp.), endemic to Indian Himalayas, were taken up for exploring their protein content, dietary protein contribution potential, amino acid composition and amino acid score. Protein contents in all the seven species were in the order of S. labiatus > S. plagiostomus > S. progastus > S. esocinus > S. curvifrons > S. richardsonii > S. niger. Statistically, S. labiatus was found to be significantly superior (p < 0.05) to S. progastus, S. esocinus, S. curvifrons, S. richardsonii and S. niger with respect to protein content. Correspondingly, the dietary protein contribution potential to pre-school children (2–6 years old) was found to be highest in S. labiatus. Out of the seventeen detected amino acids, alanine was abundant in S. curvifrons, S. esocinus, S. niger, and S. plagiostomus, and leucine in S. labiatus, S. progastus and S. richardsonii. Among the essential amino acids, leucine followed by phenylalanine was the most abundant amino acid in all the fishes. The amino acid score values of leucine, isoleucine and lysine for pre-school children were found to be highest in S. labiatus. Overall, S. labiatus showed distinctly protein concentration, dietary protein contribution potential and amino acid score especially for leucine, isoleucine and lysine.     

Superselective transcatheter arterial embolization in patients with acute peripancreatic bleeding complications: review of 44 cases

Purpose

To evaluate the efficacy of superselective transcatheter arterial embolization (TAE) in the treatment of acute peripancreatic bleeding complications.

Methods

During a 9-year period, 44 patients with acute bleeding of the peripancreatic arteries underwent TAE in our institution. Thirty-eight patients were treated using microcatheters and 6 patients with a diagnostic catheter. Embolic agents included coils (n = 38), polyvinyl alcohol (PVA) particles (n = 2), isobutyl cyanoacrylate (n = 2), coils plus PVA particles (n = 1), and coils plus isobutyl cyanoacrylate (n = 1). Outcome measures included technical success, clinical success, and the rate of complications.

Results

Identified bleeding sources included gastroduodenal artery (n = 14), splenic artery (n = 9), pancreaticoduodenal artery (n = 6), common hepatic artery (n = 5), superior mesenteric artery branches (n = 4), proper hepatic artery (n = 3), and dorsal/transverse pancreatic artery (n = 3). Technical success with effective control of active bleeding was achieved in 41/44 patients (93 %). Clinical success attributed to TAE alone was documented in 40/44 patients (91 %). The rate of major complications was 2 % including death in one patient.

Conclusions

Superselective TAE allows effective, minimally invasive control of acute peripancreatic bleeding complications with a low rate of therapeutically relevant complications.

     

Renal shear wave elastography for the assessment of nephron hypertrophy: a cross-sectional study in chronic kidney disease

Purpose

To investigate the association of renal elasticity to microscopic findings of nephron hypertrophy and nephrosclerosis.

Methods

Patients who underwent renal biopsy were enrolled. Renal elasticity was measured by acoustic radiation force impulse, and nephron size (glomerular volume, non-sclerotic glomerular density, and mean profile tubular area) and nephrosclerosis (globally sclerotic glomeruli and interstitial fibrosis) were estimated. Nephron hypertrophy was indicated by larger glomerular volume, larger tubular area, and lower non-sclerotic glomerular density. Nephrosclerosis was indicated by a higher percentage of globally sclerotic glomeruli and higher severity of fibrosis.

Results

Renal elasticity was negatively correlated with glomerular volume (r = ? 0.480, P = 0.024) and mean tubular area (r = ? 0.469, P = 0.028), but it was not correlated with non-sclerotic glomerular density (r = 0.205, P = 0.359), percentage of globally sclerotic glomeruli (r = 0.057, P = 0.800), and severity of fibrosis (r = 0.014, P = 0.950). In a multiple linear regression analysis, glomerular volume and mean tubular area were independently associated with renal elasticity (std β = ? 0.454, P = 0.015 and std β = ? 0.577, P = 0.007, respectively).

Conclusion

Renal elasticity was correlated with microstructural findings of nephron hypertrophy. Measuring renal elasticity could help in detecting kidney disease.

     

Assessment of aortic stiffness among patients with systemic lupus erythematosus and rheumatoid arthritis by magnetic resonance imaging

To evaluate aortic stiffness by MRI in female patients with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA) in comparison to controls. We measured aortic strain, distensibility and pulse wave velocity (PWV) by MRI in 30 SLE patients, 31 RA patients and 53 matched controls. Mean PWV in SLE and RA patients were higher in comparison to controls (9.2 ± 4.4 vs. 7.6 ± 3.0 m/s, p = 0.04) and (6.2 ± 2.3 vs. 5.4 ± 1.7, p = 0.04) respectively. Aortic distensibility among RA patients was significantly lower in comparison to controls (4.4 ± 4.6 vs. 5.8 ± 4.9 kPa^?1 × 10^?3, p = 0.04). A significant correlation was found between PWV and age (r = 0.67, p < 0.001), Framingham risk score (r = 0.61, p < 0.001), waist to hip ratio (r = 0.45, p < 0.001), systolic blood pressure (r = 0.37, p = 0.01), diabetes (r = 0.32, p = 0.001) and dyslipidemia (r = 0.32, p = 0.001). In multivariate analysis for the prediction of PWV, variables which were found significant included: RA (p = 0.01), age (p < 0.001) and hypertension (p = 0.01) for patients with RA and SLE (p = 0.02), waist to hip ratio (p < 0.001) and total cholesterol (p < 0.001) for patients with SLE. Arterial stiffness, characterized by metrics of aortic distensibility and pulse wave velocity derived from MRI, is increased in SLE and RA female patients.     

The Effect of Evolving Strategies in the Surgical Management of Organ-Confined Prostate Cancer: Comparison of Data from 2005 to 2014 in a Multicenter Setting

Introduction

The objective of this study was to evaluate changes of patient characteristics and surgical techniques in radical prostatectomy in Germany within the last decade.

Methods

Data from 44 German prostate cancer centers were included in the study. Patients’ characteristics (age, initial PSA value), surgical techniques (open vs. minimally invasive approaches), perioperative parameters (operating time, rate of nerve-sparing (NS) radical prostatectomies (RPs), hospitalization time, catheter indwelling time, surgical margin status, number of dissected lymph nodes (LN)), and pathological findings (tumor stage, Gleason score) were analyzed.

Results

Data from 11,675 patients who underwent RP between 2005 and 2014 were analyzed. The rate of open RP approaches decreased by 1.7% (p = 0.0164), the rate of minimally invasive approaches increased by 1.8% (p = 0.0164). Robot-assisted RPs (RARP) increased by 4.6% (p < 0.0001). The number of NS procedures and pelvic lymphadenectomy (LA) increased by 4.5% (p < 0.0001) and 4.7% (p < 0.0001), respectively. Catheter indwelling time and hospitalization time decreased by 1 day (p < 0.0001). No change in the rate of positive surgical margins (p = 0.5061) and the ratio of positive lymph nodes removed (p = 0.4628) was observed. The number of Gleason ≤6 tumors decreased significantly (p < 0.0001).

Conclusions

The number of RARP has significantly increased over the past decade and there is a trend towards surgeries on more advanced tumors with higher yields of lymph nodes dissected. At the same time, the rate of nerve-sparing procedures has significantly increased.

     

Short-Term Effects of a Combined Nutraceutical on Lipid Level,Fatty Liver Biomarkers,Hemodynamic Parameters,and Estimated Cardiovascular Disease Risk: A Double-Blind,Placebo-Controlled Randomized Clinical Trial

Introduction

There is a growing interest in nutraceuticals improving cardiovascular risk factor levels and related organ damage.

Methods

This double-blind, placebo-controlled randomized clinical trial aims to compare the effect of a combined nutraceutical containing red yeast rice (10 mg), phytosterols (800 mg), and l-tyrosol (5 mg) on lipid profile, blood pressure, endothelial function, and arterial stiffness in a group of 60 patients with polygenic hypercholesterolemia resistant to Mediterranean diet.

Results

After 8 weeks of treatment, when compared to the placebo group, the active treated patients experienced a more favorable percentage change in total cholesterol (?16.3% vs 9.9%, P < 0.001 always), LDL-C (?23.4% vs ?13.2%, P < 0.001 always), and hepatic steatosis index (?2.8%, P < 0.01 vs ?1.8%, P < 0.05). Moreover, ALT (?27.7%, P < 0.001), AST (?13.8%, P = 0.004), and serum uric acid (?12.3%, P = 0.005) were reduced by the tested nutraceutical compound both compared to randomization and to placebo, which did not affect these parameters (P < 0.01 for all). Regarding the hemodynamic parameters, there was a decrease of systolic blood pressure (?5.6%) with the active treatment not observed with placebo (P < 0.05 vs baseline and placebo) and endothelial reactivity improved, too (?13.2%, P < 0.001 vs baseline). Consequently, the estimated 10-year cardiovascular risk score improved by 1.19% (SE 0.4%) (P = 0.01) in the nutraceutical-treated patients.

Conclusion

The tested nutraceutical association is able to improve the positive effects of a Mediterranean diet on a large number of CV risk factors and consequently of the estimated CV risk.

Trial registration

ClinicalTrials.gov identifier NCT02492464.

Funding

IBSA Farmaceutici.

     

Effect of steatosis on liver signal and enhancement on multiphasic contrast-enhanced magnetic resonance imaging

Purpose

To investigate the effect of steatosis on liver signal and enhancement in multiphasic contrast-enhanced (MCE) MRI.

Materials and methods

In this IRB-approved, HIPAA-compliant, retrospective, observational study, 1217 MCE abdominal MRIs performed during 2014 at a single institution were reviewed. Of these, 1085 were excluded, due to potential factors other than steatosis that may affect liver signal intensity and/or enhancement. In the remaining 132, liver fat fraction (FF) was calculated from the in- and opposed-phase 2D T1-weighted images. Liver signal intensity, absolute enhancement, and relative enhancement on fat-suppressed (Dixon method) 3D T1-weighted images before and after injection of gadobutrol (arterial, portal venous, and equilibrium phases) were plotted against co-localized FF values and the linear trend was evaluated by Pearson correlation coefficient (r). P values <0.05 were considered statistically significant.

Results

Liver signal intensity negatively correlated with FF for all phases (r = ?0.388 to ?0.544, p < 0.001). Absolute enhancement negatively correlated with FF for the portal venous and equilibrium phases (r = ?0.286 and ?0.289, respectively, p < 0.001), but not for the arterial phase (r = ?0.042, p = 0.632). Relative enhancement did not significantly correlate with FF for any phase (p ≥ 0.125).

Conclusion

Steatosis reduces liver signal intensity in MCE MRI. This effect of steatosis was reduced in calculated absolute enhancement and eliminated in calculated relative enhancement.

     

A Randomized Trial Investigating the Pharmacokinetics,Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects

Introduction

Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects.

Methods

In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3). The primary endpoint was semaglutide exposure at steady state [area under the curve (AUC_0–168h)].

Results

Steady-state exposure of semaglutide was similar for both populations: AUC_0–168h estimated race ratio (ERR), Japanese/Caucasian: 0.5 mg, 1.06; 1.0 mg, 0.99; maximum concentration (C_max) ERR: 0.5 mg, 1.06; 1.0 mg, 1.02. Exposure after the first dose (0.25 mg) was slightly higher in Japanese versus Caucasian subjects (AUC_0–168h ERR 1.11; C_max ERR 1.14). Dose-dependent increases in AUC_0–168h and C_max occurred in both populations. Accumulation was as expected, based on the half-life (t_1/2, ~ 1 week) and dosing interval of semaglutide. Significant body weight reductions were observed with semaglutide 0.5 mg and 1.0 mg in Japanese (both p ≤ 0.05) and Caucasian (both p ≤ 0.05) subjects versus placebo. No new safety issues were identified.

Conclusions

The pharmacokinetic, pharmacodynamic, and safety profiles of semaglutide were similar in Japanese and Caucasian subjects, suggesting that no dose adjustment is required for the clinical use of semaglutide in Japanese subjects.

Funding

Novo Nordisk A/S, Denmark.

Trial registration

ClinicalTrials.gov identifier NCT02146079. Japanese trial registration number JapicCTI-142550.

     

Burden of Atopic Dermatitis in the United States: Analysis of Healthcare Claims Data in the Commercial,Medicare, and Medi-Cal Databases

Introduction

Comparative data on the burden of atopic dermatitis (AD) in adults relative to the general population are limited. We performed a large-scale evaluation of the burden of disease among US adults with AD relative to matched non-AD controls, encompassing comorbidities, healthcare resource utilization (HCRU), and costs, using healthcare claims data. The impact of AD disease severity on these outcomes was also evaluated.

Methods

Adult AD patients in the Commercial (n = 83,106), Medicare (n = 31,060), and Medi-Cal (n = 5550) databases were matched (1:1) to non-AD controls by demographic characteristics. AD patients were stratified by disease severity (higher, lower) using treatment as a surrogate measure of severity. The comorbidity burden, HCRU, and costs were evaluated during a 12-month follow-up period.

Results

In the Commercial, Medicare, and Medi-Cal populations, patients with AD had a significantly higher overall comorbidity burden (P < 0.0001), an increased risk of asthma and allergic rhinitis (both P < 0.0001), higher HCRU (P < 0.05), and higher mean total per patient costs (Commercial: US$10,461 versus US$7187; Medicare: US$16,914 versus US$13,714; Medi-Cal; US$19,462 versus US$10,408; all P < 0.0001), compared with matched non-AD controls. Higher disease severity was associated with an increased comorbidity burden (P < 0.0001), HCRU (P < 0.05), and total costs (Commercial: US$14,580 versus US$7192; Medicare: US$21,779 versus US$12,490; Medi-Cal; US$22,123 versus US$16,639; all P < 0.0001) relative to lower severity disease.

Conclusion

In this large-scale, healthcare claims database analysis, AD patients had a significantly higher comorbidity burden, HCRU, and costs compared with matched non-AD controls. Higher disease severity was associated with an even greater comorbidity and economic burden.

Funding

Sanofi and Regeneron Pharmaceuticals, Inc.

     

Safety and tolerability of Kinesio<Superscript>®</Superscript> Taping in patients with arm lymphedema: medical device clinical study

Purpose

The aim of this study is to assess the safety and tolerability of Kinesio^® Taping (KT) in patients with arm lymphedema.

Method

Medical device clinical study in women with arm lymphedema. Kinesio^® Tex Gold bandage was applied by the KT technique. Assessments and interviews were carried out both at the beginning and 4 days after intervention. Skin disorders, reported tolerance and modification of limb volume and function after intervention were assessed. Changes in limb volume and functionality before and after intervention were compared by the Student’s t test and the Wilcoxon Signed-Rank test, considering significant p value <0.05.

Results

Twenty-four women were studied. After intervention, no patient had cutaneous lesions, vesicle or limb hyperthermia, and 4.2 % presented skin peeling and redness. Most patients reported no change in social life and that they felt safer in the daily activity and were very pleased with the treatment. The patients presented improvement of upper limb functionality after intervention (p?<?0.001). No difference of limb volume was found after intervention (p?=?0.639).

Conclusions

Kinesio^® Tex Gold bandage by the KT technique proved to be safe and tolerable in patients with lymphedema, with improved functionality and no change of the affected limb volume.

     

Seasonal Dynamics,Influence of Weather Factors and Forecasting of Cotton Sap Feeders in North India

Analyses of the scenario of cotton sap feeders [leaf hoppers, Amrasca biguttula biguttula (Ishida), thrips, Thrips tabaci Lindeman and whiteflies, Bemisia tabaci Gennadius] based on their population dynamics (numbers/three leaves/plant) for north zone cotton growing locations viz., Faridkot (30.40°N, 74.45°E), and Ludhiana (30.91°N, 75.85°E) of Punjab, Hisar (29.15°N, 75.70°E) of Haryana and Sriganganagar (29.92°N, 73.88°E) of Rajasthan indicated significantly higher A. biguttula biguttula infestation during 2013 (7.0) and 2014 (14.0) over previous eight seasons, increasing whitefly incidence after every two years, and declining T. tabaci infestation at Faridkot (Punjab). Bemisia tabaci incidence was highest during 2013 (26.4) and 2014 (26.9) at Hisar. Peak population and period of sap feeders varied across locations and population between seasons of the same location differed during early and late crop growth stages. The importance of sap feeders was of the order: A. biguttula biguttula > B. tabaci > T. tabaci at Ludhiana (Punjab). Thrips tabaci and B. tabaci were dominant at Sriganganagar (Rajasthan). Increasing trend of A. biguttula biguttula, T. tabaci and B. tabaci were observed over years at all locations but for declining population levels of T. tabaci at Ludhiana (Punjab) and Sriganganagar (Rajasthan). Multiple linear regression forecast models in respect of sap feeders for the four locations were developed using SAS 9.3. Minimum and maximum temperatures besides rainfall significantly predicted the population of each sap feeder for the current, 1 and 2 weeks after.