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Evaluation of the stability of furosemide in tablet form during six-month storage in spaceflight and peculiarities of its pharmacokinetics and pharmacodynamics under conditions of anti-orthostatic hypokinesia

Drug Metab Pers Ther. 2022 Feb 24. doi: 10.1515/dmpt-2021-0149. Online ahead of print.

ABSTRACT

OBJECTIVES: The present study investigated the stability of furosemide under space-flight conditions on board the International Space Station, as well as its pharmacokinetics and pharmacodynamics under conditions simulating exposure to some space-flight factors.

METHODS: Quantitative analysis of furosemide tablets by HPLC was performed before spaceflight (background), then after six months storage under normal ground conditions (control) and under spaceflight conditions (SF). The pharmacokinetics and pharmacodynamics of furosemide were studied in six healthy volunteers after a single oral dose of 40 mg under normal conditions (background) and under anti-orthostatic hypokinesia (ANOH).

RESULTS: Quantitative content of furosemide in tablets before SF was 40.19 ± 0.28 mg (100.47 ± 0.71%), after 6 months storage: under normal conditions (control) – 39.9 ± 0.39 mg (99.73 ± 0.98%), under SF – 39.24 ± 0.72 mg (98.11 ± 1.80%), which was within the prescribed limits. Studying basic hemodynamic parameters showed that in ANOH conditions 6 h after furosemide administration there was a statistically significant increase of the stroke volume (SV) (+36.5 Δ%), a tendency for increasing of the stroke index (SI) (+36.5 Δ%) and decreasing of the total peripheral resistance (TPR) (-21.9 Δ%) compared to baseline study.

CONCLUSIONS: It has been established that various factors of space flight (overloading, excessive vibration, microgravity, etc.) do not negatively influence the stability of furosemide in tablet form during storage for 6 months on board the International Space Station.

PMID:35218179 | DOI:10.1515/dmpt-2021-0149

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Family-based treatment of children with severe obesity in a public healthcare setting: Results from a randomized controlled trial

Clin Obes. 2022 Feb 25:e12513. doi: 10.1111/cob.12513. Online ahead of print.

ABSTRACT

To compare the effectiveness of family-based behavioural social facilitation treatment (FBSFT) versus treatment as usual (TAU) in children with severe obesity. Parallel-design, nonblinded, randomized controlled trial conducted at a Norwegian obesity outpatient clinic. Children aged 6-18 years referred to the clinic between 2014 and 2018 were invited to participate. Participants were randomly allocated using sequentially numbered, opaqued, sealed envelopes. FBSFT (n = 59) entailed 17 sessions of structured cognitive behavioural treatment, TAU (n = 55) entailed standard lifestyle counselling sessions every third month for 1 year. Primary outcomes included changes in body mass index standard deviation score (BMI SDS) and percentage above the International Obesity Task Force cut-off for overweight (%IOTF-25). Secondary outcomes included changes in sleep, physical activity, and eating behaviour. From pre- to posttreatment there was a statistically significant difference in change in both BMI SDS (0.19 units, 95% confidence interval [CI]: 0.10-0.28, p < .001) and %IOTF-25 (5.48%, 95%CI: 2.74-8.22, p < .001) between FBSFT and TAU groups. FBSFT participants achieved significant reductions in mean BMI SDS (0.16 units, (95%CI: -0.22 to -0.10, p < .001) and %IOTF-25 (6.53%, 95% CI: -8.45 to -4.60, p < .001), whereas in TAU nonsignificant changes were observed in BMI SDS (0.03 units, 95% CI: -0.03 to 0.09, p = .30) and %IOTF-25 (-1.04%, 95% CI: -2.99 to -0.90, p = .29). More FBSFT participants (31.5%) had clinically meaningful BMI SDS reductions of ≥0.25 from pre- to posttreatment than in TAU (13.0%, p = .021). Regarding secondary outcomes, only changes in sleep timing differed significantly between groups. FBSFT improved weight-related outcomes compared to TAU.

PMID:35218145 | DOI:10.1111/cob.12513

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The efficacy of topical Marham-e-Akbar in chronic atopic dermatitis – an open-label interventional study

Drug Metab Pers Ther. 2022 Feb 25. doi: 10.1515/dmpt-2021-0195. Online ahead of print.

ABSTRACT

OBJECTIVES: Chronic atopic dermatitis (AD) is an inflammatory skin condition marked by intense pruritus, dry skin, and severe impact on the life quality of the patients. Conventionally, it is managed by using emollients, calcineurin inhibitors, and topical corticosteroids. In Unani medicine, eminent scholars advocated many drug formulations including topical Marham-e-Akbar for effective healing of AD but scientific evidence is scarce. Hence, this study was designed.

METHODS: This was a single-arm clinical trial conducted on 30 participants aged 18-65 years suffering from chronic AD after obtaining written informed consent. The trial intervention was Marham-e-Akbar consisting of Murdār Sang (Plumbi oxidum); Sindūr (red lead); olive oil (Olea europaea oil); Kath (Acacia catechu extract); Safeda Kāshgari (Zinc oxide); Sirka (vinegar); and Phitkirī (alum) to be applied twice daily for 42 days. The objective parameters were SCORAD and DLQI, while the subjective parameters included itching, scaling, and erythema assessed on a customized VAS scale and 4-point Likert scale.

RESULTS: The pre-post analysis inferred statistically significant attenuation in subjective parameters (itching, scaling, and erythema) and objective scales (SCORAD) and (DLQI) with p<0.001.

CONCLUSIONS: The study findings deduced that Marham-e-Akbar is effective in the amelioration of chronic atopic dermatitis and quality of life of the patients as well.

PMID:35218174 | DOI:10.1515/dmpt-2021-0195

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Chemical constituents of the roots of Schisandra chinensis

Chem Biodivers. 2022 Feb 25. doi: 10.1002/cbdv.202100962. Online ahead of print.

ABSTRACT

One new phenylpropanoid schineolignin D ( 1 ), one new sesquiterpene (-)-(7 S ,10 S )-3,11,12, 13-tetrahydroxycalamenene ( 2 ), one new quinic acid 4-( E )-O-coumaroylquinic acid ethyl ester ( 3 ), and seven known compounds ( 4-10 ) were isolated from the roots of Schisandra chinensis . Their chemical structures were characterized by NMR spectroscopic analyses. All compounds were assessed for their neuroprotective effects on PC12 cell lines induced by H 2 O 2 . The results suggested that compounds 1, 3-4 and 7 exhibited statistically significant neuroprotective activities with the negative control group at 12.5μM.

PMID:35218144 | DOI:10.1002/cbdv.202100962

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Trends in publication of general surgery research in Australia, 2000-2020

ANZ J Surg. 2022 Feb 26. doi: 10.1111/ans.17543. Online ahead of print.

ABSTRACT

BACKGROUND: The significance of evidence-based surgery has resulted in a shift towards producing high-quality surgical research. The aim of this bibliometric analysis was to evaluate trends in publication of general surgery research in Australia from 2000 to 2020.

METHODS: General surgery publications including clinical trials, randomized controlled trials (RCTs), systematic reviews and meta-analyses by Australian-affiliated authors between 2000 and 2020 were extracted from PubMed. Titles, abstracts, journals and authors were independently screened by two investigators and arbitrated by a third. Publication type and area of focus were manually entered. Quality of articles was measured by trends in impact factor (IF) and SCImago Journal Rank (SJR). Descriptive statistics were used to summarize data and identify trends.

RESULTS: Three hundered and ninety-eight articles met inclusion criteria for this study, with a progressive increase in publications over the study period. RCTs and systematic reviews accounted for 109 and 234 publications, respectively. The median number of authors remained constant (p = 0.060). There was a significant increase in publication of clinical trials and RCTs (p < 0.001) as well as systematic reviews and meta-analyses (p < 0.001). The median IF increased from 1.93 to 3.08, whilst median SJR increased from 1.11 to 1.16, equivalent to organic growth of journal IF and SJR over this period. Female authorship significantly increased over time (p < 0.001).

CONCLUSION: There is a trend towards increased quantity, quality and diversity in Australian general surgery publications, which is indicative of the progression and importance of robust modern surgical research.

PMID:35218136 | DOI:10.1111/ans.17543

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Maternal perception of spousal support in raising children with developmental disability in the context of family and child variables

J Child Adolesc Psychiatr Nurs. 2022 Feb 25. doi: 10.1111/jcap.12372. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this study was to examine the relationship between the variables of mental, physical, and emotional problems in children with developmental disabilities (DDs) and the spousal support perceived by the mothers of those children.

METHODS: One hundred forty-three children diagnosed with autism spectrum disorder (ASD, n:43), intellectual disability (ID, n:28), cerebral palsy (CP, n:47), or Down syndrome (DS, n:25) were included in this study. The support that mothers received from their spouses was evaluated using the Spousal Support Scale (SSS). Aggressive behavior in the children was evaluated using the anger-aggression subscale of the Social Competence and Behavior Evaluation Scale (SCBE-30). The data obtained were then subjected to statistical comparisons.

RESULTS: Multiple comparisons revealed no significant difference between the DD diagnosis groups (ID, CP, ASD, and DS) in terms of spousal support or spousal support sub-dimension scores (p > 0.05). Significant negative correlation was found between anger-aggression subscale scores and SSS sub-parameters (emotional support r = -0.315 p < 0.001, financial and informational support r = -0.285 p < 0.001, appreciation r = -0.299 p < 0.001, social support r = -0.381 p < 0.001, and spouse support score r = -0.389 p < 0.001).

CONCLUSION: Children’s anger-aggression levels were adversely affected by a lack of spousal support for their mothers.

PMID:35218093 | DOI:10.1111/jcap.12372

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Longitudinal Changes in Global Cerebral Blood Flow in Cognitively Normal Older Adults: A Phase-Contrast MRI Study

J Magn Reson Imaging. 2022 Feb 26. doi: 10.1002/jmri.28133. Online ahead of print.

ABSTRACT

BACKGROUND: Characterization of blood supply changes in older individuals is important in understanding brain aging and diseases. However, prior studies largely focused on cross-sectional design, thus change in cerebral blood flow (CBF) could not be assessed on an individual level.

PURPOSE: To evaluate longitudinal short-term changes in global CBF in cognitively normal older adults.

STUDY TYPE: Prospective, longitudinal, and cohort.

POPULATION: One-hundred twenty-seven cognitive-normal participants (mean age 69 ± 7 years, 47 males) underwent serial MRI with an average follow-up time of 2.1 years.

FIELD STRENGTH/SEQUENCE: 3 T phase-contrast (PC), three-dimensional magnetization-prepared-rapid-acquisition-of-gradient-echo (MPRAGE) and fluid-attenuated inversion recovery (FLAIR) MRI.

ASSESSMENT: Total CBF was measured with PC MRI allowing assessment of quantitative flow in four major feeding arteries by a trained radiologist with >3 years’ experience (O.K.). Brain volume was obtained from MPRAGE MRI and measured by T1-MultiAtlas MRICloud tool. The ratio between total CBF and brain volume yielded global CBF in mL/100 g/min. White matter hyperintensity (WMH) was measured automatically using a Bayesian probability approach on FLAIR.

STATISTICAL TESTS: Linear mixed effect model was used to simultaneously assess cross-sectional age-differences and longitudinal age-changes in CBF. Spearman rank correlation was used to evaluate the relationship between CBF change and WMH progression. A P-value of <0.05 (two-tailed) was considered significant.

RESULTS: Global CBF decreased with age at a longitudinal rate of -0.56 mL/100 g/min/year (95% confidence interval [CI]: -1.09, -0.03), compared to a cross-sectional rate of -0.26 mL/100 g/min/year (95% CI: -0.41, -0.11). Changes in CBF were significantly associated with progression of WMH (Spearman rank correlation r = -0.25), as those participants who had a more rapid CBF reduction had greater increases in WMH volumes and the relationship remained significant when adjusting for baseline vascular risk scores. Additionally, age-related changes in whole-brain volume were found to be -0.151%/year (95% CI: -0.186, -0.116).

DATA CONCLUSION: These findings suggest that brain aging in older adults is accompanied by a rapid longitudinal reduction in CBF, the rate of which is associated with white matter damage.

LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY STAGE: 2.

PMID:35218111 | DOI:10.1002/jmri.28133

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Trends in gross body coordination and cardiorespiratory fitness- A hierarchical Bayesian Analysis of 35 000 2nd Graders

Scand J Med Sci Sports. 2022 Feb 25. doi: 10.1111/sms.14146. Online ahead of print.

ABSTRACT

OBJECTIVE: A negative decline of motor competence in children has been observed over the last decades. Though, most studies derive their inferences from only two distant points in time and thus neglect to investigate the variability of the temporal trends.

METHODS: Between the year 2000 and 2011, 35 018 second graders performed the Körperkoordinationstest für Kinder (KTK), consisting of four items (WB, HH, JS and MS) and a six-minute run test (6MRT). A hierarchical Bayesian regression model with varying intercepts and temporal trends was fitted to the data. Age, sex and BMI-categories were included as input variables. The outcome variables were z-standardized to the initial cohort.

RESULTS: In all four KTK-items we observed a yearly decline of -0.020 (95% UI -0.038 to -0.001) for WB, -0.054 (95% UI -0.071, -0.037) for HH, -0.028 (95% UI -0.045 to -0.012) for JS and -0.088 (95% UI -0.108 to -0.067) for MS. For the 6MRT no trend was identified. Overweight and obese children showed a disadvantage in all tests scores. Negative time-interactions were observed for overweight and obese children in HH and JS. A substantial between-city variation for all temporal trends was observed. The predictive validation for all models but MS was successful.

CONCLUSION: A general negative decline was confirmed for coordinative abilities but not in cardiorespiratory fitness. For all outcome variables a substantial between-city variation was observed, highlighting the importance of environmental factors in motor development. Overweight and obese children demonstrated an urgent need for action.

PMID:35218079 | DOI:10.1111/sms.14146

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Birth during the Covid-19 pandemic: What childbearing people in the United States needed to achieve a positive birth experience

Birth. 2022 Feb 25. doi: 10.1111/birt.12616. Online ahead of print.

ABSTRACT

BACKGROUND: The COVID pandemic exposed many inadequacies in the maternity care system in the United States. Maternity care protocols put in place during this crisis often did not include input from childbearing people or follow prepandemic guidelines for high-quality care. Departure from standard maternity care practices led to unfavorable and traumatic experiences for childbearing people. This study aimed to identify what childbearing people needed to achieve a positive birth experience during the pandemic.

METHODS: This mixed-methods, cross-sectional study was conducted among individuals who gave birth during the COVID pandemic from 3/1/2020 to 11/1/2020. Participants were sampled via a Web-based questionnaire that was distributed nationally. Descriptive and bivariate statistics were analyzed. Thematic and content analyses of qualitative data were based on narrative information provided by participants. Qualitative and convergent quantitative data were reported.

RESULTS: Participants (n = 707) from 46 states and the District of Columbia completed the questionnaire with 394 contributing qualitative data about their experiences. Qualitative findings reflected women’s priorities for (a) the option of community birth, (b) access to midwives, (c) the right to an advocate at birth, and (d) the need for transparent and affirming communication. Quantitative data reinforced these findings. Participants with a midwife provider felt significantly better informed. Those who gave birth in a community setting (at home or in a freestanding birth center) also reported significantly higher satisfaction and felt better informed. Participants of color (BIPOC) were significantly less satisfied and more stressed while pregnant and giving birth during the pandemic.

CONCLUSIONS: High-quality maternity care places childbearing people at the center of care. Prioritizing the needs of childbearing people, in COVID times or otherwise, is critical for improving their experiences and delivering efficacious and safe care.

PMID:35218067 | DOI:10.1111/birt.12616

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Are we choosing mobilization regimens for autologous stem cell transplantation in multiple myeloma wisely: A single center comparison of GCSF+/-plerixafor vs cyclophosphamide/GCSF+/-plerixafor

J Clin Apher. 2022 Feb 26. doi: 10.1002/jca.21976. Online ahead of print.

ABSTRACT

BACKGROUND: Autologous stem cell transplantation (ASCT) is a standard consolidation treatment for eligible patients with multiple myeloma (MM). There is no standardized mobilization regimen for collection of CD34+ stem cells, which is crucial to the success of ASCT. Cyclophosphamide/GCSF is an effective regimen, although reported associated toxicities include risk of febrile neutropenia (FN). Since plerixafor was introduced in Canada, this mobilization agent has been increasingly used as needed with GCSF at Kingston Health Science Centre (KHSC), with elimination of cyclophosphamide. This single center, retrospective, quality improvement study evaluates mobilization and ASCT outcomes of MM patients who had undergone stem cell mobilization at KHSC with cyclophosphamide/GCSF+/-plerixafor without antibiotics, cyclophosphamide/GCSF+/-plerixafor with antibiotics, and GCSF+/-plerixafor without antibiotics.

METHODS: A retrospective chart review was conducted evaluating 137 patients. The primary outcome measure was FN rates with mobilization. Balancing measures include CD34+ cell collected, plerixafor usage, days of apheresis and transplant outcomes. Chi-square, ANOVA, or Kruskal-Wallis methods were used to test statistical significance where appropriate.

RESULTS: Our study noted a higher total and day one CD34+ count in the two groups utilizing cyclophosphamide in mobilization. All nine cases of FN occurred in these two groups (P < .05). Addition of antibiotics decreased, but did not eliminate risk of FN. There were no significant differences in the rate of plerixafor usage and number of apheresis days. Difference in transplant outcomes, including engraftment and transfusion support, were statistically but not clinically significant. A larger sample size may be needed to explore this fully. There was no significant difference in length of transplant hospital stay.

CONCLUSION: The elimination of cyclophosphamide from mobilization regimens for MM appears to significantly reduce FN rates, without increasing balancing measures such as total number of apheresis days, plerixafor usage, duration of transplant hospitalization or mortality outcomes.

PMID:35218068 | DOI:10.1002/jca.21976