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Clinical effectiveness of fluticasone furoate nasal spray for perennial allergic rhinitis in children: a comprehensive review

Int J Technol Assess Health Care. 2023 Jun 16;39(1):e35. doi: 10.1017/S026646232300034X.

ABSTRACT

OBJECTIVE: To assess the clinical effectiveness of fluticasone furoate nasal spray (FFNS) versus placebo on nasal symptoms and safety in children with perennial allergic rhinitis (AR).

METHODS: A comprehensive review was conducted with data obtained from Medline and Embase databases up to April 2023. The population of interest was patients aged 2-12 years with perennial AR. The selection was limited to randomized controlled trials (RCTs), comparing FFNS with placebo. Outcomes of interest included the reflective total nasal symptoms scores (rTNSS) and safety. To assess the minimal clinically important difference for rTNSS, the Cohen’s guideline was used. If the pooled standardized mean difference (SMD) and the lower limit of the 95 percent confidence interval (CI) exceeded the threshold of -0.20, effects were considered clinically significant.

RESULTS: Three RCTs (959 pediatric patients) were selected. One study evaluated the short-term use of FFNS, another evaluated the long-term use of FFNS, and another evaluated both the short-term and long-term use of FFNS. FFNS produced a statistically significant reduction over placebo in rTNSS (SMD -0.18; 95 percent CI -0.35 to -0.01, p = 0.03) in long-term treatment studies, but not in short-term treatment studies. However, since the mean reduction did not reach the minimum clinically important difference (SMD -0.20), these results were considered clinically not relevant. Safety outcomes with FFNS were similar to placebo.

CONCLUSIONS: The currently available evidence suggests that FFNS, 110 μg once daily, compared to placebo, does not produce a meaningful clinical effect on nasal symptom in children with perennial AR.

PMID:37325979 | DOI:10.1017/S026646232300034X

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Correlation between gastro-oesophageal reflux disease (GERD) lung volumes and exacerbation of bronchial asthma: Italian pilot observational retrospective study GERDAS

Monaldi Arch Chest Dis. 2023 Jun 15. doi: 10.4081/monaldi.2023.2640. Online ahead of print.

ABSTRACT

Reflux asthma is an entity characterised by typical symptoms and in some cases is ‘silent’ and is more dangerous when associated with obesity and sleep apnoea syndrome. Its prevalence in the general population is high, as demonstrated by numerous studies listed below, and it is particularly a problem in the paediatric population; where, despite treatment by medical specialists, asthma symptoms are poorly controlled with a high risk of acute exacerbations. The aim of this clinical study is to show how the addition of a particular type of alginate (Deflux plus sachets) containing hyaluronic acid and melatonin at low doses administered over a prolonged period of six months, causes a reduction in vagal reflex stimulation of the oesophagus and pulmonary microaspiration reflexes by regulating lower oesophageal sphincter (LES) motility in asthmatic patients; improving the ACT score (asthma control test score). In the reported statistical analysis, ROC curves were performed for sensitivity and specificity for the analysed parameters, including the ACT score with statistically significant data p<0.0001. We conclude that the combination of conventional therapy for reflux asthma associated with alginates may improve the risk of acute asthma exacerbation and dynamic lung volumes.

PMID:37325973 | DOI:10.4081/monaldi.2023.2640

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Radiographic measures of the pelvis differ in British shorthair cats with dystocia and eutocia

Vet Radiol Ultrasound. 2023 Jun 16. doi: 10.1111/vru.13265. Online ahead of print.

ABSTRACT

The size of an animal’s pelvis can have a substantial impact on the ease or difficulty of giving birth, which can vary depending on the breed. Radiography is a medical imaging technique that is commonly utilized in clinical cases to assess pelvic dimensions. The present retrospective, observational study was designed to evaluate pelvimetric differences in radiographic images of British Shorthair (BS) cats with dystocia and eutocia. Pelvimetric values (linear distance, angle, area, height/width) for ventrodorsal and laterolateral radiographic images were recorded in 15 BS cats with dystocia and 15 BS cats with eutocia. Statistical analysis of the obtained measurement values was performed. When the pelvimetric data were examined overall, it was seen that mean values, except the PL (pelvis length) measurement, were higher in cats with eutocia than in cats with dystocia. Vertical diameter, conjugate vera, coxal tuberosities, transversal diameter, acetabula, pelvic inclination, ischiatic arch, pelvis inlet area (PIA), and pelvic outlet area (POA) values were significantly higher in cats with eutocia than in cats with dystocia (P < 0.05). Mean PIA and POA measurement values in cats with dystocia were 22.89 ± 2.38 cm2 and 19.59 ± 1.90 cm2 , respectively; in cats with eutocia, the mean was calculated as 27.16 ± 2.76 cm2 and 23.18 ± 1.88 cm2 , respectively. In conclusion, the present study revealed that pelvimetric values, except the PL measurement, were higher in cats with eutocia than in cats with dystocia. Findings can be used to assist veterinarians in future clinical decision-making for pregnant BS cats.

PMID:37325948 | DOI:10.1111/vru.13265

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Efficacy and safety of irinotecan combined with raltitrexed or irinotecan monotherapy for salvage chemotherapy of esophageal squamous cell cancer: A prospective, open label, randomized phase II study

Cancer Med. 2023 Jun 16. doi: 10.1002/cam4.6264. Online ahead of print.

ABSTRACT

BACKGROUND: Esophageal squamous cell cancer (ESCC) accounts for approximately 90% of esophageal cancer cases in China. There are no standard regimens for second or third-line chemotherapy of metastatic squamous esophageal cancer. The objective of this study was to investigate the security and effectiveness of irinotecan combined with raltitrexed or irinotecan monotherapy for salvage chemotherapy of ESCC.

METHODS: One hundred and twenty-eight patients with metastatic ESCC confirmed by histopathology were enrolled into this study. These patients had failure of the first-line chemotherapy combination of fluorouracil or platinum or paclitaxel and had not undergone chemotherapy with irinotecan or raltitrexed previously. Patients were randomly divided into irinotecan combined with raltitrexed group (experiment group) and irinotecan monotherapy group (control group). Overall survival (OS) and progression-free survival (PFS) were the primary endpoint.

RESULTS: In the control group, the median PFS (mPFS) and median OS (mOS) of patients were 3.37 and 5.3 months. In the experiment group, mPFS and mOS were 3.91 and 7.0 months. There was statistical significance of PFS and OS between two groups (PFS P = 0.002, OS P = 0.01). In subgroup analysis, in the second-line treatment, the mPFS of control and experiment group, was 3.90 and 4.60 months, mOS was 6.95 and 8.5 months, which was statistically significant differences between the two groups. (PFS P = 0.001, OS P = 0.005), In the third-line and beyond treatment, mPFS of control and experiment group was 2.80 and 3.19 months, mOS were 4.5 and 4.8 months. But there was no significant difference of PFS or OS between the two groups (PFS P = 0.19, OS P = 0.31). There was no statistical significance of toxicity side effects between two groups.

CONCLUSIONS: The PFS and OS of irinotecan plus raltitrexed may be better than that of irinotecan monotherapy, especially in second line treatment, which should be confirmed with a phase III study including much more patients.

PMID:37325938 | DOI:10.1002/cam4.6264

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Perivascular Macrophages Mediate Microvasospasms After Experimental Subarachnoid Hemorrhage

Stroke. 2023 Jun 16. doi: 10.1161/STROKEAHA.122.042290. Online ahead of print.

ABSTRACT

BACKGROUND: Subarachnoid hemorrhage (SAH) is characterized by acute and delayed reductions of cerebral blood flow (CBF) caused, among others, by spasms of cerebral arteries and arterioles. Recently, the inactivation of perivascular macrophages (PVM) has been demonstrated to improve neurological outcomes after experimental SAH, but the underlying mechanisms of protection remain unclear. The aim of our exploratory study was, therefore, to investigate the role of PVM in the formation of acute microvasospasms after experimental SAH.

METHODS: PVMs were depleted in 8- to 10-week-old male C57BL/6 mice (n=8/group) by intracerebroventricular application of clodronate-loaded liposomes and compared with mice with vehicle liposome injections. Seven days later, SAH was induced by filament perforation under continuous monitoring of CBF and intracranial pressure. Results were compared with sham-operated animals and animals who underwent SAH induction but no liposome injection (n=4/group each). Six hours after SAH induction or sham surgery, numbers of microvasospasms per volume of interest and % of affected pial and penetrating arterioles were examined in 9 standardized regions of interest per animal by in vivo 2-photon microscopy. Depletion of PVMs was proven by quantification of PVMs/mm3 identified by immunohistochemical staining for CD206 and Collagen IV. Statistical significance was tested with t tests for parametric data and Mann-Whitney U test for nonparametric data.

RESULTS: PVMs were located around pial and intraparenchymal arterioles and were effectively depleted by clodronate from 671±28 to 46±14 PVMs/mm3 (P<0.001). After SAH, microvasospasms was observed in pial arteries and penetrating and precapillary arterioles and were accompanied by an increase to 1405±142 PVMs/mm3. PVM depletion significantly reduced the number of microvasospasms from 9 IQR 5 to 3 IQR 3 (P<0.001).

CONCLUSIONS: Our results suggest that PVMs contribute to the formation of microvasospasms after experimental SAH.

PMID:37325921 | DOI:10.1161/STROKEAHA.122.042290

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Evaluation of the Dunning Kruger effect in relation to vaccination: a study of messages on the social network LinkedIn.

Rev Esp Salud Publica. 2023 Jun 15;97:e202306051.

ABSTRACT

OBJECTIVE: The Dunning-Kruger effect refers to an excess of confidence regarding one’s abilities and knowledge; trust leads to transmitting information in an assertive manner, regardless of its validity or veracity, of experts, but of great impact on public opinion. This study evaluated the existence of the Dunning-Kruger effect in messages related to vaccination against COVID-19 on LinkedIn.

METHODS: 448 messages were evaluated and the authors’ knowledge and training on the subject were related. In the statistical treatment, the Chi-square test was performed to determine if there is a significant association between the variables, establishing the level of significance at P<0.05. These procedures were carried out using SPSS statistical software.

RESULTS: 448 messages were analyzed. Of these, 153 reflected very high certainty, 115 medium certainty, 107 low certainty and 73 reflected doubts. The group that issued the most messages with absolute certainty (41.8%) was the group with minimal knowledge about COVID-19. Of this group without knowledge on the subject, only 7.1% expressed messages without expressing certainty. The group with very high knowledge on the subject was more likely to reflect uncertainty, communicating 15.7% of the messages with absolute certainty and 37.1% with zero certainty.

CONCLUSIONS: It is obtained that those people with less knowledge express their messages more assertively and present less acceptance of the COVID-19 vaccine in their speeches. The presence of the Dunning-Kruger effect in relation to COVID-19 vaccination is demonstrated.

PMID:37325904

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Armed conflict exposure and mental health: examining the role of imperceptible violence

Med Confl Surviv. 2023 Jun 16:1-23. doi: 10.1080/13623699.2023.2222360. Online ahead of print.

ABSTRACT

Armed conflict exposure is associated with multiple mental health problems. However, more needs to be known about the differential effects of particular modalities of armed conflict violence and war methods on mental health. This study a) examined the modalities of violence employed in the Colombian armed conflict and b) assessed their association with mental health problems in armed conflict survivors. Using armed conflict data from the Colombian Armed Conflict Events Information System, we identified three violence modalities: armed confrontations, indiscriminate attacks, and selective violence. Descriptive statistics showed that selective violence generated most (86%) of the 333,219 victims of the Colombian armed conflict between 1996 and 2016. A subsample of armed conflict survivors (n = 551) from the 2015 Colombian Mental Health Survey was used to assess the association of each modality of violence with depression and anxiety, Post Traumatic Stress Disorder (PTSD), and substance abuse. Adjusted Odds Ratios (aOR) (p < .05, 95% CI) showed that survivors of selective violence crimes such as forced disappearance of loved ones, kidnapping, sexual violence, and massacres were at increased risk of experiencing Common Mental Health Disorders, PTSD symptoms, and hazardous drinking. Identifying those at elevated risk for developing mental health problems and substance misuse among survivors of armed conflict may help to use limited resources more effectively.

PMID:37325901 | DOI:10.1080/13623699.2023.2222360

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Predictive significance of lymphocyte level and neutrophil-to-lymphocyte ratio values during radiotherapy in cervical cancer treatment

Cancer Med. 2023 Jun 16. doi: 10.1002/cam4.6221. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of this research was to analyze the prognostic significance of the minimum count of lymphocytes (LY) and the corresponding ratio of neutrophil-to-lymphocyte (NLR) in cervical cancer (CC) patients receiving radiotherapy.

METHODS: We retrospectively collected data from 202 CC patients who received concurrent chemoradiotherapy or radiotherapy alone at our hospital. Statistical methods including the Kaplan-Meier method, log-rank test and the Cox proportional hazards model were included to examine survival differences and identify independent factors that may affect overall survival (OS) and progression-free survival (PFS).

RESULTS: The research enrolled a total of 202 patients. Patients with higher LY levels and lower NLR values during radiotherapy had significantly better survival prognosis than those with lower LY levels and higher NLR values. Multivariate COX regression analysis revealed that FIGO stage I, pathological types of SqCC, absence of lymph node metastasis, concurrent chemoradiotherapy, higher LY levels during radiotherapy, and lower NLR values before radiotherapy were independently associated with poorer PFS. Similarly, FIGO stage I, absence of lymph node metastasis and lower NLR values during and before radiotherapy were independently linked with poorer OS.

CONCLUSION: Minimum LY value and its corresponding NLR during radiotherapy serve as prognostic factors for CC.

PMID:37325889 | DOI:10.1002/cam4.6221

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Changes in physical activity level of adolescents and its relationship with mental health during regular COVID-19 prevention and control

Brain Behav. 2023 Jun 16:e3116. doi: 10.1002/brb3.3116. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to analyze the impact of regular prevention and control of COVID-19 on the physical activity level (PAL) of adolescents and the relationship between PAL and mental health.

METHODS: Using the convenience sampling method, two stages of the on-site cross-sectional investigation were conducted in 11 middle schools in Guiyang City in China. There were 1132 participants who completed the Physical Activity Questionnaire for old children (PAQ-C) in October 2020, and 1503 participants who completed the PAQ-C and Mental Health Inventory of Middle-school students (MMHI-60) in October 2021. All participants reported their demographic data. Descriptive, quantitative statistics were used for data analysis. One-way ANOVA was used to explore associations between PAL and mental health.

RESULTS: The results of statistical analysis showed a gradual yearly increase in the PAL of teenagers, and the PAL of male junior middle school students has a significant increase (p < .05); while that of adolescents in Grade 10 significantly decreased (p < .001). There is a statistically significant correlation between adolescents’ mental health (except for anxiety) and PAL (p < .05). The overall abnormal rate of mental health was 27.9%; The PAL and the total mean score of mental health had a negative correlation (p < .001). There was a significant difference between mental health scores and corresponding PAL (p < .001). Furthermore, there are statistically significant differences in scores of mental health factors corresponding to varying PAL among junior high school students and male students (p < .05).

CONCLUSIONS: The regular epidemic prevention and control measures had significant adverse effects on the PAL of girls and high school adolescents, especially Grade 10 adolescents. Improving adolescents’ PAL can promote their mental health. Interventions based on PAL slightly lower than the level recommended in the physical activity guidelines can bring significant mental health effects.

PMID:37325875 | DOI:10.1002/brb3.3116

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Prior and posterior checking of implicit causal assumptions

Biometrics. 2023 Jun 16. doi: 10.1111/biom.13886. Online ahead of print.

ABSTRACT

Causal inference practitioners have increasingly adopted machine learning techniques with the aim of producing principled uncertainty quantification for causal effects while minimizing the risk of model misspecification. Bayesian nonparametric approaches have attracted attention as well, both for their flexibility and their promise of providing natural uncertainty quantification. Priors on high-dimensional or nonparametric spaces, however, can often unintentionally encode prior information that is at odds with substantive knowledge in causal inference-specifically, the regularization required for high-dimensional Bayesian models to work can indirectly imply that the magnitude of the confounding is negligible. In this paper, we explain this problem and provide tools for (i) verifying that the prior distribution does not encode an inductive bias away from confounded models and (ii) verifying that the posterior distribution contains sufficient information to overcome this issue if it exists. We provide a proof-of-concept on simulated data from a high-dimensional probit-ridge regression model, and illustrate on a Bayesian nonparametric decision tree ensemble applied to a large medical expenditure survey.

PMID:37325868 | DOI:10.1111/biom.13886