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The Journal of Dermatological Treatment Dec 2024For individuals with atopic dermatitis (AD), interpreting scientific papers that present clinical outcomes including the Eczema Area and Severity Index (EASI) and... (Review)
Review
A systematic review investigating the proportion of clinical images shared in prospective randomized controlled trials involving patients with atopic dermatitis and systemic pharmacotherapy.
For individuals with atopic dermatitis (AD), interpreting scientific papers that present clinical outcomes including the Eczema Area and Severity Index (EASI) and Investigators Global Assessment may be difficult. When compared to tabulated data and graphs, images from before and after treatment are often far more meaningful to these patients that ultimately will be candidates for the treatment. This systematic review focused on determining the frequency of clinical image sharing in AD research. Conducted in accordance with PRISMA guidelines, the review concentrated on randomized controlled trials that investigated predefined and available systemic treatments for AD. The search was performed in the MEDLINE database for studies published from the inception until 21 December 2023. The review included 60 studies, encompassing 17,799 randomized patients. Across these studies, 16 images representing 6 patients were shared in the manuscripts, leading to a sharing rate of 0.3‰. The almost missing inclusion of patient images in clinical trial publications hinders patient understanding. Adding images to scientific manuscripts could significantly improve patients' comprehension of potential treatment outcomes. This review highlights the need for authors, the pharmaceutical industry, study sponsors, and publishers to enhance and promote patient information through increased use of visual data.
Topics: Humans; Dermatitis, Atopic; Prospective Studies; Randomized Controlled Trials as Topic; Treatment Outcome; Administration, Cutaneous; Severity of Illness Index
PubMed: 38569598
DOI: 10.1080/09546634.2024.2338280 -
Acta Dermato-venereologica Apr 2024Atopic dermatitis is a cutaneous inflammatory disease characterized by intense pruritus, which is often underestimated despite its direct impact on patients'...
Atopic dermatitis is a cutaneous inflammatory disease characterized by intense pruritus, which is often underestimated despite its direct impact on patients' health-related quality of life and the high burden it poses. The authors' goal was to design a qualitative tool to guide patients and healthcare professionals in their assessment and interpretation of pruritus intensity using a numerical rating scale. The draft of this tool, henceforth "guideline", was developed based on a systematic literature review and focus groups comprising patients and a scientific committee. This draft was validated with an independent group of patients and the final version was designed following their feedback. According to the results of the systematic review, pruritus impacts 6 health-related quality of life domains: sleep quality; emotional status; overall health-related quality of life; physical function; social/sexual activity; productivity, particularly affecting sleep quality and the emotional domain. Patients considered that physical function was the most strongly affected domain, followed by sleep quality and emotional well-being, establishing that a minimum pruritus intensity of 4 and 7 points impacts moderately and severely, respectively, on the different domains of patients' health- related quality of life. The guideline may help patients and healthcare professionals to interpret and assess pruritus intensity using a numerical rating scale and to understand the impact of pruritus on patients' health-related quality of life.
Topics: Humans; Dermatitis, Atopic; Quality of Life; Pruritus; Emotions; Administration, Cutaneous; Severity of Illness Index
PubMed: 38566531
DOI: 10.2340/actadv.v104.18255 -
The Journal of the Association of...Clinical trials of pre-exposure prophylaxis (PrEP) to prevent HIV infection have established its efficacy as upwards of 99%. Despite this, the effectiveness of this...
Clinical trials of pre-exposure prophylaxis (PrEP) to prevent HIV infection have established its efficacy as upwards of 99%. Despite this, the effectiveness of this medication has been shown to be diminished by individual factors, such as medication adherence. We completed a systematic review to identify and describe interventions to improve oral PrEP adherence. Overall, 16 articles were located. Two of the articles reported on results from the same trial and were collapsed for analysis, bringing the total to 15 studies. Twelve unique PrEP adherence interventions were tested, with the most common intervention being the use of mobile phone technology, which was used in 7 (46%) of the studies. Ten (67%) studies found that medication adherence improved when participants received an intervention to support adherence. Adherence intervention strategies effectively improved PrEP adherence. Further research into PrEP adherence interventions is warranted, particularly among diverse groups.
Topics: Humans; HIV Infections; Pre-Exposure Prophylaxis; Medication Adherence; Anti-HIV Agents; Administration, Oral; Cell Phone; Male
PubMed: 38564213
DOI: 10.1097/JNC.0000000000000460 -
International Journal of Chronic... 2024To comparison of the application of Vibrating Mesh Nebulizer and Jet Nebulizer in chronic obstructive pulmonary disease (COPD). (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To comparison of the application of Vibrating Mesh Nebulizer and Jet Nebulizer in chronic obstructive pulmonary disease (COPD).
RESEARCH METHODS
This systematic review and meta-analysis was conducted following the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) statements. The primary outcome measures analyzed included: The amount of inhaler in the urine sample at 30 minutes after inhalation therapy (USAL0.5), The total amount of inhaler in urine sample within 24 hours (USAL24), Aerosol emitted, Forced expiratory volume in 1 second (FEV), Forced vital capacity (FVC).
RESULTS
Ten studies were included with a total of 314 study participants, including 157 subjects in the VMN group and 157 subjects in the JN group. The data analysis results of USAL0.5, MD (1.88 [95% CI, 0.95 to 2.81], P = 0.000), showed a statistically significant difference. USAL24, MD (1.61 [95% CI, 1.14 to 2.09], P = 0.000), showed a statistically significant difference. The results of aerosol emitted showed a statistically significant difference in MD (3.44 [95% CI, 2.84 to 4.04], P = 0.000). The results of FEV showed MD (0.05 [95% CI, -0.24 to 0.35], P=0.716), the results were not statistically significant. The results of FVC showed MD (0.11 [95% CI, -0.18 to 0.41], P=0.459), the results were not statistically significant. It suggests that VMN is better than JN and provides higher aerosols, but there is no difference in improving lung function between them.
CONCLUSION
VMN is significantly better than JN in terms of drug delivery and utilization in the treatment of patients with COPD. However, in the future use of nebulizers, it is important to select a matching nebulizer based on a combination of factors such as mechanism of action of the nebulizer, disease type and comorbidities, ventilation strategies and modes, drug formulations, as well as cost-effectiveness, in order to achieve the ideal treatment of COPD.
Topics: Humans; Administration, Inhalation; Albuterol; Bronchodilator Agents; Drug Delivery Systems; Equipment Design; Nebulizers and Vaporizers; Pulmonary Disease, Chronic Obstructive; Respiratory Aerosols and Droplets
PubMed: 38562440
DOI: 10.2147/COPD.S452191 -
Respiratory Medicine May 2024Mild asthma treatment recommendations include intermittent inhaled corticosteroid (ICS)/formoterol dosing or regular ICS dosing with short-acting β-agonist reliever.... (Meta-Analysis)
Meta-Analysis
A network meta-analysis of the association between patient traits and response to regular dosing with ICS plus short-acting β-agonist reliever or ICS/formoterol reliever only in mild asthma.
INTRODUCTION/BACKGROUND
Mild asthma treatment recommendations include intermittent inhaled corticosteroid (ICS)/formoterol dosing or regular ICS dosing with short-acting β-agonist reliever. Due to the heterogeneity of asthma, identification of traits associated with improved outcomes to specific treatments would be clinically beneficial.
AIMS/OBJECTIVES
To assess the impact of patient traits on treatment outcomes of regular ICS dosing compared with intermittent ICS/formoterol dosing, a systematic literature review (SLR) and network meta-analysis (NMA) was conducted. Searches identified randomised controlled trials (RCTs) of patients with asthma aged ≥12 years, containing ≥1 regular ICS dosing or intermittent ICS/formoterol dosing treatment arm, reporting traits and outcomes of interest.
RESULTS
The SLR identified 11 RCTs of mild asthma, of 14,516 patients. A total of 11 traits and 11 outcomes of interest were identified. Of these, a feasibility assessment indicated possible assessment of three traits (age, baseline lung function, smoking history) and two outcomes (exacerbation rate, change in lung function). The NMA found no significant association of any trait with any outcome with regular ICS dosing relative to intermittent ICS/formoterol dosing. Inconsistent reporting of traits and outcomes between RCTs limited analysis.
CONCLUSIONS
This is the first systematic analysis of associations between patient traits and differential treatment outcomes in mild asthma. Although the traits analysed were not found to significantly interact with relative treatment response, inconsistent reporting from the RCTs prevented assessment of some of the most clinically relevant traits and outcomes, such as adherence. More consistent reporting of respiratory RCTs would provide more comparable data and aid future analyses.
Topics: Humans; Asthma; Formoterol Fumarate; Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Randomized Controlled Trials as Topic; Treatment Outcome; Network Meta-Analysis; Anti-Asthmatic Agents; Drug Therapy, Combination; Adult; Male; Female; Middle Aged; Age Factors; Smoking; Adolescent
PubMed: 38561078
DOI: 10.1016/j.rmed.2024.107610 -
European Journal of Cancer (Oxford,... Dec 2023Quality of life (QoL) assessment and patient-reported outcomes appear to be crucial in the rationale and interpretation of non-inferiority (NI) trials. The aim of this...
BACKGROUND
Quality of life (QoL) assessment and patient-reported outcomes appear to be crucial in the rationale and interpretation of non-inferiority (NI) trials. The aim of this study was to assess the inclusion of QoL among endpoints in phase III NI oncology trials and the relevance of QoL results in the reporting and interpretation of these studies.
MATERIALS AND METHODS
By PubMed search and hand-search of 11 selected journals, we identified phase III NI trials in adult patients affected by solid tumours, published between 2012 and 2021. Trials were classified according to 4 NI strategies: (1) different drugs; (2) alternative drug administration routes; (3) shorter treatment duration; (4) "deintensification" of treatment schedule. Three main endpoints were: (1) the proportion of publications including QoL among endpoints; (2) the proportion of primary publications reporting QoL results; (3) the proportion of trials with available QoL results actually favoring the experimental treatment out of trials declaring NI.
RESULTS
106 publications were eligible. QoL was included among endpoints in 59 studies (55.7%), and QoL results were available in 40 primary publications (37.7%). In the 73 trials testing the NI of different drugs, QoL was included in 43 trials (58.9%) and QoL results were present in 31 publications (42.5%). Among the 74 trials formally demonstrating NI, only 19 trials (25.7%) had QoL results actually supporting the experimental treatment.
CONCLUSIONS
In many NI trials in oncology, assessment and reporting of QoL are deficient. Furthermore, most trials formally claiming NI cannot count on QoL results actually supporting the experimental arm.
Topics: Adult; Humans; Quality of Life; Neoplasms; Medical Oncology; Patient Reported Outcome Measures
PubMed: 38557561
DOI: 10.1016/j.ejca.2023.113374 -
Farmacia Hospitalaria : Organo Oficial... 2024The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous... (Review)
Review
OBJECTIVE
The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs.
METHOD
A systematic review was performed following the PRISMA 2020 Guidelines by searching PubMed with the descriptors: "silicone" AND "syringes" AND ("intraocular" OR "intravitreal") and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences.
RESULTS
Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone, the administration technique, the physicochemical aspects of silicone release, and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialized syringes, the existing syringes for this use have been collected, finding two that will probably be commercialized in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic.
CONCLUSIONS
From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.
Topics: Syringes; Humans; Silicone Oils; Intravitreal Injections; Off-Label Use; Spain
PubMed: 38556370
DOI: 10.1016/j.farma.2024.01.008 -
Drug Discovery Today May 2024The ocular thin film presents a potential solution for addressing challenges to ocular drug delivery. In this review, we summarise the findings of a comprehensive review... (Meta-Analysis)
Meta-Analysis Review
The ocular thin film presents a potential solution for addressing challenges to ocular drug delivery. In this review, we summarise the findings of a comprehensive review analysing 336 formulations from 68 studies. We investigated the physical and mechanical properties of ocular thin films, categorised into natural polymer-based, synthetic polymer-based, and combined polymer films. The results showed that the type of polymers used impacted mucoadhesion force, moisture absorption:moisture loss ratio, pH, swelling index, and elongation percentage. Significant relationships were found between these properties within each subgroup. The results also highlighted the influence of plasticisers on elongation percentage, mucoadhesion force, swelling index, and moisture absorption:moisture loss ratio. These findings have implications for designing and optimising ocular drug formulations and selecting appropriate plasticisers to achieve formulations with the desired properties.
Topics: Humans; Polymers; Drug Delivery Systems; Administration, Ophthalmic; Eye; Animals
PubMed: 38552779
DOI: 10.1016/j.drudis.2024.103964 -
Frontiers in Immunology 2024While the association between vitamin D and several inflammatory biomarkers in asthma patients has been extensively reported, it remains unclear whether supplementation... (Meta-Analysis)
Meta-Analysis
BACKGROUND
While the association between vitamin D and several inflammatory biomarkers in asthma patients has been extensively reported, it remains unclear whether supplementation modifies these biomarkers. This review aims to evaluate the impact of vitamin D supplementation on inflammatory biomarkers measured in individuals with asthma.
METHODS
We conducted a systematic review of randomized controlled trials (RCTs) published until November 2022 in six electronic databases evaluating the impact of vitamin D supplementation (any dose, form, administration route, frequency, or duration) compared to placebo in children or adults. The two co-primary outcomes were serum IgE and blood eosinophils reported at the endpoint. Secondary outcomes included other markers of type 2 inflammation (e.g., sputum eosinophils, fractional exhaled nitric oxide, etc.), anti-inflammatory biomarkers (e.g., interleukin (IL)-10, etc.), markers of non-type 2 inflammation (e.g., high-sensitivity C-reactive protein, etc.), and non-specific biomarkers (e.g., macrophages, etc.). Data were aggregated using fixed or random effect models.
RESULTS
Thirteen RCTs (5 in adults, 5 in pediatric patients, and 3 in mixed age groups) testing doses of vitamin D supplementation ranging from 800 to 400,000 IU over periods of 6 weeks to 12 months were included. Eight studies provided data on serum IgE and four on blood eosinophils. As secondary outcomes, three studies reported on sputum eosinophils, four on FeNO, five on serum IL-10, and two on airway IL-10. Compared to placebo, vitamin D supplementation had no significant effect on serum IgE (Mean difference [MD] [95% CI]: 0.06 [-0.13, 0.26] IU/mL), blood eosinophils (MD [95% CI]: - 0.02 [-0.11, 0.07] 10/μL), or FeNO (MD [95% CI]: -4.10 [-10.95, 2.75] ppb) at the endpoint. However, the vitamin D supplementation group showed higher serum IL-10 levels compared to placebo (MD [95% CI]: 18.85 [1.11, 36.59] pg/ml) at the endpoint. Although data could not be aggregated, narrative synthesis suggested no significant effect of supplementation on sputum eosinophils and IL-10 in both sputum and exhaled breath condensate, at the endpoint.
CONCLUSION
Vitamin D supplementation in individuals with asthma was not associated with lower inflammatory biomarkers related to type 2 inflammation. However, it was significantly associated with higher serum IL-10 compared to placebo.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42022365666.
Topics: Adult; Humans; Child; Interleukin-10; Randomized Controlled Trials as Topic; Vitamin D; Vitamins; Asthma; Biomarkers; Inflammation; Immunoglobulin E; Dietary Supplements
PubMed: 38545098
DOI: 10.3389/fimmu.2024.1335968 -
Pharmaceutics Feb 2024The blood-brain barrier (BBB) regulates brain substance entry, posing challenges for treating brain diseases. Traditional methods face limitations, leading to the... (Review)
Review
BACKGROUND
The blood-brain barrier (BBB) regulates brain substance entry, posing challenges for treating brain diseases. Traditional methods face limitations, leading to the exploration of non-invasive intranasal drug delivery. This approach exploits the direct nose-to-brain connection, overcoming BBB restrictions. Intranasal delivery enhances drug bioavailability, reduces dosage, and minimizes systemic side effects. Notably, lipid nanoparticles, such as solid lipid nanoparticles and nanostructured lipid carriers, offer advantages like improved stability and controlled release. Their nanoscale size facilitates efficient drug loading, enhancing solubility and bioavailability. Tailored lipid compositions enable optimal drug release, which is crucial for chronic brain diseases. This review assesses lipid nanoparticles in treating neuro-oncological and neurodegenerative conditions, providing insights for effective nose-to-brain drug delivery.
METHODS
A systematic search was conducted across major medical databases (PubMed, Ovid MEDLINE, and Scopus) up to 6 January 2024. The search strategy utilized relevant Medical Subject Heading (MeSH) terms and keywords related to "lipid nanoparticles", "intranasal administration", "neuro-oncological diseases", and "neurodegenerative disorders". This review consists of studies in vitro, in vivo, or ex vivo on the intranasal administration of lipid-based nanocarriers for the treatment of brain diseases.
RESULTS
Out of the initial 891 papers identified, 26 articles met the eligibility criteria after a rigorous analysis. The exclusion of 360 articles was due to reasons such as irrelevance, non-reporting selected outcomes, the article being a systematic literature review or meta-analysis, and lack of method/results details. This systematic literature review, focusing on nose-to-brain drug delivery via lipid-based nanocarriers for neuro-oncological, neurodegenerative, and other brain diseases, encompassed 60 studies. A temporal distribution analysis indicated a peak in research interest between 2018 and 2020 (28.3%), with a steady increase over time. Regarding drug categories, Alzheimer's disease was prominent (26.7%), followed by antiblastic drugs (25.0%). Among the 65 drugs investigated, Rivastigmine, Doxorubicin, and Carmustine were the most studied (5.0%), showcasing a diverse approach to neurological disorders. Notably, solid lipid nanoparticles (SLNs) were predominant (65.0%), followed by nanostructured lipid carriers (NLCs) (28.3%), highlighting their efficacy in intranasal drug delivery. Various lipids were employed, with glyceryl monostearate being prominent (20.0%), indicating preferences in formulation. Performance assessment assays were balanced, with in vivo studies taking precedence (43.3%), emphasizing the translation of findings to complex biological systems for potential clinical applications.
CONCLUSIONS
This systematic review reveals the transformative potential of intranasal lipid nanoparticles in treating brain diseases, overcoming the BBB. Positive outcomes highlight the effectiveness of SLNs and NLCs, which are promising new approaches for ailments from AD to stroke and gliomas. While celebrating progress, addressing challenges like nanoparticle toxicity is also crucial.
PubMed: 38543223
DOI: 10.3390/pharmaceutics16030329