Search Results for: Analisi sull’uso dei farmaci anti-osteoporotici in sette database europei

Introduction
In China, there is a lack of standardised clinical imaging databases for multidimensional evaluation of cardiopulmonary diseases. To address this gap, this study protocol launched a project to build a clinical imaging technology integration and a multicentre database for early warning and stratification of cardiopulmonary dysfunction in the elderly.

Methods and analysis
This study employs a cross-sectional design, enrolling over 6000 elderly participants from five regions across China to evaluate cardiopulmonary function and related diseases. Based on clinical criteria, participants are categorized into three groups: a healthy cardiopulmonary function group, a functional decrease group and an established cardiopulmonary diseases group. All subjects will undergo comprehensive assessments including chest CT scans, echocardiography, and laboratory examinations. Additionally, at least 50 subjects will undergo cardiopulmonary exercise testing (CPET). By leveraging artificial intelligence technology, multimodal data will be integrated to establish reference ranges for cardiopulmonary function in the elderly population, as well as to develop early-warning models and severity grading standard models.

Ethics and dissemination
The study has been approved by the local ethics committee of Shanghai Changzheng Hospital (approval number: 2022SL069A). All the participants will sign the informed consent. The results will be disseminated through peer-reviewed publications and conferences.

Introduction
Raltegravir is a potent HIV-integrase strand transfer inhibitor (INSTI). Despite its strong activity against HIV-1 strains resistant to other antiretroviral drug classes, it is usually used in combination with other antiretroviral drugs due to the empirical requirement for anti-HIV drug combinations to ensure effective anti-retroviral therapy (ART). As an early-arriving INSTI, raltegravir is clinically familiar for its safety, tolerability and treatment effectiveness. High-dose calcium carbonate formulated as an antacid (as opposed to a supplement formulation) taken orally together with raltegravir is known to reduce systemic raltegravir exposure due to chelation and reduced absorption. This study aims to assess the effect of daily calcium carbonate antacid as TUMS Ultra Strength (US) administration in lower doses, as currently used for oral calcium supplementation, on the steady-state pharmacokinetics (PKs) of once-daily oral raltegravir.

Methods and analysis
This is an open-label, three-treatment series in three periods in a single group, fixed-sequence PK study in 12 healthy adult volunteers with HIV on ART. Subjects will take 1200 mg of raltegravir single QD oral dose alone for 7 days (period one), then raltegravir 1200 mg with calcium carbonate 500 mg from day 8 to day 14 (period two) and raltegravir 1200 mg with calcium carbonate 1000 mg from day 15 to day 22 (period three). We will conduct serial PK sampling from observed dosing on days 7, 14 and 21, with 24-hour PK sampling scheduled for days 8, 15 and 22. Follow-up will continue until day 51.

Ethics and dissemination
This study will adhere to the ICH GCP Guidelines and the Declaration of Helsinki. Ethics approval was obtained from the Ottawa Health Science Network Research Ethics Board under study ID 20190750–01 hour. Informed consent will be obtained from all participants prior to enrolment. This protocol will be published in a peer-reviewed journal prior to the study’s completion and closure. Results generated from this activity will also be reported in a peer-reviewed journal.

Trial registration number
NCT04258475.

Background
While previous studies have shown an association between anti-Mullerian hormone (AMH) levels and endometriosis, there are limited data on the relationship between AMH levels and age among women with endometriosis.

Objectives
The present study aimed to investigate the associations between age and AMH levels in women with and without endometriosis.

Design and setting
A cross-sectional, population-based study using data from the ongoing Tehran Lipid and Glucose Study.

Participants
A total of 1005 eligible reproductive-age women were selected. These participants were categorised into two groups: women with confirmed endometriosis (n=305) and controls (n=700).

Interventions
None.

Outcome measures
Association between AMH levels and age among women with endometriosis and healthy controls, using linear, quadratic and segmented regression analyses.

Results
A total of 1005 women aged 18–48 years participated in the study, including 305 (30.3%) with endometriosis and 700 (69.7%) healthy controls. Women with endometriosis had significantly lower AMH levels compared with healthy controls (1.99±1.42 vs 2.30±1.61 ng/mL; p=0.029). In healthy controls, an increase of 1 year was associated with –0.15 ng/mL of AMH (95% CI: –0.17 to –0.14). Segmented regression identified a threshold at 27 years (1.92), with a sharper decline below this age (slope: –0.35, 95% CI: –0.47 to –0.23; p

Objective
This study investigates the effects of dexmedetomidine on short-term and long-term survival rates in intensive care unit (ICU) patients with ischaemic stroke.

Design
This is a retrospective study.

Setting
Data were sourced from the Medical Information Mart for Intensive Care IV database.

Participants
This study analysed 2816 patients with ischaemic stroke from the US Intensive Care database.

Interventions
Dexmedetomidine administration during the ICU stay was defined as the exposure.

Methods
Patients were categorised into the dexmedetomidine group and the control group. Cox regression analysis was used to identify factors that may influence the 28-day mortality rate of patients with ischaemic stroke. High-risk factors were incorporated as covariates, and a 1:1 propensity score matching using the logit model was constructed to compare the prognosis between the two groups.

Primary and secondary outcome measures
The primary outcome was 28-day mortality. The secondary outcomes included in-hospital mortality, ICU length of stay, hospital length of stay, mechanical ventilation duration and 180-day mortality in discharged patients.

Results
A total of 2816 patients were included. Cox regression analysis revealed that dexmedetomidine use was associated with a reduced risk of 28-day mortality. Following propensity score matching, each group comprised 407 patients. Dexmedetomidine was found to improve 28-day mortality (27.8% vs 36.6%, p=0.007). However, it was also associated with the prolonged length of hospital and ICU stay (p=0.002). Among discharged patients, dexmedetomidine use was also associated with an improved 180-day mortality rate (p=0.0019).

Conclusion
The use of dexmedetomidine is associated with improved short-term and long-term prognosis in patients with ischaemic stroke and could potentially confer benefits in those receiving mechanical ventilation.

Caldo, afa? Anche i farmaci “soffrono”. Ma cosa accade davvero ai medicinali quando le temperature schizzano così in alto come in questi giorni?Disattenzioni come lasciare una medicina in macchina o…

Il vademecum di Aifa per i medicinali in valigia

Aifa, attenzione a quelli per ansia e ipertensione

Limitate alterazioni metaboliche indotte da farmaci psichiatrici

In this phase II trial of postmenopausal women with osteoporosis, narlumosbart demonstrated superiority over placebo in increasing BMD at 12 months following administration at 6-month intervals, with a tolerable safety profile in the short term, consistent with that of anti-RANKL monoclonal antibodies.

Objectives
Modern healthcare is delivered by an increasingly multidisciplinary team, complicating workforce management. Patient safety inquiries have led to reports such as the Francis and Berwick reports (2013), which consistently emphasise the need for proper staffing to ensure patient safety. While nursing has seen progress with safe staffing guidelines, there remains a significant gap in guidance for medical staff. In the UK, consultants are the senior members of the medical profession who have achieved a Certification of Completion of Training (CCT) and are able to practice independently. The number of required consultants is based on population needs, and future consultant numbers are used to determine the number of doctor training positions. However, this approach often overlooks the specific staffing needs of individual hospitals, particularly regarding patient safety. Although a named consultant is responsible for patient care, the medical workforce that handles day-to-day operations in acute hospitals consists of a diverse group of staff who require varying degrees of supervision based on their competency and seniority. This group includes medical associates, such as physician associates, and resident doctors (formerly known as junior doctors) who themselves are a heterogeneous group needing different levels of oversight. As a result, the previous focus solely on consultant staffing requirements must be broadened to address the realities of patient care. At present, no single resource provides a comprehensive summary of staffing recommendations that includes all groups within the non-consultant medical workforce. This research aims to identify existing guidance for this part of the medical workforce to support healthcare management. The objectives of this study are, therefore, to identify guidance and recommendations for safe staffing levels from a patient safety perspective for non-consultant medical staff in UK acute hospitals.

Design
A scoping literature review was conducted and is reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Data sources
This used five search strategies: internal website searches, Google Scholar searches, general Google searches, medical database searches via Ovid and a snowballing strategy.

Eligibility criteria
English-language resources published from 2015 to 2024 that provide specific guidance on safe medical staffing levels for National Health Service acute hospitals in the UK.

Data extraction and synthesis
Thematic analysis was employed to identify patterns in the diverse guidance discovered, using a hybrid approach that combined human and AI methods. The benefits and limitations of this method are discussed.

Results
The review yielded 10 703 resources, of which 10 met all eligibility criteria for analysis. Identified themes include staffing requirements, staffing recommendations and a tiered system approach.

Conclusions
Medical staffing is complex due to the varying roles and competencies involved. While some guidance exists, there is a clear need for more comprehensive recommendations that go beyond specific specialities. Future research should focus on developing a medical safe staffing tool and addressing the barriers to comprehensive guidance, both of which would enhance patient care.

Introduction
Diarrhoea is a common problem in people living with HIV. Some trials have demonstrated the effectiveness of zinc supplementation in the prevention and treatment of diarrhoea; however, several studies employing the effectiveness of zinc supplementation for reducing diarrhoea in HIV infection have reported heterogeneous outcomes, necessitating a systematic review to provide an exhaustive summary of current evidence. This review aims to pool the available evidence on the effectiveness of zinc supplementation on diarrhoea in HIV infection.

Methods and analysis
This systematic review protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. A systematic literature search will be conducted in Chinese and English databases, including PubMed, Scopus, Google Scholar, Cochrane Library, EMBASE, Web of Science, China National Knowledge Infrastructure, Chinese Scientific Journal Database, SinoMed and Wanfang, as part of our search strategy from inception to 17 May 2025. Two reviewers will independently identify eligible studies and extract data. The risk of bias in included studies will be assessed using version 2 of the Cochrane risk-of-bias tool for randomised trials. The risk ratio and 95% CIs will be used to estimate the efficacy of treatment and evaluation approach to rate the certainty of evidence. Cochran’s Q and the I2 will be used to evaluate statistical heterogeneity. Data will be analysed using Stata version 13.0.

Ethics and dissemination
Because no patients were involved, ethical approval was not required. The final results of this research will be submitted to a peer-reviewed journal or presented at relevant conferences, and any deviations from this protocol will be recorded and explained in the final report.

PROSPERO registration number
CRD42022328098.

Introduction
Pain is one of the most bothersome symptoms that affects patients with inflammatory bowel disease (IBD) but is often inadequately treated. Inadequate pain control in the inpatient setting not only impacts patients’ experience but increases opioid use and hospital length of stay. Opioids are often considered first-line treatment for severe pain but are associated with significant morbidity and mortality in IBD. Non-steroidal anti-inflammatory drugs are a non-opioid analgesic option, but concerns regarding their contribution to IBD flares have limited their use. Brain-gut behavioural therapies (BGBT), such as cognitive behavioural therapy, meditation and gut-directed hypnotherapy, are effective for pain management and have a role in the treatment of IBD symptoms. However, the use of BGBT in IBD is challenging, given limited access to behavioural health specialists, especially in the inpatient setting. Virtual reality (VR)-directed BGBT programmes can bridge this gap and enhance pain treatment for inpatients with IBD. Therefore, in this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.

Methods and analysis
We will recruit 40 patients with IBD who are hospitalised at Michigan Medicine and who endorse IBD-related pain. We will assess patient-reported outcomes (pain rating, IBD-specific symptoms, perceived stress, mood) before and after treatment, cumulative inpatient analgesic requirements and hospital length of stay. Our primary objective will be to establish intervention feasibility defined by the frequency and percentage of enrolled participants that use the VR-directed BGBT inpatient intervention in any capacity. Our secondary objective will be to evaluate intervention acceptability by conducting semistructured interviews with study participants. We will also explore the preliminary effectiveness of VR-directed BGBT on patient-reported outcomes and healthcare utilisation as compared with historic controls.

Ethics and dissemination
The study was approved by the institutional review board of the University of Michigan Medical School on 10 October 2023 (HUM00240999). All human subjects will be required to sign an informed consent document prior to study participation. Study findings will be reported through peer-reviewed publication.

Trial registration number
NCT06188793.

Per l’uso innovativo dell’IA nella scoperta di farmaci e vaccini

A Bergamo tornano presto ad accendersi i riflettori sulla Sanità che cambia pelle tra bisogni di salute sempre più impellenti e una governance da rivedere per gestire la spinta di…

Farmaci e vaccini sono al primo posto in Italia per surplus con l’estero, con oltre 21 miliardi di attivo nel 2024, mentre i nuovi record di produzione (56 miliardi) ed…

Objectives
To evaluate how insurance influences the risk of a dementia diagnosis among a large, diverse cohort of US civilian adults with traumatic brain injury (TBI) over a 22-year period.

Design
This is a retrospective cohort study involving individuals diagnosed with TBI.

Setting
The study used the Merative MarketScan Research Database, specifically drawing from the Commercial Claims and Encounters, Medicare Supplemental and Medicaid databases, from 2000 to 2022 in the USA. These databases provide comprehensive insights into healthcare services received by enrollees, including inpatient and outpatient services, outpatient prescription claims, clinical utilisation records and healthcare expenditures.

Participants
267 473 adults aged 55 and older who were diagnosed with a TBI between 1 January 2000 and 31 December 2022. Individuals with unknown TBI severity and dementia claims 2 years preceding TBI were excluded. TBI and dementia diagnoses were identified using International Classification of Disease 9th and 10th editions codes from inpatient and outpatient admission records.

Interventions
None.

Primary and secondary outcome measures
We compared the incidence of all-cause dementia across different insurance types to assess potential disparities in diagnosis following TBI. Cox proportional hazards models, with age as the time scale, were used to study the association between insurance type and dementia diagnosis following a TBI. Models were adjusted for key demographic variables, medical comorbidities and psychiatric conditions to account for potential confounding.

Results
Of the 267 473 individuals with TBI, 12.7% were diagnosed with dementia over a mean follow-up period of 40 months (SD of 42 months). Dementia incidence differed significantly by insurance type, with 18.2% for Medicaid recipients, 17.3% for Medicare beneficiaries and only 2.3% among individuals with commercial insurance. The adjusted HR for dementia was notably higher among individuals enrolled on Medicaid (HR 2.9, 95% CI: 2.8 to 3.1) and Medicare (HR 2.1, 95% CI: 2.0 to 2.2), when compared with those with commercial insurance.

Conclusions
Individuals with TBI covered by Medicaid and Medicare are significantly more likely to be diagnosed with dementia, with a 2.9-fold and 2.1-fold increase risk, respectively, compared with those with commercial insurance. Addressing insurance-related disparities in dementia diagnosis is crucial for building a more equitable healthcare system. It is essential that individuals with TBI cases, regardless of their insurance type, have access to comprehensive care and preventive interventions to achieve the best possible long-term outcomes.