Current Medical Research and Opinion最新文献

Background: Serum albumin is a well-known biomarker in sepsis, and several albumin-based ratios have been proposed to enhance its prognostic performance. However, it remains unclear whether these composite indices outperform serum albumin alone in predicting outcomes in septic patients.

Methods: We conducted a prospective observational study including 413 adult patients with sepsis admitted to the Intermediate Care Unit of Santorso Hospital, Italy, between January 2023 and June 2024. Clinical data, laboratory parameters, and six albumin-based ratios were collected at admission. The primary outcome was 30-day mortality. Prognostic performance was assessed using ROC curves, Brier Scores, and Decision Curve Analysis (DCA). Correlation with clinical severity was evaluated using Spearman's correlation with SOFA and APACHE II scores.

Results: Among the 413 patients enrolled, 30-day mortality was 16.9%. Serum albumin demonstrated the highest predictive value compared to all albumin-based ratios. DCA confirmed the superior net clinical benefit of serum albumin across a wide range of threshold probabilities, especially in early risk stratification. LAR showed comparable performance in AUC but lower clinical utility in DCA. Albumin also showed the strongest inverse correlation with SOFA (ρ = -0.276, p < 0.001) and APACHE II (ρ = -0.391, p < 0.001) scores.

Conclusions: Serum albumin is a strong, independent predictor of 30-day mortality in patients with sepsis and outperforms multiple albumin-based ratios in both statistical and clinical utility. Its use in early risk stratification should be encouraged in clinical practice. Further multicenter studies are warranted to confirm these findings and explore their generalizability.

Objective: We evaluated real-world treatment patterns and unmet needs associated with migraine preventive medications in Japan following the introduction of calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs), focusing on persistence, switching, and adherence rates.

Methods: This retrospective cohort study analyzed JMDC (previously Japan Medical Data Center) claims data (index date: April 2021 to January 2024) for treatment-naïve patients who initiated oral migraine preventive medications (OMPMs; n = 12,750) and patients initiating CGRP mAbs (n = 3,280). Persistence was defined as continuous therapy without a 60-day or longer gap. Treatment patterns were evaluated at 3, 6, and 12 months post-initiation.

Results: Most patients were female (74.1% OMPMs, 78.1% CGRP mAbs), over half of childbearing age. For OMPM initiators, persistence rates declined from 49.7% at 3 months to 21.7% at 12 months, with antiepileptics showing highest persistence (27.0%). CGRP mAb initiators demonstrated higher initial persistence (85.6% at 3 months), declining to 36.5% at 12 months. 22.9% of OMPM and 19.7% of CGRP mAb patients switched by 12 months. Among OMPM switchers, only 20% switched to CGRP mAbs. Both cohorts had a high prevalence of comorbidities, including non-migraine headaches (approx. 50%), mental health disorders (26-31%), and sleep disorders (approx. 29%).

Conclusion: Substantial unmet needs exist in migraine preventive treatment in Japan, as demonstrated by low 12-month persistence across all medication classes. Despite higher initial persistence, CGRP mAbs showed similar declining patterns over time, indicating most migraine patients do not remain on their index treatment and suggesting the need for additional options.

Patient engagement (PE) has evolved from an emerging concept to a fundamental ethos underpinning healthcare research and communication. In this commentary, we explore the historical evolution in medical research from patients being participants in clinical trials to becoming integral partners in communicating medical research findings. The progression from "why" to "how" PE should occur represents a fundamental shift in the medical publication landscape. We also highlight the International Society for Medical Publication Professionals' (ISMPP) journey in embracing and advancing PE within medical publications through ISMPP's initiatives and activities, including the establishment of its PE Task Force, patient membership, and support programs, while examining the cultural transformations occurring within the profession. Looking ahead, we discuss opportunities for expanding patient roles, improving accessibility to tools and frameworks, and integrating patient perspectives into leadership positions. This commentary serves as both a reflective narrative and a call to action for medical publication professionals to champion authentic and meaningful PE, ensuring publications truly engage and serve the patients at the heart of the research they describe, as exemplified by ISMPP.

Objective: This study aimed to report the 10-year experience of implantation, removal, and adjustment of a totally implantable venous access port (TIVAP) under the guidance of digital subtraction angiography (DSA) at a territory medical center.

Methods: The medical records of consecutive patients who underwent implantation, removal, and adjustment of the TIVAP under DSA guidance from January 2014 to March 2024 were retrospectively reviewed.

Results: In total, 290 consecutive patients who underwent TIVAP implantation were included, of which, 136 (46.9%) were men and 154 (53.1%) were women, with a mean age of 44.4 ± 16.5 years. The mean radiation dose was 4.9 ± 1.4 mGy. The operation time was 34.1 ± 3.8 min. The technical success rate was 100%. During a median follow-up of 239 days, 9 cases showed complications. No significant differences were found in age, sex, operation time, and radiation dose between the subclavian vein (SCV) and internal jugular vein (IJV) groups, while there were fewer complications in the IJV group (p = 0.039), and 114 consecutive patients who underwent TIVAP removal were included, of which, 49 (43.0%) were men and 65 (57.0%) were women, with a mean age of 44.3 ± 15.4 years. The median radiation dose was 3.8 (1.3-62.3) mGy. The median interval time from implantation to removal was 358.5 (2-3650) days. The operation time was 34.4 ± 6.1 min. The technical success rate was 100%. No significant differences were observed between the SCV and IJV groups. Cases with fracture and dislocation of the catheters were defined as the complicated group, while the others were defined as the uncomplicated group. The operation time (45.7 ± 12.4 vs. 33.7 ± 4.6 min) and radiation dose (45.4 ± 10.8 vs. 4.2 ± 2.2 mGy) between the above two groups were significantly different (both p < 0.05); A total of nine consecutive patients who underwent adjustment of the TIVAP were included, of which three patients had dislocation of the catheter and six patients had kinking of the catheters. They were all successfully adjusted using a pigtail catheter and/or gooseneck snare. The average operation time and radiation dose were 20.8 ± 5.6 min and 3.2 ± 1.3 mGy.

Conclusion: Implantation, removal, and adjustment of the venous port access under DSA guidance were safe and efficient. For the removal and adjustment of complicated cases, using the pigtail catheter and/or gooseneck snare under DSA guidance was efficient. In addition, the IJV seems to be a safer venous access site with a lower complication rate than the SCV.

Introduction: Diabetes Mellitus is a chronic disease characterised by elevated plasma glucose (PG) levels. HbA1c has been widely utilized for diabetes diagnosis. However, certain conditions restrict its use. In such cases, plasma glucose (PG) measurements and self-monitoring blood glucose (SMBG) are recommended. This case series highlights the importance of considering both HbA1c and PG or SMBG in the evaluation of patients with diabetes.

Case report: This case series presents three cases of patients with diabetes who exhibited a discrepancy between PG and HbA1c levels. Only one patient demonstrated isolated microcytosis, while the remaining two had completely normal hematologic profiles. Due to this discrepancy, hemoglobin electrophoresis was conducted, revealing various hemoglobinopathies in all cases.

Conclusion: For patients with discrepancies between PG levels and HbA1c, we suggest a thorough evaluation that includes consideration of potential hemoglobinopathies. These hemoglobin variants can present with isolated microcytosis or entirely normal hematologic parameters and may lead to falsely low HbA1c values. In cases of discordance between PG and HbA1c, hemoglobin electrophoresis can serve as a valuable diagnostic tool. Identifying hemoglobinopathies before determining treatment regimens can help mitigate the risk of complications from inadequate treatment, and awareness of HbA1c limitations allows clinicians to use both HbA1c and PG/SMBG to optimize diabetes management and minimize the risk of diabetic complications.

Objective: To explore the efficacy and safety of brexpiprazole for the treatment of agitation symptoms in clinically relevant subgroups of patients with dementia due to Alzheimer's disease.

Methods: Data were pooled for brexpiprazole (2 or 3 mg/day) and placebo from two international, randomized, double-blind trials in adults with a clinical diagnosis of Alzheimer's dementia with mild-to-severe cognitive dysfunction and with agitation (ClinicalTrials.gov identifiers: NCT01862640, NCT03548584). Change in agitation frequency over 12 weeks was measured using the Cohen-Mansfield Agitation Inventory (CMAI). Safety measures included treatment-emergent adverse events (TEAEs). In this post hoc analysis, thirteen clinically relevant subgroups were investigated based on care setting (institutionalized, non-institutionalized), severity of cognitive dysfunction (mild/moderate, severe), co-occurring behavioral symptoms (psychosis, depression, anxiety, irritability, sleep disturbance), and use of concomitant medications for dementia (acetylcholinesterase inhibitor, memantine) and psychiatric conditions (antidepressant, benzodiazepine).

Results: In the randomized sample (N = 621), mean age was 74 years (range 55-90 years), 344 (55.4%) participants were female, and 277 (44.6%) were male. Over 12 weeks, brexpiprazole showed numerically greater reduction in agitation frequency than placebo in 12 of 13 subgroups. The only exception was "concomitant benzodiazepines", which was a small subgroup (n = 71), but showed efficacy for brexpiprazole in secondary analyses. The largest differences in favor of brexpiprazole versus placebo were for the concomitant antidepressant, co-occurring sleep disorder, and co-occurring psychosis subgroups. The overall incidence of TEAEs was generally consistent across subgroups.

Conclusion: In these exploratory analyses, brexpiprazole reduced symptoms of agitation across a wide range of patients with agitation associated with dementia due to Alzheimer's disease.

Objective: Several vaccines are recommended for 16-23-year-olds in the United States, but coverage varies widely across these vaccines. Previous studies have indicated that routine healthcare visits are associated with vaccination uptake. This study aimed to describe healthcare visit patterns among 16-23-year-olds to identify challenges and inform opportunities to reach adolescents and young adults for vaccination.

Methods: A descriptive, retrospective database analysis was conducted of commercially insured and Medicaid-insured 16-23-year-olds from 2019-2022 using IQVIA's PharMetrics^® Plus claims database and open-source Longitudinal Prescription/Medical claims databases. The proportion of 16-23-year-olds with healthcare provider (HCP) visits, visit types, provider types involved, visits including vaccination, and specific vaccines delivered were analyzed.

Results: In 2022, 68.2% of commercially insured 16-23-year-olds had ≥1 HCP visit. Most commercially insured and Medicaid-insured individuals with ≥1 HCP visit had sick visits (72.9-80.6%). The proportion of individuals with preventative visits was lower as age increased (commercially insured: 73.2% at 16, 67.4% at 18, 56.3% at 19, and 45.3% at 23 years). Lower proportions of individuals with preventative visits with increasing age were also seen among Medicaid-insured individuals, ranging from 53.7% at 16 years to 28.0% at 23 years. Among 16-18-year-olds with ≥1 HCP or pharmacy visit in 2022, 52.6% in the commercial cohort and 33.0% in the Medicaid cohort had ≥1 visit that involved vaccination; for 19-23-year-olds, these proportions were 34.5% and 25.6%, respectively. Vaccination rates by vaccine type were largely aligned with the ages specified by recommendations, but nonetheless were low.

Conclusion: Approximately one-third of commercially insured 16-23-year-olds did not have an annual HCP visit, and among commercially insured and Medicaid-insured individuals who did have visits, a substantial proportion did not have preventative visits; this proportion was higher with increasing age. The proportions of visits with vaccination were particularly low for 19-23-year-olds. Targeted interventions to promote routine visits, including framing these as opportunities for immunization, may help to increase vaccination uptake; based on the findings of this analysis, these efforts should consider age-specific shifts in health-seeking behaviors.

Chronic kidney disease (CKD) is a global issue that raises inflammation and heightens the risk of progressing to advanced CKD, requiring renal replacement therapy. It also significantly increases the likelihood of cardiovascular and vascular diseases, hospitalizations, functional decline, and reduced quality of life, particularly in older adults. CKD prevalence rises with age, affecting 25-30% of older adults. Despite that, the fact is that CKD is underdiagnosed in this population. Diagnosing CKD in older patients is difficult because accurate tests are limited, common serum creatinine-based formulas depend on muscle mass (often low in this group), and age-related renal function decline further complicates assessment. Comprehensive management can help achieve therapeutic goals in the old population with CKD through assessments and care plans. This care includes a combination of lifestyle changes, cardiovascular risk factors control, the use of drugs with proven renal and cardiovascular benefits, as well as the adequate management of specific clinical conditions, including the general clinical comorbidities, renal-related conditions and recognition of geriatric syndromes, helping patients manage their condition and involving them in decisions about their care. In this narrative review, the epidemiology, clinical profile and management of CKD in the old population are updated.

Objective: Patient involvement in pharmaceutical industry-sponsored publications is a rapidly evolving practice. It is supported by industry guidelines, but currently inconsistent across organizations. This study aimed to qualitatively map the landscape of current practices and gaps in patient involvement in peer-reviewed journal publications of pharmaceutical industry-sponsored research, and to define the specific roles and activities in which patients are involved.

Methods: This qualitative, patient-led study was conducted using semi-structured interviews with purposively sampled experts in patient engagement and publications, including patients. Interviews were conducted online, transcribed, and thematically analysed. Landscape elements were visually mapped, and themes were generated through an inductive and experientially situated thematic analysis.

Results: Interviews were conducted with 20 participants recruited globally, with a majority from the United Kingdom. Participants represented diverse stakeholder categories and reported patient involvement across all stages and aspects of the publication lifecycle, with patients both as external consultants and as professionals working within the system. Five overarching themes and 20 sub-themes were identified, including: patient identities and roles; principles and values; processes and practices; variations over time and across organizations; and impact. Significant gaps were identified in consistency, quality, and scale, for example including gaps in infrastructure barriers and diversity.

Conclusions: Patient involvement in pharmaceutical publications is actively happening across the publication lifecycle and is rapidly growing and evolving. This study provides an evidence base via a qualitative mapping of the experiential landscape and highlights the need for established best practices to support consistency and quality in meaningful patient involvement in publications.