Therapeutics and Clinical Risk Management最新文献

{"title":"Risk Factors for Hypoglycemia in Type 2 Diabetes Mellitus Patients Using Once-Weekly Semaglutide: A Matched Case-Control Study.","authors":"Palanisamy Amirthalingam, Fawaz Ahmed Alarawi, Loay Mohammed Jassas Alagwar, Mohammed Sulaiman Alatawi, Mohanad Saleh Saeed Alfahmi Alzahrani, Ali Oudah A Albalwi, Ahmed Alrashidi, Ahmed Mohsen Elsaid Hamdan, Saleh Fahad Alqifari, Hanan Alshareef, Ahmed Aljabri, Nizar Sirag, Shahul Hameed Pakkir Mohamed, Mostafa A Sayed Ali","doi":"10.2147/TCRM.S610579","DOIUrl":"10.2147/TCRM.S610579","url":null,"abstract":"<p><strong>Background: </strong>The semaglutide once-weekly injection (Sema-OWI) is widely accepted for managing type-2 diabetes mellitus (T2DM) patients, particularly those seeking weight loss. However, hypoglycemia is continually challenging healthcare practitioners, and the underlying factors have yet to be conclusively reported. The study aimed to investigate the underlying characteristics of T2DM patients undergoing sema-OWI treatment.</p><p><strong>Methods: </strong>A matched case-control study design was employed with a 1:4 (case:control) ratio. Univariable conditional logistic regression was used for the preliminary analysis of the association between patient characteristics and the occurrence of hypoglycemia using a matched odds ratio (mOR). Then, multivariable conditional logistic regression was performed using the predictors, with adjusted mOR (mORadj), including body mass index (BMI) and glycosylated hemoglobin (HbA1C), adjusted for the significant confounders identified in the univariable conditional logistic regression.</p><p><strong>Results: </strong>Forty-five cases diagnosed with the hypoglycemic event and 180 controls were recruited according to a 1:4 (case:control) ratio. According to univariable conditional logistic regression, Patients treated with sema-OWI for 4-6 months (mOR = 0.052; p<0.001) and more than 6 months (mOR = 0.045; p = 0.001) were least likely to experience hypoglycemia. Obese patients (mOR = 0.110; p = 0.041) and those with an HbA1C level >9 (mOR = 0.254; p < 0.001) were also least likely to experience hypoglycemia. According to multivariable conditional logistic regression analysis, the model was adjusted for the number of T2DM medications and Sema-OWI duration, confirming that obesity and higher HbA1C levels (>9) were associated with a lower likelihood of hypoglycemia. On the other hand, the above results establish that the normal body mass index and lower HbA1C levels (<7) were associated with a higher likelihood of hypoglycemia.</p><p><strong>Conclusion: </strong>Patients with T2DM treated with sema-OWI require careful monitoring, particularly during the first 3 months. Normal BMI and HbA1C levels <7 are considered risk factors for hypoglycemia.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"610579"},"PeriodicalIF":2.6,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13245618/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148211001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Extracellular Vesicle-Based Strategies for the Prevention of Chemotherapy-Induced Cardiotoxicity.","authors":"Zhaoqin Shen, Jie Qiu, Wei Yu, Rumeng Chen, Yuancong Jiang","doi":"10.2147/TCRM.S597871","DOIUrl":"10.2147/TCRM.S597871","url":null,"abstract":"<p><p>Chemotherapy-induced cardiotoxicity (CIC) is a major limitation of modern anticancer therapy, particularly with anthracyclines and targeted agents, and contributes to long-term cardiovascular complications in cancer survivors. Extracellular vesicles (EVs) are nanoscale lipid-bilayer particles that mediate intercellular communication through the transfer of proteins, nucleic acids, and lipids. Emerging evidence indicates that EVs play a dual role in CIC. On one hand, EVs released from tumor cells or stressed cardiomyocytes can propagate cardiotoxic signals by modulating pathways related to oxidative stress, mitochondrial dysfunction, apoptosis, and inflammatory responses. On the other hand, EV-associated molecular cargo, including specific microRNAs and proteins, shows promise as minimally invasive biomarkers for early detection and monitoring of cardiac injury during chemotherapy. In addition, EVs derived from stem or progenitor cells, as well as engineered EVs with modified cargo or surface ligands, have demonstrated cardioprotective potential by attenuating oxidative damage, suppressing apoptosis, and modulating immune and inflammatory signaling in the injured myocardium. Despite these advances, several barriers hinder clinical translation, including vesicle heterogeneity, limited targeting specificity, challenges in standardized isolation and characterization, and insufficient safety and efficacy validation. This review summarizes the mechanistic roles of EVs in the development of CIC, highlights their emerging value as diagnostic biomarkers and therapeutic carriers, and discusses current technical challenges and future directions for translating EV-based strategies into clinical cardio-oncology practice.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"597871"},"PeriodicalIF":2.6,"publicationDate":"2026-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13242996/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148211030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association Between Insulin Regimen and Cardiovascular Risk in Indonesian Patients with Type 2 Diabetes Mellitus: A Cross-Sectional Study.","authors":"Ramdhani M Natsir, Eli Halimah, Ajeng Diantini, Jutti Levita","doi":"10.2147/TCRM.S611165","DOIUrl":"10.2147/TCRM.S611165","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality among patients with type 2 diabetes mellitus (T2DM). Despite the widespread use of insulin therapy, evidence on how different insulin regimens influence cardiovascular risk stratification remains limited and inconsistent, particularly in Asian populations, including Indonesia.</p><p><strong>Purpose: </strong>To evaluate the association between insulin regimens and cardiovascular risk, as assessed by the Framingham Risk Score (FRS), among patients with T2DM.</p><p><strong>Methods: </strong>A cross-sectional study was conducted involving 118 patients with T2DM receiving insulin therapy, including basal insulin therapy and combined basal-prandial insulin therapy. Cardiovascular risk was assessed using the FRS and categorized as low, moderate, or high. Differences between groups were analyzed using the Chi-square test. The association between insulin regimen and cardiovascular risk was evaluated using ordinal logistic regression.</p><p><strong>Results: </strong>Most patients in both treatment groups were classified as having high cardiovascular risk according to the FRS. After adjustment for potential confounders, the insulin regimen was not significantly associated with cardiovascular risk (OR = 2.14; 95% CI: 0.81-5.65; p = 0.124). In contrast, the duration of T2DM was significantly associated with cardiovascular risk (OR = 3.63; 95% CI: 1.30-10.15; p = 0.014).</p><p><strong>Conclusion: </strong>Cardiovascular risk among patients with T2DM receiving insulin therapy was predominantly moderate to high. The insulin regimen was not significantly associated with cardiovascular risk, whereas the duration of T2DM played a more prominent role in cardiovascular risk stratification.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"611165"},"PeriodicalIF":2.6,"publicationDate":"2026-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13242994/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148211035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Evidence for Combination Sedation: Propofol Plus Dexmedetomidine and Clinical Outcomes in Mechanically Ventilated ICU Patients.","authors":"Jialin Qi, Weihua Gao, Qian Ni, Zishun Liang, Wei Wang, Tong Qiao, Baoyan Wang","doi":"10.2147/TCRM.S597422","DOIUrl":"10.2147/TCRM.S597422","url":null,"abstract":"<p><strong>Purpose: </strong>This retrospective multicenter cohort study evaluated the real-world effectiveness of propofol alone versus a propofol-plus-dexmedetomidine combination on clinical outcomes in mechanically ventilated ICU patients.</p><p><strong>Methods: </strong>Adult mechanically ventilated ICU patients receiving long-term continuous infusion sedation (≥48 h) with either propofol alone or propofol plus dexmedetomidine were identified from the MIMIC-IV and eICU databases. An external validation cohort from Nanjing Drum Tower Hospital (2013-2022) was assembled using the same eligibility criteria. Patients were categorized into a propofol monotherapy group (Pro) and a propofol plus dexmedetomidine group (Pro+Dex). Outcomes included 28-day all-cause mortality, incident delirium, ICU length of stay, duration of mechanical ventilation, and longitudinal changes in mean arterial pressure, heart rate, and oxygen saturation.</p><p><strong>Results: </strong>Among 5495 patients (Pro: n=4730; Pro+Dex: n=765), the Pro+Dex regimen was associated with lower 28-day mortality (adjusted HR: 0.45, 95% CI: 0.36-0.56; P < 0.001) and a markedly reduced incidence of delirium (adjusted OR: 0.28, 95% CI: 0.21-0.37; P < 0.001), but with a modestly longer ICU stay (13.07 vs 10.60 days; adjusted ratio: 1.23, 95% CI: 1.18-1.29). Mechanical ventilation duration did not differ significantly between groups (154.79 vs 157.64 hours; adjusted ratio: 0.98, 95% CI: 0.92-1.05). Longitudinal mixed-effects models suggested a more stable MAP trajectory and lower HR with Pro+Dex, while SpO₂ was slightly lower on average but remained stable over time. Subgroup analyses were broadly consistent with the overall cohort. In the external validation cohort, Pro+Dex was also associated with significantly lower 28-day mortality, whereas the reduction in delirium incidence did not reach statistical significance.</p><p><strong>Conclusion: </strong>In this large real-world multicenter study, combination sedation with propofol and dexmedetomidine was associated with lower 28-day mortality and a lower risk of delirium, without a significant difference in mechanical ventilation duration, although ICU length of stay was modestly longer.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"597422"},"PeriodicalIF":2.6,"publicationDate":"2026-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13222770/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148151308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Maternal, Fetal, and Neonatal Outcomes of Additional Dihydroartemisinin-Piperaquine to Trimethoprim-Sulfamethoxazole in Intermittent Preventive Treatment for Malaria in HIV-Positive Pregnancies: A Systematic Review and Meta-Analysis.","authors":"Vycke Yunivita, Amanda Jessie Maharani, Cheryl Antoinette Bernadus, Eva Ianty Julwana Sinaga, Evita Rahel Simanjuntak","doi":"10.2147/TCRM.S571864","DOIUrl":"10.2147/TCRM.S571864","url":null,"abstract":"<p><strong>Purpose: </strong>This systematic review evaluates the addition of Dihydroartemisinin-Piperaquine (DHA-PPQ) to Trimethoprim-Sulfamethoxazole (TMP-SMX) for Intermittent Preventive Treatment (IPT) in HIV-positive pregnancies, focusing on its effects on malaria infection, maternal adverse events, fetal adverse events, and birth outcomes.</p><p><strong>Patients and methods: </strong>Following PRISMA guidelines, we searched PubMed, Cochrane, Google Scholar, and Scopus until December 16, 2024. Out of 390 studies, three were included, assessed for bias using ROB 2.0, and analyzed with random-effects meta-analysis in RevMan 5.4.1.</p><p><strong>Results: </strong>We analyzed three studies involving 1353 participants who received 800/160 mg of TMP-SMX, with or without 40/320 mg of DHA-PPQ administered three times. The addition of DHA-PPQ showed a non-significant trend toward lower malaria infection outcomes, including maternal parasitaemia (OR: 0.83; 95% CI [0.52, 1.33], p = 0.44) and rates of placental malaria (OR: 0.66; 95% CI [0.40, 1.08], p = 0.10). DHA-PPQ significantly lowered maternal adverse events (OR: 0.78; 95% CI [0.67, 0.91], p = 0.003), which included low hemoglobin (OR: 0.83; 95% CI [0.69, 1.00], p = 0.05), gastrointestinal events (OR: 0.66; 95% CI [0.46, 0.95], p = 0.03), neurological events (OR: 0.61; 95% CI [0.22, 1.69], p = 0.35), and skin reactions (OR: 0.40; 95% CI [0.08, 2.11], p = 0.28). No significant differences were observed in fetal adverse events (OR: 1.05; 95% CI [0.68, 1.65], p = 0.69), which comprised spontaneous abortion (OR: 1.81; 95% CI [0.60, 5.51], p = 0.30), stillbirth (OR: 1.02; 95% CI [0.55, 1.89], p = 0.95), and congenital anomalies (OR: 0.89; 95% CI [0.32, 2.47], p = 0.83). Finally, no significant effect was observed on birth outcomes (OR: 1.13; 95% CI [0.88, 1.45], p = 0.81), including low birth weight (OR: 1.15; 95% CI [0.85, 1.56], p = 0.36) and premature birth (OR: 1.08; 95% CI [0.70, 1.68], p = 0.73).</p><p><strong>Conclusion: </strong>Additional DHA-PPQ shows promising efficacy in reducing malaria infection, a statistically significant reduction in maternal adverse events, with no significant differences in fetal and birth outcomes.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"571864"},"PeriodicalIF":2.6,"publicationDate":"2026-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13222561/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148144890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Early versus Delayed Vasopressin Initiation on 28-Day Mortality in Older Adults with Septic Shock.","authors":"Lina Liu, Haina Shi, Lei Zhang, Jiagui Ma","doi":"10.2147/TCRM.S583585","DOIUrl":"10.2147/TCRM.S583585","url":null,"abstract":"<p><strong>Background: </strong>The optimal timing for initiating adjunctive vasopressin in septic shock remains controversial, with limited evidence specific to older adults who may have altered physiological responses. This study aimed to investigate the association between the timing of vasopressin initiation and 28-day mortality in older adults with septic shock.</p><p><strong>Methods: </strong>In this retrospective observational cohort study, we enrolled 197 older adults (≥65 years) with septic shock who received vasopressin within 72 hours of norepinephrine initiation. Patients were categorized into an early group (vasopressin within 6 hours of norepinephrine; n=119) and a delayed group (vasopressin between 6-72 hours; n=78). The primary outcome was 28-day all-cause mortality, analyzed using multivariable Cox regression adjusting for potential confounders.</p><p><strong>Results: </strong>The 28-day mortality was significantly lower in the early vasopressin group compared to the delayed group (36.1% vs. 57.7%, <i>p</i><0.01). In the multivariate Cox analysis, early initiation was independently associated with a reduced risk of 28-day mortality (HR = 0.48, 95% CI: 0.31-0.74, p < 0.01). Secondary outcomes also favored the early group, including a higher rate of hemodynamic response (62.2% vs. 44.9%, <i>p</i>=0.02), more mechanical ventilation-free days (11.9 vs. 8.4 days, <i>p</i>=0.03) and more continuous renal replacement therapy (CRRT)-free days (13.2 vs. 9.5 days, <i>p</i>=0.03).</p><p><strong>Conclusion: </strong>In older adults with septic shock, early initiation of vasopressin within six hours of norepinephrine commencement was independently associated with significantly lower 28-day mortality and improved hemodynamic and organ function outcomes.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"583585"},"PeriodicalIF":2.6,"publicationDate":"2026-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13220813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148138900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the Current Tools for Fall Risk Assessment in Older Adults Across Southeast Asia and the Need for Culturally Adapted Models: A Scoping Review.","authors":"Dhika Dharmansyah, Laili Rahayuwati, Iqbal Pramukti, Kuswandewi Mutyara","doi":"10.2147/TCRM.S611180","DOIUrl":"10.2147/TCRM.S611180","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Falls are a leading cause of unintentional injury, functional disability, and premature mortality among older adults worldwide, ranking second among causes of unintentional injury-related death globally according to the World Health Organization (WHO), with the burden disproportionately concentrated in low- and middle-income countries, including those across Southeast Asia (SEA). Assessing fall risk is central to primary prevention; however, it remains unclear which tools are recommended or validated for clinical practice across the 11 nations of the Association of Southeast Asian Nations (ASEAN) and whether existing Western-developed instruments adequately account for culturally specific risk determinants in this region.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Aim: &lt;/strong&gt;This scoping review aimed to identify, review, and map the available literature on fall risk assessment tools used in older adults across SEA countries and to explore the extent to which cultural practices and local wisdom influence their applicability and the need for culturally adapted models.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This scoping review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and the Joanna Briggs Institute (JBI) methodology. Searches were conducted in March 2026 in the Scopus, PubMed/MEDLINE, and Web of Science (WoS) databases. English-language, full-text articles published between 2015 and 2025 from the 11 ASEAN countries were eligible; open-access status was preferred but non-open-access records were also obtained via institutional subscription and author contact. The protocol was pre-registered on the Open Science Framework (OSF; https://doi.org/10.17605/OSF.IO/5DHXK).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Thirty-two primary-data studies from Thailand (n=12), Malaysia (n=10), Indonesia (n=5), Vietnam (n=3), and Singapore (n=2) met the inclusion criteria; three additional regional secondary reviews informed cut-off triangulation. Twelve fall risk tool categories were identified. Western tools dominated (84.4% of primary-data studies) with minimal cultural adaptation. The Timed Up and Go (TUG) test was the most frequently used instrument (25/32 studies), but it showed variable cut-off values (8-14.3 s). Six ASEAN countries had no eligible primary studies. The weighted mean proportion of female participants was 63.4%; community-dwelling samples predominated (65.6%).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Current fall risk assessment research in SEA is geographically concentrated and dominated by unadapted Western tools. Cultural practices central to SEA - floor-level mobility, barefoot ambulation, and domestic environmental hazards - are systematically unaddressed. Urgent investment in culturally adapted tool development, multicentre validation, and digital scaling is required across ASEAN. We propose an integrative framework, Southeast Asian Fall Assessment for Living and Locality (SEA-FALL","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"611180"},"PeriodicalIF":2.6,"publicationDate":"2026-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13205118/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148043720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The ESINEA Study: A Novel Screening Tool for Identifying Patient Safety Incidents and Adverse Events in Hospitalized Patients-An Index-Date Cohort Evaluation.","authors":"Fiorela C Dueñas Lopez, Alba Fernández-Arroyo García, M Angélica Rivera Núñez, Beatriz Díaz-Pollán, Carmen Sobrino Jiménez, Concepción Murillo Gayo, Covadonga Mendieta Azcona, Cristina Jiménez Núñez, Gema Yagüe de Antonio, Inés Narrillos Martín, Javier Guijarro Eguinoa, José Jonay Ojeda Feo, María Asunción González de la Viuda, María Del Carmen Bautista Reina, María Fernández Velilla Peña, María Jiménez-Gonzalez, Marta Duque Alcorta, Miguel Álvarez-Montero, Miguel González Muñoz, Miguel Lorente Romeo, Nelson M Buitrago Sánchez, Olga Rogozina, Paloma López Ortego, Ramón Pardo Puras, Rosario Maria Torres Santos Olmo, Silvia Iniesta Pérez, Susana Chajma Izquierdo, Susana Martín López, Teresa Del Rosal, Paola Parra Ramírez, Yuri Fabiola Villán Villán, Alberto Martín Vega, Elena Ramírez","doi":"10.2147/TCRM.S565087","DOIUrl":"10.2147/TCRM.S565087","url":null,"abstract":"<p><strong>Background: </strong>This study, ESINEA, investigated the period prevalence and characteristics of Patient Safety Incidents (PSIs) at La Paz University Hospital. PSIs were operationally defined as healthcare-related events with the potential to cause patient harm, including near misses, incidents, and adverse events (AEs) resulting in actual injury. Recognizing the critical importance of patient safety and the limitations of existing AE detection methods, the study aimed to improve identification and understanding of these incidents.</p><p><strong>Methodology: </strong>An index-date inpatient cohort study was conducted, including all patients hospitalized at La Paz University Hospital on April 23^rd, 2023 (n=870 episodes), with follow-up from admission to discharge. The methodology involved two phases: (i) electronic health records screening using a novel trigger-based tool, and (II) expert adjudication to confirm the PSIs and AEs, serving as the reference standard for tool validation.</p><p><strong>Results: </strong>The population showed a high rate of urgent admissions (79%) and a predominance of older patients (75-85 years old, 19.5%). Phase I identified at least one positive screening trigger in 58% of patients. Following expert adjudication, the period prevalence of PSI was 47.9% (95%CI: 45.16-50.72), and AEs were confirmed in 27% (95% CI: 24.17-30.06). Phase II confirmed that PSI accounted for 92.35% of the positive screening. The most frequent incidents occurred during \"patient care and follow-up\" (29.95%), followed by \"Healthcare-Associated Infections\" (17.21%). Vulnerability to PSI was significantly higher among older patients, those with longer hospital stays, and those with higher comorbidity burdens. Although 34.17% of PSIs were deemed preventable, slightly lower than the expected 40%;the analysis identified 88 distinct types of improvement actions to enhance patient safety.</p><p><strong>Conclusion: </strong>The ESINEA study identified a high period prevalence of AEs (27%) in hospitalized patients, which is higher than the estimated 10% prevalence often cited. Although direct comparisons require caution due to differences in detection sensitivity and study design, these findings underscore the need for enhanced care coordination, infection prevention, and stricter protocol adherence, particularly among vulnerable populations.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"565087"},"PeriodicalIF":2.6,"publicationDate":"2026-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13200203/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148035366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adjunctive Cannabidiol for Drug-Resistant Epilepsy: A Systematic Review and Meta-Analysis of Randomized Trials Across Syndromes, Formulations, and Dose Ranges.","authors":"Reza Pratama, Muhaimin Muhaimin, Miski Aghnia Khairinisa, Anis Yohana Chaerunisaa","doi":"10.2147/TCRM.S601774","DOIUrl":"10.2147/TCRM.S601774","url":null,"abstract":"<p><strong>Background: </strong>Cannabidiol (CBD) has emerged as a promising adjunctive therapy for drug-resistant epilepsy, yet clinical findings remain heterogeneous across trials. This meta-analysis aimed to evaluate the efficacy, safety, and formulation-dependent performance of CBD in patients with treatment-resistant epilepsies.</p><p><strong>Methods: </strong>A systematic review and meta-analysis were conducted in accordance with PRISMA 2020 guidelines, including randomized, double-blind, placebo-controlled trials of adjunctive CBD in drug-resistant epilepsy. Literature was sourced from PubMed/MEDLINE, Scopus, and the Cochrane Central Register of Controlled Trials (CENTRAL). Data were synthesized using random-effects models to estimate pooled risk ratios (RRs) with 95% confidence intervals (CIs) for seizure reduction and adverse events. Subgroup analyses explored the influence of epilepsy syndrome, CBD dose, and formulation type.</p><p><strong>Results: </strong>Seven randomized controlled trials involving 1154 participants met inclusion criteria. Adjunctive CBD significantly reduced seizure frequency compared with placebo (pooled RR = 0.72, 95% CI 0.71-0.73; p < 0.0001). The effect was consistent across Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex, with optimal efficacy observed at 20 mg/kg per day of highly purified oral CBD. Liposomal CBD produced modest benefit, whereas transdermal formulations showed no short-term efficacy. Adverse events were predominantly mild and comparable to placebo, although elevations in hepatic enzymes and somnolence occurred more frequently in patients receiving concomitant valproate or clobazam.</p><p><strong>Conclusion: </strong>Adjunctive oral CBD provides a reproducible and clinically meaningful reduction in seizures in drug-resistant epilepsy, with an acceptable safety profile. Oral CBD at 20 mg/kg per day represents the current benchmark for efficacy, while alternative formulations require further evaluation. Future research should address long-term outcomes, optimal dosing strategies, and formulation refinement to improve tolerability and accessibility in diverse epileptic populations.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"601774"},"PeriodicalIF":2.6,"publicationDate":"2026-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13196805/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148017362","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of TUS-NMES Combined with Glucocorticoid on Clinical Outcomes and Rehabilitation Efficacy of Neurosyphilis Patients with Cerebral Infarction.","authors":"Jun Dai, Fanghua He, Yating Xu, Na Lei, Dan Zhang, Wenchao He, Fengfeng Zhu, Shuangshuang Chen, Xinyi Shan, Minzhi Wu, Xuehua Zhang","doi":"10.2147/TCRM.S583163","DOIUrl":"10.2147/TCRM.S583163","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the effects of transcranial ultrasound-neuromuscular electrical stimulation (TUS-NMES) combined with glucocorticoid (GC) as adjunctive intervention to standard penicillin therapy on clinical outcomes and rehabilitation efficacy in neurosyphilis (NS) patients with cerebral infarction.</p><p><strong>Methods: </strong>A total of 309 NS patients with cerebral infarction were randomly divided into general group (N = 79, penicillin), GC group (N = 77, penicillin and GC), TUS-NMES group (N = 75, penicillin and TUS-NMES), and combination group (N = 78, penicillin and GC & TUS-NMES). Baseline data, clinical symptoms, laboratory indicators, Fugl-Meyer assessment scale (FMA), and National Institute of Health stroke scale (NIHSS) scores before and after treatment were compared. Twelve-month rehabilitation outcomes were analyzed using Kaplan-Meier curves.</p><p><strong>Results: </strong>No serious adverse events occurred during treatment; only mild, transient discomforts, including slight scalp tingling, local muscle tremor, headache, and insomnia, were reported, all of which were alleviated after timely management and did not significantly affect the treatment process or patient recovery. After treatment, all groups showed significant improvement (<i>P</i> < 0.05), with the combination group demonstrating the greatest effect, including prolonged prothrombin time, higher nitric oxide, lower NIHSS, and higher FMA scores. At 12 months, the combination group (43.59%) showed a higher treatment improvement rate than the general (25.32%) and GC (27.27%) groups (<i>P</i> < 0.05), as well as the optimal recovery effect.</p><p><strong>Conclusion: </strong>TUS-NMES combined with GC, as an adjunct to standard penicillin therapy, improves clinical symptoms, coagulation, and neurological function, and enhances rehabilitation outcomes in NS patients with cerebral infarction.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"583163"},"PeriodicalIF":2.6,"publicationDate":"2026-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13189074/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147989139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}