Categories
Nevin Manimala Statistics

Efficacy and safety of sacubitril/valsartan in patients on peritoneal dialysis: a systematic review and meta-analysis

J Bras Nefrol. 2026 Jul-Sep;48(3):e20250318. doi: 10.1590/2175-8239-JBN-2025-0318en.

ABSTRACT

BACKGROUND: Sacubitril/valsartan is a recommended medication for managing heart failure (HF). However, its role in peritoneal dialysis (PD) patients remains uncertain. We conducted this systematic review and singlearm meta-analysis to assess the efficacy and safety of sacubitril/valsartan in this population.

METHODS: We systematically searched PubMed, EMBASE, and Cochrane Central until December 2024 for randomized controlled trials (RCTs) and observational studies assessing changes in left ventricular ejection fraction (LVEF), N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, systolic blood pressure (SBP), left atrial diameter (LAD), and left ventricular end-diastolic dimension (LVDd) with sacubitril/valsartan use in PD patients. Safety endpoints included hyperkalemia, hypotension, and angioedema. Statistical analyses were performed in R, using proportions for binary and mean differences (MDs) for continuous outcomes.

RESULTS: Nine studies were included, comprising 8 observational studies and 1 RCT, involving 343 PD patients. LVEF improved significantly (MD 5.22; 95% CI, 3.86 to 6.58; p < 0.0001; I2 = 38.9%). Sacubitril/valsartan reduced NT-proBNP levels (MD -5630.40; 95% CI, -9177.57 to -2083.23; p = 0.0019; I2 = 86%) and SBP (MD -14.59; 95% CI, -20.59 to -8.59; p < 0.0001; I2 = 93.5%). No statistically significant changes were noted in LAD (p = 0.0561) or LVDd (p = 0.1037). Hypotension and angioedema were rare events, whereas hyperkalemia showed a slight increase (11.94%).

CONCLUSION: Sacubitril/valsartan was associated with improvements in cardiac function surrogates and blood pressure in PD patients with HF, with an overall acceptable safety profile despite a modest increase in hyperkalemia. These findings suggest potential benefit in this understudied population, though confirmation in adequately powered RCTs remains necessary.

PMID:41931676 | DOI:10.1590/2175-8239-JBN-2025-0318en

Categories
Nevin Manimala Statistics

Timing of Initiation of Pharmacologic Venous Thromboembolism Prophylaxis in Patients With Intracerebral Hemorrhage

Neurologist. 2026 Apr 3. doi: 10.1097/NRL.0000000000000662. Online ahead of print.

ABSTRACT

OBJECTIVE: Optimal timing of initiation of pharmacologic venous thromboembolism (VTE) prophylaxis following intracerebral hemorrhage is controversial. This study aims to assess the association between the timing of pharmacologic VTE prophylaxis initiation and the risk of VTE and hemorrhagic complications.

METHODS: This was a multicenter, retrospective cohort study completed at 7 community hospitals. This study included patients with nontraumatic intracerebral hemorrhage admitted from August 1, 2023, to July 31, 2024. A total of 111 patients were assessed and categorized based on the administration of early (≤48 h) versus delayed (>48 h) initiation of VTE prophylaxis.

RESULTS: Findings showed no statistically significant difference in the primary outcome of the incidence of VTE with early versus delayed initiation of VTE prophylaxis (5% vs. 8%, P=0.713). Secondary outcomes included incidence of deep vein thrombosis (5% vs. 8%, P=0.713), pulmonary embolism (0% vs. 0%), hematoma enlargement (16% vs. 15%, P=0.623), median intensive care unit (ICU) length of stay (3 vs. 3.5 d, P=0.670), hospital length of stay (7 vs. 8 d, P=0.724), inpatient all-cause mortality (8% vs. 7%, P=1.000), and discharge disposition.

CONCLUSION: Early pharmacologic VTE prophylaxis (≤48 h from ICH onset) was not found to be statistically significant in lowering the incidence of VTE. This occurred with no statistically significant differences in hematoma enlargement, increased inpatient mortality, or increased length of ICU/hospital stay. Additional adequately powered studies are needed to determine if early pharmacologic VTE prophylaxis is associated with a lower incidence of VTE.

PMID:41931660 | DOI:10.1097/NRL.0000000000000662

Categories
Nevin Manimala Statistics

Single-Agent Doxorubicin Adjuvant Chemotherapy for Resectable Grade 2/3 Soft Tissue Sarcomas: A Retrospective Study

Oncology (Williston Park). 2026 Mar 16;40(2):106-114. doi: 10.46883/2026.25921066.

ABSTRACT

BACKGROUND: Soft tissue sarcomas (STS) are rare but aggressive tumors. Although surgery and radiotherapy are standard treatments for localized STS, the role of adjuvant chemotherapy, particularly doxorubicin, in high-grade STS is debated.

METHODS: This retrospective study evaluated the effectiveness of single-agent doxorubicin in resectable grade 2 and 3 STS, with a focus on oncologic outcomes. Adults with biopsy-confirmed STS of the extremities or trunk, treated at a tertiary center in Taiwan between January 2004 and March 2020, were included. Primary outcomes were distant metastasis-free survival (DMFS) and overall survival (OS).

RESULTS: The study enrolled 62 patients in either the single-agent doxorubicin adjuvant chemotherapy group (n = 8) or the observation-only group (n = 54). The mean age was 45.4 years in the adjuvant chemotherapy group and 58.2 years in the observation-only group. The 3-year OS was 100% in the chemotherapy group and 60% in the observation group (log-rank P = .064). The 3-year DMFS rate was 75% in the chemotherapy group and 45% in the observation group (log-rank P = .078).

CONCLUSION: In resectable, high-grade STS of 8 cm or more, single-agent doxorubicin as adjuvant chemotherapy showed a trend toward improved OS and DMFS compared with observation alone; however, statistical significance was not reached.

PMID:41931644 | DOI:10.46883/2026.25921066

Categories
Nevin Manimala Statistics

Comparison of the 3 Most Commonly Used Modified PD-1 Inhibitors Plus Chemotherapy in Inoperable Wild-Type Non-Small Cell Lung Cancer

Oncology (Williston Park). 2026 Mar 16;40(2):123-133. doi: 10.46883/2026.25921065.

ABSTRACT

OBJECTIVE: Immunotherapy combined with chemotherapy is a standard treatment for advanced non-small cell lung cancer (NSCLC). However, the comparative efficacy and safety of cost-efficient modified PD-1 inhibitors remain incompletely characterized. This study aimed to determine the optimal choice for the 3 most commonly used modified PD-1 inhibitors-tislelizumab, sintilimab, and camrelizumab-combined with chemotherapy in locally advanced or metastatic NSCLC.

MATERIALS AND METHODS: We conducted a retrospective study of patients with NSCLC who received chemotherapy plus 1 of the modified PD-1 inhibitors. The primary objective was to compare survival and therapeutic responses across groups. The secondary objective was to analyze adverse events in each group.

RESULTS: No significant differences were observed in median progression-free survival (PFS) or overall survival across the 3 groups. However, PD-L1-positive patients (tumor proportion score ≥ 1%) demonstrated significantly prolonged PFS with tislelizumab ( P = .038) and sintilimab ( P = .031) vs camrelizumab. The incidence of immune-related adverse events did not differ statistically across treatments.

CONCLUSION: Although survival outcomes were comparable among the 3 PD-1 inhibitors in the overall cohort, tislelizumab and sintilimab showed superior PFS in PD-L1-positive subgroups, suggesting biomarker-driven therapeutic selection. These findings underscore the importance of PD-L1 status in optimizing immunotherapy regimens for advanced NSCLC, offering clinical insights for personalized treatment strategies.

PMID:41931642 | DOI:10.46883/2026.25921065

Categories
Nevin Manimala Statistics

Exploring the Influencing Factors of Quality of Life During Maintenance Phase in Patients With Breast Cancer-Related Lymphedema

Oncology (Williston Park). 2026 Mar 16;40(2):115-122. doi: 10.46883/2026.25921064.

ABSTRACT

PURPOSE: This study aims to understand the degree of influence of the severity of lymphedema on quality of life (QOL) in patients with breast cancer-related lymphedema (BCRL) during the maintenance phase, and to understand the influencing factors of QOL to identify targeted interventions to improve QOL for patients with BCRL.

METHODS: This cross-sectional study was conducted among patients with BCRL who underwent complete decongestive therapy during the intensive phase of BCRL treatment from January 2022 to December 2024 at the lymphedema outpatient clinic. General information and the specific QOL scale for upper limb lymphedema were collected. One-way ANOVA and multiple linear regression were used in IBM SPSS (Statistical Package for Social Sciences) version 25to analyze factors affecting QOL.

RESULTS: This study included a total of 153 patients, with an overall QOL score of 48.52 plus or minus 12.112. Multivariate linear analysis indicated that the time from discovery of lymphedema to treatment and the severity of lymphedema affected the QOL of patients with BCRL during the maintenance phase.

CONCLUSION: Long-term monitoring and timely treatment are necessary for patients with BCRL. Before the start of the maintenance phase, it is important for lymphedema therapists to treat BCRL disease as soon as possible.

PMID:41931641 | DOI:10.46883/2026.25921064

Categories
Nevin Manimala Statistics

Effect of a Web-based Decision Support System on Nursing Students’ Care Plan Preparation: A Post-test Control Group Experimental Study

Comput Inform Nurs. 2026 Apr 3. doi: 10.1097/CIN.0000000000001498. Online ahead of print.

ABSTRACT

Care plans are critical tools for guiding health care decisions. Integrating technology-based educational tools may enhance students’ ability to prepare these plans effectively. This study aimed to evaluate the impact of a web-based decision support system on nursing students’ skills in preparing care plans. This is an experimental study. Students in the control group used traditional paper-based methods. In contrast, those in the intervention group used a web-based decision support system to develop care plans based on provided case scenarios (Supplemental Digital Content 1, http://links.lww.com/CIN/A515). Data were collected using an inte rview form, a datasheet, a Nursing Care Plan Evaluation Case, and an N-Care evaluation form. Thematic analysis was used for qualitative data, and descriptive statistics were applied to analyze quantitative data. The experimental group achieved significantly higher care planning scores (Z = -3.041, P = .002, r = 0.475) and total scores (Z = -2.284, P = .022, r = 0.357) than the control group. Students reported positive experiences using the N-Care system and expressed interest in continued use while suggesting minor improvements. Compared to traditional teaching methods, a web-based decision support significantly improved nursing students’ ability to prepare care plans.

PMID:41931639 | DOI:10.1097/CIN.0000000000001498

Categories
Nevin Manimala Statistics

Effectiveness of mindfulness-based stress reduction in managing fatigue, anxiety, and depression among non-small cell lung cancer patients receiving surgery and adjuvant chemotherapy: A randomized controlled trial

Medicine (Baltimore). 2026 Apr 3;105(14):e48134. doi: 10.1097/MD.0000000000048134.

ABSTRACT

BACKGROUND: Non-small cell lung cancer (NSCLC) patients undergoing surgery and adjuvant chemotherapy often experience debilitating physical and psychological symptoms, including cancer-related fatigue, anxiety, and depression. Mindfulness-based stress reduction (MBSR) has emerged as a complementary intervention to alleviate these burdens and enhance quality of life, but evidence in NSCLC populations remains limited.

METHODS: This randomized controlled trial enrolled 80 NSCLC patients, evenly divided into an MBSR group and a Control group. The MBSR group underwent an 8-week mindfulness program, while the Control group received standard care. Outcomes, including fatigue (Piper Fatigue Scale), anxiety (Self-Rating Anxiety Scale), depression (Self-Rating Depression Scale), self-efficacy (General Self-Efficacy Scale), and mindfulness awareness (Mindful Attention Awareness Scale), were assessed at 4 time points: baseline (before surgery), at the fourth week (before chemotherapy), and at 1 and 3 months post-intervention. Statistical analyses included repeated-measures ANOVA and t tests to evaluate group differences.

RESULTS: The MBSR group demonstrated significant improvements across all outcomes compared to the Control group. Fatigue levels in the MBSR group peaked at the fourth week but returned close to baseline levels by 3 months post-intervention, while the Control group maintained elevated fatigue scores (P < .05). Anxiety (Self-Rating Anxiety Scale) and depression (Self-Rating Depression Scale) scores significantly decreased in the MBSR group by the fourth week and continued to improve at subsequent time points (P < .01). Self-efficacy (General Self-Efficacy Scale) and mindfulness awareness (Mindful Attention Awareness Scale) showed consistent improvements in the MBSR group, with significant differences evident at 1 and 3 months post-intervention (P < .01).

CONCLUSIONS: Mindfulness-based stress reduction effectively reduced fatigue, anxiety, and depression while enhancing self-efficacy and mindfulness awareness in NSCLC patients undergoing surgery and chemotherapy. These findings support the integration of mindfulness-based interventions into routine care to improve patient well-being during and after treatment.

PMID:41931358 | DOI:10.1097/MD.0000000000048134

Categories
Nevin Manimala Statistics

Dental treatment outcomes under general anesthesia in pediatric patients with and without autism spectrum disorder: A retrospective analysis

Medicine (Baltimore). 2026 Apr 3;105(14):e46066. doi: 10.1097/MD.0000000000046066.

ABSTRACT

This study compared perioperative dental treatment outcomes under general anesthesia (GA) between children with autism spectrum disorder (ASD) and neurotypical peers, focusing on treatment duration, complication rates, and clinical predictors. This retrospective comparative study analyzed records of 160 children aged 5 to 12 years who underwent dental treatment under GA at a university hospital in Turkey (January 2023-May 2025). The ASD group (n = 80) included patients diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), while the control group (n = 80) comprised age- and sex-matched neurotypical children requiring GA due to cooperation difficulties. Data included demographic variables, American Society of Anesthesiologists (ASA) classification, caries indices (dmft/DMFT), GA and operative durations, types of procedures, and perioperative complications. Statistical analyses used the Shapiro-Wilk, Mann-Whitney U, and chi-square/Fisher exact tests, with multivariable regression to identify predictors. Effect sizes (Cohen d) and 95% confidence intervals (CI) were calculated. ASD patients were older (8.20 ± 1.79 vs 5.27 ± 1.29 years, P < .001; Cohen d = 1.79, 95% CI: 1.38-2.20) and more often ASA II (64.2% vs 24.1%, P < .001). They had lower dmft but higher DMFT scores (P < .001). GA and treatment durations were shorter in the ASD group (GA: 120 vs 155 minutes, Cohen d = 0.75; treatment: 85 vs 130 minutes, Cohen d = 0.72; both P < .001), reflecting fewer treated teeth (11.5 ± 2.9 vs 14.1 ± 3.2; P < .001). Perioperative complications were higher among ASD patients (32.1% vs 7.6%; odds ratio = 5.7, 95% CI: 2.0-15.0; P < .001), most commonly bradycardia, nausea, and emergence agitation. Multivariable regression identified ASA II status and caries burden – but not ASD diagnosis – as independent predictors of prolonged GA and treatment times. Children with ASD had shorter GA durations but significantly higher perioperative complication rates. ASA II status and caries burden predicted longer operative times. These findings emphasize the need for ASD-specific perioperative protocols, preventive strategies, and multidisciplinary care.

PMID:41931349 | DOI:10.1097/MD.0000000000046066

Categories
Nevin Manimala Statistics

Post-marketing signal detection of fruquintinib-associated adverse events using the FAERS database

Medicine (Baltimore). 2026 Apr 3;105(14):e48239. doi: 10.1097/MD.0000000000048239.

ABSTRACT

Fruquintinib, a targeted therapeutic agent approved in 2018 for the treatment of metastatic colorectal cancer, is gradually being applied in an expanding range of clinical settings. Given the complexities associated with real-world dosing, a comprehensive evaluation of its safety profile is essential for optimizing clinical decision-making. We conducted a retrospective pharmacovigilance study utilizing a spontaneous reporting system. Reports related to Fruquintinib were extracted through a standardized data cleaning process and cross-validated using 3 complementary signal detection algorithms: proportional reporting ratio, Bayesian confidence propagation neural network, and reporting odds ratio (ROR). This approach was employed to systematically assess the drug’s safety and identify potential adverse event signals. A total of 92 statistically significant safety signals were identified from 1188 independent cases included in the analysis, corresponding to 1836 adverse event reports. The signal distribution exhibited organ system specificity, with gastrointestinal reactions being the most prevalent category. These reactions primarily manifested as typical drug-related toxicities, including diarrhea and nausea. Other notable complications included neurological, respiratory, dermatological, renal, and cardiovascular events. Important aes not mentioned in the instructions, such as bone marrow suppression (ROR = 11.17), peripheral neuropathy (ROR = 4.24) and dehydration (ROR = 3.98), were also discovered. This study systematically characterizes the post-marketing safety profile of Fruquintinib through a multi-algorithm synergistic analysis, confirming that its safety profile aligns with the clinically expected outcomes based on its mechanism of action. Future research should focus on analyzing drug interaction mechanisms and exploring biomarkers to develop a precise risk-benefit assessment model.

PMID:41931348 | DOI:10.1097/MD.0000000000048239

Categories
Nevin Manimala Statistics

Potential protective role of vitamin C in peripheral artery disease: A Mendelian randomization and NHANES analysis

Medicine (Baltimore). 2026 Apr 3;105(14):e48220. doi: 10.1097/MD.0000000000048220.

ABSTRACT

Although numerous studies have investigated the associations between micronutrients and peripheral artery disease (PAD), most existing evidence is observational and limited by confounding and lack of causal inference. To address these gaps, we combined Mendelian randomization (MR) analysis using genetic data with supportive epidemiologic evidence from National Health and Nutrition Examination Survey (NHANES) to examine the relationships between micronutrient status and PAD risk. This study was conducted in 2 phases. First, we used genome-wide association study summary statistics to assess the causal effects of 15 circulating micronutrients on PAD risk through 2-sample MR. A bidirectional MR was also performed to explore the possibility of a reverse causal effect between PAD and potential candidate micronutrients. In the second phase, we analyzed data from 3 cycles of the NHANES (1999-2004). Logistic regression and restricted cubic spline models were used to examine the association between dietary intake of potential candidate micronutrients and PAD risk, adjusting for relevant covariates. MR analysis showed that higher genetically predicted vitamin C levels were significantly associated with a reduced risk of PAD (inverse-variance-weighted odds ratio (OR) = 0.509, 95% confidence interval (CI): 0.356-0.727; P <.001), with no evidence of reverse causality. In the NHANES analysis, lower dietary vitamin C intake was independently and nonlinearly associated with higher PAD risk (overall prevalence 7.9%), showing an L-shaped relationship with a threshold at 225.82 mg/day. Compared to the lowest quartile, PAD risk was lower in the second quartile (adjusted OR = 0.79; 95% CI: 0.64-0.98) and third quartile (adjusted OR = 0.94; 95% CI: 0.63-1.38). No significant interactions were found in the subgroup analysis. Both genetic evidence from MR and supportive observational evidence from NHANES suggest that vitamin C may play a protective role in the development of PAD.

PMID:41931342 | DOI:10.1097/MD.0000000000048220