Therapeutics And Clinical Risk Management[JOURNAL]
Sun
200 papers
Exploring the Effects of Prone Position Ventilation Combined with Drug on Clinical Outcomes in Neonates with ARDS: A Single-Center Retrospective Cohort Study.
Lin C, Huang T, Wu H … +3 more , Lin Y, Guo C, Li L
Ther Clin Risk Manag · 2026 · PMID 42088933 · Full text
OBJECTIVE: To evaluate the association of prone position ventilation combined with intravenous ambroxol versus conventional supine ventilation on clinical outcomes in neonates with acute respiratory distress syndrome (AR...
OBJECTIVE: To evaluate the association of prone position ventilation combined with intravenous ambroxol versus conventional supine ventilation on clinical outcomes in neonates with acute respiratory distress syndrome (ARDS). METHODS: Neonates with ARDS admitted to the Neonatal Intensive Care Unit (NICU) of the Second Affiliated Hospital of Fujian Medical University between January 2023 and December 2024 were included. A total of 80 neonates were allocated into two groups (n=40 each) based on a temporal shift in clinical practice: an Observation Group receiving prone positioning (target >16 hours/day) plus intravenous ambroxol (7.5 mg/kg twice daily for 5 days), and a Control Group receiving supine ventilation alone. Both groups received standard lung-protective ventilation and co-interventions per protocol. The primary outcome was ventilator-free days (VFDs) to day 28. RESULTS: The primary outcome, VFDs, was significantly higher in the observation group (median [IQR]: 18 [15-21] days) than in the control group (14 [10-17] days; P=0.003). The observation group also had a shorter duration of mechanical ventilation (mean difference: 2.04 days; 95% CI: 1.55 to 2.53; P<0.001) and a shorter hospital length of stay (mean difference: 6.55 days; 95% CI: 5.61 to 7.49; P<0.001). Physiological parameters improved more favorably in the observation group, with a significant Group × Time interaction for the Oxygenation Index (P<0.001) and a lower peak inspiratory pressure at 72 hours (adjusted mean difference: -1.95 cmHO; 95% CI: -2.45 to -1.45; P<0.001). The overall incidence of major complications was lower in the observation group (12.5% vs. 47.5%; Relative Risk: 0.26; 95% CI: 0.11 to 0.62; P=0.001). CONCLUSION: In this cohort, the combination therapy was associated with significantly improved respiratory outcomes and a lower complication rate in neonates with ARDS, suggesting it may be a beneficial adjunctive strategy. These findings warrant validation in a prospective randomized trial.
rs10010131A in is Associated with Elevated Serum Urea in Type 2 Diabetes Patients Treated with SGLT2 Inhibitors.
Naja K, Elashi AA, Hedaya L … +4 more , Anwardeen NR, Al-Shafai M, Rizzo M, Elrayess MA
Ther Clin Risk Manag · 2026 · PMID 42078124 · Full text
INTRODUCTION: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are effective agents for type 2 diabetes (T2D) management, yet interindividual variability in response mechanisms remains unclear. This study examined gene...
INTRODUCTION: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are effective agents for type 2 diabetes (T2D) management, yet interindividual variability in response mechanisms remains unclear. This study examined genetic interactions influencing clinical and biochemical outcomes among SGLT2i treated patients. METHODS: Data from 13,808 Qatar Biobank participants were analyzed, including 207 propensity score-matched T2D patients stratified into three groups: SGLT2i-treated, metformin monotherapy, and drug-naïve. Significant clinical traits across groups were further assessed for genotype effects within SGLT2i treated patients. RESULTS: Compared with both comparators, SGLT2i-treated individuals showed elevated serum urea (FDR < 0.05). Genetic analysis identified an association between the rs10010131 A allele and higher urea levels exclusively in SGLT2i treated patients (β = +0.63 mmol/L per A allele, 95% CI [0.14-1.11], p = 0.012). This variant showed strong linkage disequilibrium = 0.95, D' = 0.99) with rs6446482 in . Kidney-specific eQTL data revealed reduced expression in A-allele carriers. DISCUSSION: These findings suggest a novel pharmacogenetic interaction between WFS1 rs10010131 and urea regulation under SGLT2i therapy. The observed effect could likely reflect a genotype-related renal adaptive response rather than dysfunction, emphasizing the potential of pharmacogenomic profiling to enhance precision treatment for T2D.
Camrelizumab Plus Apatinib in Advanced Unresectable Alveolar Soft Part Sarcoma and Undifferentiated Pleomorphic Sarcoma Patients: A Single-Center, Exploratory Case Series.
Tan H, Wang H, Zhou J … +4 more , Jiang L, Shi S, Wang W, Chi Y
Ther Clin Risk Manag · 2026 · PMID 42051923 · Full text
BACKGROUND: Certain histologic subtypes of advanced soft tissue sarcomas, including alveolar soft part sarcoma (ASPS) and undifferentiated pleomorphic sarcoma (UPS), lack standardized therapeutic options following anthra...
BACKGROUND: Certain histologic subtypes of advanced soft tissue sarcomas, including alveolar soft part sarcoma (ASPS) and undifferentiated pleomorphic sarcoma (UPS), lack standardized therapeutic options following anthracycline-based first-line therapy. This study was to investigate the efficacy and safety of camrelizumab plus apatinib in advanced unresectable ASPS or UPS. METHODS: In this single-center, exploratory case series, patients with ASPS or UPS received a combination of camrelizumab and apatinib. The primary endpoint was the objective response rate (ORR), while the exploratory endpoints included progression-free survival (PFS), overall survival (OS), and safety. RESULTS: The median follow-up period was 24.0 months, with an ORR of 88.9% (8/9). In the ASPS subgroup (n=7), neither the median PFS (mPFS) nor median OS (mOS) was reached, while the ORR was 100.0% (7/7). In the UPS subgroup (n=2), the mPFS was 7.5 months and the mOS was 9.5 months, with the ORR of 50.0% (1/2). One patient with ASPS died from immune-mediated myocarditis; all other adverse events (AEs) were grade 1-2 and manageable with symptomatic treatment. CONCLUSION: The combination therapy of camrelizumab and apatinib may provide benefits in clinical outcomes for ASPS, while the outcomes in UPS appears more variable, warranting further study. Close monitoring for AEs, especially fatal complications such as immune-mediated myocarditis, is essential. REGISTRATION: ClinicalTrials.gov (identifier: NCT04447274), registration date: 23-Jun-2020.
Pregnancy Outcomes Following Medical Therapy versus Levonorgestrel-Releasing Intrauterine System for Atypical Endometrial Hyperplasia.
Wang M, Zhao S, Yuan H … +3 more , Zhao M, Hang C, Yuan R
Ther Clin Risk Manag · 2026 · PMID 42037655 · Full text
OBJECTIVE: To compare pregnancy outcomes between systemic progestin therapy and levonorgestrel-releasing intrauterine system (LNG-IUS) in patients with atypical endometrial hyperplasia (AEH) desiring fertility preservati...
OBJECTIVE: To compare pregnancy outcomes between systemic progestin therapy and levonorgestrel-releasing intrauterine system (LNG-IUS) in patients with atypical endometrial hyperplasia (AEH) desiring fertility preservation. METHODS: This single-center retrospective cohort study included AEH patients who underwent fertility-sparing treatment between January 2017 and December 2024. Patients received either systemic progestins (medroxyprogesterone acetate [MPA] 250-600 mg/day, megestrol acetate [MA] 160-320 mg/day, or dydrogesterone 20-40 mg/day) or LNG-IUS. Primary outcomes were clinical pregnancy rate and live birth rate. Secondary outcomes included time to pregnancy (TTP), conception mode, and disease recurrence rate. Propensity score matching (PSM) controlled for confounders including age, body mass index, polycystic ovary syndrome, and infertility duration. RESULTS: Of 186 patients (121 medical therapy, 65 LNG-IUS), 58 per group were analyzed after PSM. Complete remission rates were 77.6% (45/58) versus 84.5% (49/58) (adjusted OR 1.52, 95% CI 0.71-3.26, p=0.28). Among patients achieving complete remission, clinical pregnancy rates were 51.1% (23/45) versus 67.3% (33/49) (adjusted OR 2.14, 95% CI 1.08-4.25, p=0.029). Live birth rates were 37.8% (17/45) versus 55.1% (27/49) (adjusted OR 2.28, 95% CI 1.13-4.62, p=0.022). Median TTP was 8.5 months (IQR 6-14) versus 6.0 months (IQR 4-10) (HR 1.64, 95% CI 1.12-2.41, p=0.011). Per-protocol analysis yielded consistent results. CONCLUSION: LNG-IUS treatment was associated with significantly higher clinical pregnancy rates, live birth rates, and shorter TTP compared to systemic progestin therapy. These findings support LNG-IUS as a preferred fertility-sparing option for AEH patients, particularly when expedited conception is desired. Results should be interpreted considering the retrospective design, heterogeneous dosing, and potential residual confounding.
Dynamic Evolution Characteristics and Nursing Intervention Windows of Perioperative Deep Vein Thrombosis in Patients with Lower Extremity Traumatic Fractures: A Prospective Cohort Study.
Hu X, Wang Y, Li Y … +3 more , Cao H, He M, Li Y
Ther Clin Risk Manag · 2026 · PMID 42028127 · Full text
BACKGROUND AND PURPOSE: Deep vein thrombosis (DVT) is a major complication after lower extremity traumatic fractures. Current nursing assessment is largely postoperative-centered and may overlook risk evolution during th...
BACKGROUND AND PURPOSE: Deep vein thrombosis (DVT) is a major complication after lower extremity traumatic fractures. Current nursing assessment is largely postoperative-centered and may overlook risk evolution during the preoperative waiting period. METHODS: In this prospective observational cohort study, 948 patients with lower extremity traumatic fractures were enrolled between January 2019 and January 2026. Serial color Doppler ultrasound examinations were performed at five timepoints: admission, preoperative, postoperative day 1, postoperative day 3, and discharge. Univariate and multivariate logistic regression analyses were used to identify predictors of preoperative DVT. A dynamic nomogram was developed and evaluated using receiver operating characteristic analysis, calibration, decision curve analysis, and SHAP-based interpretation. RESULTS: The overall incidence of perioperative DVT was 32.9% (312/948). DVT showed a distinct "twin-peak" temporal pattern, with the highest incidence during the preoperative waiting period and a second peak on postoperative day 3. Thrombi also shifted from predominantly distal veins at admission to greater proximal involvement after surgery. Independent predictors of preoperative DVT were age >65 years, preoperative waiting time >3 days, D-dimer >1.85 mg/L, albumin <35 g/L, and time from injury to admission >12 h. The nomogram showed good discrimination (AUC 0.905, 95% CI 0.882-0.928), outperforming individual predictors such as D-dimer (AUC 0.796). Decision curve analysis demonstrated clinical net benefit, and SHAP analysis identified D-dimer and albumin as the most influential variables. CONCLUSION: Perioperative DVT after lower extremity fractures follows a dynamic pattern with a critical preoperative risk window. The proposed nomogram may support stage-specific nursing assessment and targeted interventions, particularly by reducing preoperative delay and optimizing nutritional status.
qCON and qNOX-Guided Sedation Monitoring During Gastrointestinal Endoscopy: A Prospective Observational Preliminary Study.
Liu Q, Wei D, Han X … +3 more , Cheng W, Yang X, Min S
Ther Clin Risk Manag · 2026 · PMID 42016204 · Full text
BACKGROUND: The depth of sedation during gastrointestinal endoscopy is predominantly assessed based on clinical experience due to the absence of a universally recognized objective standard. This study aimed to evaluate t...
BACKGROUND: The depth of sedation during gastrointestinal endoscopy is predominantly assessed based on clinical experience due to the absence of a universally recognized objective standard. This study aimed to evaluate the utility of two novel electroencephalography-derived parameters, the quantitative consciousness index (qCON) and the quantitative nociception index (qNOX), for sedation and analgesia monitoring, and to determine the optimal qCON range correlated with optimal procedural stability. METHODS: In this prospective observational study, a total of 220 patients scheduled for elective gastroscopy or colonoscopy were enrolled. All patients received propofol and sufentanil for sedation and analgesia according to routine clinical practice. Depth of anesthesia and nociceptive responses were continuously monitored using qCON and qNOX. Hemodynamic parameters, body movement, and coughing were recorded at predefined time points. The primary outcome was defined as optimal procedural stability, characterized by hemodynamic fluctuations within 10% of baseline combined with the absence of body movement or coughing. RESULTS: A qCON range of 55-63 was observed to be associated with optimal procedural stability (95% confidence interval [CI]: 55.25-62.62 for gastroscopy; 55.25-62.52 for colonoscopy). A strong correlation between qCON and qNOX was observed (gastroscopy: qNOX = 0.78 × qCON + 26.1, = 0.714; colonoscopy: qNOX = 0.83 × qCON + 22.47, = 0.716; p < 0.001). The qNOX index demonstrated a more rapid response to noxious stimuli than qCON during recovery phases. CONCLUSION: The qCON index appears to provide an objective approach to assessing sedation depth in sedated gastrointestinal endoscopy. Our findings suggest that qCON values within the range of 55 to 63 are associated with optimal procedural stability as defined in this study. Combined monitoring with qCON and qNOX may provide complementary information to support a balanced approach to intra-procedural sedation management, thereby potentially enhancing the safety and overall quality of sedation management. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov (Registration Number: NCT06604156) on April 11, 2024.
Comparison of Percutaneous Coronary Intervention Outcomes for in-Stent vs de Novo Chronic Total Occlusions: A Meta-Analysis.
Mao Q, Xie L, Wu J
Ther Clin Risk Manag · 2026 · PMID 42016203 · Full text
BACKGROUND: Chronic coronary total occlusion (CTO) represents a formidable challenge in interventional cardiology, occurring either within previously implanted stents (in-stent CTO) or in non-stented native vessels (de n...
BACKGROUND: Chronic coronary total occlusion (CTO) represents a formidable challenge in interventional cardiology, occurring either within previously implanted stents (in-stent CTO) or in non-stented native vessels (de novo CTO). We aimed to compare the outcomes of percutaneous coronary intervention (PCI) between patients with in-stent and de novo CTO through a systematic review and meta-analysis. METHODS: PubMed, Embase, ScienceDirect, CENTRAL, and Google Scholar databases were searched for comparative studies published up to 20 September 20, 2025. A meta-analysis was conducted to calculate the odds ratios (OR) using a random effects model. RESULTS: Nineteen studies that compared 73,945 patients with in-stent CTO and 651,961 patients with de novo CTO were included. There was no statistically significant difference in technical success between the two groups (OR, 0.97; 95% CI, 0.87, 1.08; I=0%; p=0.67). Pooled analysis of early outcomes demonstrated no statistically significant difference in the risk of all-cause mortality, major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis, or tamponade between the two groups. We also noted no statistically significant differences in long-term all-cause or cardiac mortality between the two groups. However, a meta-analysis of long-term data indicated that patients with in-stent CTO have a statistically significantly increased risk of MACE, MI, and target vessel revascularization (TVR) compared to those with de novo CTO. CONCLUSION: Our results indicate that in-stent CTO-PCI has success rates similar to those of de novo CTO-PCI. There was no difference in short-term adverse outcomes between the two groups; however, patients undergoing in-stent CTO PCI had an increased risk of MACE and MI, mainly driven by the significantly increased need for TVR.
Effect of Dexmedetomidine Combined with Esketamine on Postoperative Fatigue in Patients Undergoing Total Laparoscopic Hysterectomy: A Single-Center Randomized Double-Blinded Controlled Trial.
Wu L, Wang Y, Chai Y … +4 more , Qiu Z, Yin J, Zhang B, Wang G
Ther Clin Risk Manag · 2026 · PMID 42016202 · Full text
PURPOSE: The purpose of this experiment is to study the impact of dexmedetomidine combined with esketamine on postoperative fatigue in patients who undergo total laparoscopic hysterectomy. PATIENTS AND METHODS: A total o...
PURPOSE: The purpose of this experiment is to study the impact of dexmedetomidine combined with esketamine on postoperative fatigue in patients who undergo total laparoscopic hysterectomy. PATIENTS AND METHODS: A total of 176 patients who received elective total laparoscopic hysterectomy were included in the study and divided into four groups: control group (Group C), dexmedetomidine group (Group D), esketamine group (Group E), and dexmedetomidine combined with esketamine group (Group DE). Group D received dexmedetomidine intervention, Group E received esketamine intervention, and Group DE received the combined intervention of dexmedetomidine and esketamine. The primary outcome was the 10-item Identity-Consequence Fatigue Scale (ICFS-10) scores, which were assessed before surgery and on postoperative days 3, 5, 7, and 30. Secondary outcomes included postoperative Visual Analog Scale (VAS) scores, Pittsburgh Sleep Quality Index (PSQI) scores, extubation time, first postoperative ambulation time, first postoperative flatus time, and nausea and vomiting incidence among four groups. RESULTS: Compared with Group C, Groups D, E, and DE had lower scores on ICFS-10 and PSQI on postoperative days 3, 5, and 7, as well as lower movement VAS scores at the postoperative 24 and 48 hours (0.05). A lower fatigue incidence was also observed in Group DE on postoperative days 3, 5, and 7. Group DE showed a reduced rate of adverse events (vasoactive drug administration, postoperative nausea and vomiting, and requirement for rescue analgesia) compared with Group C (0.05). No intergroup differences in ICFS-10 scores or fatigue incidence were found on postoperative day 30 (0.05). CONCLUSION: For patients undergoing total laparoscopic hysterectomy, the combined use of dexmedetomidine and esketamine enhances early postoperative fatigue levels and lowers the incidence of fatigue. However, this combination has no significant effect on fatigue on postoperative day 30.
Efficacy and Safety of Anthracyclines Combined with Temozolomide Regimens for the Treatment of Advanced Leiomyosarcoma: A Retrospective Study.
Tan H, Zhou J, Shi S … +7 more , Jiang L, Zuo L, Su A, Wang H, Sun Y, Xuan W, Chi Y
Ther Clin Risk Manag · 2026 · PMID 42011328 · Full text
BACKGROUND: Leiomyosarcoma (LMS) is an aggressive soft tissue sarcoma with high rates of hematogenous metastasis and recurrent relapse, with a 5-year survival rate of 17.0%. This study evaluated the clinical efficacy of...
BACKGROUND: Leiomyosarcoma (LMS) is an aggressive soft tissue sarcoma with high rates of hematogenous metastasis and recurrent relapse, with a 5-year survival rate of 17.0%. This study evaluated the clinical efficacy of an anthracycline plus temozolomide (ATEM) regimen in advanced LMS and explored the feasibility of dynamic circulating tumor DNA (ctDNA) monitoring for early detection of disease progression. METHODS: This retrospective study included patients with advanced LMS who received ATEM between September 2018 and December 2024. The efficacy, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), objective response rate (ORR), and disease control rate (DCR), as well as safety, were assessed. The median progression-free survival (mPFS) and median overall survival (mOS) were calculated using Kaplan-Meier survival curves. A subset of patients treated with TEM-containing regimens between December 2023 and December 2024 underwent longitudinal ctDNA monitoring. RESULTS: Forty-seven patients were included, with a median follow-up of 39.5 months. The mPFS was 12.0 months and mOS was 37.5 months. One patient achieved clinical CR, 9 achieved PR, 33 had SD and 4 experienced PD. The ORR was 21.3% (10/47), and DCR was 91.5% (43/47). The most common adverse events were leukopenia (42.6%), neutropenia (32.0%), and thrombocytopenia (14.9%). Grade 4 neutropenia occurred in three patients, including one case complicated by febrile neutropenia. All cases were managed successfully with supportive treatment. No treatment-related deaths were observed. In this pilot investigation of 7 patients, ctDNA levels consistently reflected clinical disease status and treatment response. CONCLUSION: ATEM regimen demonstrated promising efficacy in advanced LMS, with survival outcomes comparable to or better than in prior first-line treatments. ctDNA monitoring showed promise as a non-invasive biomarker for disease monitoring and treatment guidance. Prospective, multi-center studies are warranted to validate these findings.
Clinical Outcomes of Percutaneous Mitral Valve Repair with Mitraclip: A Longitudinal Observational Study (The Mitra-Angio-CDO Study).
Melo-Burbano LÁ, Bonilla-Bonilla DM, Daza-Arana JE … +3 more , Lozada-Ramos H, Dager AE, Fonseca JA
Ther Clin Risk Manag · 2026 · PMID 41973195 · Full text
BACKGROUND: The MitraClip device is used as an endovascular therapy for mitral valve repair in patients with severe mitral insufficiency and high surgical risk. This therapy was used for the first time in Colombia in 201...
BACKGROUND: The MitraClip device is used as an endovascular therapy for mitral valve repair in patients with severe mitral insufficiency and high surgical risk. This therapy was used for the first time in Colombia in 2013, after its authorization by the National Institute of Drug and Food Surveillance. MATERIALS AND METHODS: A quantitative, observational, descriptive, longitudinal study was conducted, with an analytical component stratified by age, in adults who underwent mitral valve repair with MitraClip from March 2013 to June 2022 to determine the clinical outcomes associated with hospitalization, mortality, complications, and health-related quality of life. RESULTS: A total of 94 patients with a mean age of 70.3±10.3 years were evaluated, most of whom were male (65%), hypertensive (80%), and had New York Heart Association class III-IV classification (90.4%) and functional mitral insufficiency (93.6%) classified as severe (74.5%). The recurrence of all-cause hospitalization was 39.4%, of which 88% corresponded to heart failure. The immediate success of the procedure, determined as mitral insufficiency classified as ≤moderate after implantation, was 93.6% (p < 0.001). In-hospital mortality was 2.1%, mortality at 6 months was 12.8% (≤70 years 11.6% vs >70 years 13.7%, p = 0.007), mortality at 1 year was 16%, and mortality at 2 years was 20.2%. The incidence of complications was low, the most frequent one being atrial fibrillation (7.4%), followed by major bleeding requiring transfusion (4.3%). The Kansas City Cardiomyopathy Questionnaire scale was used, with a mean score of 69.9±19.3. CONCLUSION: Percutaneous mitral valve repair with MitraClip is a safe technique that directly affects survival and quality of life. There was a low incidence of complications related to the procedure and the patient's preoperative condition, with results comparable to those of studies carried out in Europe and the United States.
Artificial Intelligence in the Diagnosis and Management of Pulmonary Tuberculosis: A Review of Current Applications and Future Perspectives.
Ou Y, Zhang Q, Meng C … +5 more , Zhou X, Na M, Yu Z, Ma W, Huang C
Ther Clin Risk Manag · 2026 · PMID 41937887 · Full text
Pulmonary tuberculosis (PTB) remains a major global public health challenge, with traditional diagnostic and management approaches plagued by diagnostic delays, time-consuming drug resistance testing, and subjective effi...
Pulmonary tuberculosis (PTB) remains a major global public health challenge, with traditional diagnostic and management approaches plagued by diagnostic delays, time-consuming drug resistance testing, and subjective efficacy assessment. Artificial intelligence (AI) has emerged as a revolutionary solution for these bottlenecks. This review comprehensively summarizes AI's current applications in PTB care: deep learning models enable automated detection, segmentation and activity differentiation of PTB lesions on chest X-ray/CT with performance comparable to or exceeding human experts (sensitivity >90% for X-ray detection); AI-driven whole-genome sequence analysis rapidly predicts anti-TB drug resistance, shortening testing time from weeks to days; multimodal AI models also show potential in dynamic treatment response monitoring and individualized outcome prediction. However, AI's clinical translation is hindered by data quality/bias, poor model generalizability, low algorithm interpretability, and regulatory/ethical issues. Future priorities include multimodal data fusion, federated learning, prospective clinical validation, and developing lightweight AI models for resource-limited settings. Interdisciplinary collaboration is critical to transform AI from a research tool into a safe, reliable and equitable clinical assistant for PTB care.
Real-World Evidence on Statin Use for Traumatic Brain Injury Associated Degenerative Neurological Disorders.
Lin YH, Tsai IJ, Chang YA … +2 more , Huang CH, Chang CC
Ther Clin Risk Manag · 2026 · PMID 41918954 · Full text
BACKGROUND: Traumatic brain injury (TBI) is a major risk factor for subsequent neurodegenerative disorders. Emerging evidence suggests that statins may mitigate neuroinflammation and lipid dysregulation after TBI. This s...
BACKGROUND: Traumatic brain injury (TBI) is a major risk factor for subsequent neurodegenerative disorders. Emerging evidence suggests that statins may mitigate neuroinflammation and lipid dysregulation after TBI. This study aimed to evaluate the association between statin use and the risk of post-TBI degenerative neurological disorders in a global, real-world population. METHODS: We conducted a retrospective cohort study using the TriNetX global research network and a 1:1 propensity score matching procedure to balance demographic, clinical, and medication covariates. Patients with the first TBI diagnosis from 2000 onward were included. Individuals with continuous statin use every year from 1 year before to 5 years after the index date were classified as the statin treated group, whereas those with no statin prescriptions during the same period were categorized as the untreated group. Patients younger than 18 years and those with pre-index dementia, stroke, or CNS infection were excluded. A 1:1 propensity score matching procedure was applied to balance demographic, clinical, and medication covariates. Cox proportional hazards models estimated hazard ratios (HRs) for vascular dementia, non-vascular dementia, stroke, depression, and Parkinson's disease during the 5-year follow-up. RESULTS: After matching, 21,427 patients were included in each group. Statin-treated patients demonstrated higher risks of all neurologic outcomes compared with untreated individuals, including vascular dementia (HR 2.47; 95% CI, 1.83-3.34), non-vascular dementia (HR 1.45; 95% CI, 1.30-1.61), stroke (HR 1.80; 95% CI, 1.70-1.89), depression (HR 1.91; 95% CI, 1.79-2.04), and Parkinson's disease (HR 1.63; 95% CI, 1.34-1.98). Subgroup analyses showed consistent risk elevations across sex and age categories. CONCLUSION: The current Real-World data do not provide evidence supporting the use of statins primarily for neuroprotection after TBI. These findings underscore the importance of pursuing alternative therapeutic strategies that directly target TBI-associated neurodegenerative mechanisms.
Preoperative Portal Vein Thrombosis Grading Predicts Post-Transplant Thrombosis and Survival.
Liu Y, Tian JS, Wang YN … +3 more , Wang ZR, Cao J, Shi ZY
Ther Clin Risk Manag · 2026 · PMID 41913805 · Full text
BACKGROUND: Previous studies have suggested an association between preoperative portal vein thrombosis (PVT) and post-transplant PVT occurrence, but comprehensive evidence evaluating the impact of thrombosis severity gra...
BACKGROUND: Previous studies have suggested an association between preoperative portal vein thrombosis (PVT) and post-transplant PVT occurrence, but comprehensive evidence evaluating the impact of thrombosis severity grading remains limited. OBJECTIVE: To investigate the influence of preoperative PVT grading on cumulative PVT occurrence time and survival outcomes following liver transplantation. METHODS: This retrospective cohort study consecutively enrolled patients undergoing deceased donor liver transplantation between April 2020 and October 2023. All patients underwent dual-modality imaging assessment (Doppler ultrasound combined with contrast-enhanced CT/MRI) for PVT grading according to the Yerdel classification. A standardized anticoagulation protocol was implemented postoperatively. Statistical analyses included Kaplan-Meier curves for cumulative incidence, Fine-Gray competing risk models adjusting for death as a competing event, multivariable Cox regression analysis, and comprehensive sensitivity analyses. RESULTS: Among 126 enrolled patients, the preoperative PVT grading distribution showed significant differences in cumulative post-transplant PVT risk (Grade 0: 14.3%, Grade I: 52.4%, Grade II: 71.4%, Grade III: 85.7%, p<0.001). Fine-Gray competing risk analysis confirmed grading as an independent predictor after adjusting for death (subdistribution hazard ratio [sHR] for Grade III vs Grade 0: 6.24, 95% CI: 3.81-10.21, p<0.001). The combined predictive model incorporating PVT grading, donor factors, and ALBI score achieved superior discrimination (1-year AUC: 0.876; 2-year AUC: 0.843) compared to binary PVT assessment alone (1-year AUC: 0.739, p<0.001). Tertile-based risk stratification revealed significant differences in 3-year survival rates (high-risk: 76.2%, intermediate-risk: 88.1%, low-risk: 95.2%, p<0.001). CONCLUSION: Preoperative PVT grading represents a crucial predictor of cumulative PVT risk and survival differences after liver transplantation. Implementation of dual-modality imaging assessment and risk-stratified anticoagulation protocols may optimize post-transplant outcomes.
Clinical and Procedural Predictive Model for Pneumothorax Risk After CT-Guided Lung Biopsy.
Qin Y, Zhao Z, Zhang L … +2 more , Shao X, Wang Q
Ther Clin Risk Manag · 2026 · PMID 41908913 · Full text
PURPOSE: To develop and validate a model integrating clinical/imaging and procedural variables to predict pneumothorax after CT-guided percutaneous lung nodule biopsy. METHODS: We retrospectively enrolled 395 patients an...
PURPOSE: To develop and validate a model integrating clinical/imaging and procedural variables to predict pneumothorax after CT-guided percutaneous lung nodule biopsy. METHODS: We retrospectively enrolled 395 patients and split them 7:3 into training (n=276) and validation (n=119) cohorts. Variables with P < 0.15 in group comparisons (combined with clinical relevance) were selected as candidates and analyzed using age- and sex-adjusted univariable logistic regression. Two prespecified logistic models were fitted: a baseline model (clinical/imaging variables only) and a full model (baseline plus procedural variables). Discrimination, calibration, and clinical utility were assessed using ROC curves, calibration plots, and decision curve analysis (DCA). RESULTS: Pneumothorax occurred in 22.1% (training) and 22.7% (validation). The baseline model contained BMI and emphysema grade; the full model additionally included patient position (prone or lateral vs supine) and the number of needle adjustments. In training, the full model outperformed the baseline (AUC 0.722 vs 0.630; P=0.018). In validation, AUC was 0.720 vs 0.670 (P=0.307), but the difference did not reach statistical significance. Sensitivity was higher with the full model (0.667 vs 0.593). Both models showed good calibration; the full model was closer to the ideal line across predicted probabilities of 0.1-0.5. DCA indicated greater net benefit for the full model across most threshold probabilities. CONCLUSION: A model combining clinical/imaging and procedural characteristics may facilitate peri-operative risk communication and support peri-procedural risk management for CT-guided lung nodule biopsy.
Exploring the Comprehensive Treatment of Hashimoto's Thyroiditis with Traditional Chinese Medicine from the Perspective of Modern Medicine.
Zhang J, Huang G
Ther Clin Risk Manag · 2026 · PMID 41908912 · Full text
Hashimoto's thyroiditis (HT) is a common autoimmune disorder characterized by the presence of thyroid-specific autoantibodies and lymphocytic infiltration within the thyroid gland. Although its etiology is multifactorial...
Hashimoto's thyroiditis (HT) is a common autoimmune disorder characterized by the presence of thyroid-specific autoantibodies and lymphocytic infiltration within the thyroid gland. Although its etiology is multifactorial and complex-encompassing genetic susceptibility, environmental influences, and epigenetic modifications-HT primarily presents as primary hypothyroidism. Conventional management predominantly involves hormone replacement therapy; however, Traditional Chinese Medicine (TCM) has demonstrated promising efficacy and safety in the treatment of HT. This review critically examines the application of TCM in HT management, contextualized within contemporary understandings of the disease's pathophysiology. TCM exerts therapeutic effects through multiple mechanisms, including immunomodulation, attenuation of oxidative stress, and inhibition of thyroid cell apoptosis. Clinical studies indicate that TCM interventions, such as herbal formulations and acupuncture, can effectively enhance thyroid function, decrease autoantibody levels, and improve patients' quality of life. The integration of TCM with standard Western medical treatments offers a valuable complementary strategy for HT, addressing both symptomatic relief and underlying immune dysregulation. Nonetheless, there remains a need for large-scale, multicenter randomized controlled trials to establish standardized treatment protocols and to confirm the long-term safety and efficacy of TCM approaches. Overall, TCM represents a promising adjunctive therapeutic option for HT, expanding the range of treatment modalities beyond conventional hormone replacement. Future investigations should aim to elucidate the molecular mechanisms underlying TCM's effects and to optimize therapeutic regimens to maximize clinical benefits.
ECG-Guided Antiarrhythmic Therapy in Acute Coronary Syndrome: A Multidimensional Assessment of Biomarkers, Cardiac Function, and Quality of Life.
Li X, Liu X, Jing M … +3 more , Yang C, Luo H, Li L
Ther Clin Risk Manag · 2026 · PMID 41908911 · Full text
OBJECTIVE: To evaluate the impact of electrocardiogram (ECG)-guided antiarrhythmic strategy on serum biomarkers, cardiac function, and quality of life in patients with acute coronary syndrome (ACS) and arrhythmias. METHO...
OBJECTIVE: To evaluate the impact of electrocardiogram (ECG)-guided antiarrhythmic strategy on serum biomarkers, cardiac function, and quality of life in patients with acute coronary syndrome (ACS) and arrhythmias. METHODS: This prospective observational cohort enrolled 80 ACS patients with arrhythmias managed via a monitor-alert-response-titration pathway (observation group) during January-December 2024. Propensity score-matched controls (n = 80) received conventional experience-based antiarrhythmic therapy. Comparisons included in-hospital antiarrhythmic interventions, arrhythmia control, adverse events, and myocardial injury/stress biomarkers (NT-proBNP, hs-cTnI, hs-cTnT, hs-CRP) at T0 (baseline), T1 (2-day), and T2 (7-day). Cardiac function (LVEF, LVEDD, LVEDVI, E/e') and patient-reported outcomes [Seattle Angina Questionnaire (SAQ), 6-minute walk test (6MWT)] were assessed at T0, T3 (1-month), and T4 (6-month). Major adverse cardiovascular events (MACE) were recorded over 6 months. RESULTS: The observation group demonstrated higher β-blocker utilization, guideline adherence, and drug adjustment rates ( < 0.05). Arrhythmia control was superior in the observation group at T2 (93.75% vs 82.50%, < 0.05). More pronounced reductions in all biomarkers were observed in the observation group at T1 and T2 ( < 0.05). Greater improvements in LVEF, LVEDD, LVEDVI, E/e', SAQ scores, and 6MWT distance were sustained in the observation group at T3 and T4 ( < 0.05). The 6-month MACE rate was lower in the observation group (13.75% vs 32.50%, < 0.05). CONCLUSION: ECG-guided antiarrhythmic therapy improves pharmacotherapy quality and arrhythmia control, accelerating myocardial injury and stress attenuation. This strategy approach enhances cardiac recovery, reverse remodeling, functional capacity, and quality of life, ultimately reducing long-term cardiovascular risk.
From Tradition to Future: Pathophysiological Mechanisms and Clinical Research Progress in the Treatment of Hypothyroidism with Traditional Chinese Medicine--A Narrative Review.
Piao L, Ma J, Zhao N … +3 more , Liu C, Hou Y, Wang T
Ther Clin Risk Manag · 2026 · PMID 41889672 · Full text
Hypothyroidism, a prevalent endocrine disorder primarily resulting from inadequate thyroid hormone secretion, is commonly attributed to etiologies, such as Hashimoto's thyroiditis and iodine deficiency. Currently, levoth...
Hypothyroidism, a prevalent endocrine disorder primarily resulting from inadequate thyroid hormone secretion, is commonly attributed to etiologies, such as Hashimoto's thyroiditis and iodine deficiency. Currently, levothyroxine (LT4) replacement therapy is the standard treatment in Western medicine. However, suboptimal therapeutic responses in certain patients have motivated the investigation of alternative interventions. In recent years, TCM, particularly the integrative approach of combining acupuncture with herbal medicine, has demonstrated promising potential in the management of hypothyroidism. Through a systematic review of 12 randomized controlled trials (RCTs) onTCM for hypothyroidism conducted in the past decade, this article found that TCM exerts therapeutic effects by regulating immune function, improving thyroid antibody levels, and modulating metabolic status. Commonly used herbs include Astragalus membranaceus (Huangqi), Codonopsis pilosula (Dangshen), and Rehmannia glutinosa (Shudihuang), whose mechanisms of action involve key signaling pathways such as MAPK and PI3K-AKT.Acupuncture and moxibustion therapies target specific acupoints (e.g. Guanyuan and Zusanli) to improve thyroid function by regulating apoptosis and the associated signaling cascades. Multiple randomized controlled trials have demonstrated that the combination of acupuncture and herbal medicine not only significantly ameliorates clinical symptoms, but also modulates serum concentrations of TSH, T3, and T4, thereby enhancing treatment efficacy. Nonetheless, current research is limited by factors such as small sample sizes, insufficient long-term follow-up, and a lack of comprehensive mechanistic studies. Future investigations employing large-scale, multi-center, high-quality clinical trials are warranted to further substantiate the efficacy and safety of these integrative therapeutic modalities.
Effects of ICS + LABA Combination Therapy on Asthma Control: An Observational Study in Real-World Settings.
Han P, Wang L
Ther Clin Risk Manag · 2026 · PMID 41889671 · Full text
BACKGROUND: Inhaled corticosteroids (ICS) combined with long-acting β2-agonists (LABAs) remain the cornerstone of maintenance therapy in persistent asthma. Although multiple trials have demonstrated short-term efficacy,...
BACKGROUND: Inhaled corticosteroids (ICS) combined with long-acting β2-agonists (LABAs) remain the cornerstone of maintenance therapy in persistent asthma. Although multiple trials have demonstrated short-term efficacy, there is a lack of comprehensive, long-term data on the impact of ICS/LABA therapy on asthma control, exacerbation frequency, and pulmonary function in real-world clinical settings. This study aims to fill this gap by evaluating the effects of ICS/LABA therapy over a 24-month period in a real-world cohort. METHODS: We conducted a retrospective cohort study involving 237 adult patients with moderate-to-severe persistent asthma treated at Wuhan Hankou Hospital between January 2021 and December 2023. Eligible participants had ≥12 months of documented ICS/LABA use. Patients were evaluated for asthma control using the Asthma Control Test (ACT), frequency of acute exacerbations requiring systemic corticosteroids, pulmonary function (FEV % predicted), and adverse drug reactions. Data were collected at baseline, 12 months, and 24 months. RESULTS: After 24 months, the proportion of patients achieving well-controlled asthma (ACT ≥20) increased significantly from 42.6% at baseline to 73.0% (P < 0.001). Mean FEV improved from 72.1 ± 10.4% to 79.8 ± 11.2% predicted (P = 0.002). The annualized exacerbation rate declined from 2.1 ± 1.0 to 0.8 ± 0.6 episodes per patient (P < 0.001). Medication adherence, defined as ≥80% refill rate, was significantly associated with greater improvements in ACT and FEV. Reported side effects included oropharyngeal candidiasis (8.0%), dysphonia (5.1%), and tremors (3.8%), but no serious adverse events were documented. CONCLUSION: Continuous use of inhaled corticosteroids in combination with long-acting β-agonists was associated with sustained improvements in asthma control, enhanced lung function, and a reduction in the frequency of exacerbations. These findings support the continued use of ICS/LABA therapy as an effective and safe strategy for long-term asthma management in clinical practice.
Clinical Efficacy of Levocarnitine-Alprostadil Combination Therapy on Indicators of Renal Function, Oxidant-Antioxidant Balance, and Systemic Inflammation in Patients with End-Stage Diabetic Nephropathy.
Cheng L, Wan S, Min Y … +5 more , Tu C, Mao D, Wang Q, Fu S, Xiong F
Ther Clin Risk Manag · 2026 · PMID 41884608 · Full text
OBJECTIVE: To investigate the effects of combined Levocarnitine and Alprostadil therapy on renal function, oxidant-antioxidant balance, and systemic inflammation in patients with end-stage diabetic nephropathy (ESDN). ME...
OBJECTIVE: To investigate the effects of combined Levocarnitine and Alprostadil therapy on renal function, oxidant-antioxidant balance, and systemic inflammation in patients with end-stage diabetic nephropathy (ESDN). METHODS: This retrospective study included 104 ESDN patients admitted to our hospital between April 2021 and April 2023 who met all inclusion criteria. All patients were on maintenance hemodialysis for chronic kidney failure due to ESDN. Based on the treatment regimen received, patients were divided into two groups: the control (n=51) received intravenous Alprostadil (20 μg/day) for 30 days in addition to standard care, and the observation group (n=53) received additional intravenous Levocarnitine (1.0 g/day) for 30 days. Clinical efficacy, renal function parameters [blood urea nitrogen (BUN), cystatin C (Cys-C), 24-hour urinary protein (24 h Upro)], oxidative stress markers [malondialdehyde (MDA), superoxide dismutase (SOD), reactive oxygen species (ROS)], inflammatory factors [C-reactive protein (CRP), interleukin-1β (IL-1β), interleukin-6 (IL-6)], and adverse reactions were compared between groups. RESULTS: The cumulative treatment effectiveness (defined as the sum of patients with "markedly effective" and "effective" outcomes) was significantly higher in the observation group (92.45%) compared to the control group (78.43%, P<0.05). Post-treatment, the observation group demonstrated significantly greater improvements in all parameters: lower BUN (4.35±1.06 vs 5.29±1.12 mmol/L), Cys-C (1.21±0.34 vs 1.75±0.46 mg/L), 24 h Upro (66.79±18.37 vs 75.17±19.54 mg/24h), MDA (3.54±0.89 vs 4.63±1.08 nmol/mL), ROS (371.34±46.32 vs 417.53±48.16 U/mL), CRP (5.02±0.83 vs 6.63±0.94 mg/L), IL-1β (11.04±2.38 vs 13.61±2.67 pg/mL), and IL-6 (12.78±3.51 vs 16.84±4.53 pg/mL), alongside higher SOD (88.17±9.34 vs 72.49±8.71 U/mL) (P<0.05). Adverse reaction incidence showed no significant difference (16.98% vs 13.73%, P>0.05). CONCLUSION: In ESDN patients, the combination of Levocarnitine and Alprostadil demonstrates superior cumulative treatment effectiveness over Alprostadil monotherapy in improving renal function, reducing oxidative stress, and attenuating inflammation, without increasing the incidence of adverse reactions.
Impact of Individualized Positive End-Expiratory Pressure Guided by Driving Pressure on Postoperative Atelectasis Assessed by Lung Ultrasound in Laparoscopic Surgery Patients: A Randomized Controlled Trial.
Zhang Y, Zhu J, Xi C … +5 more , Su S, Bai Y, Zhang Y, Shen W, Wang G
Ther Clin Risk Manag · 2026 · PMID 41877897 · Full text
PURPOSE: Pulmonary atelectasis frequently develops during laparoscopic procedures under general anesthesia, often leading to postoperative pulmonary complications (PPCs). Given the connection between high driving pressur...
PURPOSE: Pulmonary atelectasis frequently develops during laparoscopic procedures under general anesthesia, often leading to postoperative pulmonary complications (PPCs). Given the connection between high driving pressure and these complications, this study employed ultrasonography to assess whether individualized positive end-expiratory pressure (PEEP) titration by minimum driving pressure reduces postoperative atelectasis. PATIENTS AND METHODS: Adult patients with medium-to-high-risk PPCs who were scheduled for laparoscopic procedures were allocated to receive either a fixed PEEP of 5 cmHO (Group C) or minimum driving pressure-guided individualized PEEP (Group D). The primary outcome was the lung ultrasound score (LUS) on postoperative day 1, and LUSs at other postoperative time points were also recorded. The secondary outcomes were occurrence of atelectasis evaluated by ultrasonography and occurrence of PPCs within 7 days postoperatively. RESULTS: A total of 106 participants were assigned randomly, with 102 included in the final analysis. Individualized PEEP resulted in better intraoperative respiratory mechanics. Compared with Group C, Group D demonstrated a more substantial decrease in the LUS on postoperative day 1 (4[3-6] vs 6[5-8], < 0.001), and this benefit persisted until postoperative day 3. Moreover, the occurrence of atelectasis evaluated by ultrasonography in Group D was considerably lower than that in Group C at 15 min after extubation (58.8% vs 80.4%, = 0.018), and this advantage persisted until postoperative day 2. Compared with Group C, Group D experienced fewer PPCs within 7 days after surgery (13.7% vs 31.4%, = 0.033), whereas other postoperative recovery indicators were not significantly different. CONCLUSION: In adult patients undergoing laparoscopic surgery, compared with a fixed PEEP of 5 cmHO, the driving pressure-guided individualized PEEP strategy improved postoperative LUSs and reduced incidences of early postoperative atelectasis assessed by ultrasound. Furthermore, it was associated with fewer PPCs and lower rates of atelectasis in the first 7 postoperative days.
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