Therapeutics And Clinical Risk Management[JOURNAL]
Sun
200 papers
Surgeons Knowledge, Attitude, and Practice Toward Preoperative Inflammatory Bowel Disease Medications and Post-Operative Complications.
Alhassan N, Alnwdel AN, Beyari MB … +4 more , Aldeligan SH, Alhassan R, Abdulla MH, Bin Traiki T
Ther Clin Risk Manag · 2025 · PMID 40726728 · Full text
BACKGROUND: Biologics, particularly anti-TNF agents, have transformed the management of inflammatory bowel disease (IBD), but concerns about their perioperative safety persist. OBJECTIVE: This study evaluates the knowled...
BACKGROUND: Biologics, particularly anti-TNF agents, have transformed the management of inflammatory bowel disease (IBD), but concerns about their perioperative safety persist. OBJECTIVE: This study evaluates the knowledge, attitudes, and practices of surgeons in Saudi Arabia regarding the preoperative management of IBD patients undergoing surgery while on biological treatments. METHODS: A cross-sectional survey was conducted among 115 surgeons. Participants included general and colorectal surgeons with extensive experience in IBD management. Data were analyzed to assess knowledge, attitudes, and practices related to the impact of biologics, corticosteroids, and immunomodulators on wound healing and postoperative complications. RESULTS: The response rate of 67.8% and Most surgeons (74.4%) believed biologics negatively affect wound healing, despite evidence suggesting their safety. Corticosteroids were unanimously recognized for their adverse effects, while immunomodulators were widely perceived as safe. A majority preferred tapering biologics and corticosteroids 4 weeks preoperatively but continued immunomodulators. Differences between specialties were observed, with colorectal surgeons demonstrating greater adherence to evidence-based guidelines compared to general surgeons, who expressed more concerns about biologics' risks. CONCLUSION: This study identifies a persistent gap between evidence and practice in the perioperative management of IBD patients on biologics among Saudi surgeons, with general surgeons often stopping biologics due to safety concerns despite evidence of their safety, while colorectal surgeons are more likely to follow current guidelines. Unnecessary cessation may increase disease flare risk, highlighting the need for targeted education and multidisciplinary collaboration to optimize surgical outcomes.
Adverse Event Management in Patients with Platinum-Resistant Ovarian Cancer Treated with Niraparib and Anlotinib: Updates from the Phase II, Multi-Center ANNIE Study.
Deng T, Yan L, Li J … +11 more , Liu G, Yin A, Feng Y, Zheng M, Zhang C, Huang H, Huang Q, Lin A, Jiang J, Kong B, Liu J
Ther Clin Risk Manag · 2025 · PMID 40718116 · Full text
BACKGROUND: The primary analysis of the ANNIE study demonstrated promising anti-tumor activity of the niraparib-anlotinib combination in platinum-resistant recurrent ovarian cancer (PROC). We report updated overall survi...
BACKGROUND: The primary analysis of the ANNIE study demonstrated promising anti-tumor activity of the niraparib-anlotinib combination in platinum-resistant recurrent ovarian cancer (PROC). We report updated overall survival (OS) and safety data and the management of key treatment-emergent adverse event (TEAE) from the ANNIE study. METHODS: In the multi-center, single-arm, Phase 2 ANNIE study, enrolled patients received oral niraparib 200 mg or 300 mg (baseline bodyweight-directed) once daily and anlotinib 10 mg (12 mg before protocol amendment) once daily on days 1-14 of each 21-day cycle. Safety management involved a multidisciplinary team comprising specialist physicians, who performed monitoring and intervention for key comorbidities and TEAEs. RESULTS: Forty patients were enrolled. After a median follow-up of 19.0 months, the updated median OS was 18.2 months (95% confidence interval: 12.1-not evaluable). The most common TEAEs were hypertension (n=22, 55%), leukopenia (n=18, 45%), hand-foot syndrome (n=17, 43%), thrombocytopenia (n=15, 38%), neutropenia (n=14, 35%), and hypertriglyceridemia (n=12, 30%). Hypertension and cardiovascular events were mostly managed by early interventions using beta-blockers. Hypertriglyceridemia was mostly managed using atorvastatin and simvastatin. Hematological toxicities were consistent with prior studies and no severe hematologic events occurred. Protocol amendment was implemented to reduce the incidence of hand-foot syndrome, while topical glucocorticoids and non-steroidal anti-inflammatory drugs were used in patients with apparent symptoms. CONCLUSION: The updated OS analysis showed sustained long-term efficacy of niraparib-anlotinib in PROC patients. The safety data reflected satisfactory tolerability and adverse event management, supporting the involvement of a multidisciplinary disease management team in ovarian cancer care. CLINICAL TRIAL REGISTRATION: NCT04376073.
Physical and Cognitive Impairments at ICU Discharge are Associated with High Long-Term Mortality in ICU Survivors with Solid Malignancies: A Retrospective Cohort Study.
Lee SY, Huh JW, Hong SB … +2 more , Lim CM, Ahn JH
Ther Clin Risk Manag · 2025 · PMID 40718115 · Full text
BACKGROUND: Many ICU survivors experience post-ICU physical, cognitive, or mental impairments. In ICU survivors with solid malignancies, post-ICU impairments can impede further cancer treatments and negatively impact the...
BACKGROUND: Many ICU survivors experience post-ICU physical, cognitive, or mental impairments. In ICU survivors with solid malignancies, post-ICU impairments can impede further cancer treatments and negatively impact their outcomes. This study aimed to investigate post-ICU mortalities and their risk factors at ICU discharge in ICU survivors with solid malignancies. METHODS: In this retrospective cohort study, adult patients with solid malignancies who were unexpectedly admitted to the medical ICU of a tertiary hospital between 2016 and 2022 and survived to ICU discharge were included. Data at ICU discharge were collected from electronic medical records. In-hospital and 1-year mortality and their risk factors were analyzed. RESULTS: Of the 708 ICU survivors, 25.1% died in the hospital, and 61% died within one year. At ICU discharge, 20.9% had delirium, 3.8% had coma, and 80.6% had impaired mobility. Respiratory support, including bilevel positive airway pressure (BiPAP), high-flow nasal cannula (HFNC), or other oxygen therapies was used in 88.7% of patients. Delirium (adjusted OR 1.73; 95% CI 1.04-2.87; p = 0.035), coma (adjusted OR 5.63; 95% CI 2.09-16.17; p < 0.001), limited mobility (adjusted OR 2.41; 95% CI 1.22-5.14; p = 0.015), and use of BiPAP (adjusted OR 21.63; 95% CI 5.36-99.57; p < 0.001) or HFNC (adjusted OR 7.08; 95% CI 2.45-23.99; p < 0.001) were independently associated with in-hospital mortality. One-year survival was significantly lower in patients with delirium (35%, p < 0.001), coma (26%, p < 0.001), limited mobility (37%, p = 0.003), or those receiving respiratory support at ICU discharge (35%, p < 0.001). CONCLUSION: A considerable portion of ICU survivors with solid malignancies died in the hospital or within one year after ICU discharge in our study. Cognitive, mobility, and pulmonary impairments at ICU discharge were significant risk factors for both in-hospital and long-term mortality.
Preoperative Neutrophil-to-Albumin Ratio as a Prognostic Indicator in Advanced Gastric Cancer Undergoing Radical Gastrectomy.
Ye H, Kang R, Chen M … +2 more , Zhang S, Yang J
Ther Clin Risk Manag · 2025 · PMID 40704140 · Full text
OBJECTIVE: This study aimed to evaluate the prognostic significance of the preoperative neutrophil-to-albumin ratio (NAR) in patients with advanced gastric cancer undergoing radical gastrectomy. METHODS: A retrospective...
OBJECTIVE: This study aimed to evaluate the prognostic significance of the preoperative neutrophil-to-albumin ratio (NAR) in patients with advanced gastric cancer undergoing radical gastrectomy. METHODS: A retrospective analysis was conducted involving 526 patients diagnosed with locally advanced gastric adenocarcinoma who underwent radical gastrectomy between January 2017 and December 2019. Preoperative NAR values were calculated using neutrophil count and serum albumin levels obtained within 24 hours of admission. Patients were stratified into high-NAR and low-NAR groups using an optimal cut-off value determined by receiver operating characteristic analysis. Kaplan-Meier curves, univariate, and multivariate Cox regression analyses were used to evaluate overall survival and recurrence-free survival. RESULTS: The optimal NAR cut-off value was identified as 2.8. Patients with high NAR exhibited significantly worse overall survival and recurrence-free survival compared to the low-NAR group. High NAR was significantly associated with advanced tumor stage, incomplete resection status, administration of chemotherapy and radiotherapy, and poor histological differentiation (all P < 0.0001). Multivariate analyses confirmed NAR as an independent prognostic factor for both overall survival (HR=2.67; 95% CI, 1.97-4.25; p = 0.002) and recurrence-free survival (HR=3.51; 95% CI, 1.58-5.26; p = 0.003). CONCLUSION: The preoperative neutrophil-to-albumin ratio is an independent and reliable prognostic biomarker for overall and recurrence-free survival in patients with advanced gastric cancer undergoing radical gastrectomy. Due to its accessibility, simplicity, and predictive value, the neutrophil-to-albumin ratio can effectively facilitate risk stratification, personalized clinical decision-making, and targeted interventions to improve patient outcomes.
Comparative Cost-Effectiveness of Two Artificial Liver Therapies in Early-Stage Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Retrospective Cohort Study.
Chen J, Luo Q, Wang L … +5 more , Zheng L, Zhang Y, Liu Y, Peng L, Xu W
Ther Clin Risk Manag · 2025 · PMID 40672705 · Full text
PURPOSE: This study aimed to compare the cost-effectiveness of the double plasma molecular adsorption system sequential low-volume plasma exchange (DPMAS+LPE) versus conventional plasma exchange (PE) in treating early-st...
PURPOSE: This study aimed to compare the cost-effectiveness of the double plasma molecular adsorption system sequential low-volume plasma exchange (DPMAS+LPE) versus conventional plasma exchange (PE) in treating early-stage hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF). PATIENTS AND METHODS: A total of 215 early-stage HBV-ACLF patients were assigned to either DPMAS+LPE or conventional PE groups. After propensity score matching (1:1), 101 matched pairs were analyzed. We compared 30- and 90-day survival rates and direct medical costs from the healthcare payer's perspective. Cost-effectiveness analysis was performed with a willingness-to-pay (WTP) threshold of $12,681 and $38,043, equivalent to 1 and 3 times China's 2023 per capita GDP. Univariate and probabilistic sensitivity analyses (Bootstrap method) were used to assess parameter uncertainty. RESULTS: Over the 90-day follow-up period, the DPMAS+LPE group had numerically higher survival rates compared to the PE group, but this difference was not statistically significant (91.04% vs 83.07%, Logrank: =0.094). Compared to PE, DPMAS+LPE showed no economic benefit at 30 days. At 90 days, each 1% increase in the survival rate with DPMAS+LPE required an additional $3013.68 in medical costs, demonstrating cost-effectiveness. In the cirrhosis subgroup, the 90-day average total medical cost of the DPMAS+LPE group was lower than that of the PE group. At a WTP threshold of $12,681, the probability of DPMAS+LPE being cost-effective was 14% at 30 days and 75% at 90 days. At a WTP of $38,043, these probabilities increased to 45% and 90%, respectively. Univariate sensitivity analysis demonstrated that variations in the 90-day survival rates and costs for both groups still favored DPMAS+LPE within the 95% confidence interval. However, when the number of DPMAS+LPE treatments exceeded 4.4, it was no longer cost-effective. CONCLUSION: Compared to PE, DPMAS+LPE demonstrated cost-effectiveness at 90 days in early-stage HBV-ACLF patients, particularly those with cirrhosis. While DPMAS+LPE can be considered a suitable artificial liver therapy option for early-stage HBV-ACLF, careful consideration must be given to the number of treatments to ensure cost-effectiveness.
Challenges in Traditional Chinese Medicine Clinical Trials: How to Balance Personalized Treatment and Standardized Research?
Hu Y, Wang Z, Ni K … +1 more , Yang J
Ther Clin Risk Manag · 2025 · PMID 40666695 · Full text
Randomized controlled trials (RCTs), as the highest level of evidence and the gold standard in clinical research, occupy a central position in modern medical research due to their stringent variable control and high inte...
Randomized controlled trials (RCTs), as the highest level of evidence and the gold standard in clinical research, occupy a central position in modern medical research due to their stringent variable control and high internal validity. However, their vacuum-like research environment and standardized treatment approaches face significant challenges in traditional Chinese medicine (TCM), which emphasizes Treatment Tailored to Individual and Treatment Based on Syndrome Differentiation, focusing on personalized treatment according to a patient's constitution, age, gender, and lifestyle, and diagnosis based on specific syndromes. This approach lacks systematic modern clinical research and unified standards, conflicting with RCTs' standardized design, thus limiting TCM trials and posing serious challenges to its modernization and internationalization. This study systematically collected and categorized data on the registration status, study type, design, interventions and control measures, research objectives, primary outcome measures of registered trials by searching the ClinicalTrials.gov using TCM-related keywords. It reveals the current status and distribution patterns of TCM clinical registration trials. Evidence suggests that TCM clinical trials urgently need to seek a balance between standardized research and individualized treatment to address the limitations of RCTs in the TCM field, like implementation difficulties and the neglect of individual differences. To address this, the paper proposes an innovative research framework centered on pragmatic RCTs, highlighting randomization based on patient preferences to gather real-world evidence. Additionally, it suggests constructing a multidimensional core information set for standardized diagnosis of TCM syndromes by integrating disease and syndrome data to enhance diagnostic scientificity and increase the credibility and international acceptance of TCM clinical trials. The introduction of this framework effectively integrates the traditional characteristics of TCM with modern scientific methods, providing essential theoretical support and innovative solutions for the design and implementation of TCM clinical research, thereby enhancing TCM's role in global health.
Exploring the Complementary Role of Traditional Chinese Medicine in Enhancing Percutaneous Coronary Intervention Outcomes: Mechanisms, Benefits, and Future Research Directions.
Zheng S, Guo J, Wang Q
Ther Clin Risk Manag · 2025 · PMID 40666694 · Full text
BACKGROUND: Percutaneous coronary intervention (PCI) is a cornerstone treatment for coronary artery disease (CAD), yet opportunities remain to improve clinical outcomes, symptom management, and long-term prognosis. Tradi...
BACKGROUND: Percutaneous coronary intervention (PCI) is a cornerstone treatment for coronary artery disease (CAD), yet opportunities remain to improve clinical outcomes, symptom management, and long-term prognosis. Traditional Chinese Medicine (TCM), with its multi-target and multi-pathway mechanisms, offers a promising complementary approach to enhance PCI efficacy. METHODS: A systematic search was conducted in PubMed and Web of Science using the terms: ("Percutaneous Coronary Intervention" AND "Traditional Chinese Medicine") and ("Percutaneous Coronary Intervention" AND "Chinese Herbal Drugs"). Randomized controlled trials (RCTs) with ≥100 participants were included to evaluate TCM's clinical efficacy in PCI. Pharmacological studies were also reviewed to explore underlying mechanisms. RESULTS: A review of 20 RCTs showed that TCM plays multiple roles in CAD treatment during PCI. Specific interventions such as Danhong Injection, Tongxinluo Capsule, and Shenzhu Guanxin Granule were found to alleviate angina symptoms, restore cardiac function, reduce cardiac biomarkers, prevent no-reflow/slow-flow phenomena, inhibit in-stent restenosis, and improve prognosis while reducing complications. Mechanistically, TCM exerts its effects through antiplatelet action, anti-inflammation, inhibition of smooth muscle proliferation, vasodilation, microcirculation improvement, and endothelial protection. CONCLUSION: This systematic review highlights the complementary benefits of TCM in PCI for CAD patients. Effective interventions such as Danhong Injection and Tongxinluo Capsule contribute to symptom relief, cardiac function restoration, restenosis inhibition, and prognosis improvement. These benefits are linked to TCM's multi-target mechanisms, including anti-inflammatory and antiplatelet effects. Future high-quality studies are needed to further validate these findings and refine clinical applications.
The Effect of Repairing the Integrity of the Calcaneofibular Ligament During Calcaneal Fracture Surgery on Postoperative Ankle Joint Function.
Huang Z, Chen M, Ye Z
Ther Clin Risk Manag · 2025 · PMID 40666693 · Full text
BACKGROUND: Calcaneal fracture is a common fracture in clinical practice. Open reduction and internal fixation of the calcaneal plate inevitably require cutting or damaging the calcaneofibulartibial fibrous ligament (CFL...
BACKGROUND: Calcaneal fracture is a common fracture in clinical practice. Open reduction and internal fixation of the calcaneal plate inevitably require cutting or damaging the calcaneofibulartibial fibrous ligament (CFL) beneath the sheath of the fibular muscle tendon. Hence, calcaneal fractures are mainly treated through the lateral L-shaped extension approach. However, there is still controversy over whether the integrity of CFL can be repaired during surgery. Thus, we aimed to explore the effect of repairing CFL during calcaneal fracture surgery on postoperative ankle joint function. METHODS: In this retrospective study, we analyzed the clinical data of 84 patients with Sanders type II and III calcaneal fractures admitted to Wuhan Fourth Hospital from March 2021 to May 2023. According to whether CFL was repaired during surgery, the patients were divided into a repair group (n=44) and non-repair group (n=40). These patients underwent surgery by the same surgeon. The perioperative conditions between the two groups were compared. After a one-year follow-up, the rates of excellent ankle function and incidence of complications was also compared. RESULTS: The duration of surgery and hospitalization in the repair group was longer than that in the non-repair group, and the intraoperative blood loss was greater than that in the non-repair group (<0.05). After surgery, the excellent and good rate of ankle function in the repair group (90.91%) was higher than that in the non-repair group (67.50%) (<0.05). The incidence of complications in the repair group (9.09%) was not significantly higher than that in the non-repair group (7.50%) (>0.05). CONCLUSION: Although preserving CFL integrity during calcaneal fracture surgery increases the duration of surgery and hospitalization, the postoperative recovery of range of motion is good, the rate of excellent ankle function is significantly improved, and there is no significant increase in complications.
Establishment and Verification of Risk Prediction Model for Adverse Outcomes After Hip Arthroplasty in Elderly Patients.
Ding J, Sun G, Ren Y … +5 more , Xu J, Hu Q, Luo J, Wu Z, Chu T
Ther Clin Risk Manag · 2025 · PMID 40662076 · Full text
BACKGROUND: Adverse outcomes after hip arthroplasty in elderly patients are frequently observed; however, most existing studies concentrate on single complications. Comprehensive predictive models for a wider range of ad...
BACKGROUND: Adverse outcomes after hip arthroplasty in elderly patients are frequently observed; however, most existing studies concentrate on single complications. Comprehensive predictive models for a wider range of adverse outcomes remain insufficient. This study explores this issue and proposes new approaches for clinical practice. PURPOSE: This study aimed to construct and verify risk prediction model for adverse outcomes after hip arthroplasty in elderly patients. PATIENTS AND METHODS: The TRIPOD checklist was followed to guide the reporting of this study. Data from 620 subjects who underwent hip arthroplasty at a tertiary A-level hospital from January 1, 2021 to December 31, 2023 were used for the modelling group. Additionally, 264 post-hip arthroplasty patients admitted to the orthopaedic department of another tertiary A-level hospital from January 1, 2024 to December 31, 2024 were selected as the validation group. Risk prediction models were constructed by logistic regression, plotted in column line graphs and evaluated for their predictive effectiveness. RESULTS: The factors included in the prediction model were age, malignancy history, surgical procedure, albumin, prothrombin time, ASA grade, operation duration, and changeover surgery status. Hosmer-Lemeshow test, =5.418, =0.712, the area under the receiver operating characteristic curve (AUC) was 0.902. The Youden index is 0.668, with a sensitivity of 0.84 and a specificity of 0.828. The correct practical application rate was 83.33%. CONCLUSION: The risk prediction model constructed in this study demonstrates favourable predictive performance and can serve as a reference for healthcare professionals in predicting the risk of adverse outcomes after hip arthroplasty in elderly patients.
Erratum: Impact of Hypertension and Antihypertensive Treatment on COVID-19 Severity: A Retrospective Observational Study in Ternopil Region, Ukraine [Corrigendum].
Ther Clin Risk Manag · 2025 · PMID 40656026 · Full text
[This corrects the article DOI: 10.2147/TCRM.S527151.].
[This corrects the article DOI: 10.2147/TCRM.S527151.].
The Effect of Minimal-Dose S-Ketamine Administration Post-Surgery on Opioids Consumption and Functional Rehabilitation Exercises in Patients Undergoing Minimally Invasive Radical Resection of Esophageal Cancer.
Xie J, Shen F, Wang X … +4 more , Yao J, Zhou L, Huang L, Sun J
Ther Clin Risk Manag · 2025 · PMID 40641594 · Full text
STUDY OBJECTIVE: To examine the impact of minimal-dose S-ketamine on postoperative analgesia in patients undergoing minimally invasive radical resection for esophageal cancer, with a focus on reducing opioid consumption,...
STUDY OBJECTIVE: To examine the impact of minimal-dose S-ketamine on postoperative analgesia in patients undergoing minimally invasive radical resection for esophageal cancer, with a focus on reducing opioid consumption, enhancing analgesic quality, and facilitating postoperative recovery. METHODS: A total of 216 patients undergoing minimally invasive radical resection of esophageal cancer under general anesthesia were randomly assigned into two groups (S-ketamine and control group), receiving intravenous S-ketamine (0.015 mg/kg/h) or an equal volume of saline for 48 h postoperatively. The primary outcome was cumulative oxycodone consumption in the first 48 h postoperatively. Secondary outcomes included functional activity score (FAS) after one bolus administration, numerical rating scale (NRS) pain scores at rest and when coughing, cumulative oxycodone consumption in different time periods, incidence of postoperative nausea and vomiting (PONV), level of sedation (LOS) score, time to first postoperative flatulence, postoperative delirium, activities of daily living assessed by BI (Barthel Index) and so on. MAIN RESULTS: The postoperative opioid consumption within 48 hours in S-ketamine group was significantly lower than those in placebo group ( < 0.001), and the difference between the two groups was 40% (mean: 44.5 mg vs 74.8 mg). FAS after one bolus administration and BI in the S-ketamine group were notably superior to those in the control group ( < 0.001). There were Statistical differences between the two groups in the NRS scores at rest at postoperative hour 48 ( = 0.001) and the NRS scores when coughing at postoperative hour 12 ( = 0.011) with mean differences of -0.3 and 0.4, respectively. CONCLUSION: Minimal-dose S-ketamine for managing acute postoperative pain in patients undergoing radical resection for esophageal cancer led to a 40% reduction in opioid consumption and promoted rehabilitation.
Endovascular Treatment in Stroke Patients of Working Age: A Multicenter Observational Study of Real-World Outcomes.
Zhou Y, Mofatteh M, Zheng Z … +10 more , Liu F, Zhou S, Ma J, Yan Z, Lai Y, Li W, Chen W, Abdalkader M, Regenhardt RW, Liu X
Ther Clin Risk Manag · 2025 · PMID 40636546 · Full text
PURPOSE: The prevalence of acute ischemic stroke (AIS) is increasing among people of working age, posing socioeconomic and healthcare challenges. Inability to return to work can have significant negative consequences and...
PURPOSE: The prevalence of acute ischemic stroke (AIS) is increasing among people of working age, posing socioeconomic and healthcare challenges. Inability to return to work can have significant negative consequences and contribute to the economic burden of stroke. Endovascular treatment (EVT) has been established as the standard of care for large vessel occlusion AIS patients. In this study, we aimed to identify factors predicting favorable outcome among working age AIS patients undergoing EVT. PATIENTS AND METHODS: We analyzed data from 309 patients from five comprehensive stroke centers between 2019 and 2023. All patients were working age (18<59) with symptoms onset of within 24 hours. Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3 was considered as successful recanalization. We used 3-months mRS post-EVT to evaluate the outcome; mRS of 0-2 was defined as favorable outcome, whereas mRS of 3-6 was considered unfavorable outcome. RESULTS: The unfavorable outcome group consisted of 150 patients, and 159 patients were in the favorable outcome group. More people in the unfavorable outcome group had diabetes (29.33% vs 15.72%, p=0.004) and hypertension (61.33% vs 40.88, p<0.001). A multivariable regression analysis demonstrated that several factors, including successful recanalization (odds ratio (OR) 5.298, 95% confidence interval (CI) 1.735-16.174, p=0.003), pre-EVT NIHSS (OR 0.892, 95% CI 0.852-0.934, p=0.000), baseline Alberta stroke program early CT score (ASPECTS) (OR 1.609, 95% CI 1.274-2.032, p=0.000), hypertension (OR 0.477, 95% CI 0.270-0.845, p=0.011), diabetes mellitus (OR 0.413, 95% CI 0.208-0.820, p=0.011), and symptomatic intracerebral hemorrhage (sICH) (OR 0.045, 95% CI 0.006-0.359, p=0.003) can predict the outcome of patients undergoing EVT. CONCLUSION: Favorable outcome of working age patients with AIS undergoing EVT can be predicted using multiple factors, including hypertension, diabetes mellitus, successful recanalization, pre-EVT NIHSS, baseline ASPECTS, and sICH.
Prognostic Value of Spontaneous Potential in Left Atrial Posterior Wall Isolation and Radiofrequency Ablation for Non-Paroxysmal Atrial Fibrillation.
Chen ZY, Zhong YH, Gong KZ … +3 more , Chen XH, Xu Z, Zhang FL
Ther Clin Risk Manag · 2025 · PMID 40636545 · Full text
OBJECTIVE: This study aimed to examine the long-term effects of left atrial posterior wall spontaneous potential (SP) in patients with non-paroxysmal atrial fibrillation (AF) who underwent pulmonary vein isolation (PVI)...
OBJECTIVE: This study aimed to examine the long-term effects of left atrial posterior wall spontaneous potential (SP) in patients with non-paroxysmal atrial fibrillation (AF) who underwent pulmonary vein isolation (PVI) combined with left atrial posterior wall isolation (PVI+BOX) ablation. METHODS: Clinical data were retrospectively collected from 140 patients with symptomatic non-paroxysmal atrial fibrillation (NPAF) who underwent first-time radiofrequency ablation between 2022 and 2023. Based on the surgical procedure, patients were categorized into the pulmonary vein isolation group (PVI group) and the pulmonary vein isolation + left atrial posterior wall isolation group (PVI+BOX group). The PVI+BOX group was further subdivided into the spontaneous potential group (SP group) and the no-spontaneous potential group (no-SP group) based on the presence of SP after left atrial posterior wall isolation. Patients underwent monthly follow-ups in the clinic or via telephone and received 72-hour dynamic electrocardiography (ECG) at 3 and 12 months postoperatively. AF recurrence was compared among the groups, and factors associated with recurrence following AF ablation were analyzed. RESULTS: The PVI+BOX group included 78 cases, with 45 in the no-SP group and 33 in the SP group, while the PVI group comprised 62 cases. No significant difference was observed in the postoperative recurrence-free rate between the PVI+BOX and PVI groups. However, the SP group exhibited a higher postoperative recurrence-free rate compared to both the no-SP group ( = 0.039) and the PVI group ( = 0.020). No significant difference was found in the late recurrence-free rate between the no-SP and PVI groups. Multivariate logistic regression analysis indicated that the duration of AF and the presence of left atrial posterior wall SP were independent risk factors for post-ablation recurrence in patients with NPAF. CONCLUSION: The presence of SP post-left atrial posterior wall isolation suggests a better long-term outcome in patients with NPAF following PVI+BOX catheter ablation.
Impact of Hypertension and Antihypertensive Treatment on COVID-19 Severity: A Retrospective Observational Study in Ternopil Region, Ukraine.
Hrebenyk M, Maslii S, Shevchuk O … +2 more , Komorovsky R, Korda M
Ther Clin Risk Manag · 2025 · PMID 40625672 · Full text
BACKGROUND: Hypertension (HP) may significantly affect the prognosis of COVID-19 illness. Understanding the epidemiological and clinical characteristics of post-COVID-19 patients with HP and other comorbidities is import...
BACKGROUND: Hypertension (HP) may significantly affect the prognosis of COVID-19 illness. Understanding the epidemiological and clinical characteristics of post-COVID-19 patients with HP and other comorbidities is important for improving outcomes. METHODS: We conducted a retrospective observational study in the Ternopil region of Ukraine involving 926 subjects: 848 individuals in the post-COVID period (0-90 days after a negative SARS-CoV-2 PCR test) and 78 (8.4%) in a control group. Data on medical history, clinical manifestations, treatment modalities, and pathomorphological findings were collected. Patients were categorized into four groups based on COVID-19 severity: mild, moderate, severe, and critical. RESULTS: HP was present in 46.2% of patients, with a prevalence of 75.0% among fatal cases (p<0.001). Diabetes mellitus (DM) was diagnosed in 17.6%. HP was not associated with increased susceptibility to SARS-CoV-2 infection. In-hospital mortality risk significantly correlated with age (r=0.306, p<0.001), HP (r=0.145, p=0.001), DM (r=0.144, p=0.001), combined HP and DM (r=0.159, p<0.001), and irregular antihypertensive treatment (r=-0.118, p=0.037). However, regular use of ACE inhibitors or ARBs did not significantly affect prognosis. Multivariable logistic regression identified age and irregular antihypertensive treatment as independent predictors of in-hospital mortality. CONCLUSION: HP was not associated with increased susceptibility to SARS-CoV-2 infection, based on similar prevalence rates in patients and controls, but was linked to worse outcomes when combined with other risk factors. Age and irregular antihypertensive treatment emerged as independent predictors of in-hospital mortality. These findings highlight the importance of regular blood pressure management in reducing the severity and improving the prognosis of COVID-19 in hypertensive patients.
The Higher Incidence of Liver Injury in HCC Patients Compared to Other Malignancies During Immune-Checkpoint Inhibitor Therapy is Primarily Due to Tumor Progression.
Wang Y, Liu L, Zhao M … +3 more , Chen W, Chen Y, Zhao X
Ther Clin Risk Manag · 2025 · PMID 40584026 · Full text
BACKGROUND: The study explores the incidence and clinical features of immune-related liver injury (irLI) in hepatocellular carcinoma (HCC) patients compared to those with other malignancies receiving immune checkpoint in...
BACKGROUND: The study explores the incidence and clinical features of immune-related liver injury (irLI) in hepatocellular carcinoma (HCC) patients compared to those with other malignancies receiving immune checkpoint inhibitors (ICIs). METHODS: A retrospective analysis was conducted on patients treated with ICIs at Beijing Friendship Hospital. Individuals who experienced liver injury consistent with the criteria specified in the Common Terminology Criteria for Advanced Event version 5.0 for irLI were included in the study. The cohort was divided into an HCC group and a non-HCC malignancy group. HCC patients were further classified into three subgroups based on liver injury: no injury, irLI, or non-immune-related liver injury. Data on demographics, laboratory results, and mortality rates were compared. RESULTS: The study included 292 hCC patients and 1248 patients with other malignancies. Both groups underwent a similar number of ICIs cycles (p=0.237). Liver injury was more common in HCC patients [98 (33.6%) vs 288 (23.1%), p<0.001], but the irLI incidence was comparable between the groups [17 (5.8%) vs 62 (5.0%), p=0.556]. Tumor progression-related liver injury was higher in HCC patients (12.0%) compared to other malignancies (4.6%). Mortality rates showed no significant differences between groups. CONCLUSION: HCC patients with underlying liver disease are more prone to liver injury during ICIs therapy, mainly due to tumor progression rather than irLI.
Comparative Impact of Intravenous Iron Sucrose and Ferric Carboxymaltose on Hypophosphatemia and Anemia Parameters in Iron Deficiency Anemia: A Retrospective Study.
Aslan S, Doğan S, Sarıaydın M … +3 more , Vural A, Kuloglu E, Muhtaroğlu A
Ther Clin Risk Manag · 2025 · PMID 40584025 · Full text
AIM: This study aimed to determine the incidence of hypophosphatemia and evaluate anemia parameters following intravenous iron sucrose (IS) and iron carboxymaltose (FCM) therapy in patients diagnosed with iron deficiency...
AIM: This study aimed to determine the incidence of hypophosphatemia and evaluate anemia parameters following intravenous iron sucrose (IS) and iron carboxymaltose (FCM) therapy in patients diagnosed with iron deficiency anemia (IDA). METHODS: This retrospective study included 108 patients aged 18-67 who were diagnosed with IDA and received either FCM or IS therapy. The patients were divided into two groups: iron sucrose (n=55, 51%) and ferric carboxymaltose (n=53, 49%). We collected and analysed data on patient demographics, doses of FCM and IS, and laboratory parameters including serum phosphorus, ferritin, total iron-binding capacity (TIBC), iron, and haemoglobin (Hg) values. RESULTS: The pre-treatment blood phosphorus levels were significantly lower in the IS group than in the FCM group (p = 0.029). Following intravenous iron treatment, the TIBC and phosphorus levels were higher in the IS group compared to the FCM group (p = 0.011 and p <0.001, respectively). The ferritin levels were significantly higher in the FCM group compared to the IS group (p = 0.002). CONCLUSION: It is important to be aware that hypophosphatemia may occur after intravenous iron therapy for iron deficiency anemia. Therefore, phosphate levels should be monitored closely following treatment. Furthermore, it would appear that hypophosphatemia is more prevalent following FCM therapy compared to IS.
Airway Organoid Models as Pivotal Tools for Unraveling Molecular Mechanisms and Therapeutic Targets in Respiratory Diseases: A Literature Review.
Jiang SP, Lin BQ, Zhou XQ … +7 more , Li MH, Feng ZC, Qin YY, Lin SQ, Zhou ZQ, Peng Y, Li L
Ther Clin Risk Manag · 2025 · PMID 40584024 · Full text
Respiratory inflammatory and infectious diseases continue to impose a substantial global health burden, compounded by persistent gaps in understanding their pathogenic mechanisms and limited therapeutic advancements. To...
Respiratory inflammatory and infectious diseases continue to impose a substantial global health burden, compounded by persistent gaps in understanding their pathogenic mechanisms and limited therapeutic advancements. To address these challenges, this review systematically analyzed literature from PubMed, Web of Science, and Scopus databases (2005-2025) to evaluate the evolution and applications of airway organoid models in respiratory disease research. Key findings include: (1) the convergence of traditional culture techniques with advanced methodologies - including 3D matrix embedding, bioprinting and organoids-on-chips technologies - has enabled unprecedented recapitulation of human airway architecture and multicellular interactions; (2) these novel models provide unique insights into disease pathogenesis, host-microbe dynamics, and drug response variability; (3) the inherent capacity to maintain native cellular diversity and disease-associated phenotypes positions airway organoids as crucial platforms for personalized medicine approaches. Collectively, these advances establish airway organoids as transformative tools that bridge conventional in vitro models and clinical reality. Looking ahead, coupling organs-on-chips platforms with microgravity culture and single-cell lineage tracing will catalyze fundamental breakthroughs in respiratory disease research.
Tranexamic Acid Demonstrated a Trend Toward Decreased Perioperative Blood Loss in Posterior Decompression Surgery of Patient with Metastatic Spinal Tumor.
Cui Y, Li H, Mi C … +4 more , Wang B, Pan Y, Yu W, Shi X
Ther Clin Risk Manag · 2025 · PMID 40574905 · Full text
BACKGROUND: To explore the effect of tranexamic acid (TXA) on perioperative blood loss in posterior decompression surgery of patient with metastatic spinal tumor. METHODS: Three hundred sixty-eight consecutive patients b...
BACKGROUND: To explore the effect of tranexamic acid (TXA) on perioperative blood loss in posterior decompression surgery of patient with metastatic spinal tumor. METHODS: Three hundred sixty-eight consecutive patients between May 2011 and Aug 2022 were retrospectively reviewed. One hundred eighty patients (182 surgeries) met the criteria and were included in the study. Sixty-two surgeries received preoperative intravenous TXA (TXA group), and 120 did not (non-TXA group). The primary outcome was total blood loss. -test, Mann-Whitney U, and chi-square tests were used to evaluate the difference in baseline data, total blood loss, and other outcome measures between the two groups. RESULTS: Patients with hyper vascular tumors had significantly more blood loss compared with non-hyper vascular tumors (2002(1531,2792) mL vs 1469(1036,1962) mL, p=0.001). There was no significant different in the postoperative venous thromboembolism of the lower limb between the two groups. For patients with non-hyper vascular tumors, the blood loss (1216(827, 1709) mL vs 1561(1146, 2019) mL, p = 0.012) and postoperative drainage (1-day post-operation: 240(150,290) mL vs 280(150,395) mL, p=0.040; 3-days post-operation: 450(348,630) mL vs 613(398,799) mL, p=0.025) of TXA group were significantly less compared with that of the non-TXA group. Meanwhile, the TXA group had significantly less postoperative hospitalization compared with the non-TXA group (11.0(9.0, 13.3) days vs 12.5(9.0, 16.3) days, p=0.023). For patients with hyper vascular tumors, there were no significant differences in the blood loss and amount of postoperative drainage between the two groups. CONCLUSION: Preoperative intravenous TXA demonstrated a trend toward decreased perioperative blood loss in posterior decompression surgery of spinal metastases with non-hyper vascular tumors.
Retrospective Analysis of Prognostic Factors and Pregnancy Outcomes in Patients with Moderate-to-Severe Intrauterine Adhesions Following Hysteroscopic Adhesiolysis and Modified Intrauterine Stent Intervention.
Peng Q, Cao CX, Chen YN … +4 more , Liu WC, Zhao RK, Jiang QJ, Zhou Q
Ther Clin Risk Manag · 2025 · PMID 40567858 · Full text
OBJECTIVE: To assess the clinical prognosis and reproductive outcomes in individuals presenting with moderate-to-severe intrauterine adhesion (IUA) following the administration of hysteroscopic adhesiolysis (HA) in conju...
OBJECTIVE: To assess the clinical prognosis and reproductive outcomes in individuals presenting with moderate-to-severe intrauterine adhesion (IUA) following the administration of hysteroscopic adhesiolysis (HA) in conjunction with modified intrauterine stents. METHODS: A cohort comprising 156 individuals diagnosed with IUA (105 with moderate severity and 51 with severe severity) was enrolled. Subsequent to hysteroscopic intervention, all participants received intrauterine stent placement during the immediate postoperative phase. A comprehensive follow-up period of 2 years post-stent removal was instituted. RESULTS: The occurrence of adhesion recurrence increased progressively, demonstrating a recurrence rate of 11.54% at hysteroscopic reevaluation administrated in 3 months after surgery and surging to 32.69% during the 2-year follow-up period. Comparative analysis indicated a statistically significant reduction in recurrence rates among patients with moderate IUA compared to severe IUA (P < 0.05). The median duration of stent placement was determined to be 4 months. Postoperatively, patients exhibited a cumulative pregnancy rate of 71.79%, with a live birth rate of 79.28%. Significantly, patients with moderate IUA exhibited a significantly elevated pregnancy rate in comparison to those with severe IUA (P = 0.004). Multifactorial logistic regression analysis revealed that the severity of IUA was an independent risk factor for recurrence risk. Furthermore, the severity of IUA and postoperative re-adhesion emerged as contributory factors to the infertility observed in these patients. CONCLUSION: The combination of HA with a modified intrauterine stent demonstrates efficacy in the treatment of IUA; however, outcomes remain suboptimal for cases characterized by severity. The prognostic assessment of patients and the suggested criteria for the removal of intrauterine stents, as delineated in the study, are considered both feasible and recommendable for clinical practice. Furthermore, conscientious and attentive management is imperative for the mitigation of adverse pregnancy such as early pregnancy loss in individuals afflicted with IUA during pregnancy.
A Retrospective Study on the Effect of STA Anesthesia Technique in the Extraction of Impacted Teeth in Dental Outpatients and Its Impact on Patient Anxiety Levels.
Xu J, Su J, Liu G … +2 more , Ying W, Yuan F
Ther Clin Risk Manag · 2025 · PMID 40567857 · Full text
OBJECTIVE: To analyze the effect of the Single Tooth Anesthesia (STA) technique in dental outpatient patients undergoing the extraction of impacted teeth and its impact on patient anxiety levels. METHODS: This retrospect...
OBJECTIVE: To analyze the effect of the Single Tooth Anesthesia (STA) technique in dental outpatient patients undergoing the extraction of impacted teeth and its impact on patient anxiety levels. METHODS: This retrospective study included clinical data from 130 patients who underwent the extraction of a single mandibular impacted tooth in our dental outpatient department between April 2022 and June 2024. According to the anesthesia method, patients were divided into two groups: the Traditional Group (n = 65, receiving traditional local injection anesthesia) and the STA Group (n = 65, receiving Single Tooth Anesthesia). Parameters including intraoperative bleeding, duration of anesthesia, extent of anesthetic infiltration, blood pressure [systolic blood pressure (SBP), diastolic blood pressure (DBP)], heart rate (HR), pain [visual analog scale (VAS)], compliance (Frankl treatment compliance scale), tolerance (Houpt behavior scale), and anxiety level [modified dental anxiety scale (MDAS)] were compared between the two groups. RESULTS: There were no significant differences in the amount of bleeding, anesthesia duration, or infiltration range between the two groups (P > 0.05). In the Traditional Group, SBP at 3 minutes after anesthesia and post-extraction was significantly higher than before anesthesia (P < 0.05), whereas DBP and HR showed no significant changes (P > 0.05). In the STA Group, SBP, DBP, and HR remained stable across the three time points (P > 0.05). Compared with the Traditional Group, the STA Group showed significantly lower pain scores, reduced anxiety, and higher rates of treatment compliance and tolerance (P < 0.05). CONCLUSION: Within the limitations of this retrospective study, the STA anesthesia technique showed advantages over traditional local injection anesthesia in reducing pain and anxiety, while improving compliance and tolerance during impacted tooth extraction in dental outpatients.
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