Therapeutics And Clinical Risk Management[JOURNAL]
Sun
200 papers
The Therapeutic Role of Biologics in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): A Review of the Current Evidence.
Chen W, Wen Y, Wang J … +3 more , Meng X, Su L, Wu Y
Ther Clin Risk Manag · 2026 · PMID 41868416 · Full text
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a complex inflammatory condition that is primarily categorized as either Type 2 (T2) or non-T2. The T2 inflammatory pathway plays a pivotal role in the pathogenesis of...
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a complex inflammatory condition that is primarily categorized as either Type 2 (T2) or non-T2. The T2 inflammatory pathway plays a pivotal role in the pathogenesis of T2 CRSwNP. A significant proportion of patients do not respond to systemic glucocorticoid regimens or repeated surgical interventions, which severely impacts their long-term quality of life and presents a therapeutic challenge. Recent studies confirm that biologics are an effective treatment for severe or refractory CRSwNP. This review systematically collates the latest advances in biological therapies for CRSwNP by conducting extensive searches of the PubMed, Embase, and Cochrane Library databases from the inception of these databases up to October 2025. The review focuses on elucidating the pathological mechanisms of CRSwNP and the classification and target mechanisms of biologics. It also examines the current research landscape regarding variability in biologics efficacy. Substantial clinical evidence indicates that these biologics can effectively alleviate symptoms of sinusitis, reduce turbinate volume, and improve patients' quality of life. They also demonstrate potential in improving comorbid conditions, offering novel therapeutic options for severe or refractory CRSwNP. However, challenges remain in identifying biomarkers and selecting suitable biologics, requiring further research to enable personalized treatment strategies.
Real-World Clinical Effectiveness and Migraine-Related Healthcare Resource Utilization in Patients Initiating Fremanezumab in Germany and the United Kingdom.
Heinze A, Afridi SK, Totev TI … +9 more , Krasenbaum LJ, Terasawa E, Akcicek H, Hipp J, Dhiraj D, Sun R, Yim E, Yilma B, Driessen MT
Ther Clin Risk Manag · 2026 · PMID 41868415 · Full text
PURPOSE: Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, is approved in Germany and the United Kingdom (UK) for patients experiencing migraine ≥4 days per month, and it is reimbur...
PURPOSE: Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, is approved in Germany and the United Kingdom (UK) for patients experiencing migraine ≥4 days per month, and it is reimbursed for patients where ≥4-5 (Germany) or ≥3 (UK) prior migraine preventive treatments have failed. We evaluated real-world clinical effectiveness and healthcare resource utilization (HCRU) in patients initiating fremanezumab in Germany and the UK. METHODS: This non-interventional, retrospective, physician panel-based, online, multicenter chart review study included adult patients with chronic migraine (CM) or episodic migraine (EM) with first fremanezumab treatment initiation (index date) from June 2019 or later (Germany), and from June 2020 or later (UK). Changes in monthly migraine days (MMD), monthly headache days (MHD), and disability outcomes (Migraine Disability Assessment [MIDAS] and Headache Impact Test-6 [HIT-6]) were evaluated from baseline (pre-index) to 3 months post-index, and changes in HCRU were evaluated from 6 months pre-index to 6 months post-index. RESULTS: The study population included 207 German and 183 UK patients (CM, 48.3% and 95.1%; monthly dosing, 59.4% and 51.9%, respectively). Reductions in MMD and MHD were observed in the German cohort (percent reductions: 60.2% and 55.1%, respectively) and the UK cohort (51.9% and 47.3%, respectively; all < 0.001 vs baseline). Reductions in mean MIDAS and HIT-6 scores (all < 0.01 vs baseline), outpatient office visits, urgent care/emergency room visits, and inpatient admissions were also observed (all < 0.05 vs baseline) for both countries. CONCLUSION: Fremanezumab demonstrated real-world clinical effectiveness in German and UK cohorts and may decrease the burden of migraine for patients and providers.
Ten-Year Outcomes of Modular Reverse Shoulder Arthroplasty Assessed by 3D Motion Analysis.
Hetto P, Liewald F, Maier MW … +2 more , Tsitlakidis S, Spranz D
Ther Clin Risk Manag · 2026 · PMID 41868414 · Full text
INTRODUCTION: Modular reverse total shoulder arthroplasty (RSA) is a widely accepted treatment for cuff tear arthropathy (CTA), aimed at alleviating pain and improving range of motion (ROM). However, objective long-term...
INTRODUCTION: Modular reverse total shoulder arthroplasty (RSA) is a widely accepted treatment for cuff tear arthropathy (CTA), aimed at alleviating pain and improving range of motion (ROM). However, objective long-term data on RSA's impact on activities of daily living (ADL) are sparse. This study is the first to evaluate maximum ROM and ADL performance 10 years after RSA using a 3D motion analysis model. MATERIALS AND METHODS: A case control study with a total of 29 patients with RSA was divided into two groups: 14 patients with an average follow up of 10 years (long-term group) and 15 patients with a follow-up after 6 months (postoperative group). 3D motion analysis was conducted using a Vicon measurement system and HUX shoulder model. Maximum ROM and activity-related ROM (AROM) were assessed during predefined ADLs. Statistical analyses included independent -tests, calculation of effect sizes (Cohen's d), and adjustment for age and sex using ANCOVA with Bonferroni correction for multiple comparisons. RESULTS: At year follow-up, patients demonstrate only slightly lower maximum and activity-related ROM compared to patients 6 months after surgery. Significant differences between the two groups were noted for shoulder flexion during "neck grip" (postoperative 87.7 ± 14.3° vs long-term 70.1 ± 24.3°; Δ = 17.6°, p = 0.016, d = 0.86) and "book" (postoperative 76.5 ± 8.9° vs long-term 67.8 ± 10.7°; Δ = 8.7°, p = 0.017, d = 0.58) as well as internal/external rotation during "armpit washing" (postoperative 27.2 ± 13.0 vs long-term 15.9 ± 7.6°; Δ = 11.3°, p = 0.011, d = 0.64) (p < 0.05), while other movements showed no significant differences. DISCUSSION: 3D motion analysis revealed comparable maximum ROM and similar range used during ADL following RSA. Long-term deterioration in flexion aligns with previous studies but remains within an acceptable range. The reduced AROM over time may be influenced by natural aging or implant-related factors, though performing ADL was possible. CONCLUSION: Patients after RSA demonstrate good ROM while being able to perform ADL over the long term. With the exceptions of few outcomes, patients 10 years and 6 months after RSA show similar ROM, with good functionality, underscoring the durability and benefits of RSA in managing CTA. Further research with larger cohorts is recommended to confirm these findings. LEVEL OF EVIDENCE: Case control study, Level III.
Prospective Evaluation of Postoperative SIRS and Serum Inflammatory Indices in Percutaneous Nephrolithotomy Patients.
Arslantas YB, Sonmez G, Baydilli N … +4 more , Bas U, Tosun H, Demirci D, Akinsal EC
Ther Clin Risk Manag · 2026 · PMID 41868413 · Full text
INTRODUCTION: This study aimed to evaluate the relationship between postoperative systemic inflammatory response syndrome (SIRS) and a broad set of 30 commonly used clinical parameters, along with novel acute inflammatio...
INTRODUCTION: This study aimed to evaluate the relationship between postoperative systemic inflammatory response syndrome (SIRS) and a broad set of 30 commonly used clinical parameters, along with novel acute inflammation predictive indices such as the systemic immune-inflammation index (SII), the aggregate index of systemic inflammation (AISI), and the systemic inflammation response index (SIRI), in patients undergoing percutaneous nephrolithotomy (PCNL). METHODS: A total of 233 patients aged 18-75 years who underwent PCNL were prospectively included. All clinical variables and serum-based inflammatory indices, including SII, SIRI, and AISI, were prospectively pre-defined in the study protocol prior to patient enrollment. All patients had sterile preoperative urine cultures and no known disease that could cause fever. Clinical characteristics, operative findings, laboratory parameters, and serum-based inflammatory indices (SII, SIRI, AISI) were recorded. The median preoperative stone size was 270.0 mm (IQR: 180.0-447.0). Stone-free rates and postoperative SIRS development were assessed. Multivariate logistic regression analysis was used to determine independent predictors of SIRS. ROC analyses were conducted to evaluate the predictive performance of inflammatory indices. RESULTS: The clinically significant stone-free rate was 89.3% (208/233), while the complete stone-free rate was 79.1% (182/233). Postoperative SIRS occurred in 75 patients (32.1%). According to multivariate logistic regression analysis, operation position, residual stone, white blood cell count (10/µL), serum hemoglobin drop (g/dl), amount of physiological serum used (L), and positive renal pelvis urine culture were independently associated with SIRS. Inflammatory indices calculated from serum values, including SII, SIRI, and AISI, were directly associated with SIRS. ROC analysis demonstrated a moderate correlation between these indices and SIRS. DISCUSSION: The findings of this prospective study indicate that postoperative SIRS risk can be predicted preoperatively and intraoperatively using a combination of commonly utilized clinical parameters and serum-based inflammatory indices. Higher values of SII, SIRI, and AISI were moderately predictive of SIRS development. Identifying high-risk patients prior to or during PCNL may help clinicians implement early preventive strategies and optimize postoperative management.
Risk Factors for Ileus After Radical Gastrectomy for Gastric Cancer and Construction of a Nomogram Prediction Model.
Niu M, Qiao Y, Wang B … +1 more , Zhang J
Ther Clin Risk Manag · 2026 · PMID 41868412 · Full text
OBJECTIVE: To construct a nomogram prediction model for ileus after radical gastrectomy for gastric cancer. METHODS: The 424 gastric cancer patients were assigned into a modeling group of 297 cases and a validation group...
OBJECTIVE: To construct a nomogram prediction model for ileus after radical gastrectomy for gastric cancer. METHODS: The 424 gastric cancer patients were assigned into a modeling group of 297 cases and a validation group of 127 cases. The modeling group was assigned into the ileus group of 54 cases and the non ileus group of 243 cases based on the occurrence of postoperative ileus. LASSO regression analysis and multivariate logistic regression analysis were used to screen the influencing factors of ileus after radical gastrectomy for gastric cancer. The nomogram model was constructed for predicting ileus after radical gastrectomy for gastric cancer. The calibration curve was used to evaluate the calibration degree of the model. ROC curve was used to evaluate the model discrimination. The clinical decision curve was used to analyze the clinical applicability of the model. RESULTS: LASSO regression analysis and multivariate logistic regression analysis showed that age (OR=4.999), previous abdominal surgery (OR=3.836), operative time (OR=3.541), IL-6 (OR=1.339), and TNF-α (OR=8.254) were all independent risk factors for ileus after radical gastrectomy for gastric cancer (P<0.05). The deviation correction curves of the modeling group and the validation group were both close to the ideal curve, with Hosmer-Lemeshow test showed x=7.785, 6.145, P=0.236, 0.372; the AUC of the ROC curve was 0.940 (95% CI: 0.898~0.981) and 0.904 (95% CI: 0.855~0.954). Both the modeling group and the validation group had high net returns within the threshold probability ranges of 0.02~0.86 and 0.02~0.80. CONCLUSION: The nomogram prediction model constructed in this study can serve as an early warning indicator for ileus after radical gastrectomy for gastric cancer, guiding clinical decision-making.
Aspartate Aminotransferase-to-Platelet Ratio Index (APRI) as a Predictor of Mortality in Patients with Femoral Fracture: A Retrospective Cohort Analysis.
Kuo PJ, Wu SC, Hsu SY … +1 more , Hsieh CH
Ther Clin Risk Manag · 2026 · PMID 41868411 · Full text
BACKGROUND: Femoral fractures carry high mortality in elderly patients. The aspartate aminotransferase-to-platelet ratio index (APRI), a noninvasive liver function marker, may reflect physiological vulnerability. Its pro...
BACKGROUND: Femoral fractures carry high mortality in elderly patients. The aspartate aminotransferase-to-platelet ratio index (APRI), a noninvasive liver function marker, may reflect physiological vulnerability. Its prognostic role in trauma remains unclear. METHODS: We retrospectively analyzed 4,310 adult patients (2009-2023) with femoral fractures undergoing surgery. APRI was calculated on admission. The primary outcome was in-hospital mortality. Multivariable logistic regression and ROC analysis identified independent predictors and optimal APRI cut-off. RESULTS: Among 4,310 patients, 85 (2.0%) died in-hospital. Non-survivors had significantly higher APRI (1.4±1.5 vs 0.7±2.1, p = 0.008), higher AST levels, and greater injury severity. APRI independently predicted mortality (adjusted OR 1.57 per unit, 95% CI 1.41-1.98, p = 0.023). ROC analysis yielded an AUC of 0.670. An APRI ≥0.74 provided 55% sensitivity and 78% specificity. Patients with APRI ≥0.74 had higher mortality (4.9% vs 1.1%, adjusted OR 2.82, p < 0.001) and longer hospital stays. CONCLUSION: Given APRI's moderate predictive value for adverse outcomes, we cautiously recommend including APRI in preoperative risk assessment for hip fracture patients. This approach may help identify high-risk cases for targeted interventions.
Comparison of a Kidney Intensive Care Unit Healthcare-Led Model versus a Traditional Haemodialysis Nurse-Led Model for Continuous Renal Replacement Therapy: A Retrospective Observational Study.
Zhang T, Jiang G, Yan H … +9 more , Wang J, Lan X, Bai J, Deng Y, Zhang N, Gao Q, Shen Y, Wang X, Wei R
Ther Clin Risk Manag · 2026 · PMID 41859204 · Full text
BACKGROUND: The optimal organisational model for delivering continuous renal replacement therapy (CRRT) to critically ill patients remains a subject of investigation. OBJECTIVE: This study compared the impact of a kidney...
BACKGROUND: The optimal organisational model for delivering continuous renal replacement therapy (CRRT) to critically ill patients remains a subject of investigation. OBJECTIVE: This study compared the impact of a kidney intensive care unit (KICU) healthcare-led model with a traditional haemodialysis nurse-led model on key clinical process indicators and patient outcomes during CRRT. METHODS: In this retrospective observational study, patients requiring CRRT admitted to the KICU of a tertiary hospital between January 2022 and December 2023 were selected. Patients were divided into two groups based on the treatment leadership: the KICU group, where CRRT was led by intensive care unit supervising physicians and nurses certified in critical care blood purification techniques, and the control group, led by supervising physicians and haemodialysis nurses. Data were collected via the hospital information system and nursing records. After propensity score matching, 1180 patients were included in each group. Supplementary multivariable regression analyses were performed to provide adjusted effect estimates. Outcomes included treatment interruption rate, catheter-related infection rate, complication rate, actual delivered effluent dose, catheter insertion to treatment initiation time and patient satisfaction. RESULTS: The KICU group demonstrated a significantly lower overall complication rate (1.8% vs 3.7%, = 0.004) and a higher rate of achieving the prescribed effluent dose (87.7% vs 81.2%, < 0.001). Time to CRRT initiation was shorter in the KICU group (23.75 ± 2.43 vs 30.60 ± 6.36 minutes, < 0.05). Patient satisfaction was also higher ( < 0.05). No significant differences were found in treatment interruption or catheter-related infections. The benefits of the KICU model on these key outcomes remained statistically significant in multivariable-adjusted analyses. CONCLUSION: Continuous renal replacement therapy management by a dedicated KICU multidisciplinary team was associated with a lower complication rate, improved delivery of the prescribed dialysis dose, faster treatment initiation and higher patient satisfaction compared with a traditional model. These findings suggest that a structured, healthcare-led model can optimise the CRRT process for critically ill patients. Further multicentre studies are warranted to confirm these results.
A Narrative Review and Risk-Stratification Framework for Preventing LNG-IUS Expulsion in Adenomyosis.
Zhao J, Chen J, Wang X … +1 more , Wang H
Ther Clin Risk Manag · 2026 · PMID 41859203 · Full text
Levonorgestrel-releasing intrauterine system (LNG-IUS) expulsion rates are markedly elevated (15-37.5%) in patients with adenomyosis compared to those with normal uteri (3-10%), significantly compromising treatment effic...
Levonorgestrel-releasing intrauterine system (LNG-IUS) expulsion rates are markedly elevated (15-37.5%) in patients with adenomyosis compared to those with normal uteri (3-10%), significantly compromising treatment efficacy and adherence. Existing evidence on risk factor mitigation is fragmented, lacking a structured management framework. This narrative review synthesizes current literature to identify key determinants of expulsion-including uterine enlargement, intracavitary lesions, and insertion techniques-and evaluates preventive strategies such as GnRH-agonist pretreatment and imaging-guided placement. Its primary aim is to propose a novel, three-tiered risk-stratification model that tailors management (conventional, augmented, or advanced fixation approaches) to individual patient profiles based on anatomical, procedural, and clinical factors. This structured approach seeks to optimize LNG-IUS retention and resource allocation. Prospective validation through randomized controlled trials remains essential to establish evidence-based, personalized protocols.
Low-Dose Dexmedetomidine Reduces Median Effective Doses of Propofol Required for Successful Gastroscope Insertion: A Prospective Randomized Controlled Dose-Finding Trial.
Zhu Q, Hao PP, Cui LL … +2 more , Liu FK, Xue FS
Ther Clin Risk Manag · 2026 · PMID 41859202 · Full text
PURPOSE: Patients undergoing painless gastrointestinal endoscopy (GIE) typically receive propofol-based sedation. However, the exact dose of propofol when combined with low-dose dexmedetomidine for this procedure remains...
PURPOSE: Patients undergoing painless gastrointestinal endoscopy (GIE) typically receive propofol-based sedation. However, the exact dose of propofol when combined with low-dose dexmedetomidine for this procedure remains unclear. The objective of this study was to determine and compare the median effective doses (ED, the doses required for successful gastroscope insertion in 50% of the subjects) of propofol when used with low-dose dexmedetomidine (0.3 µg/kg) premedication versus propofol alone during painless GIE. PATIENTS AND METHODS: Adult outpatients aged 18 to 65 years scheduled for GIE were enrolled. Participants were randomized to receive either 0.9% saline (Group S) or 0.3 µg/kg of dexmedetomidine (Group D) intravenously over 5 min before induction with propofol. Using modified Dixon's up-and-down method (MDUDM), the initial induction dose of propofol was 1.5 mg/kg, adjusted in a step size of 0.1 mg/kg. ED of propofol required for successful endoscope insertion was calculated by averaging the midpoints of all sequential crossovers. Using isotonic regression analysis, ED and ED (the effective doses required for successful gastroscope insertion in 95% of the subjects) were then extrapolated. All adverse events during painless GIE were recorded. RESULTS: Thirty patients were enrolled per group. Using MDUDM, the ED of propofol for successful gastroscope insertion was significantly lower in Group D (1.48 ± 0.10 mg/kg) than in Group S (1.82 ± 0.16 mg/kg; < 0.001). The ED and ED of propofol were extrapolated to 1.80 mg/kg (83% confidence interval [CI], 1.649-1.882) and 2.10 mg/kg (83% CI, 2.081-2.124) for Group S, respectively, using isotonic regression analysis. These values were significantly lower in Group D, at 1.40 mg/kg (83% CI, 1.297-1.452) and 1.70 mg/kg (83% CI, 1.667-1.753). CONCLUSION: Premedication with low-dose dexmedetomidine (0.3 µg/kg) significantly reduces the median effective doses of propofol required for successful gastroscope insertion during painless GIE.
Ultrasound Assessment of Preoperative Gastric Contents for Predicting Aspiration Risk in Surgical Patients: A Scoping Review and Future Directions.
Li Y, Tang L, Zou S … +3 more , Zhu X, Zhang B, Xie C
Ther Clin Risk Manag · 2026 · PMID 41859201 · Full text
INTRODUCTION: This scoping review aims to summarise studies evaluating gastric contents in surgical patients using preoperative ultrasound, discuss current challenges, and propose future directions. METHODS: The system r...
INTRODUCTION: This scoping review aims to summarise studies evaluating gastric contents in surgical patients using preoperative ultrasound, discuss current challenges, and propose future directions. METHODS: The system retrieved data from 8 databases, including PubMed, with a search period spanning from the inception to May 11, 2025. The scoping review follows the JBI scoping review framework and the PRISMA-ScR reporting guidelines. RESULTS: A total of 44 studies were included. The research involved various perioperative populations and surgical procedures, with a "full stomach" rate ranging from 0% to 57.7%. Ultrasound operators included anesthesiologists, sonographers, and medical consultants. Assessment methods comprised qualitative, quantitative, or combined approaches. Evaluation metrics included gastric contents nature, Perlas 3-point grading system, gastric antral cross-sectional area (CSA), and gastric volume. CONCLUSION: Preoperative gastric ultrasound can provide information about gastric contents, thereby aiding in the identification of aspiration risk and enabling the adoption of appropriate anaesthesia strategies. However, existing studies still face limitations, including restricted study populations and sample sizes, variations in operator training, a lack of consensus on an evaluation metric threshold value, and diverse gastric volume calculation models. Future studies should expand their scale, enhance training for clinicians in gastric ultrasound, and standardise assessment positions, threshold values, and selection criteria for calculation models. Furthermore, we believe that integrating artificial intelligence with gastric ultrasound can overcome the limitations of manual measurement, offering a direction for precise and convenient preoperative assessment of gastric contents.
Impact of the Charlson Comorbidity Index on the Short-Term and Long-Term Prognoses of Patients with Coronary Artery Disease Undergoing Percutaneous Coronary Intervention.
Ma Y, Luo H, Zhao H … +6 more , Zhao O, Ma L, Yang W, Yi M, Sun L, Li J
Ther Clin Risk Manag · 2026 · PMID 41859200 · Full text
BACKGROUND: The Charlson Comorbidity Index (CCI) is widely used to assess comorbidity burden, its prognostic role in patients undergoing percutaneous coronary intervention (PCI) remains underexplored. This study aimed to...
BACKGROUND: The Charlson Comorbidity Index (CCI) is widely used to assess comorbidity burden, its prognostic role in patients undergoing percutaneous coronary intervention (PCI) remains underexplored. This study aimed to investigate the impact of CCI on in-hospital adverse events and long-term major adverse cardiovascular and cerebrovascular events (MACCEs) in patients with coronary artery disease (CAD) treated with PCI. METHODS: A total of 572 consecutive CAD patients who underwent PCI between October 2016 and October 2020 were included. Patients were divided into low (CCI ≤ 4, n = 453) and high (CCI > 4, n = 119) comorbidity burden groups. Clinical characteristics, in-hospital adverse events, and long-term MACCEs were compared. Multivariate logistic regression and Cox proportional hazards models were used to identify independent predictors of outcomes. RESULTS: Compared to the low-CCI group, patients in the high-CCI group were older, more frequently male, and had higher rates of diabetes, left main CAD, and multivessel disease (all p < 0.05). In-hospital adverse events were significantly more common in the high-CCI group (13.4% vs 2.0%, p < 0.01). CCI was an independent predictor of in-hospital events (OR = 3.13; 95% CI: 1.40-7.02). During a median follow-up of five years, the high-CCI group had a significantly higher incidence of MACCEs (51.3% vs 6.2%; HR = 2.72; 95% CI: 2.25-3.30, p < 0.01). CONCLUSION: CCI is a significant and independent predictor of both in-hospital and long-term adverse outcomes in CAD patients undergoing PCI.
Clinical Outcomes and Safety of Ureteral Catheter-Assisted Antegrade Guidewire Intubation in the Laparoscopic-Endoscopic Rendezvous Procedure for Cholelithiasis with Choledocholithiasis: A Retrospective Cohort Study.
Shi B, Feng J, Hu P … +7 more , Lv S, Wang B, Wang Q, Fang Z, Wang A, Zhang W, Zhang F
Ther Clin Risk Manag · 2026 · PMID 41859199 · Full text
BACKGROUND AND PURPOSE: The laparoscopic-endoscopic rendezvous procedure, which integrates laparoscopic cholecystectomy with intraoperative endoscopic retrograde cholangiopancreatography (ERCP), is an established therape...
BACKGROUND AND PURPOSE: The laparoscopic-endoscopic rendezvous procedure, which integrates laparoscopic cholecystectomy with intraoperative endoscopic retrograde cholangiopancreatography (ERCP), is an established therapeutic strategy for patients with cholelithiasis and concomitant choledocholithiasis. This study evaluated the impact of ureteral catheter-assisted antegrade guidewire intubation on the procedural success rate and duration of the rendezvous technique, with additional assessment of safety and clinical efficacy. METHODS: Clinical data were retrospectively analyzed from patients with cholelithiasis and concomitant choledocholithiasis who underwent laparoscopic cholecystectomy at the South Campus of Taizhou Hospital (Enze Hospital), Zhejiang Province, between May 2019 and December 2022. A total of 116 patients were assigned to either a control group or an intervention group in which ureteral catheter-assisted guidewire insertion was employed. RESULTS: The success rate of antegrade guidewire intubation was 98.3% in the intervention group, compared to 91.2% in the control group. The intervention group demonstrated a statistically significant reduction in guidewire insertion time ( < 0.05). No statistically significant differences were observed between groups in terms of intraoperative hospitalization costs, total hospitalization duration, postoperative serum amylase levels or postoperative hospitalization duration ( > 0.05). The total operative duration tended to be lower but did not reach statistical significance in the intervention group compared to the control group, with a p-value of 0.054. No cases of postoperative bile leakage were reported. In the control group, the incidence of acute pancreatitis was 2%, and the incidence of hyperamylasemia was 28.8%. In the intervention group, hyperamylasemia occurred in 25.9% of cases, with no reported instances of acute pancreatitis. Additionally, one patient in the control group developed a pulmonary embolism, and two patients developed ascites accompanied by fever. CONCLUSION: The use of ureteral catheter-assisted antegrade guidewire intubation during the laparoscopic-endoscopic rendezvous procedure appears to be a safe and clinically effective approach for managing cholelithiasis and concomitant choledocholithiasis. This technique is associated with a high success rate of guidewire realignment, reduced procedural duration, and a lower incidence of procedure-related complications.
Efficacy of an Intelligent Closed-Loop Warming System in Preventing Perioperative Hypothermia and Improving Recovery in Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial.
Chen R, Du Y, He X … +7 more , Fan J, Zhang Y, Bai Y, Liu M, Shen W, Yu T, Wang G
Ther Clin Risk Manag · 2026 · PMID 41853688 · Full text
PURPOSE: To evaluate the efficacy of an intelligent closed-loop warming system compared with conventional warming methods in preventing perioperative hypothermia and improving postoperative recovery in patients undergoin...
PURPOSE: To evaluate the efficacy of an intelligent closed-loop warming system compared with conventional warming methods in preventing perioperative hypothermia and improving postoperative recovery in patients undergoing video-assisted thoracoscopic surgery (VATS). PATIENTS AND METHODS: A total of 118 adult patients scheduled for elective VATS were randomly assigned to the conventional warming group (n = 59) or the intelligent closed-loop warming group (n = 59). Conventional warming management employed an underbody warming blanket, supplemented with blood and fluid warming when core temperature fell below 36.0°C. The intelligent closed-loop warming system utilized wireless sensors and an automated feedback-controlled warming unit to maintain core temperature between 36.5°C and 37.0°C. Core temperature was continuously monitored from anesthesia induction to post-anesthesia care unit (PACU) discharge. The primary outcome was the incidence of perioperative hypothermia (core temperature < 36.0°C). Secondary outcomes included mean and minimum intraoperative temperature, extubation time, PACU temperature, postoperative complications, length of hospital stay (HLOS), and hospitalization cost. RESULTS: Perioperative hypothermia occurred in significantly fewer patients in the intelligent group than in the conventional group (25.4% vs. 76.3%, < 0.001). The intelligent closed-loop warming system maintained higher mean (36.40 ±0.33°C vs. 35.96 ± 0.45°C, < 0.001) and minimum (36.09 ± 0.35°C vs. 35.58 ± 0.58°C, < 0.001) core temperatures. Extubation time was shorter (5.12 ± 2.31 min vs. 9.69 ± 8.27 min, < 0.001), PACU temperature was higher ( = 0.001), postoperative fever incidence was lower (0% vs. 13.6%, = 0.006), and HLOS was reduced (10.02 ± 3.87 vs. 11.63 ± 4.25 days, = 0.034). No significant differences were observed in infection rate or hospitalization cost. CONCLUSION: The intelligent closed-loop warming system effectively prevents perioperative hypothermia and enhances postoperative recovery in VATS patients. It provides precise thermal regulation and better clinical outcomes, supporting its application in perioperative temperature management.
Therapeutic Efficacy of Full-Endoscopic Unilateral Laminotomy with Bilateral Decompression for Degenerative Cervical Myelopathy: A Retrospective Cohort Study.
Gong W, Tang S, Wu W … +2 more , Lu H, Ma X
Ther Clin Risk Manag · 2026 · PMID 41815508 · Full text
BACKGROUND: This study aims to evaluate the efficacy and potential advantages of full-endoscopic unilateral laminotomy with bilateral decompression (FE-ULBD) for degenerative cervical myelopathy (DCM) as a minimally inva...
BACKGROUND: This study aims to evaluate the efficacy and potential advantages of full-endoscopic unilateral laminotomy with bilateral decompression (FE-ULBD) for degenerative cervical myelopathy (DCM) as a minimally invasive posterior decompression technique. METHODS: We retrospectively reviewed 123 patients treated between January 2020 and January 2025. Procedures were selected based on predefined clinical/imaging indications and shared decision-making. FE-ULBD was primarily applied to 1-2-level posterior compression, whereas multilevel disease underwent laminoplasty or laminectomy with internal fixation. Patients were assigned to Group A (FE-ULBD, n=28), Group B (single-door laminoplasty, n=60), and Group C (laminectomy with internal fixation, n=35). Baseline characteristics, perioperative parameters (operative time, blood loss, length of stay), clinical outcomes (mJOA at multiple time points and modified MacNab criteria), and complications were compared among groups. In Group A, intervertebral height, C2-C7 Cobb angle, and dural sac cross-sectional area (DSCA) were evaluated pre- and postoperatively. Outcomes were assessed preoperatively, at 3 months postoperatively, and at final follow-up (mean 8.07 ± 2.24 months). RESULTS: Group A had significantly shorter operative time, reduced blood loss, and a shorter hospital stay compared to Groups B and C (all P<0.05). mJOA improved significantly from baseline in all groups at 3 months and at final follow-up (within-group P<0.05). No significant between-group differences were observed in absolute mJOA or ΔmJOA at either time point (all P>0.05). The excellent/good rate by modified MacNab criteria at final follow-up was 89.3% in Group A, 76.7% in Group B, and 77.1% in Group C (P>0.05). The overall complication rate was lower in Group A (P<0.05). In Group A, intervertebral height and C2-C7 Cobb angle showed no significant postoperative change, whereas DSCA increased significantly (P<0.05). CONCLUSION: In this retrospective cohort, FE-ULBD was associated with less perioperative morbidity and fewer complications while providing neurological recovery comparable to conventional posterior approaches in selected DCM patients.
A Narrative Review of Remnant Cholesterol as an Independent Atherogenic Lipoprotein in Type 2 Diabetes: Pathophysiology and Clinical Implications.
Natsir RM, Halimah E, Diantini A … +1 more , Levita J
Ther Clin Risk Manag · 2026 · PMID 41799835 · Full text
BACKGROUND: T2DM is characterized not only by chronic hyperglycemia but by a complex disturbance in triglyceride-rich lipoprotein (TRL) metabolism. Among the resulting lipid fractions, remnant cholesterol (RC) has emerge...
BACKGROUND: T2DM is characterized not only by chronic hyperglycemia but by a complex disturbance in triglyceride-rich lipoprotein (TRL) metabolism. Among the resulting lipid fractions, remnant cholesterol (RC) has emerged as a potentially independent atherogenic driver that persists despite optimal low-density lipoprotein cholesterol (LDL-C) control. Growing evidence suggests that RC integrates metabolic dysregulation, insulin resistance (IR), and inflammatory signaling, thereby contributing to the "residual risk" of vascular complications in DM. OBJECTIVE: To evaluate whether RC functions as an independent atherogenic lipoprotein in T2DM and to assess its clinical implications for risk prediction and therapeutic targeting. METHODS: This narrative review examined relevant cohort studies, genetic analyses, mechanistic experiments, and clinical trials published in the last decade with emphasis on RC definitions, measurement approaches, associations with macrovascular and microvascular outcomes, and therapeutic modulation. RESULTS: RC elevation in T2DM reflects impaired TRL clearance driven by IR, hepatic VLDL overproduction, and adipose lipolysis. Across large cohorts, RC consistently predicts incident T2DM, major cardiovascular events, renal deterioration, and peripheral arterial disease independent of LDL-C, triglycerides, HbA1c, and inflammatory markers. RC trajectories and visit-to-visit variability further strengthen risk discrimination, suggesting that dynamic fluctuations reflect underlying metabolic instability. Thresholds associated with vascular injury vary across populations (≈0.56-0.80 mmol/L). Therapeutically, high-intensity statins, EPA-based therapy, and emerging APOC3/ANGPTL3 inhibitors lower RC to varying degrees, yet outcome trials targeting RC specifically remain scarce. CONCLUSION: RC represents a distinct atherogenic entity in T2DM. Its strong and independent associations with cardiovascular and renal events position it as a critical, yet underrecognized, contributor to diabetic vascular risk. Incorporating RC into routine risk assessment and exploring targeted interventions may bridge the persistent gap between LDL-C lowering and actual event reduction. Future studies should prioritize standardized measurement, mechanistic elucidation, and randomized trials directly testing whether lowering RC can modify clinical outcomes.
Association Between Serum Vitamin D Levels and Metformin Efficacy in Obese Type 2 Diabetes Patients: A Retrospective Cohort Study Based on HbA1c Reduction.
Wang Y, Liu H, Li Y … +3 more , Wang X, He C, Wei Z
Ther Clin Risk Manag · 2026 · PMID 41716534 · Full text
PURPOSE: To investigate the association between baseline serum 25-hydroxyvitamin D [25(OH)D] levels and glycemic response to metformin monotherapy in obese adults with type 2 diabetes mellitus (T2DM). PATIENTS AND METHOD...
PURPOSE: To investigate the association between baseline serum 25-hydroxyvitamin D [25(OH)D] levels and glycemic response to metformin monotherapy in obese adults with type 2 diabetes mellitus (T2DM). PATIENTS AND METHODS: This single-center retrospective cohort study analyzed the electronic medical records (January 2021-December 2023) of obese T2DM patients initiating metformin monotherapy. Participants were stratified by baseline 25(OH)D levels: deficiency (<20 ng/mL, n = 256) or sufficiency (≥20 ng/mL, n = 171). Propensity score matching (1:1) balanced covariates (age, sex, BMI, HbA1c, diabetes duration, comorbidities, season), yielding 142 matched pairs (n = 284). The primary outcome was absolute HbA1c reduction (ΔHbA1c) at 3 months. Multivariable linear regression, subgroup, and sensitivity analyses were performed. RESULTS: In the matched cohort, vitamin D-sufficient patients achieved a clinically meaningful and statistically significant greater HbA1c reduction versus vitamin D-deficient patients (mean difference: 0.34%; 95% CI: 0.16-0.52%; p < 0.001). Baseline 25(OH)D positively correlated with ΔHbA1c (r = 0.32, p < 0.001). Multivariable regression confirmed that vitamin D sufficiency independently predicted greater ΔHbA1c (adjusted β = 0.41%, 95% CI: 0.22-0.60%, p < 0.001). Subgroup analyses revealed enhanced effects in females (p-interaction = 0.018), patients >60 years (β = 0.49% vs ≤60 years 0.33%, p-interaction = 0.009), and baseline HbA1c ≥8.5% (β = 0.56% vs <8.5% 0.21%, p-interaction = 0.003). Adverse events were comparable between groups. CONCLUSION: Higher baseline vitamin D levels (≥20 ng/mL) are associated with significantly improved metformin efficacy in obese T2DM patients, particularly among females, older adults, and those with poorer glycemic control. Vitamin D status may serve as a predictive biomarker for metformin response.
Retrospective Analysis: Comparative Effects of General Anesthesia versus Quadratus Lumborum Block-Supplemented General Anesthesia on Postoperative Outcomes in Patients Undergoing Laparoscopic Myomectomy.
Yan R, Kuang M
Ther Clin Risk Manag · 2026 · PMID 41532029 · Full text
BACKGROUND AND OBJECTIVE: This retrospective study analyzed to compare the effects of general anesthesia (GA) versus combined anesthesia (CA) on postoperative pain and negative emotions in patients undergoing uterine fib...
BACKGROUND AND OBJECTIVE: This retrospective study analyzed to compare the effects of general anesthesia (GA) versus combined anesthesia (CA) on postoperative pain and negative emotions in patients undergoing uterine fibroid surgery, providing evidence for optimizing anesthesia protocols aiming to achieve more effective analgesia and improve patient satisfaction scores. METHODS: A retrospective analysis was conducted on data from 148 patients who underwent uterine fibroid surgery at a tertiary hospital between April 2023 and December 2024. Patients were divided into a control group (GA) and a study group (CA) based on anesthesia type. The control group received conventional GA, while the study group received ropivacaine quadratus lumborum block (QLB) combined with GA. After propensity score matching (PSM), 74 patients were included in each group. The primary outcome was postoperative 2-12h visual analog scale (VAS) pain scores. Secondary outcomes included stress indicators (ACTH, Cor), emotional scales (SAS/SDS), cognitive function (MMSE), and sleep quality (PSQI). RESULTS: The study group had shorter anesthesia duration, postoperative flatus time, postoperative ambulation time, and hospital stay compared to the control group (all P<0.05). VAS scores at 2h, 4h, 8h, and 12h postoperatively were significantly lower in the study group (all P<0.05). Preoperative differences in emotional, stress, cognitive, and sleep indicators were not statistically significant (all P>0.05). Postoperatively, the study group showed significantly lower SAS/SDS scores, ACTH/Cor levels, and PSQI scores, alongside higher MMSE scores compared to the control group (all P<0.05). CONCLUSION: Combined anesthesia effectively reduces postoperative pain and negative emotions in uterine fibroid patients, lowers stress levels, improves sleep quality, and promotes rapid recovery, making it worthy of clinical promotion.
Safety and Efficacy Comparison of Ticagrelor versus Other P2Y12 Inhibitors in Combination with Oral Anticoagulants as a Part of DAPT/SAPT in Patients with Concomitant Atrial Fibrillation and Coronary Artery Disease: A Meta-Analysis.
Li Y, Gong J, Liu N
Ther Clin Risk Manag · 2025 · PMID 41497404 · Full text
OBJECTIVE: We performed a meta-analysis of randomized controlled trials to assess the safety and efficacy of ticagrelor or other P2Y12 inhibitors in combination with oral anticoagulants as a part of DAPT/SAPT for the pat...
OBJECTIVE: We performed a meta-analysis of randomized controlled trials to assess the safety and efficacy of ticagrelor or other P2Y12 inhibitors in combination with oral anticoagulants as a part of DAPT/SAPT for the patients with atrial fibrillation (AF) and acute coronary disease (ACS) or undergoing percutaneous coronary intervention (PCI). METHODS: We searched PubMed, Web of Science and ClinicalTrials.gov for randomized controlled trials (published from January 1, 1998, up to June 6, 2023; no language restrictions) comparing safety and efficacy of ticagrelor and DOACs or VKAs combination treatment arm with or without aspirin to other P2Y12 inhibitors treatment strategies. Main endpoints were clinically relevant bleeding as safety outcomes, all-cause mortality, and major adverse cardiovascular events (MACE) as efficacy outcomes. RESULTS: Of 248 identified studies, 3 were eligible and were included in our analysis (N= 9463 participants). Ticagrelor and DOAC or VKA combination treatment with or without aspirin strategy was associated with an increased rate of bleeding compared with clopidogrel (odds ratio [OR] 1.39, 95% CI 1.15 to 1.67, I=0%). MACE was similar between ticagrelor versus clopidogrel (OR 1.00, 95% CI 0.54 to 1.86, I=68.1%) and between ticagrelor versus prasugrel (OR 0.86, 95% CI 0.28 to 2.65, I=0%). CONCLUSION: The use of ticagrelor is associated with significantly higher rates of bleeding when compared with clopidogrel in patients with concomitant atrial fibrillation and coronary artery disease.
Prehospital Tranexamic Acid Combined with Blood Transfusion Reduced the Short-Term Mortality Risk in Trauma Patients at Risk for Hemorrhage.
Qian Z, Yang B
Ther Clin Risk Manag · 2025 · PMID 41497403 · Full text
BACKGROUND: Hemorrhage is a leading cause of preventable death in trauma. While both blood transfusion and tranexamic acid (TXA) improve outcomes, the combined effect of prehospital TXA and transfusion remains uncertain....
BACKGROUND: Hemorrhage is a leading cause of preventable death in trauma. While both blood transfusion and tranexamic acid (TXA) improve outcomes, the combined effect of prehospital TXA and transfusion remains uncertain. This study aims to evaluate the impact of prehospital TXA combined with blood transfusion on short-term mortality in trauma patients at risk for hemorrhage. METHODS: We performed a retrospective cohort study of 408 adult trauma patients at risk for hemorrhage admitted between 2018 and 2023. Patients were grouped into transfusion only (n=240) or prehospital TXA plus transfusion (n=168). The primary outcome was 30-day mortality. Secondary outcomes included 24-hour mortality, transfusion requirements, multiple organ failure (MOF), and venous thromboembolism (VTE). RESULTS: Compared with transfusion alone, prehospital TXA plus transfusion significantly reduced 30-day mortality (14.3% vs 31.3%, p<0.01) and 24-hour mortality (6.0% vs 19.6%, p<0.01). The TXA group also had lower MOF incidence (14.3% vs 28.7%, p<0.01) and required less plasma and crystalloid resuscitation, without an increase in VTE (p=0.17). Kaplan-Meier analysis confirmed a survival advantage (log-rank p<0.01), and multivariate Cox regression identified combination therapy as an independent predictor of reduced 30-day mortality (HR=2.16, 95% CI: 1.35-3.46, p<0.01). CONCLUSION: Prehospital TXA combined with transfusion significantly improves short-term survival and reduces organ failure in bleeding trauma patients, without increasing thromboembolic risk. These findings support early integration of TXA into prehospital transfusion protocols.
Safety and Efficacy of Intra-Osseous versus Intravenous Vascular Access for Out-of-Hospital Cardiac Arrest: A Systematic Review and Meta-Analysis.
Cai M, Dai Y
Ther Clin Risk Manag · 2025 · PMID 41488200 · Full text
BACKGROUND: The immediate administration of drugs and fluids is critical for successful resuscitation in out-of-hospital cardiac arrest (OHCA). Vascular access selection plays a pivotal role in ensuring timely delivery o...
BACKGROUND: The immediate administration of drugs and fluids is critical for successful resuscitation in out-of-hospital cardiac arrest (OHCA). Vascular access selection plays a pivotal role in ensuring timely delivery of therapeutic interventions during OHCA management. This study aims to compare the safety and efficacy of intraosseous (IO) and intravenous (IV) access in OHCA management. METHODS: We conducted a comprehensive search of PubMed, EMbase, Google Scholar, and the Cochrane Library databases to identify studies published up to February 20th, 2025, evaluating IO and IV access in OHCA patients. The outcomes of interest included return of spontaneous circulation (ROSC), survival from hospital admission to discharge, neurological outcome, comorbidities, and access time. RESULTS: Twenty-three studies, comprising 48945 cases of IO access and 188966 cases of IV access for OHCA management, were included. Overall, the rate of favorable neurological outcome was similar between patients with IO and IV access (odds ratio [OR] = 0.73; 95% confidence interval [CI] = 0.37 to 1.45, I=95.3%). IO access was associated with significantly lower odds of shockable rhythms in both adult (OR = 0.77; 95% CI = 0.70 to 0.85, I=86%) and pediatric (OR = 0.20; 95% CI = 0.12 to 0.33) patients. Additionally, IO access was linked to a lower rate of ROSC in pediatric OHCA patients (OR = 0.30; 95% CI = 0.21 to 0.42). Prospective studies and those with unadjusted time to intervention analysis demonstrated markedly lower rates of survival at discharge, favorable neurological outcome, and ROSC in the IO group compared to the IV group. It should also be noted that the interpretation of the results should take into account the high heterogeneity and potential biases, despite the corresponding subgroup analyses we conducted. CONCLUSION: In OHCA management, IO access may be associated with less favorable outcomes in terms of survival, neurological function, and ROSC compared to IV access. Further research is needed to address limitations and provide more robust evidence regarding the comparative effectiveness of intraosseous and intravenous access in this clinical setting.
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