Therapeutics And Clinical Risk Management[JOURNAL]
Sun
200 papers
The Association Between Preoperative Triglyceride Glucose Index and Postoperative Adverse Cardiovascular Events in Non-Cardiac Surgery: A Single-Center Study From China.
Hao J, Qu L, Yang Y … +2 more , Sun Y, Xu G
Ther Clin Risk Manag · 2025 · PMID 40248335 · Full text
BACKGROUND: The incidence of postoperative adverse cardiovascular events (PACE) in non-cardiac surgery has significantly increased, severely affecting surgical outcomes and patient prognosis. This study investigates the...
BACKGROUND: The incidence of postoperative adverse cardiovascular events (PACE) in non-cardiac surgery has significantly increased, severely affecting surgical outcomes and patient prognosis. This study investigates the relationship between preoperative triglyceride-glucose (TyG) index and PACE in patients who underwent non-cardiac surgery. METHODS: We conducted a single-center retrospective study, including adult patients (age ≥18 years) who underwent non-cardiac surgery. Univariate and multivariate logistic regression analyses assessed the relationship between the TyG index and PACE. Nonlinear correlations were investigated using restricted cubic splines (RCS). Additionally, subgroup analysis was performed to evaluate the relationship between the TyG index and PACE in different subsamples. RESULTS: 16,066 patients were studied, among which 1505 cases (9.37%) developed PACE, with a median TyG index of 8.61 (8.22, 9.07). Using the lowest quartile of the TyG index as a reference, the fully adjusted (ORs) (95% CIs) for PACE in the second, third, and fourth quartiles of the TyG index were 1.78 (1.49~2.11), 2.16 (1.81~2.59), and 2.30 (1.88~2.83), respectively. After adjusting for all confounding factors, we found that patients with the highest TyG index had a 68% increased risk of PACE (OR 1.68, 95% CI 1.50~1.90). The results of the subgroup analysis were similar to those of the primary analysis. The RCS model suggests a linear positive correlation between the TyG index and the risk of PACE occurrence. (P for overall < 0.001, P for nonlinear = 0.547). CONCLUSION: This cohort study indicates that preoperative TyG index is linearly and positively correlated with an increased incidence of PACE in the non-cardiac surgery population. This finding suggests that intensifying the evaluation of the TyG index may provide a more convenient and effective tool for identifying individuals at risk of PACE during non-cardiac surgeries.
Association of Prognostic Nutritional Index with Post-Discharge Bleeding After Percutaneous Coronary Intervention in ACS Patients on DAPT.
Elkenany NM, Sabah ZU, Agiba NA … +9 more , Elmahdy HK, Elsherbiny EAY, Said SRA, Nassef EM, Alhawy AME, Ahmed MSM, Elsharkawy AMS, Hussein AMM, Elmalah AA
Ther Clin Risk Manag · 2025 · PMID 40231032 · Full text
PURPOSE: Malnutrition increases bleeding risk by reducing thrombogenicity, impairing platelet aggregation, prolonging bleeding time, and promoting systemic inflammation, which affects vascular permeability and angiogenes...
PURPOSE: Malnutrition increases bleeding risk by reducing thrombogenicity, impairing platelet aggregation, prolonging bleeding time, and promoting systemic inflammation, which affects vascular permeability and angiogenesis. The Prognostic Nutritional Index (PNI), calculated from serum albumin and lymphocyte count, reflects both nutritional and inflammatory status. This study aimed to assess PNI's association with bleeding risk in acute coronary syndrome (ACS) patients on dual antiplatelet therapy (DAPT). PATIENTS AND METHODS: This prospective, single-center observational cohort study enrolled 1843 patients presenting with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI). ROC analysis determined 42.7 as the optimal PNI cut-off value for risk stratification. Participants were stratified into distinct groups based on Prognostic Nutritional Index (PNI) cut-off values, a composite marker derived from serum albumin levels and peripheral lymphocyte counts, reflecting both nutritional and inflammatory status. Patients were prospectively followed for 12 months post-discharge to assess the occurrence of actionable bleeding events, with the aim of evaluating the association between PNI and post-PCI bleeding risk. RESULTS: The study cohort had a mean age of 66.4, with 65.16% male. After PCI, 98.04% were on DAPT. Patients were divided into Group I (PNI ≥ 42.7, n = 1290) and Group II (PNI < 42.7, n = 553). During follow-up, 5.58% of patients experienced actionable bleeding, with 3.5% in Group I and 10.3% in Group II (p < 0.0001). Multivariable Cox regression analysis revealed that PNI < 42.7 was a significant independent predictor of bleeding (HR: 1.7; 95% CI: 1.1-2.5; p < 0.003). CONCLUSION: Baseline PNI is an independent predictor of post-discharge bleeding in ACS patients on DAPT after PCI, suggesting it could be a valuable tool for risk stratification of bleeding in these patients.
The Application of Deep Brain Stimulation on Multiple Sclerosis Tremors and the Emerging Targets: A Mini-Review.
Zhang Z, Tang H, Li Y … +1 more , Tan Y
Ther Clin Risk Manag · 2025 · PMID 40196423 · Full text
Multiple sclerosis (MS) tremors, which are a common cause of disability, do not always respond to pharmacological treatment. Contrastingly, deep brain stimulation (DBS) in the thalamic or subthalamic areas (especially in...
Multiple sclerosis (MS) tremors, which are a common cause of disability, do not always respond to pharmacological treatment. Contrastingly, deep brain stimulation (DBS) in the thalamic or subthalamic areas (especially in the zona incerta, ZI) has prompted a response in suppressing MS tremors. In this study, we searched the relevant literature to further investigate the positive and negative effects of using DBS planted in different brain areas to suppress MS tremors. The unique effects of GABAergic agents from the ZI pertain to both the basal ganglia thalamocortical and cerebellar thalamocortical loops, in addition to the brain stem motor effector, where tremor oscillation may be transmitted. From this, the ZI is an effective target for ameliorating MS tremors through surgical treatment. Stimulation of the ZI, even bilaterally, could better control MS tremors, and with fewer side effects than targeting the thalamic area. Thus, the ZI is a promising target for regulating MS tremors. This review on MS tremor suppression will help to further understand the benefits of DBS on the ZI compared to DBS on the thalamic area in terms of managing MS tremors.
Recurrent Rhegmatogenous Retinal Detachment: Characteristics, Risk Factors, and Outcomes.
Aleshawi A, Al-Dwairi R, Saleh OA … +6 more , Adi S, Al Beiruti S, Alasheh A, Alsaadi MA, Ouda ZH, Allouh MZ
Ther Clin Risk Manag · 2025 · PMID 40191804 · Full text
PURPOSE: Rhegmatogenous retinal detachment (RRD) is a severe retinal disorder that can lead to vision impairment and potentially blindness. After RRD repair surgery, every vitreoretinal surgeon aims to understand the cha...
PURPOSE: Rhegmatogenous retinal detachment (RRD) is a severe retinal disorder that can lead to vision impairment and potentially blindness. After RRD repair surgery, every vitreoretinal surgeon aims to understand the characteristics of the RRD and to achieve permanent flattening without any recurrence. This study aimed to identify factors predisposing patients to recurrent RRD. PATIENTS AND METHODS: This retrospective study was conducted at King Abdullah University Hospital and included all patients who underwent pars plana vitrectomy for RRD repair between January 2015 and December 2023. All demographic, clinical, operative, and outcome data were extracted. The primary outcome was to assess the risk factors affecting the recurrence of RRD. The secondary outcome included factors affecting the final status (flat or detached) of the retina. Using proper statistical methods, the results were generated. RESULTS: The study comprised 348 patients with primary RRD, of whom 44.5% had a previous ocular surgical history. The rate of recurrent RRD was 28.2%. At the last follow-up, 12.6% of the whole patients had persistent retinal detachment without anatomical successful reattachment. Superior-based RRD was the most common type, affecting 145 of 290 patients, and macular involvement in the RRD was observed in 80% of the cases. Recurrent RRD was higher in younger ages, longer duration of symptoms, extensive total type of RRD, involvement of inferior quadrants, detached macula, presence of proliferative vitreoretinopathy, and insufficient prophylactic laser retinopexy (p < 0.05). On multivariate logistic analysis, extensive total RRD, presentation duration, and insufficient prophylactic laser retinopexy were considered as a significant independent factor. CONCLUSION: Duration of symptoms, involvement of more quadrants, and insufficient laser retinopexy could influence RRD recurrence. These results may coincide with previous literature but provide insights into the newly investigated population. Increasing the awareness of RRD symptoms, identifying high-risk patients, and ensuring prompt surgical intervention may reduce RRD-related complications and decrease the rate of recurrence.
Retrospective Study on the Comparative Efficacy of Intra-Articular Injection and Photodynamic Therapy in the Treatment of TMD.
Wei X, Gao J, Tian Z … +3 more , Zhao F, Wang H, Yan W
Ther Clin Risk Manag · 2025 · PMID 40166374 · Full text
OBJECTIVE: To compare the effectiveness of intra-articular injection and photodynamic therapy (PDT) in the treatment of temporomandibular joint disorder (TMD). METHODS: A retrospective analysis was conducted on the clini...
OBJECTIVE: To compare the effectiveness of intra-articular injection and photodynamic therapy (PDT) in the treatment of temporomandibular joint disorder (TMD). METHODS: A retrospective analysis was conducted on the clinical data of 91 TMD patients admitted to our hospital from August 2022 to February 2024. Patients were divided into the control group (n=45, treated with intra-articular injection) and the observation group (n=46, treated with PDT). Clinical outcomes, pain levels [Visual Analog Scale (VAS)], maximum mouth opening, masseter muscle pain threshold, Fricton Temporomandibular Joint Index (including Joints Number (JN), Joint Pain (JP), Muscle Masseter (MM), Disc Displacement Index (DI), Mandibular Position (MP), Pain Index (PI), and Clinical Measurement Index (CMI)], oral health [Oral Health Impact Profile-14 (OHIP-14)], and quality of life [Short Form-36 (SF-36)] were compared between the two groups. RESULTS: The total effective rate in the observation group (91.30%) was significantly higher than the control group (75.56%) (p<0.05). VAS scores showed significant group (F=5.487), time (F=8.356), and interaction effects (F=6.931) (p<0.05). Within-group comparisons showed a significant decrease in VAS scores 1 and 4 weeks after treatment (p<0.05), with the observation group showing lower VAS scores than the control group (p<0.05). After treatment, maximum mouth opening and masseter muscle pain threshold increased in both groups, with the observation group showing greater improvement (p<0.05). Fricton Temporomandibular Joint Index scores decreased significantly in both groups, with the observation group showing a more significant reduction (p<0.05). OHIP-14 scores decreased, and SF-36 scores increased in both groups, with the observation group showing greater improvement (p<0.05). CONCLUSION: PDT is more effective than intra-articular injection in treating TMD. PDT further relieves pain, increases maximum mouth opening and masseter muscle pain threshold, reduces the Fricton index, and improves oral health and quality of life.
A Novel Three-Step Technique for the Simple, Safe, and Efficient Complete Removal of Idiopathic Epiretinal Membrane.
Wei Q, Cai C, Yi L … +4 more , Li M, Zhang W, Chen J, Qiu Q
Ther Clin Risk Manag · 2025 · PMID 40160477 · Full text
PURPOSE: This study aimed to assess a new three-phase method's efficacy and safety in treating idiopathic macular epiretinal membrane (ERM). METHODS: The novel technique involved a precise sequence: flap creation - wide...
PURPOSE: This study aimed to assess a new three-phase method's efficacy and safety in treating idiopathic macular epiretinal membrane (ERM). METHODS: The novel technique involved a precise sequence: flap creation - wide margin- extensive peeling. Following the pars plana vitrectomy (PPV), to locate the epiretinal membrane, we stained the internal limiting membrane (ILM) with indocyanine green (ICG), using the stained ILM beneath as a guide to initiate the ERM flap. To minimize the force required for membrane peeling and traction on the underlying retina, we utilized a curved DSP scraper to form a wide-margin parallel arc along the inner aspect of the vascular arcade from the nasal to temporal side. Subsequently, the wide margin of the ERM was grasped tightly with ILM forceps, and traction was applied towards the central macular area to peel off the entire membrane. Finally, ICG staining was applied to ensure that the ERM was completely removed. The technique requires precise mastery of the three-step surgical skills and proficient use of specialized instruments. RESULTS: In a sample of 55 cases, the surgery achieved significant treatment outcomes. All surgeries were successfully performed with an average duration of 4.23±0.34 minutes for ERM peeling. At the 12-month postoperative follow-up, the mean logarithm of the minimum angle of resolution best-corrected visual acuity (BCVA) significantly improved from 4.74±0.30 to 4.27±0.34. The average central macular thickness (CMT) significantly decreased from 503.64±111.88μm to 353.38±72.64μm. There are no intraoperative or postoperative complications and there was no recurrence. CONCLUSION: The novel technique is a fast, simple, effective and safe surgical technique for treating idiopathic ERM. It significantly improves visual outcomes and reduces the occurrence of complications and recurrence.
Serum RIPK1, Acute Lung Injury, and Outcomes in Severe Traumatic Brain Injury: A Multicenter Prospective Study.
Cai L, Dou X, Dong W … +8 more , Zou K, Zhang L, Hong H, Zhang X, Liu J, Tian D, Wu X, Zhang J
Ther Clin Risk Manag · 2025 · PMID 40129517 · Full text
BACKGROUND: Receptor-interacting protein kinase-1 (RIPK1), a regulator of necroptosis, is involved in acute brain injury and acute lung injury (ALI). Here, serum RIPK1 levels were measured after severe traumatic brain in...
BACKGROUND: Receptor-interacting protein kinase-1 (RIPK1), a regulator of necroptosis, is involved in acute brain injury and acute lung injury (ALI). Here, serum RIPK1 levels were measured after severe traumatic brain injury (sTBI), with an endeavor to unveil its prognostic implications and mediation effects of ALI. METHODS: In this multicenter prospective study, serum RIPK1 levels were gauged in 100 healthy individuals and 158 sTBI patients in need of decompressive craniectomy for brain herniation. The collected materials encompassed the Glasgow Coma Scale (GCS), pupil enlargement status, basal cisternal shapes, ALI, etc. The extended Glasgow outcome scale (GOSE) was employed for estimating neurological impairments at posttraumatic 180-day mark. Multifactorial analytical methods were applied to assess relevancies. RESULTS: Patients, as opposed to controls, had markedly raised serum RIPK1 levels, with the even substantially higher levels in those with lower GCS scores, bilateral pupil enlargement or obliterated basal cisterns. Using restricted cubic spline, RIPK1 levels were linearly related to occurrent risks of the four outcome variables of interest, that is 180-day death, overall survival, poor prognosis (GOSE scores 1-4) and ALI. RIPK1 levels independently predicted these outcome variables. RIPK1 levels had noninteractional effects with age, sex, hypertension, diabetes, smoking and alcohol habits in terms of its association with these outcome variables. RIPK1 levels exhibited high discriminatory efficiency for these outcome variables under the receiver operating characteristic curve. RIPK1 levels, via partial mediation by ALI, were associated with death and poor prognosis of patients. CONCLUSION: Elevated serum RIPK1 levels of patients with sTBI may be highly related to trauma severity, and risks of poor outcomes and ALI; and ALI partially explains the links between serum RIPK1 levels, death and poor prognosis, substantializing serum RIPK1 as a serological prognostic predictor of good prospect in sTBI.
Hepatic Safety Considerations in the Use of Ulipristal Acetate for Symptomatic Uterine Fibroids.
Semmler A, de Lange ME, Drenth JPH … +4 more , Vermeer NS, Bet PM, Huirne JAF, Hehenkamp WJK
Ther Clin Risk Manag · 2025 · PMID 40123751 · Full text
INTRODUCTION: Ulipristal acetate (UPA, 5 mg) demonstrated efficacy in symptom reduction for patients with symptomatic fibroids. While registration and post-marketing trials assessing UPA identified few hepatic concerns,...
INTRODUCTION: Ulipristal acetate (UPA, 5 mg) demonstrated efficacy in symptom reduction for patients with symptomatic fibroids. While registration and post-marketing trials assessing UPA identified few hepatic concerns, post-marketing concerns about potential drug-induced liver injury (DILI) led to significant restrictions, including indication restriction, warning labels and mandatory liver function monitoring. These measures, along with two marketing suspensions, resulted in a decline in UPA use, ultimately leading to the withdrawal of its marketing authorization previously in Canada, Australia, as well as Singapore and in 2024, at the request of the marketing authorization holder for commercial reasons, also for the European Union. METHODS: This narrative review critically evaluates the hepatic safety considerations associated with UPA. RESULTS: On reassessment, the risk of severe DILI with UPA is low at 13.5:100.000, with an incidence of 1 in 200,000 for liver transplantation. These numbers are lower than with many other widely prescribed medications, where no regular liver monitoring is recommended. UPA was subjected to strict liver test monitoring although proof of effectiveness of these measures in preventing serious DILI was lacking. While the risk of severe hepatotoxic events is important to consider, a balanced approach to safety measures is needed, particularly in light of the higher risks associated with alternative treatment options such as surgical intervention. CONCLUSION: While UPA had a unique place in the treatment of uterine fibroids, overly cautious regulatory measures due to exceedingly rare DILI incidences led to the withdrawal of its marketing authorization in most parts of the world. There is a need for an improved understanding of DILI mechanisms and causality assessments to aid in the development of more proportional regulatory responses, balancing patient safety and sustained access to effective innovative treatment.
Association of Perioperative Nursing Care with Incidence of Surgical Site Infections and Short-Term Outcomes in Primary Liver Cancer Patients: A Retrospective Comparison with Standard Care.
Yang B, Guo X, Qi K … +1 more , Sun S
Ther Clin Risk Manag · 2025 · PMID 40123750 · Full text
BACKGROUND: Surgical site infections (SSIs) are a significant complication following liver surgery (LS) for primary liver cancer (PLC), contributing to increased morbidity, prolonged hospital stays, and higher healthcare...
BACKGROUND: Surgical site infections (SSIs) are a significant complication following liver surgery (LS) for primary liver cancer (PLC), contributing to increased morbidity, prolonged hospital stays, and higher healthcare costs. This study aimed to evaluate the association of perioperative nursing care (PNC) with the incidence of SSIs and short-term outcomes, comparing patients receiving structured PNC to those receiving standard care. METHODS: A retrospective study was conducted at [specific location] between January 2016 and February 2019. A total of 360 PLC patients undergoing LS were included and divided into an observation group (PNC) and a control group (standard care). Outcome measures included SSI incidence, length of hospital stay, and independent predictors of SSIs. Logistic regression analysis was used to identify significant factors. RESULTS: Among the 360 included PLC patients, 180 received PNC while 180 did not. Patients in the PLC group had a significantly lower incidence of SSIs (28.3% vs 47.2%, P = 0.026) and shorter hospital stays (median: 8.2 vs 13.3 days, P = 0.049) compared to the control group. Multivariate logistic regression identified PNC as a significant protective factor against SSIs (OR = 2.01, 95% CI: 1.08-3.85, P = 0.031). Other significant predictors included education level (college or above: OR = 0.44, 95% CI: 0.24-0.79, P = 0.006) and comorbidities (more than two: OR = 2.21, 95% CI: 1.31-3.76, P = 0.003). CONCLUSION: PNC emerged as an independent risk factor for SSIs in PLC patients undergoing LS. Thus, the provision of PNC is crucial for reducing the risk of SSIs and improving short-term outcomes in PLC patients undergoing LS.
Therapeutics and Clinical Risk Management - 20 Anniversary.
Walsh GM, Wang Y
Ther Clin Risk Manag · 2025 · PMID 40123749 · Full text
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Comparison of Ultrasound-Guided Thoracic Paravertebral Block Versus Thoracic Paravertebral Block Combined With Serratus Anterior Plane Block or Erector Spinae Block Following Video-Assisted Thoracoscopic Lobectomy.
Zheng MM, Xie J, Tan W … +3 more , Yuan CW, Qi DY, Sun J
Ther Clin Risk Manag · 2025 · PMID 40110493 · Full text
PURPOSE: Compared the efficacy of ultrasound-guided thoracic paravertebral block (TPVB) and thoracic paravertebral combined with serratus anterior plane block (SAPB) or erector spinae block (ESPB) following video-assiste...
PURPOSE: Compared the efficacy of ultrasound-guided thoracic paravertebral block (TPVB) and thoracic paravertebral combined with serratus anterior plane block (SAPB) or erector spinae block (ESPB) following video-assisted thoracoscopic lobectomy(VATL). PATIENTS AND METHODS: This retrospective study analyzed the medical records of 295 patients who underwent VATL surgery between August 2021 and January 2023. Patients were divided into three groups: TPVB (92 patients), TPVB combined with SAPB (106 patients), and TPVB combined with ESPB (97 patients). The primary outcomes were postoperative pain levels, measured using an 11-point visual analogue scale (VAS) both at rest and during coughing at 2, 6, 12, 24, and 48 hours postoperatively, as well as cumulative oxycodone consumption within 24 and 48 hours postoperatively. RESULTS: Postoperative cumulative oxycodone consumption within 24 and 48 hours was significantly lower in the TPVB+SAPB and TPVB+ESPB groups compared to the TPVB group ( < 0.001), with no significant difference between the TPVB+SAPB and TPVB+ESPB groups. The TPVB group exhibited higher VAS pain scores both at rest and during coughing at 2 and 6 hours postoperatively compared to the other two groups ( < 0.005). Within 24 hours postoperatively, the Area Under Curve (AUC) for VAS scores at rest was significantly lower in the TPVB+SAPB group than in the other two groups ( < 0.05), while the AUC for coughing pain was significantly lower in the TPVB+ESPB group compared to the TPVB group ( = 0.049). Nausea or vomiting occurred more frequently in the TPVB group compared to the other groups ( = 0.016). CONCLUSION: TPVB combined with SAPB or ESPB provides superior analgesic effects compared to TPVB alone after video-assisted thoracoscopic lobectomy, with both techniques showing comparable analgesic efficacy. However, TPVB+SAPB may offer slightly better analgesia at rest, while TPVB+ESPB may have a potential advantage in reducing postoperative nausea and vomiting.
Synergistic Effect of the CHADS-VASc Score and Left Atrial Epicardial Adipose Tissue Volume on Predicting Atrial Fibrillation Recurrence After Ablation.
Sang C, Gu R, Xia T … +6 more , Shao Y, Zhu Y, Chen F, Sun L, Gu X, Zhang C
Ther Clin Risk Manag · 2025 · PMID 40098986 · Full text
OBJECTIVE: The CHADS-VASc score and left atrial epicardial adipose tissue (LA-EAT) volume have been identified as potential risk factors for atrial fibrillation (AF) recurrence after ablation. However, there is currently...
OBJECTIVE: The CHADS-VASc score and left atrial epicardial adipose tissue (LA-EAT) volume have been identified as potential risk factors for atrial fibrillation (AF) recurrence after ablation. However, there is currently a lack of research specifically examining the interaction between these two AF risk factors. This study aims to evaluate the predictive potential of combining CHADS-VASc score and LA-EAT volume in predicting recurrence in patients with AF who undergo ablation. METHODS: The study encompassed a cohort of 507 patients who underwent ablation for AF finally. Follow-up assessments were conducted 1, 3, 6, and 12 months after ablation, including clinical evaluation, a 12-lead ECG, and 24-hour Holter monitoring. Recurrence was characterized by symptomatic or asymptomatic AF episodes or atrial tachycardia lasting more than 30 seconds, as evidenced by any ECG following the 3-month BP. Patients were stratified into groups based on the defined cut-off values of CHADS-VASc score and LA-EAT volume. Cox regression analysis was employed to estimate the risk factor of AF recurrence after ablation. The interaction between CHADS-VASc score and LA-EAT volume was assessed using the relative excess risk due to interaction (RERI), attributable proportion (AP), and synergy index (SI). RESULTS: 140 patients experienced AF recurrence after ablation during the follow-up period. Multivariable Cox regression analysis demonstrated that CHADS-VASc score and LA-EAT volume were independent risk factors for AF recurrence. Patients with higher CHADS-VASc score and LA-EAT volume exhibited a higher risk of recurrence than those with lower score and volume. Furthermore, a significant synergistic interaction existed between CHADS-VASc score and LA-EAT volume. The LA-EAT volume and clinical model combination improved the predictive value reclassification, and discriminant abilities improved significantly. CONCLUSION: There is a significant additive interaction between CHADS-VASc score and LA-EAT volume, with the coexistence of both factors significantly increasing the risk of AF recurrence after ablation.
Novel Obstetric Air Cushion for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section: A Randomized Controlled Clinical Trial.
Dong Y, Cao WW, Weng H … +2 more , Liu R, Huang DD
Ther Clin Risk Manag · 2025 · PMID 40098985 · Full text
PURPOSE: Intravenous administration of large doses of vasopressors to treat hypotension due to spinal anesthesia can adversely affect the fetus and the mother. We assessed the effect of a novel obstetric air cushion pret...
PURPOSE: Intravenous administration of large doses of vasopressors to treat hypotension due to spinal anesthesia can adversely affect the fetus and the mother. We assessed the effect of a novel obstetric air cushion pretreatment on the incidence of hypotension after spinal anesthesia. PATIENTS AND METHODS: Eighty parturients were randomly assigned to the air cushion or blank control group (Group A or B, respectively). The air cushion was placed in the lumbar area between the lower border of the costal arch and the iliac crest. The primary endpoint was the incidence of hypotension, while the secondary endpoints included norepinephrine dosage, success rate of maternal hypotension management, and adverse reactions like bradycardia. RESULTS: Hypotension occurred in 50% of the participants in Group A and 75% of those in Group B(=0.035). Group A (median 4μg, range 0-8μg) required a lower norepinephrine dose than Group B (median 4μg, range 0-12μg; =0.015). The success rate of hypotension management was significantly higher for Group A at 97.4% than for Group B at 83.3% (=0.035). Bradycardia was less frequent for Group A than for Group B (10.5% vs 30.6%, =0.032). Group A also showed a higher umbilical artery blood pH than Group B(=0.026). CONCLUSION: The novel air cushion pretreatment reduces the incidence of hypotension after spinal anesthesia in pregnant women, reduces the dose of single intravenous norepinephrine, improves the success rate of hypotension management, and increases the pH of fetal umbilical artery blood.
Clinical Manifestations and Risk Factors of Liver Injury Induced by PD-1 Inhibitors in Patients with Malignancies: A Case-Control Study.
Zhao P, Yu L, Ma W … +1 more , Zhao T
Ther Clin Risk Manag · 2025 · PMID 40092894 · Full text
BACKGROUND: Hepatic injury induced by immune checkpoint inhibitors (ICPIs) is an inevitable challenge in the era of innovative anti-tumor therapies. However, studies on immune-related liver injury are relatively insuffic...
BACKGROUND: Hepatic injury induced by immune checkpoint inhibitors (ICPIs) is an inevitable challenge in the era of innovative anti-tumor therapies. However, studies on immune-related liver injury are relatively insufficient, and the associated risk factors are still lacking. The purpose of this study was to explore the incidence and clinical manifestations of immunotherapy-related liver injury. METHODS: A retrospective case-control study was conducted involving patients treated with PD-1 inhibitors at Weifang People's Hospital, a tertiary general hospital in China, from January 1, 2021 and July 31, 2024. Univariate and multivariate logistic regression analyses were employed to identify the potential risk factors. Then, the predictive value of these risk factors was evaluated using receiver operating characteristic (ROC) curve analysis. RESULTS: In total, 300 patients were included. Among these patients, 52 patients experienced liver injury. The mean time from the initiation of immunotherapy to the onset of liver injury was 28.4 days, with a range from 2 to 219 days. 71.15% of patients developed liver injury within the first 30 days. 82.69% presented with mild cases (grade 1), 13.46% with moderate cases (grade 2), and 3.84% with severe cases (grades 3-4). The overall incidence of PD-1 inhibitors-related liver injury was 0.34%. Specifically, nivolumab exhibited the highest incidence at 2.86%, followed by sintilimab at 0.41%. Both toripalimab and camrelizumab exhibited an incidence of 0.34%, while tislelizumab had the lowest at 0.28%. Multivariate logistic regression analysis showed that GGT and AST were independent risk factors for liver injury. ROC curve analysis revealed that patients with baseline ALT≥19.5 U/L, AST≥19.5 U/L, and GGT≥28.5 U/L were at increased risk of developing liver injury. CONCLUSION: In clinical therapy, close monitoring of liver function is recommended, especially for patients with baseline ALT≥19.5 U/L, AST≥19.5 U/L, and GGT≥28.5 U/L during immunotherapy with PD-1 inhibitors.
Development and Validation of Machine Learning Models for Outcome Prediction in Patients with Poor-Grade Aneurysmal Subarachnoid Hemorrhage Following Endovascular Treatment.
Du S, Wu Y, Tao J … +9 more , Shu L, Yan T, Xiao B, Lv S, Ye M, Gong Y, Zhu X, Hu P, Wu M
Ther Clin Risk Manag · 2025 · PMID 40071129 · Full text
BACKGROUND: Endovascular treatment (EVT) has been recommended as a superior modality for the treatment of intracranial aneurysm. However, there still exists a worse percentage of poor functional outcome in patients with...
BACKGROUND: Endovascular treatment (EVT) has been recommended as a superior modality for the treatment of intracranial aneurysm. However, there still exists a worse percentage of poor functional outcome in patients with poor-grade aneurysmal subarachnoid hemorrhage (aSAH) undergoing EVT. Therefore, it is urgently needed to investigate the risk factors and develop a critical decision model in the subtype of such patients. METHODS: We extracted the target variables from an ongoing registry cohort study, PROSAH-MPC, which was conducted in multiple centers in China. We randomly assigned these patients to training and validation cohorts with a ratio of 7:3. Univariate and multivariate logistic regressions were performed to find the potential factors, and then nine machine learning models and a stack ensemble model were developed with optimized variables. The performance of these models was evaluated through several indicators, including area under the receiver operating characteristic curve (AUC-ROC). We further use Shapley Additive Explanations (SHAP) methods for the distribution of feature visualization based on the optimal models. RESULTS: A total of 226 eligible patients with poor-grade aSAH undergoing EVT were enrolled, while 89 (39.4%) has a poor 12-month outcome. Age (Adjusted OR [aOR], 1.08; 95% CI: 1.03-1.13; p = 0.002), subarachnoid hemorrhage volume (aOR, 1.02; 95% CI: 1.00-1.05; p = 0.033), World Federation of Neurosurgical Societies grade (WFNS) (aOR, 2.03; 95% CI: 1.05-3.93; p = 0.035), and Hunt-Hess grade (aOR, 2.36; 95% CI: 1.13-4.93; p = 0.022) were identified as the independent risk factors of the poor outcome. Then, the prediction models developed have revealed that LightGBM algorithm has a superior performance with an AUC-ROC value of 0.842 in the validation cohort, while the SHAP results showed that age is the most important risk factor affecting functional outcomes. CONCLUSION: The LightGBM model holds immense potential in facilitating risk stratification for poor-grade aSAH patients undergoing endovascular treatment who are at risk of adverse outcomes, thereby enhancing clinical decision-making processes. TRIAL REGISTRATION: PROSAH-MPC. NCT05738083. Registered 16 November 2022 - Retrospectively registered, https://clinicaltrials.gov/study/NCT05738083.
A Nomogram Based on S100A7 and Clinicopathological Characteristics to Predict the Efficacy of Neoadjuvant Chemotherapy in Breast Cancer: A Retrospective Study.
Zhang T, Yu X, Yang X … +3 more , Li Y, Li X, Ma L
Ther Clin Risk Manag · 2025 · PMID 40066058 · Full text
BACKGROUND: We have previously found that S100 calcium-binding protein A7 (S100A7) is strongly associated with chemoresistance in breast cancer (BC). In this study, we investigated whether S100A7 can be used to predict t...
BACKGROUND: We have previously found that S100 calcium-binding protein A7 (S100A7) is strongly associated with chemoresistance in breast cancer (BC). In this study, we investigated whether S100A7 can be used to predict the efficacy of neoadjuvant chemotherapy (NAC) and assessed its relationship with clinicopathological characteristics in BC. METHODS: We retrospectively analyzed the clinicopathological data of patients with BC who underwent NAC at the Fourth Hospital of Hebei Medical University between January 2021 and December 2021. The -test, Wilcoxon test, and chi-square test were used to compare clinicopathological characteristics between the NAC-sensitive and NAC-insensitive groups and assess the relationship between S100A7 expression and clinicopathological characteristics. Binomial logistic regression analysis was used to identify the predictors of NAC efficacy. A prediction model was constructed and visualized using a nomogram for clinical prediction of NAC efficacy. RESULTS: A total of 76 patients with BC who underwent NAC were included in this study; of these patients, 49 were sensitive to NAC, whereas 27 were insensitive to NAC. Statistically significant differences were observed in age, menstrual status, histological grade, T stage, Ki67, and S100A7 expression between the NAC-sensitive and NAC-insensitive groups. Regression analysis showed that age, histological grade, Ki67, subtype, menstrual status, TILs and S100A7 expression were predictors of NAC efficacy. However, only histological grade III (OR, 25.613; 95% CI, 1.254-523.077; = 0.035), Ki67 (OR, 9.781; 95% CI, 2.022-47.317; = 0.005), TILs (OR, 1.227; 95% CI, 1.064-1.415; = 0.005), and S100A7 expression (OR, 0.042; 95% CI, 0.010-0.174; <0.001) were independent predictors. Therefore, we constructed a model incorporating these four characteristics and visualised the model in a nomogram to predict NAC efficacy in clinical settings, with a model prediction accuracy of 0.927. CONCLUSION: S100A7 may serve as a predictor of NAC efficacy in patients with BC.
Risk of Serious Immune-Related Adverse Events with Various PD1 and PD-L1 Inhibitors: A Single-Institution, Real-Life, Comparative Study.
Boucheron T, Chiche L, Penaranda G … +9 more , Souquet M, Pegliasco H, Deturmeny J, Brunel V, Barrière N, Arbault-Bitton C, Coquet E, Diaz L, Escoda T
Ther Clin Risk Manag · 2025 · PMID 40060169 · Full text
BACKGROUND: Immune checkpoint inhibitors (ICIs) are responsible for causing immune-related adverse events (irAEs). The frequency and severity of irAEs depend on various factors, but the role of the molecule used remains...
BACKGROUND: Immune checkpoint inhibitors (ICIs) are responsible for causing immune-related adverse events (irAEs). The frequency and severity of irAEs depend on various factors, but the role of the molecule used remains unclear. Our aim was to assess the comparative safety profile of different programmed cell death-1 inhibitors (anti-PD1) and programmed cell death ligand-1 inhibitors (anti-PD-L1) in a real-life setting. METHODS: The occurrence of severe irAEs (grade ≥3) and their characteristics were recorded for all patients treated with anti-PD1 or anti-PD-L1, alone or in combination, at our center. Potential predictive factors for the occurrence of irAEs, particularly concerning the type of molecule, were identified by statistical analysis. Factors related to overall survival were also analyzed. RESULTS: A total of 406 patients who received at least one dose of anti-PD1 (68.5%) or anti-PD-L1 (31.5%) were included, among which 60% had lung cancer. The overall frequency of the different ICIs was 51%, 17.5%, 14.3%, 12.8%, and 4.4% for pembrolizumab, nivolumab, atezolizumab, durvalumab, and avelumab, respectively. Fifty-three (13%) patients experienced severe irAEs (grade 3 or 4). While there were no significant differences with regard to ICI categories (13.7% for anti-PD1 vs 11.7% for anti-PD-L1; p = 0.5878), the rates of severe irAEs were significantly different between ICIs (29.6% for nivolumab, 22.2% for avelumab, 13.8% for atezolizumab, 8.2% for pembrolizumab, and 5.8% for durvalumab; p < 0.0001). Multivariate analyses showed that treatments with nivolumab and low polymorphonuclear neutrophil level were significant risk factors for severe irAEs. The risk of early death was lower in patients who reported severe irAEs and the risk of cancer progression was greater with one of the least toxic molecules (atezolizumab). DISCUSSION: This study highlights the differences in toxicity profile of various ICIs targeting the PD1/PD-L1 axis in real-life use, as well as the identification of possible predictive biomarkers.
Health and Economic Advantages Associated With the Use of TachoSil: An Update of Systematic Review.
Colombo GL, Droghetti A, Di Matteo S … +2 more , Ottenjann H, Bruno GM
Ther Clin Risk Manag · 2025 · PMID 40046260 · Full text
BACKGROUND: The international scientific literature is systematically analyzed in this review over a period of nearly 10 years with respect to the use of the active hemostat and surgical sealant patch TachoSil, consideri...
BACKGROUND: The international scientific literature is systematically analyzed in this review over a period of nearly 10 years with respect to the use of the active hemostat and surgical sealant patch TachoSil, considering its economic effects. It`s an update of the first review published in 2014. METHODS: A PubMed systematic literature review was done from Nov 2013 up to December 2022. Based on the criteria used to select, the papers were grouped in terms of study design, surgery type, reduction in the time to hemostasis, shorter hospital stay, fewer number of post-operative complications, and the impact of TachoSil to operative procedures. RESULTS: Medical evidence of TachoSil is well documented, in different clinical studies and for several indications. In this second review 18 scientific papers were screened. In total data from 3.375 patients were analyzed, of whom 1.748 were treated with TachoSil. Nine of the 18 papers (50%) were classified as randomized clinical trials (RCTs). The time required for hemostasis following the administration of TachoSil was significantly shorter than that observed with other surgical treatment techniques, with a median time of up to four minutes. The reduction in post-operative complications was evaluated in 15 studies that were conducted on patients in a variety of surgical specialties. When using TachoSil the hospitalization duration was briefer, as observed in the past review. CONCLUSION: The second analysis of scientific papers demonstrates that TachoSil plays a supporting role in surgical procedures, enhancing hemostasis and facilitating tissue sealing when conventional techniques are inadequate.This approach has been linked to a reduction in post-operative complications, length of hospital stay, and consequently, hospital cost.
Chinese Expert Consensus on Preventing and Managing Chyle Fistula in Cervical Lymph Node Dissection for Thyroid Cancer (2024).
He Q, Tian W, Zhu J … +3 more , Wang P, Zhang H, Expert Working Group on Thyroid Surgery, Chinese Medical Doctor Association Division of Surgeons, Thyroid Disease Committee of Chinese Research Hospital, Association, General Surgery Branch of China International Exchange and Promotive Association for Medical and Health Care
Ther Clin Risk Manag · 2025 · PMID 40046259 · Full text
BACKGROUND: The prevalence of thyroid carcinoma is on the rise, with cervical lymph node metastasis being a frequent occurrence necessitating surgical intervention. Chyle fistula, a significant postoperative complication...
BACKGROUND: The prevalence of thyroid carcinoma is on the rise, with cervical lymph node metastasis being a frequent occurrence necessitating surgical intervention. Chyle fistula, a significant postoperative complication, can have a substantial impact on recovery. OBJECTIVE: To reduce the incidence of chyle fistula, enhance the effectiveness of postoperative treatment, and assist thyroid surgeons in performing cervical lymph node dissection, the consensus was compiled in a standardized and secure manner. METHODS: Drawing from the expertise of Chinese specialists in managing chyle fistula and the latest international advancements in this field following cervical lymph node dissection, the thyroid tumor experts group of Chinese Thyroid Association, Chinese College of Surgeons, Chinese Medical Doctor Association and Thyroid Disease Professional Committee of Chinese Research Association have developed innovative approaches to address this issue. An evidence-based approach was employed, integrating the knowledge and practical experience of the panelists. RESULTS: We developed twelve expert consensus recommendations, addressing the prevention, diagnosis, and treatment of postoperative chyle fistula. These recommendations included the dietary management and nutritional support, continuous negative pressure suction, local adhesive treatment, application of local compression methods, the use of somatostatin and its analogs, and surgery treatment. CONCLUSION: This evidence-based consensus would be valuable to assist front-line surgeons and medical specialists in the management of chyle fistula.
Advancing Heart Valve Replacement: Risk Mitigation of Decellularized Pulmonary Valve Preparation for Its Implementation in Public Tissue Banks.
Rodríguez Martínez JI, Castells-Sala C, Baptista Piteira AR … +11 more , Montagner G, Trojan D, Martinez-Legazpi P, Acosta Ocampo A, Fernández-Santos ME, Bermejo J, Jashari R, Pérez ML, Agustí E, Tabera J, Vilarrodona A
Ther Clin Risk Manag · 2025 · PMID 40035073 · Full text
PURPOSE: Cryopreserved homografts for valve replacement surgeries face a major problem regarding their durability after implantation and decellularized pulmonary heart valves have raised as potential new generation subst...
PURPOSE: Cryopreserved homografts for valve replacement surgeries face a major problem regarding their durability after implantation and decellularized pulmonary heart valves have raised as potential new generation substitute for these surgeries. The present study aims to document the work performed for the safe implementation in public tissue banks of a new decellularization method for human pulmonary heart valves, based on previous risk evaluation. METHODS: After assessing new preparation method associated risks, using EuroGTP-II methodologies, an extensive array of in vitro were defined to validate the new technique, mitigate the risks and provide quality and safety data. RESULTS: Initial evaluation of risks using EuroGTP II tool, showed Final Risk Score of 23 (high risk), and four studies were devised to mitigate identified risks: (i) tissue structure integrity; (ii) cell content; (iii) microbiological safety; and (iv) cytotoxicity evaluation in final tissue preparation. Protein quantification, mechanical properties, and histological evaluation indicated no tissue damage, reducing implant failure probability, while cellular content removal demonstrated a 99% DNA removal and microbiological control ensured contamination absence. Moreover, in vitro results showed no cytotoxicity. Risk re-evaluation indicated a risk reduction to moderate risk (Final Risk Score = 10), suggesting that further evidence for safe clinical use would be needed at pre-clinical in vivo evaluation to mitigate remaining risks. CONCLUSIONS: The studies performed and reviewed bibliography were able to significantly reduce the original level of risk associated with the clinical application of this homograft's preparation. However, additional in vivo studies and tissue stability tests are still necessary to address the remaining risks associated with reagents' effect on extracellular matrix and storage conditions, which could influence implant failure, before the clinical evaluation procedures can be implemented to determine the efficacy and safety of the new decellularized heart valves.
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