Therapeutics and Clinical Risk Management最新文献

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 (P < 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 (P < 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 (P < 0.05), while the AUC for coughing pain was significantly lower in the TPVB+ESPB group compared to the TPVB group (P = 0.049). Nausea or vomiting occurred more frequently in the TPVB group compared to the other groups (P = 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.

Objective: The CHA₂DS₂-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 CHA₂DS₂-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 CHA₂DS₂-VASc score and LA-EAT volume. Cox regression analysis was employed to estimate the risk factor of AF recurrence after ablation. The interaction between CHA₂DS₂-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 CHA₂DS₂-VASc score and LA-EAT volume were independent risk factors for AF recurrence. Patients with higher CHA₂DS₂-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 CHA₂DS₂-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 CHA₂DS₂-VASc score and LA-EAT volume, with the coexistence of both factors significantly increasing the risk of AF recurrence after ablation.

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(P=0.035). Group A (median 4μg, range 0-8μg) required a lower norepinephrine dose than Group B (median 4μg, range 0-12μg; P=0.015). The success rate of hypotension management was significantly higher for Group A at 97.4% than for Group B at 83.3% (P=0.035). Bradycardia was less frequent for Group A than for Group B (10.5% vs 30.6%, P=0.032). Group A also showed a higher umbilical artery blood pH than Group B(P=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.

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.

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.

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 t-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; P = 0.035), Ki67 (OR, 9.781; 95% CI, 2.022-47.317; P = 0.005), TILs (OR, 1.227; 95% CI, 1.064-1.415; P = 0.005), and S100A7 expression (OR, 0.042; 95% CI, 0.010-0.174; P<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.

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.

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.

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.

Background: Some acute ischemic stroke (AIS) patients due to large-vessel occlusion, who underwent endovascular thrombectomy (EVT), continue to experience unfavorable outcomes. Furthermore, the impact of internal carotid artery (ICA) tortuosity remains uncertain. This study aimed to determine the value of ICA tortuosity and clinical features in predicting 3-month unfavorable outcome and early neurological deterioration (END) after EVT in AIS patients through nomograms.

Methods: A total of 313 AIS patients treated with EVT at the First Affiliated Hospital of Xi'an Jiaotong University were retrospectively analyzed and randomized into two cohorts: training cohort (n=219) and validation cohort (n=94). After the selection of relevant features, nomograms for predicting the 3-month unfavorable outcome (mRS > 2) and END (an increase in NIHSS score of ≥4 within 24 hours) were established. The predictive accuracy of the nomograms was evaluated using ROC curves, calibration plots, and decision curve analysis (DCA).

Results: Among 313 patients, ICA tortuosity was observed in 19.50% (extracranial) and 21.10% (cavernous) of patients. Furthermore, 53.30% of patients experienced a 3-month unfavorable outcome, while END occurred in 15.70%. The independent predictors for the 3-month unfavorable outcome included age, NIHSS score, puncture-to-recanalization time, eTICI score, and blood glucose. The addition of two tortuosity features (extracranial and cavernous ICA tortuosity) resulted in a significant improvement in model differentiation. The nomogram that included ICA tortuosity achieved an AUC of 0.826 and 0.803 in the training and validation cohorts. ASPECT score, occlusion site, number of retriever passes, and blood glucose were identified as factors associated with END. The AUC was 0.770 and 0.772 in the training and validation cohorts. However, the incorporation of ICA tortuosity did not significantly enhance the model for predicting END.

Conclusion: ICA tortuosity characteristics significantly improve the discrimination of the nomogram model in predicting the 3-month unfavorable outcome. This can be used as guidance in clinical decision-making.