Therapeutics and Clinical Risk Management最新文献

Background: Hormone receptor-positive breast cancer (HR-positive BC), the most prevalent subtype, typically has a favorable prognosis. However, treatment decision-making and survival prediction remain challenging due to the limitations of traditional staging systems like AJCC. Improved prognostic tools are needed to enhance individualized risk stratification.

Materials and methods: Clinical information from the Surveillance, Epidemiology, and End Results (SEER) database and the First Affiliated Hospital of Nanchang University were analyzed to evaluate outcomes across HR-positive BC subtypes. Patients were divided into training and validation cohorts. A prognostic nomogram was developed using factors identified by univariate and multivariate Cox regression analyses and evaluated through C-index, Receiver Operating Characteristic (ROC) curves, calibration curves, and decision curve analysis (DCA).

Results: The study included 156,378 patients (training) and 67,016 (validation) for breast cancer-specific survival (BCSS) and 165,047 (training) and 70,732 (validation) for overall survival (OS), along with 232 external validation cases. Multivariate Cox regression analysis revealed that the ER-positive/PR-negative (HR=2.317 (2.219-2.419)) and ER-negative/PR-positive (HR=3.498 (3.143-3.894)) subtypes had worse prognosis than ER-positive/PR-positive patients. The prognosis of ER-negative/PR-positive subtype (HR=1.511 (1.686-1.351)) was also worse than that of ER-positive/PR-negative subtype. A nomogram integrating age, race, tumor size, grade, histology, bone, brain, lung, and liver metastases, tumor stage, HER2, marital status, positive lymph node numbers, and radiation therapy. The nomogram had a good C-index values and area under curve values for predicting OS and BCSS in both the training and validation set. Moreover, the DCA revealed that the nomogram performed better than the AJCC (TNM) staging system in predicting the three- and five-year OS and BCSS in both the groups.

Conclusion: This study introduces and validates a novel prognostic nomogram for HR-positive BC, providing enhanced risk stratification, particularly in regions with limited access to comprehensive genetic testing. Further validation through multicenter clinical studies is recommended to confirm its clinical utility.

Background: Limited evidence is available regarding the safety and effectiveness of early high protein intake in critically ill patients with COVID-19. Therefore, this study aims to assess the safety of early protein advancement during nutritional support in these patients.

Methods: A multi-center retrospective cohort study included adult critically ill patients with COVID-19 admitted to Intensive Care Units (ICUs) at three centers in Saudi Arabia. Patients were grouped into two groups based on the protein intake at day three of feeding initiation into low protein (≤0.8 mg/kg/day) versus high protein (>0.8 mg/kg/day) groups. Acute kidney injury (AKI) during the ICU stay was the primary endpoint, while the remaining were considered secondary endpoints.

Results: The study included 466 patients, but after cardinality matching with a 2:1 ratio, 192 were in the lower protein group compared with 96 patients in the high protein group. The rate of AKI was low in the highprotein group compared with the low protein group on day three of feeding initiation (19.9% versus 12.7%); however, this was not statistically significant (OR 0.54; 95% CI 0.26, 1.33; p=0.2). Additionally, patients in the high protein group had a higher rate of atrial fibrillation than those in the low protein group (OR 2.33; 95% CI 1.18, 4.62; p=0.02). No differences were observed in 30-day and in-hospital mortality (HR1.33, 95% CI 0.91, 1.96; p=0.14 and HR 1.21, 95% CI: 0.85, 1.72; p=0.29, respectively).

Conclusion: The advancement of protein in critically ill patients with COVID-19 was not associated with significant differences in the incidence of AKI. In contrast, the early advancement of protein in nutritional feeding within the first three days was associated with a higher incidence of atrial fibrillation.

Background: Current guidelines have not recommended an upper age limit for endovascular thrombectomy (EVT) in patients with large vessel occlusion (LVO) stroke. However, elder age links to an increased risk of poor outcome. This study aimed to investigate the efficacy of EVT in elderly versus non-elderly patients and determine the respective factors of poor outcome.

Methods: Three hundred and two consecutive patients with LVO-stroke who underwent EVT were included, and we used sensitivity analysis with restricted cubic spline to define 75 years as the inflexion point. Participants were thus dichotomized into elderly (≥75 years) and non-elderly (<75 years) groups. Brain frailty on neuroimaging was evaluated using the global cortical atrophy (GCA) scale and the Fazekas scale for white matter lesions (WML). The primary outcome was 3-month functional outcome, and the secondary outcomes were EVT efficacy and safety.

Results: Elderly patients had significantly higher incidences of hypertension, diabetes mellitus, atrial fibrillation, and more severe GCA and WML. The rate of good outcome in elderly patients was 32%, significantly lower than non-elderly patients (54%, p<0.001). There was no difference in terms of reperfusion (89% vs 93%, p=0.363) and intracranial hemorrhage (38% vs 41%, p=0.826) between two groups. In elderly patients, high degree of GCA (OR 1.15, 95% CI 1.02-1.30, p=0.012) and moderate/severe WML (OR 5.88, 95% CI 1.47-23.50, p=0.015) independently predicted 3-month poor outcomes.

Conclusion: GCA and WML play pivotal roles for the functional outcomes in elderly patients undergoing EVT for LVO-stroke, providing valuable and practical information for early prediction of long-term prognosis.

Background: The identification of predictors for major adverse cardiovascular events (MACEs) is essential for reducing mortality associated with off-pump coronary artery bypass grafting (OPCAB). The objective of this study is to assess serum periostin levels as a novel predictor of MACEs in patients undergoing OPCAB.

Methods: This prospective study included 79 patients diagnosed with coronary artery disease (CAD) who underwent OPCAB between May 2022 and May 2023. The changes in periostin levels (ΔPOSTN) were calculated using the formula: postoperative POSTN levels minus preoperative POSTN levels. Based on the optimal cut-off value determined from the receiver operating characteristic (ROC) curve, patients were categorized into Low POSTN Change (LPC) and High POSTN Change (HPC) groups for subgroup analysis. The primary outcomes assessed were MACEs, including cardiac death, myocardial infarction (MI), heart failure, and stroke.

Results: Follow up for the patients was conducted for 30 days, with 71 patients ultimately being included in the final analysis. During this period, 13 MACEs were recorded, representing an incidence rate of 18.3%. The events included 2 cases of cardiac death (2.8%), 5 cases of MI (7.0%), 5 cases of heart failure (7.0%), and 1 case of stroke (1.4%). The risk of MACEs increased by 4% for each unit increase in the ΔPOSTN (Odds Ratio [OR]: 1.04, 95% Confidence Interval [CI]: 1.01-1.06; p = 0.005). The area under the ROC curve was 0.869 (95% CI: 0.768-0.938; p < 0.001). Based on the Youden index (J = 0.683), the optimal threshold for ΔPOSTN was determined to be 16.6 µg/L, with a sensitivity of 76.9% and a specificity of 91.4%.

Conclusion: Changes in serum periostin levels during the perioperative period may serve as an independent predictor of 30-day MACEs in patients undergoing OPCAB.

Trial registration: Link of the registry: https://www.chictr.org.cn. Date of registration: 2022/05/22. Trial registration number: ChiCTR2200060220.

Background: Catheter-related bladder discomfort (CRBD) is a risk factor that impacts postoperative recovery and still troubles patients and healthcare staff. The present study is a bibliometric analysis of CRBD.

Methods: The publications on CRBD were retrieved from the Web of Science Core Collection. VOSviewer and Excel were applied to present the current status and hot spots of CRBD research. We analyzed parameters such as the annual number of publications, countries/regions, organizations, authors, journals, and keywords of the articles in this area by generating visualization graphs.

Results: A total of 127 articles were eligible, recorded by 78 journals, and drafted by 672 authors from 169 organizations in 26 countries/regions. The main type of these articles is randomized trial. Park Hee-Pyoung, Kim Hyun-Chang, and Cui Yuanshan are the most productive authors with 5 articles. Sichuan University, Seoul National University, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Capital Medical University, and Qingdao University published more articles on CRBD worldwide. China ranks No. 1 in terms of the number of publications, followed by South Korea and India. Journals specialized in anesthesiology, such as BMC Anesthesiology, Journal of Anesthesia, and British Journal of Anesthesia, are more popular with researchers in this area. The research hot spots of CRBD have concentrated on the prevention and treatment of CRBD.

Conclusion: Though formal research on CRBD started late, there is a rising tendency for the number of publications. Authors and academic teams from Asia have made significant contribution to CRBD. Journals specialized in anesthesiology are priorities for publishing articles. Previous studies mainly focused on the pharmacological and pharmacological methods to CRBD. However, CRBD is not fully settled. Either clinical or experimental studies are still needed to further improve CRBD.

Purpose: This study aimed to elaborate on the incidence, clinical features, and management of immune checkpoint inhibitors (ICIs) related cardiovascular adverse events (CVAEs) in real-world practice.

Patients and methods: We performed a retrospective chart review study on patients receiving at least one dose of ICI therapy at a Chinese tertiary hospital from March 2020 to March 2021. CVAEs were identified through clinical assessment and the Naranjo algorithm. The management and outcomes of CVAEs were monitored over a median follow-up duration of 8 months.

Results: Among the included 203 patients, 4.4% (9/203) developed CVAEs, including heart failure (n = 3), arrhythmia (n = 2), myocarditis (n = 2), and pericardial disease (n = 2), with a proportion (6/9) tending to be severe (grade 3 or grade 4). CVAEs were more common in older patients (mean age: 73.6 ± 9.2 years) and those with hypertension (p = 0.02) or heart failure (p = 0.01). Adherence to the American Society of Clinical Oncology (ASCO) guidelines for managing CVAEs was low (44%), with most cases showing partial resolution by the last follow-up.

Conclusion: We reported that the incidence of ICI-related CVAEs in the Chinese institution was higher than that in some prior studies. Adherence to guidelines for managing ICI-related CVAEs is found to be suboptimal in real-world practice and highlighted as a needed improvement.

Objective: Mesalazine is a widely used medication for treating mild to moderate inflammatory bowel disease (IBD). First identified as a potential cause of acute pancreatitis (AP) in 1989, the link between mesalazine and AP has primarily been established through case reports and a limited number of retrospective studies. This study aims to explore the characteristics of mesalazine-induced AP.

Methods: The databases of CNKI, Wanfang Data, VIP, PubMed and Web of Science were searched (up to March, 2024), and the case reports of mesalazine-related AP in IBD patients were collected and descriptively analyzed.

Results: Thirty-four reports were included, describing 42 patients (22 males, 16 females, 4 unspecified) with mesalazine-related AP. The onset of pancreatitis occurred a median of 14 days (range 1-730 days) after starting mesalazine. Common symptoms included abdominal pain (100%), vomiting (38.1%), fever (21.4%), and nausea (21.4%). Most patients had elevated serum amylase and lipase levels, with some showing raised C-reactive protein and erythrocyte sedimentation rate. Imaging tests, such as computed tomography and B-scan ultrasonography, revealed edematous infiltration and inflammation. Discontinuation of mesalazine led to symptom resolution in all patients, with 93.3% improving within a week. Alternative treatments or switching to other forms of 5-aminosalicylic acid may be considered for ongoing management. Rechallenge with mesalazine led to recurrence of AP in 21 cases, with a shorter median time to symptom onset.

Conclusion: Mesalazine-induced AP is a rare but significant adverse reaction, not related to drug dosage, and can occur at any point during treatment, typically within two weeks. The reaction can recur upon rechallenge. Discontinuation of mesalazine and symptomatic treatment typically resolves the condition.

Introduction: Traumatic patients with cervical spine motion restriction have difficulty with endotracheal intubation (ETI) due to the limitations of neck movement and mouth opening. Nevertheless, the removal of the cervical collar for ETI in a prehospital setting may lead to a deterioration in neurological outcomes. This study compares the success rate of ETI utilizing a video laryngoscope (VL) on a manikin, contrasting manual in-line stabilization (MILS) without a cervical hard collar against full immobilization.

Methods: A randomized, non-crossover study was conducted involving 56 paramedic students assigned by SNOSE to utilize various box sizes for VL intubation with MILS without a cervical hard collar or full immobilization technique on a manikin. The primary outcome was the intubation success rate. Secondary outcomes included attempts, time for successful intubation, and Cormack-Lehane classification.

Results: Fifty-six participants were evaluated; 28 were in the full immobilization group, and another 28 were in the MILS without cervical hard collar group. Baseline characteristics showed no difference between both groups. The success rate of VL intubation showed no difference between the full immobilization group and the MILS without a cervical hard collar group (28 [100%] vs 28 [100%]; 24 [85.71%] vs 27 [96.43%] on first attempt; 4 [14.29%] vs 1 [3.57%] on second attempt; p-value 0.352). Time required to perform successful intubation (median [IQR] 17.20 [12.53, 24.40] vs 17.53 [14.06, 23.73], p-value 0.694) and Cormack-Lehane classification (11 [39.29%] vs 10 [35.71%] in grade I; 16 [57.14%] vs 17 [60.71%] in grade II; 1 [3.57%] vs 1 [3.57%] in grade III, p-value 1.000) showed no statistical difference between the two groups.

Conclusion: It is unnecessary to remove the cervical hard collar when performing endotracheal intubation while using a video laryngoscope.

Gaucher disease (GD) is a rare lysosomal storage disorder resulting from a deficiency of the lysosomal enzyme glucocerebrosidase caused by biallelic variants in the GBA1 gene. Patients may present with a wide spectrum of disease manifestations, including hepatosplenomegaly, thrombocytopenia, bone manifestations, and in the case of GD types 2 and 3, neurodegeneration, cognitive delay, and/or oculomotor abnormalities. While there is no treatment for neuronopathic GD, non-neuronopathic manifestations can be efficiently managed with enzyme replacement therapy or substrate reduction therapy. However, many patients with GD experience a lengthy diagnostic odyssey, which can negatively affect their access to care and clinical outcomes. The cause of this diagnostic delay is multifaceted. Since genotype/phenotype correlations in GD are not always clear, it is difficult to predict the presence, severity, and onset of clinical manifestations. This heterogeneity, combined with the molecular complexity of the GBA1 locus, low disease prevalence, and limited knowledge of GD among providers serves as a barrier to early diagnosis of GD. In this review, we discuss such obstacles and challenges, considerations, and future steps toward improving the diagnostic journey for patients with GD.