Single-center Prospective Study Research Articles

Cerebrovascular pulsatility indicates preoperative subcortical cognitive impairment and an increased risk for postoperative delirium in elderly patients undergoing elective spine surgery.

Advances in spine surgery enable safe interventions in elderly patients, but perioperative neurocognitive disorders (pNCD), such as post-operative delirium (POD) and cognitive dysfunction (POCD), remain a serious concern. Pre-operative cognitive impairment is a major risk factor for pNCD. Comprehensive pre-operative cognitive assessments are not feasible in clinical practice, making effective screening methods desirable. This study investigates whether pre-operative cerebrovascular duplex sonography can assess subcortical (vascular) cognitive impairment and the risk for POD. This prospective single-center study recruited patients aged ≥60 years scheduled for elective spine surgery at a German university hospital. Patients underwent pre-operative assessments including cognitive abilities (CERAD test battery), structural MRI, and cerebrovascular duplex sonography. POD screening was conducted three times daily for at least 3 days. The primary hypothesis, that the mean pulsatility index (PI) of both internal carotid arteries (ICA) predicts POD risk, was tested using logistic regression. Secondary analyses examined the association between POD risk and ICA flow (time-averaged peak velocities, TAPV) and correlations with cognitive profiles and MRI characteristics. POD occurred in 22% of patients (n = 22/99) within three postoperative days. Patients with POD were significantly older (75.9 ± 5.4 vs. 70.0 ± 6.9 years, p < 0.01) but did not differ by gender (p = 0.51). ICA PI significantly predicted POD risk (OR = 5.46 [95%CI: 1.81-16.49], p = 0.003), which remained significant after adjustment for age and duration of surgery (ORadj = 6.38 [95% CI: 1.77-23.03], p = 0.005). TAPV did not inform the POD risk (p = 0.68). ICA PI Pre-operative cognitive scores were significantly associated with ICA PI (mean CERAD score: r = -0.32, p < 0.001). ICA PI was also significantly associated with total white matter lesion volume (τ = 0.19, p = 0.012) and periventricular white matter lesion volume (τ = 0.21, p = 0.007). This is the first study to demonstrate that cerebrovascular duplex sonography can assess the risk for POD in elderly spine surgery patients. Increased ICA PI may indicate subcortical impairment, larger white matter lesion load, and lower white matter volume, predisposing factors for POD. Pre-operative cerebrovascular duplex sonography of the ICA is widely available, easy-to-use, and efficient, offering a promising screening method for POD risk. Increased ICA PI could supplement established predictors like age to adjust surgical and peri-operative procedures to individual risk profiles.

Improved quality of life in head and neck cancer patients treated with modern arc radiotherapy techniques - A prospective longitudinal analysis.

The present longitudinal study aimed to evaluate the potential impact of modern radiotherapy (RT) techniques on quality of life (QOL) in patients with head and neck (HNC) cancer. In this single-center prospective study, participants were asked to complete QOL questionnaires that included the EORTC QLQ-C30, QLQ-H&N 35 and utility score by time trade-off (TTO) at three time points (2 weeks, 3 months and 6 months) after completion of RT. All patients were treated by modern RT techniques [volumetric modulated arc therapy (VMAT) or helical tomotherapy (HT)]. Patients who developed recurrence or died before the 6-month follow-up were excluded. Linear mixed models with random intercepts for participants and restricted maximum likelihood estimates were used to assess the effect of our study variables (age, sex, primary site, cancer stage, treatment, radiation dose and radiation method). Overall changes in QOL, utility scores and symptom burdens at different time points were tested using paired t tests. A total of 45 patients were recruited from 2022 to 2023. Those who completed the surveys at 2 weeks with at least 1 follow-up (30 patients, 67%) were enrolled in the final analysis. The majority of these 30 patients were men (76.7%), had oral cancer (40%), had stage III or IV disease (60%), received surgical intervention (63%) and were treated with chemoradiation (80%). A curative total dose of 66 to 70 Gy was delivered to 23 (76.7%) patients, half of whom received HT. Patients who received chemotherapy had significantly lower global QoL scales (mean difference, 27.94; 95% CI, 9.33-46.55; p=0.005). Global QOL, physical function, symptoms of sticky saliva, cough, feelings of illness and weight loss improved significantly between 2 weeks and 3 months. There was no significant difference between 3 and 6 months. Interestingly, improvements in social function, social contact, pain and nutrition reached significance at 6 months. Subgroup analysis revealed greater pain relief over time for patients who underwent HT (p=0.030). Moreover, patients who participated in swallowing rehabilitation programs had a greater decrease in nausea and vomiting (p=0.036). HNC patients treated with modern RT techniques experience improved QOL and physical function over time. The most significant improvement occurs between 2 weeks and 3 months, after which the improvement plateaus. However, social function, social contact, pain and nutrition may require longer recovery intervals after treatment. HT with daily image guidance could provide a therapeutic opportunity for improving pain relief in patients with HNC.

The influence of sex, age, and body height on the pulmonary vascular permeability index – a prospective observational study

The pulmonary vascular permeability index (PVPI) is a quotient of the extravascular lung water (EVLW) and the pulmonary blood volume (PBV). In acute respiratory distress syndrome (ARDS), the alveolar-capillary membrane integrity is disrupted. The result is a disproportionate increase of EVLW compared to the PBV and, hence, an increase in PVPI. Thus, PVPI has repetitively been discussed to extend the definition of ARDS. Besides sex, the influence of other anthropometric variables on PVPI has not been studied so far. However, since it is known that EVLW depends on body height and sex, we hypothesize that PVPI depends on anthropometric variables as well. This prospective single-center observational study included 1533 TPTD measurements of 251 non-critically ill patients (50.6% men) undergoing elective neuro-, thoracic, or abdominal surgery at the Munich Clinic Bogenhausen of the Technical University of Munich. Multivariate regressions were used to measure the influence of sex, age, and body height on PVPI. In all patients, PVPI was significantly higher in women (P < 0.001), with 34.4% having a PVPI > 2 compared to 15.9% of men. Mean PVPI significantly decreased with height (P < 0.001) and age (P < 0.001). Multivariate regressions allowed the calculation of mean reference surfaces. The 95th percentile surface for PVPI was > 3 for small and young women and well above 2 for all but tall and elderly men. In patients who underwent (lung reduction) thoracic surgery, the PVPI before and after surgery did not differ significantly (P = 0.531), and post-surgical PVPI did not correlate with the amount of lung resected (P = 0.536). Hence, we conclude that PVPI may be independent of the extent of lung volume reduction. However, PVPI is heavily dependent on sex, age, and body height. Anthropometric variables thus have a significant impact on the likelihood of misclassified abnormal PVPI. This warrants further studies since an increased PVPI, e.g. in the context of an ARDS, may be overlooked if anthropometric variables are not considered. We suggest reference surfaces based on the 95th-percentile corrected for sex, age, and height as a novel approach to normalize PVPI.

Home-based long-term physical endurance and inspiratory muscle training in children and adults with Fontan circulation.

Regular physical activity is highly recommended for patients with Fontan hemodynamics. Our aim was to investigate the effects of a long-term individualized home-based endurance training (IHET) on a bicycle ergometer in combination with inspiratory muscle training (IMT) in pediatric and adult patients after Fontan palliation. Additionally, factors influencing the trainability of Fontan palliated patients were analyzed. From 2018 to 2021 a single-center prospective study was performed initially including 25 Fontan palliated patients. During study period nine patients were excluded due to incompliance. A Magbike® bicycle ergometer (DKN Technology, France) was used for IHET and a POWERbreathe® Medic plus device (HaB GmbH, Germany) was utilized for the IMT. Over the study period, bike training was increased from 90 min of basic endurance training per week to additional 25 min of interval training per week. IMT consisted of 30 breaths per day for 6-7 days per week with pressure adaption over time. Patients underwent cardiopulmonary exercise testing (CPET) and body plethysmography including measurement of respiratory muscle strength at baseline and at follow-up examinations at 4, 10 and 22 months. Follow-up examinations were completed by 18/25 patients (72.0%) at 4 and 10 months and 16/25 patients (64.0%) at 22 months. Median exercise capacity slightly increased by 0.13 W/kg from baseline to last follow-up (p = 0.055, 95%CI: 0.0-0.36). However, a significant increase of oxygen pulse of 0.7 ml/beat (p = 0.006, 95%CI: 0.38-2.22) was detectable. IMT significantly improved respiratory function with an increase of inspiratory vital capacity (VCin/reference) by 4.0% (p = 0.016, 95%CI: 0.8-8). Median maximal inspiratory pressure increased by 1.2 kPa (p = 0.003, 95%CI: 0.64-3.19) and expiratory pressure by 1.5 kPa (p = 0.036, 95%CI: 0.08-2.29). No adverse events or unplanned interventions occurred during the study. Patients' subjective quality of life did not significantly change over the study period. In Fontan palliated patients, IHET in combination with IMT leads to a significant increase in oxygen pulse, inspiratory vital capacity as well as median maximal inspiratory and expiratory pressure but not to significant improvement of quality of life. Fontan patients should be encouraged to perform regular home-based exercise training.

Prospective Evaluation of Transsphenoidal Pituitary Surgery in Patients with Cushing's Disease: Delayed Remission and the Role of Postsurgical Cortisol as a Predictive Factor.

Transsphenoidal surgery is the treatment of choice for Cushing's disease. Successful surgery is associated with subnormal postoperative serum cortisol concentrations and cortisoluria levels, which may guide decisions regarding immediate reoperation. Remission is defined as the biochemical reversal of hypercortisolism with the re-emergence of diurnal circadian rhythm. A single-center prospective cohort study was conducted among thirty-three patients who underwent transsphenoidal pituitary surgery for Cushing's disease. Postoperative surgical outcomes, daily morning cortisolemia, and 24 h urinary-free cortisol from the first to the fifth morning were evaluated. All patients underwent surgery, with a remission rate of 81.2%. Of the 26 patients who achieved early remission, 92% remained in remission. Two patients (7.7%) showed recurrence of Cushing's disease during a mean follow-up of 81.7 months. Early postoperative hypocortisolism suggests complete removal of the tumor, correlating with high rates of remission (p < 0.001). Also, in 12.5% of patients with early cortisol values >138 nmol/L, there was a gradual late remission. In our cohort of patients, the endoscopic transsphenoidal approach was safe and effective in the treatment of Cushing's disease. We demonstrated that serum and urinary cortisol concentrations did not experience significant fluctuations from the first to the fifth day. This constitutes an accurate predictor of durable remission, comprising a distinctive finding in the intermediate term by our team.

The effectiveness and acceptability of systemic enzyme therapy in the complex treatment of vulvovaginitis caused by opportunistic microorganisms: Open-label single-center prospective comparative randomized study

The effectiveness and acceptability of systemic enzyme therapy in the complex treatment of vulvovaginitis caused by opportunistic microorganisms: Open-label single-center prospective comparative randomized study

Natural history of chronic idiopathic neutropenia of the adult

Chronic idiopathic neutropenia (CIN) is a rare benign condition caused by an immune attack against neutrophils, either primary or in the context of other autoimmune conditions, lymphoproliferative syndromes, and inborn errors of immunity. In this single-center prospective study, 131 adult CIN patients were enrolled (median age 55 years, range: 20–93). At baseline, 56% had anti-neutrophil autoantibodies and 31% had autoimmune comorbidities. Over a median 3-year follow-up, the rate of grade ≥ 2 infections was 42%, with 10% grade ≥ 3, irrespective of neutrophil counts, demographics, and anti-neutrophil antibodies positivity, and G-CSF was used in 6 patients only. No malignant evolution nor deaths were observed. Bone marrow evaluation showed a large granular lymphocyte (LGL) infiltrate in 52%, mostly polyclonal, and hypocellularity in 31% of cases. Immune-histochemistry highlighted deposits of IgG, IgM, and complement fractions C3 and C4d in most cases. Interestingly, 19% of tested patients displayed somatic mutations of myeloid genes with an association with age. In conclusion, adult CIN appears to be a benign condition without life-threatening infections, yet deserving an extensive hematologic evaluation including bone marrow assessment to inform the differential diagnosis.

Evaluation of Maternal Ischemia-Modified Albumin Levels during Pregnancy and Their Effect on Fetal Birth Weight.

Background and Objectives: The purpose of this study is to evaluate the impact of maternal ischemia-modified albumin (IMA) levels on pregnancy-related complications, fetal growth, and development over time. Materials and Methods: The prospective longitudinal and single-center study included 43 pregnant women ages 18 to 43. Routine pregnancy follow-up began at the first antenatal examination for all pregnant women before 14 weeks gestation, with IMA levels measured during the first, second, and third trimesters. The albumin cobalt binding test was used to determine the amount of ischemia-modified albumin (IMA). The patients' medical, sociodemographic, and nutritional data were analyzed. The primary outcome was to investigate how changes in maternal ischemia affected albumin levels during pregnancy and the relationship between these changes and newborn weight. Results: This study included 43 cases with a mean age of 28.5 ± 5.2 years and a mean gestation period of 39.2 ± 1.3 weeks. The mean IMA levels for cases in the first trimester, second trimester, and third trimester were 0.53 ± 0.06, 0.64 ± 0.11, and 0.64 ± 0.06, respectively. The second and third trimesters showed significantly higher levels of ischemia-modified albumin (IMA) than the first trimester (p < 0.01). There was no statistically significant difference in IMA levels between the second and third trimesters (p = 1.000; p > 0.05). There was no statistically significant correlation between fetal birth and percentage changes in IMA measurements between the first and second trimesters, the first and third trimesters, or the second and third trimesters (p > 0.05). Conclusions: Our study determined that maternal ischemia-modified albumin levels during pregnancy did not correlate with fetal birth weight. Our findings revealed that age, sociodemographic changes, BMI, weight gain, and pregnancy complications had no effect on the change in IMA levels during pregnancy. We believe that this result will serve as a benchmark for future studies on IMA levels during pregnancy.

Efficacy of subperiosteal drains in chronic subdural hematoma: a prospective randomized single-center study.

Background Chronic subdural hematomas (cSDH) are most frequently treated by evacuation via a burr-hole craniostomy procedure. Subperiosteal drains have been introduced as alternatives to subdural ones but only a few prospective studies have explored their efficacy. Thus, a prospective randomized trial was designed to assess their use. Methods The study enrolled patients with newly diagnosed surgically amenable cSDH. These patients were randomized into two groups. The first group underwent cSDH evacuation via a single burr-hole craniostomy procedure followed by placement of a subperiosteal drain; the second group underwent the identical procedure without drain placement. Patient demographics, drain volumes, duration of drainage, cSDH recurrence, and postoperative outcomes were recorded. Results Eighty-eight patients presenting with cSDH (12 with bilateral findings) from a total of 100 surgical cases were enrolled. Nine patients (1 bilateral) were lost to follow-up. Of all remaining 90 procedures, 37 were carried out with drain placement and the remaining 53 without. There were 5 recurrent cases (13,5%) in the drain group and 17 (32,1%) in the control group without drain placement. This resulted in a statistical significance (OR 0.33; p&lt;0.05) favoring the use of a drain. Conclusion Subperiosteal drain placement can be used safely and effectively to treat cSDH in conjunction with a burr-hole craniostomy procedure, significantly reducing the rate of recurrence without any additional disadvantages.

Incidence and predictors of ventilator-associated pneumonia using a competing risk analysis: a single-center prospective cohort study in Egypt

BackgroundVentilator-associated pneumonia (VAP) is a challenging nosocomial problem in low- and middle-income countries (LMICs) that face barriers to healthcare delivery and resource availability. This study aimed to examine the incidence and predictors of VAP in Egypt as an example of an LMIC while considering death as a competing event.MethodsThe study included patients aged ≥ 18 years who underwent mechanical ventilation (MV) in an intensive care unit (ICU) at a tertiary care, university hospital in Egypt between May 2020 and January 2023. We excluded patients who died or were transferred from the ICU within 48 h of admission. We determined the VAP incidence based on clinical suspicion, radiological findings, and positive lower respiratory tract microbiological cultures. The multivariate Fine-Gray subdistribution hazard model was used to examine the predictors of VAP while considering death as a competing event.ResultsOverall, 315 patients were included in this analysis. Sixty-two patients (19.7%) developed VAP (17.1 per 1000 ventilator days). The Fine-Gray subdistribution hazard model, after adjustment for potential confounders, revealed that emergency surgery (subdistribution hazard ratio [SHR]: 2.11, 95% confidence interval [CI]: 1.25–3.56), reintubation (SHR: 3.74, 95% CI: 2.23–6.28), blood transfusion (SHR: 2.23, 95% CI: 1.32–3.75), and increased duration of MV (SHR: 1.04, 95% CI: 1.03–1.06) were independent risk factors for VAP development. However, the new use of corticosteroids was not associated with VAP development (SHR: 0.94, 95% CI: 0.56–1.57). Klebsiella pneumoniae was the most common causative microorganism, followed by Pseudomonas aeruginosa.ConclusionThe incidence of VAP in Egypt was high, even in the ICU at a university hospital. Emergency surgery, reintubation, blood transfusion, and increased duration of MV were independently associated with VAP. Robust antimicrobial stewardship and infection control strategies are urgently needed in Egypt.

Hyperbilirubinemia and hepatic dysfunction in patients undergoing cardiac surgery: Predictors and outcome- A single center prospective study

Background: We aim to assess the incidence and perioperative risk factors for hyperbilirubinemia and hepatic dysfunction after cardiac surgery and determine its influence on early operative outcome. Methods: This prospective observational study was conducted on 485 patients who underwent cardiac surgical procedures from June 2022 to October 2023. Postoperative hyperbilirubinemia was defined as serum total bilirubin &gt;2.0 mg/dl. Results: The overall incidence of post operative hyperbilirubinemia was 24.5% (119 patients). Total and indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase was measured preoperatively and at day 1, day 2 and day 5. Patients undergoing valve repair or replacement had the highest incidence of hyperbilirubinemia (37.1%), followed by coronary artery bypass grafting with concomitant valve surgery (35.3%), congenital heart surgery (24.5%), and coronary artery bypass alone (12.4%). Post operative hyperbilirubinemia was associated with increased duration of inotropic support (p=0.0001), mechanical ventilation (p=0.0001), intensive care unit stay (p=0.001), hospital stay (p=0.006), and mortality (p=0.014). The perioperative factors associated with postoperative hyperbilirubinemia were increased preoperative bilirubin level (p&lt;0.0001), preoperative prothrombin time (p&lt;0.0001), cardiopulmonary bypass time (p=0.026), aortic cross clamp time (p=0.004), and blood transfusion units (p=0.0001). A significant increase of total bilirubin, aspartate aminotransferase, and alkaline phosphatase were noted in the second postoperative day. Significant relation was seen between hypotension and alkaline phosphatase, and aspartate aminotransferase change but hypothermia had not affected alanine aminotransferase, total bilirubin and indirect bilirubin change. Conclusions: Post operative hyperbilirubinemia is seen in patients undergoing cardiopulmonary bypass and is associated with high hospital mortality. The factors associated with its occurrence are increased preoperative bilirubin level, preoperative prothrombin time, cardiopulmonary bypass time, aortic cross clamp time, and blood transfusion units. Persistent hyperbilirubinemia is associated with a worse outcome than early transient hyperbilirubinemia.

Prospective Evaluation of Artificial Intelligence Triage of Incidental Pulmonary Emboli on Contrast-Enhanced CT Examinations of the Chest or Abdomen.

BACKGROUND. Artificial intelligence (AI) algorithms improved detection of incidental pulmonary embolism (IPE) on contrast-enhanced CT (CECT) examinations in retrospective studies; however, prospective validation studies are lacking. OBJECTIVE. The purpose of this study was to assess the effect on radiologists' real-world diagnostic performance and report turnaround times of a radiology department's clinical implementation of an AI triage system for detecting IPE on CECT examinations of the chest or abdomen. METHODS. This prospective single-center study included consecutive adult patients who underwent CECT of the chest or abdomen for reasons other than pulmonary embolism (PE) detection from May 12, 2021, to June 30, 2021 (phase 1), or from September 30, 2021, to December 4, 2021 (phase 2). Before phase 1, the radiology department installed a commercially available AI triage algorithm for IPE detection that automatically processed CT examinations and notified radiologists of positive results through an interactive floating widget. In phase 1, the widget was inactive, and radiologists interpreted examinations without AI assistance. In phase 2, the widget was activated, and radiologists interpreted examinations with AI assistance. A review process involving a panel of radiologists was implemented to establish the reference standard for the presence of IPE. Diagnostic performance and report turnaround times were compared using the Pearson chi-square test and Wilcoxon rank sum test, respectively. RESULTS. Phase 1 included 1467 examinations in 1434 patients (mean age, 53.8 ± 18.5 [SD] years; 753 men, 681 women); phase 2 included 3182 examinations in 2886 patients (mean age, 55.4 ± 18.2 years; 1520 men, 1366 women). The frequency of IPE was 1.4% (20/1467) in phase 1 and 1.6% (52/3182) in phase 2. Radiologists without AI, in comparison to radiologists with AI, showed significantly lower sensitivity (80.0% vs 96.2%, respectively; p = .03), without a significant difference in specificity (99.9% vs 99.9%, p = .58), for the detection of IPE. The mean report turnaround time for IPE-positive examinations was not significantly different between radiologists without AI and radiologists with AI (78.3 vs 74.6 minutes, p = .26). CONCLUSION. An AI triage system improved radiologists' sensitivity for IPE detection on CECT examinations of the chest or abdomen without significant change in report turnaround times. CLINICAL IMPACT. This prospective real-world study supports the use of AI assistance for maximizing IPE detection.

Biomarkers of mitochondrial stress and DNA damage during pediatric catheter-directed neuroangiography - a prospective single-center study.

Neuroangiography represents a critical diagnostic and therapeutic imaging modality whose associated radiation may be of concern in children. The availability of in vivo radiation damage markers would represent a key advancement for understanding radiation effects and aid in the development of radioprotective strategies. Determine if biomarkers of cellular damage can be detected in the peripheral blood mononuclear cells (PBMC) of children undergoing neuroangiography. Prospective single-site study of 27 children. Blood collected pre and post neuroangiography, from which PBMC were isolated and assayed for biomarkers of mitochondrial stress (mitochondrial membrane potential (MMP), reactive oxygen species (ROS), and mitochondrial DNA (mtDNA)) and DNA damage (γH2AX). Dose response of biomarkers vs. radiation dose was analyzed using linear regressions. The cohort was divided into higher (HD) and lower dose (LD) groups and analyzed using linear mixed models and compared using Welch's t-tests. No biomarker exhibited a dose-dependent response following radiation (γH2AX: R2 = 0.0012, P = 0.86; MMP: R2 = 0.016, P = 0.53; mtDNA: R2 = 0.10, P = 0.11; ROS: R2 = 0.0023, P = 0.81). Groupwise comparisons showed no significant differences in γH2AX or ROS after radiation (γH2AX: LD: 0.6 ± 6.0, P = 0.92; HD: -7.5 ± 6.3 AU, P = 0.24; ROS: LD: 1.3 ± 2.8, P = 0.64; HD: -3.6 ± 3.0 AU, P = 0.24). Significant changes were observed to mitochondrial markers MMP (-53.7 ± 14.7 AU, P = 0.0014) and mtDNA (-1.1 ± 0.4 AU, P = 0.0092) for HD, but not the LD group (MMP: 26.1 ± 14.7 AU, P = 0.090; mtDNA: 0.2 ± 0.4, P = 0.65). Biomarkers of mitochondrial stress in PBMC were identified during pediatric neuroangiography and warrant further investigation for radiation biodosimetry. However, isolating radiation-specific effects from those of procedural stress and general anesthesia requires further investigation.

Local and systemic side effects of COVID-19 vaccine in Tunisian cancer patients: A prospective single center study.

We aimed to evaluate the local and systemic side effects of the COVID-19 vaccine in cancer patients. we conducted a cross-sectional study including cancer patients treated at Habib Bourguiba Hospital in Sfax, Tunisia between January and March 2022. Patients should have received at least 1 dose of a COVID-19 vaccine. We interviewed a total of 106 patients, of which 80.2% were actively treated. Mean age was 52.52. Patients were vaccinated by the Pfizer/BioNTech in 59.8% and the Oxford/AstraZeneca in 22.5%. The most frequent grade 1 or 2 adverse events occurring within 7 days were: pain at injection site (71.7%) and fatigue (38.7%). Only 2 patients developed grade 3 toxicity following vaccination. The most systemic side effects were fatigue (35.8%), fever (25.4%), headache (16.9%) and arthralgia (15.1%). They were more common after the first dose of Oxford/AstraZeneca vaccine compared to the Pfizer/BioNTech vaccine (69.6% vs 42.6%; p = 0.03). Risk of any grade toxicity (local or systemic) following the first dose was correlated with female sex (p = 0.033). Our study showed that systemic side effects were more common after the first dose of Oxford/AstraZeneca vaccine compared to the Pfizer/BioNTech vaccine in cancer patient, with the predominance of any grade of local or systemic toxicity in women.

Metabolomic Effects of Liraglutide Therapy on the Plasma Metabolomic Profile of Patients with Obesity.

Liraglutide, a long-acting glucagon-like peptide-1 receptor agonist (GLP1RA), is a well-established anti-diabetic drug, has also been approved for the treatment of obesity at a dose of 3 mg. There are a limited number of studies in the literature that have looked at changes in metabolite levels before and after liraglutide treatment in patients with obesity. To this end, in the present study we aimed to explore the changes in the plasma metabolomic profile, using liquid chromatography-high resolution mass spectrometry (LC-HRMS) in patients with obesity. A single-center prospective study was undertaken to evaluate the effectiveness of 3 mg liraglutide therapy in twenty-three patients (M/F: 8/15) with obesity, mean BMI 40.81 ± 5.04 kg/m2, and mean age of 36 ± 10.9 years, in two groups: at baseline (pre-treatment) and after 12 weeks of treatment (post-treatment). An untargeted metabolomic profiling was conducted in plasma from the pre-treatment and post-treatment groups using LC-HRMS, along with bioinformatics analysis using ingenuity pathway analysis (IPA). The metabolomics analysis revealed a significant (FDR p-value ≤ 0.05, FC 1.5) dysregulation of 161 endogenous metabolites (97 upregulated and 64 downregulated) with distinct separation between the two groups. Among the significantly dysregulated metabolites, the majority of them were identified as belonging to the class of oxidized lipids (oxylipins) that includes arachidonic acid and its derivatives, phosphorglycerophosphates, N-acylated amino acids, steroid hormones, and bile acids. The biomarker analysis conducted using MetaboAnalyst showed PGP (a21:0/PG/F1alpha), an oxidized lipid, as the first metabolite among the list of the top 15 biomarkers, followed by cysteine and estrone. The IPA analysis showed that the dysregulated metabolites impacted the pathway related to cell signaling, free radical scavenging, and molecular transport, and were focused around the dysregulation of NF-κB, ERK, MAPK, PKc, VEGF, insulin, and pro-inflammatory cytokine signaling pathways. The findings suggest that liraglutide treatment reduces inflammation and modulates lipid metabolism and oxidative stress. Our study contributes to a better understanding of the drug's multifaceted impact on overall metabolism in patients with obesity.

Genetic susceptibility and clinical features of CYP2D6 associated with systemic lupus erythematosus in a Chinese population.

This study aims to explore possible susceptibility genes and clinical features for systemic lupus erythematosus (SLE) patients in a Chinese population. Expanding on the results of a prior single-center observational study involving 60 systemic lupus erythematosus patients, a subsequent single-center prospective observational study was conducted on SLE patients undergoing treatment at Nanfang Hospital Affiliated to Southern Medical University from 2021 to 2023. The identification process for drug-related target genes entailed an extensive search across PharmGKB (https://www.pharmgkb.org/), the Clinical Pharmacogenetics Implementation Consortium (CPIC),and PubMed literature databases, to pinpoint common drugs and target single nucleotide polymorphisms(SNPs)for SLE. Blood samples were individually collected and genotyped using MassARRAY® high-throughput nucleic acid mass spectrometry. Genotype frequency differences were assessed through Chi-square tests against both the larger East Asian population as well as kidney transplant recipients. Data collection relied on electronic medical records, encompassing demographic details(age, gender),medication regimens(hormones, NSAIDs, hydroxychloroquine, DMARDs, biologic agents, stomach medications, calcitriol, etc.),laboratory indicators(RF, Anti-CCP antibody, ESR, CRP, anti-ANA antibodies, dsDNA antibodies, anti-SM antibodies, S m. RNP antibodies, A LT, ALB, CR, UA, WBC, PLT, HGB, Ca, K, Glu, CHOL, TG, LDL-C, HDL-C) and lupus activity scores(SLEDAI-2K). Possible disease susceptibility genes were categorized, and SPSS26 software facilitated statistical analyses. The research encompassed a total of 137 SLE patients along with 50 SNPs. After conducting statistical analyses, it emerged that there existed significant disparities in CYP2D6 gene (rs1065852) distribution when compared against allele mutation rates within both East Asian populations (p < .05) and kidney transplant patients(p < .05). Wild-type gene (GG) constituted 14% of cases while mutant gene (GA + AA) constituted 86%. Allele mutation rate (A63.6%) was significantly higher among SLE patients (RR = 0.802; p = .0355). Furthermore, the variant rs1065852 genotype (GA + AA) demonstrated significant associations with lower CRP levels, higher HGB levels, and higher HDL-C levels (p < 0 0.05). The metabolic enzyme CYP2D6 may be used as susceptibility gene for predicting systemic lupus erythematosus and are correlated with CRP and other indicators.

Relationship between waist-to-height ratio and heart failure outcome: A single-centre prospective cohort study.

This study sought to evaluate the correlation between waist-to-height ratio (WHtR) and heart failure (HF) outcomes across different ejection fraction (EF) categories. A prospective cohort study was conducted at a comprehensive tertiary hospital in China. The participants were categorized by WHtR and EF quartiles. Outpatient or telephone follow-up occurred every 6months after the diagnosis of heart failure. The primary endpoint was all-cause mortality at 48months. Cox proportional hazard regression analyses were employed to evaluate the association between WHtR and all-cause mortality. Among 859 enrolled participants, 545 (63.4%) were male, and the mean age was 65.2±11.1years. After adjusting for age and sex, WHtR demonstrated a strong correlation with both BMI (correlation=0.703, P=0.000) and WHR (correlation=0.609, P=0.000). Individuals with a high WHtR (≥0.50) had a higher prevalence of hypertension (56.4% vs. 39.6%) and diabetes (26.5% vs. 13.7%), higher levels of TC (3.61±1.55 vs. 3.36±0.90mmol/L), TG (1.40±0.81 vs. 1.06±0.59mmol/L), and LDL-C (2.03±0.85 vs. 1.86±0.76mmol/L) compared with patients with low WHtR (<0.50). NT-proBNP levels were inversely correlated with EF values in both low and high WHtR groups. A total of 149 (18.9%) patients died at the conclusion of the follow-up period. The incidence of all-cause and cardiovascular death was higher in the low WHtR group compared with the high WHtR group [HRs=1.83 (1.30-2.58), 1.96 (1.34-2.88), respectively]. There was no significant difference in noncardiovascular mortality or rehospitalization rates between the two groups. Patients with HFrEF/low WHtR exhibited a markedly elevated risk of all-cause mortality [HR=2.31; (95% CI: 1.24-4.30)], heart failure mortality [HR=3.52; (95% CI: 2.92-8.80)], and noncardiovascular mortality [HR=4.59; (95% CI: 1.19-17.76)] compared with patients with HFrEF/high WHtR. WHtR has a negligible effect on the risk of all-cause and cardiovascular mortality in heart failure patients with preserved EFs. The obesity paradox, as delineated by WHtR, is observed in patients with HFrEF, yet absent in those with HFpEF.

Prediction of glaucoma progression by 24-h contact lens sensor profile in patients with normal-tension glaucoma

A single-center prospective cohort study was conducted to investigate whether intraocular pressure (IOP)-related 24-h contact lens sensor (CLS) profile parameters can help predict glaucoma progression in patients with normal-tension glaucoma (NTG). CLS measurements (Triggerfish; SENSIMED, Etagnières, Switzerland) at baseline without medication were performed for 24 h in one eye, following diurnal IOP measurements using Goldmann applanation tonometry at 3-h intervals. Glaucoma progression during the follow-up period of ≥ 2 years was determined based on the Guided Progression Analysis of Humphrey visual fields and/or structural progression using fundus photographs. Among 79 patients (mean values: follow-up periods, 48.1 months; age, 51.5 years; baseline IOP, 14.0 mmHg; mean deviation, − 6.04 dB), 23 showed glaucoma progression. A smaller standard deviation of nocturnal ocular pulse amplitude in the CLS profile, a larger range of diurnal IOP at baseline, and the presence of optic disc hemorrhage (DH) during the study period were significant risk factors for glaucoma progression in the multivariate Cox proportional hazards model (hazard ratio, 0.30/mVeq, 1.23/mmHg, and 4.37/presence of DH; P = 0.016, 0.017, and 0.001, respectively). CLS measurements may be useful for assessing the risk of future glaucoma progression in patients with NTG, providing supplementary information to routine IOP measurements.

Addition of Bempedoic Acid to Statin-Ezetimibe versus Statin Titration in Patients with High Cardiovascular Risk: A Single-Centre Prospective Study.

Reducing levels of low-density lipoprotein cholesterol (LDL-C) below recommended thresholds is a core component of cardiovascular prevention strategies. We hypothesized that the addition of bempedoic acid to patients already on statin-ezetimibe therapy was more effective than titrating the statin dose in reducing LDL-C. The study enrolled 120 patients at high cardiovascular risk and with LDL-C above 70 mg/dL. They were randomly divided into two groups: the bempedoic acid (BA) group, taking bempedoic acid in addition to statin plus ezitimibe, and the statin titration (ST) group, including patients who doubled the dose of statin. At 12 weeks, the BA group presented a more significant decrease in LDL-C compared to the ST group (-22.9% vs. 7.5% p 0.002). The total cholesterol decreased significantly in the BA group compared to ST (-14.8% vs.-4.7%; p 0.013) No significant between-group changes in HDL and triglycerides occurred. At 12 weeks, the number of patients who reached LDL-C lower than 70 mg/dL was 38 (63%) in the BA group versus 22 (37%) in the ST group (between groups, p 0.034). In the BA group, the LDL-lowering effect of bempedoic acid was similar between patients taking atorvastatin and rosuvastatin. No side effects occurred during the follow up period. In conclusion, the addition of bempedoic acid to statin-ezetimibe combined treatment was more effective than doubling the dose of statin in reducing LDL-C levels and increased the number of patients reaching the LDL-C goal.

A novel color-aided system for diagnosis of early gastric cancer using magnifying endoscopy with narrow-band imaging.

The Pink Zone Pattern (PP) sign is a typical color alteration of early gastric cancer (EGC) under magnifying endoscopic narrow-band imaging (ME-NBI). By integrating the color changes (PP sign) with the "vessel plus surface (VS)" classification system, we developed an innovative diagnostic system for EGC and named it "Pink Microsurface Microvascular (PSV)" system. Here, we aimed to elucidate the diagnostic performance of the PSV system for EGC. We conducted a single-center prospective clinical study (before-after design) consisting of 2 cross-sectional studies at 2 separate periods. In the before phase, 184 suspected lesions were evaluated using the VS system under ME-NBI; in the after phase, 183 suspected lesions were evaluated using the PSV system. We compared the diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) between the VS group and the PSV group. The accuracy, sensitivity, specificity, PPV, and NPV of the VS system for EGC were 84.6%, 87.0%, 83.6%, 67.8%, and 94.2%, respectively, and those for the PSV system were 93.0%, 92.0%, 93.4%, 85.2%, and 96.6%, respectively. The accuracy, specificity, and PPV of the PSV system were superior to those of the VS system. However, the sensitivity and NPV did not significantly differ between the VS system and the PSV system. The VS system was inconclusive for 22 lesions (12.0%) and the PSV system was inconclusive for 11 lesions (6.0%). The PSV system could identify more suspicious lesions than the VS system. We propose a new PSV diagnostic system by combining the VS system and the PP sign. Compared with the VS system, the PSV system could identify more suspected lesions and improve the diagnostic performance of EGC.