Incidence Of Events Research Articles

Characteristics of suitable cases for treatment with nemolizumab based on clinical findings and cutaneous adverse events

AbstractNemolizumab is an effective treatment for pruritus in atopic dermatitis, but it has a relatively high incidence of cutaneous adverse events (cAEs). To optimize the use of nemolizumab, we investigated the relationship between baseline severity in specific body areas and the frequency of cAEs. Our findings revealed that cases who discontinued treatment with nemolizumab had more severe erythema and edema/papulation on the trunk than those who continued nemolizumab. We also found that the score of excoriation on the trunk tended to be higher. These results indicate that patients with mild severity of eruptions on the trunk at initiation could be suitable for nemolizumab therapy, with the potential for long‐term continuation with the control of cAEs.

Efficacy and safety of cardiac myosin inhibitors for symptomatic hypertrophic cardiomyopathy: a meta-analysis of randomized controlled trials

IntroductionHypertrophic cardiomyopathy (HCM) is a common genetic heart disorder. It is characterized by left ventricular hypertrophy and impaired cardiac function, with forms categorized into obstructive (oHCM) and nonobstructive (nHCM). Traditional treatments address symptoms but not the underlying disease mechanism, highlighting the need for novel therapies. Cardiac myosin inhibitors such as mavacamten and aficamten present potential new treatment options.MethodsA meta-analysis of randomized controlled trials (RCTs) was conducted following PRISMA guidelines. Studies comparing cardiac myosin inhibitors with placebo were reviewed, and outcomes related to NYHA functional class, Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), LVOT gradients, and left ventricular ejection fraction (LVEF) were analyzed.ResultsSix RCTs involving 826 participants demonstrated that mavacamten and aficamten significantly improved NYHA functional class and KCCQ-CSS scores. The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) was similar between the treatment and control groups, indicating a comparable safety profile.ConclusionCardiac myosin inhibitors are effective in improving cardiac function and reducing LVOT obstruction in HCM patients. They offer a promising alternative to current treatments, with a safety profile comparable to placebo. Further research is needed to confirm long-term benefits.

The efficacy and safety of first-line monotherapies in primary therapy of invasive aspergillosis: a systematic review

ObjectiveSeveral antifungals are available for the treatment of patients with invasive aspergillosis (IA). This study aims to evaluate the relative efficacy and safety of the first-line monotherapies in primary therapy of IA through network meta-analysis (NMA).MethodsWe systematically searched PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure, VIP database, Wanfang database, and China Biology Medicine for randomized controlled trials (RCTs) up to July 2023 that evaluated the efficacy and safety of monotherapies. We performed NMA with a frequentist random effects model and assessed the certainty of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Primary outcomes were the all-cause mortality at week 12, and secondary outcomes included overall response rate, and incidence of adverse events (AEs) and severe adverse events (SAEs).ResultsA total of three RCTs involving 1,368 participants (four antifungals) were included. The NMA showed that compared to amphotericin B deoxycholate (D-AmB), the triazoles (posaconazole (POS), isavuconazole (ISA) and voriconazole (VCZ)) can improve the overall response rate in primary therapy of IA, but only VCZ and ISA can reduce the all-cause mortality at week 12 for patients with proven and probable IA (VCZ vs D-AmB: RR = 0.66, 95%CI = 0.47–0.93, moderate certainty; ISA vs D-AmB: RR = 0.52, 95%CI = 0 .31–0.86, low certainty). ISA (SUCRA = 93.50%; mean rank, 1.20) seemed to be the most effective therapy in the above population. As to proven, probable, and possible IA patients, the triazoles were superior to D-AmB in terms of reducing all-cause mortality. Furthermore, the risk of AEs and SAEs was comparable for the three triazoles, but the risk of SAEs was significantly higher for D-AmB than others.ConclusionThe efficacy and safety of triazoles are more favorable than D-AmB in the primary therapy of IA, with ISA being the optimal choice.Systematic Review RegistrationPROSPERO CRD42023407632.

Efficacy and safety of hydroxyurea therapy on patients with β-thalassemia: a systematic review and meta-analysis

ObjectiveOur aim is to review the safety and efficacy of hydroxyurea (HU) on β-thalassemia patients.MethodsStudies that evaluated the safety and efficacy of HU on β-thalassemia patients were searched in Pub-Med, Cochrane Databases, Web of Science, China-Biology-Medicine, CNKI, Embase, VIP, and WanFang data. The proportions of response rate (RR) (50% fall in transfusion need in transfusion-dependent β-thalassemia patients, or 1 g/dL elevate in hemoglobin (Hb) levels in transfusion-independent β-thalassemia patients) and good RR (transfusion-free in transfusion-dependent β-thalassemia patients or 2 g/dL elevate in Hb levels in transfusion-independent β-thalassemia patients) were utilized to evaluate the effect size (ES). The secondary outcomes were the adverse events incidence rates of HU in β-thalassemia patients.ResultsTwo randomized controlled trials (RCTs) and 25 single-armed observational studies with typically 1,748 individuals were involved in our analysis. All 27 clinical trials were reported with fair quality. HU, in transfusion-dependent β-thalassemia patients, was related to a significant decrease in transfusion requirements [a pooled RR of 0.37 and a pooled good RR of 0.65 (95% CI, 0.53–0.76)]; in transfusion-independent β-thalassemia patients, it was correlated to an excellent raise in Hb levels [a pooled RR of 0.20 (95% CI, 0.08–0.35) and a pooled good RR of 0.53 (95% CI, 0.41–0.65)]. Neutropenia and leucopenia were the most prevalent adverse events in β-thalassemia patients treated with HU, while the incidence rates of other side effects were relatively lower.ConclusionOur findings demonstrated that β-thalassemia patients tolerated and responded well to HU. Due to the control arms absence in the involved studies, more double-masked RCTs are essential for proving the safety and efficacy of HU in β-thalassemia patients.

Impact of Warfarin and Dual Antiplatelet Therapy on Graft Failure After Coronary Endarterectomy: A Retrospective Cohort Study.

Coronary endarterectomy combined with coronary artery bypass grafting (CE-CABG) effectively achieves coronary revascularization in patients with diffuse atherosclerotic coronary artery disease (CAD). However, the loss of the subendothelial tissue at the CE-CABG coronary artery accelerates local thrombosis, leading to CE-CABG graft failure. Dual antiplatelet therapy (DAT) and warfarin plus aspirin (WPA) are the two most common anticoagulation strategies post CE-CABG. This retrospective study compares the clinical outcomes and graft failure rates associated with these two approaches. This study is a retrospective cohort study. Between July 2016 and April 2024, 102 patients with diffuse CAD underwent CE-CABG. Six patients were excluded. In total, 96 patients (mean age 59.8 ± 7.7years) enrolled in the study (43 in DAT group and 53 in WPA group). The DAT group received aspirin (100mg, qd) and clopidogrel (75mg, qd) for 1 year postoperatively, transitioning to aspirin (100mg, qd) after 1 year. The WPA group received warfarin (international normalized ratio, INR remained at 1.8-2.5) and aspirin (100mg, qd) for 3 months postoperatively, followed by DAT after 3 months, changed to aspirin monotherapy after 1year. The primary endpoint was graft failure of the CE-CABG graft. Four patients died during the perioperative period (1 in DAT group, 3 in WPA group), resulting in an overall perioperative mortality rate of 4.2%. Five patients were lost for follow-up. Mean follow-up time was 38months. Three patients died during the follow-up period (1 in DAT group, 2 in WPA group). The CE-CABG graft patency of the WPA group was significantly higher compared to the DAT group (88.1% vs. 50.0%, P < 0.001). Kaplan-Meier analysis showed that the median graft failure time was significantly longer in the WPA group (77months, 95% CI 69-85) compared to the DAT group (73months, 95% CI 17-129, P = 0.017). A higher proportion of the DAT group was classified as NYHA III-IV compared to the WPA group (26.2% vs. 10.2%, P = 0.046). One patient of the WPA group had a gastrointestinal bleeding event, and the overall incidence of bleeding events was not statistically different between the two groups. Using the WPA strategy after CE-CABG significantly reduces the rate of graft failure and improves cardiac function without increasing the risk of bleeding events.

The Use of Knives With Versus Without Integrated Water-jet Function During Peroral Endoscopic Myotomy for Patients With Achalasia: A Meta-analysis.

Peroral endoscopic myotomy (POEM) is a well-established endoscopic treatment for achalasia, utilizing an endoscopic knife for dissection. Recently, new knives with an integrated water-jet (WJ) function have been introduced. This study aims to compare the technical, perioperative, and late postoperative outcomes between WJ knives and conventional (C) knives, which lack the WJ function, through a pairwise meta-analysis of published comparative studies. We conducted a systematic literature review following PRISMA guidelines to identify studies directly comparing knives with versus without a WJ function in POEM for achalasia. A random-effects model was employed, using odds ratios for dichotomous data and mean differences for continuous data as effect size metrics. The use of WJ knives demonstrated statistically significant reductions in the mean number of intraoperative instrument exchanges, mean intraoperative use of coagulation forceps, and operative times compared to the use of C knives. There were no significant differences in terms of the incidence of adverse events, subcutaneous emphysema, or mean hospital length of stay (LOS). Clinical success, defined as a postoperative Eckardt score <3, mean postoperative Eckardt scores, and the incidence of GERD requiring proton pump inhibitors (PPI) also showed no significant differences. The use of water-jet (WJ) knives demonstrates comparable efficacy to conventional (C) knives, with superior efficiency reflected in reduced operative time and fewer intraoperative instrument exchanges. In addition, in terms of safety, the lower use of coagulation forceps with WJ knives suggests reduced intraoperative bleeding. However, no significant differences were observed between the groups in terms of length of stay (LOS) and adverse events, despite a trend toward reduction. A larger number of studies with greater sample sizes is required to better assess potential differences in safety between the use of WJ and C knives.

Prospective clinical evidence from over 1,000 pan-cancer patients: a complement to fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting

BackgroundChemotherapy-induced nausea and/or vomiting (CINV) is an intractable adverse effect of anticancer drugs. Although prophylactic use of fosaprepitant may be effective in reducing CINV, there is a lack of studies evaluating the application of fosaprepitant in real world.Aims and methodsThis study prospectively observed the effectiveness and safety for the prophylaxis of CINV in a real-world clinical setting. A single dose fosaprepitant 150 mg was intravenously administered to enrolled patients 30 min prior to the chemotherapy drug. Initial data were recorded and patients were followed for 120 h (5 days). The primary endpoint is the complete response (CR) rate and the incidence of serious adverse events (SAEs). The second endpoint is the use of rescue therapy. We also performed stratified analyses to investigate the impact of different factors on fosaprepitant for the prevention of CINV in the acute phase.ResultsBetween March 2021 to August 2021, 1001 patients were enrolled in this study. CR was 77.32%, 93.61%, and 76.72% for vomiting control in 0–24 h, 24–120 h, and 0–120 h respectively, and 97.4%, 99.1%, and 96.9% for nausea control. No SAEs were recorded. 23.48% or 3.1% of patients needed rescue therapy for vomiting or nausea control respectively, most of which occurred in the acute phase. CR rate decreased with increasing emetogenicity of chemotherapeutic agents.ConclusionsSingle-dose fosaprepitant has shown good performance in real-world clinical practice. This study is the first to prospectively evaluate the efficacy and safety of fosaprepitant for the prevention of CINV in a real-world clinical setting and may be a good complement to the clinical data.

Intervention and Effect of Targeted Anesthesia Nursing Measures on Post-operative Emergence Agitation in Elderly Patients Undergoing General Anesthesia

To explore the effect of targeted anesthesia nursing measures on emergence agitation (EA) in elderly patients who were anesthetized by general anesthesia. In this study, 186 cases of elderly patients admitted to Deyang People's Hospital for general anesthesia surgery from March 2022 to March 2024 were selected prospectively, and the 186 patients included in the study were randomly divided into the control group (n=93) and the observation group (n=93) according to the method of randomized numerical table. Routine nursing measures were adopted in the resuscitation period of the control group; targeted anesthetic nursing measures were adopted in the resuscitation period of the observation group; routine nursing measures were adopted in the resuscitation period of the control group. The control group used conventional nursing measures during the resuscitation period after anesthesia, and the observation group used targeted anesthesia nursing measures during the resuscitation period after anesthesia, the incidence of EA, the incidence of EA-related complications, patient satisfaction and the incidence of hypothermia during anesthesia resuscitation in the two groups were compared. The results show that the incidence of EA in the observation group with targeted anesthesia nursing measures was significantly lower than that in the control group (P &lt; 0.05), the incidence of EA-related complications in the observation group with targeted anesthesia nursing measures was significantly lower than that in the control group (P &lt; 0.05), the satisfaction score in the observation group with targeted anesthesia nursing measures was significantly higher than that in the control group (P &lt; 0.05), and the rate of hypothermia during resuscitation of the patients in the observation group with targeted anesthesia nursing measures was significantly lower than that in the control group (P &lt; 0.05). The incidence of hypothermia during anesthesia resuscitation in the observation group was significantly lower than that in the control group (P &lt; 0.05). In summary, targeted anesthesia nursing interventions can effectively reduce the incidence of postoperative EA, the incidence of EA-related adverse events and hypothermia during resuscitation in elderly patients, and improve patient satisfaction, which is worthy of application and promotion.

Association of whole grain food consumption with lung cancer risk: a prospective cohort study

BackgroundWhether the intake of whole grain foods can protect against lung cancer is a long-standing question of considerable public health import, but the epidemiologic evidence has been limited. Therefore we aim to investigate the relationship between whole grain food consumption and lung cancer in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) cohort.MethodsDiet was assessed with a self-administered Diet History Questionnaire (DHQ) at baseline. All incident lung cancer cases were pathologically verified. Hazard ratios and 95% confidence intervals for lung cancer risk associated with whole grain food consumption were estimated by Cox proportional hazards regression.ResultsDuring a median follow-up of 12.2 years, a total of 1,706 incident lung cancer events occurred, including 1,473 (86.3%) cases of non-small cell lung cancer (NSCLC) and 233 (13.7%) of small cell lung cancer (SCLC). After multivariate adjustment, comparing the highest quarter of consumption of whole grain foods to the lowest quarter, a 16% lower rate (HR 0.84, 95% CI 0.73–0.98) of lung cancer risks and a 17% lower rate (HR 0.83, 95% CI 0.69–0.98) for NSCLC were found, but no significant difference was shown for SCLC (HR 0.95, 95% CI 0.63–1.44). These results were consistently observed after a large range of subgroup and sensitivity analyses. A linear dose-response pattern was shown for lung cancer, NSCLC, and SCLC (P for non-linearity > 0.05).ConclusionsIn this large prospective cohort study, whole grain food consumption was associated with reduced lung cancer and NSCLC. Our findings suggest a potential protective role of whole grain foods against lung cancer.

Prognostication in emergency room patients: comparing ultrasensitive and contemporary quantification of cardiac troponin levels below the 99th percentile

IntroductionCardiac troponin levels below the 99th percentile improve the predictive efficacy for cardiovascular events when associated with relevant clinical variables. However, whether ultra-sensitive analytical methods improve this predictive efficacy over less sensitive or contemporary analytical methods remains unknown.MethodsThis retrospective observational study involved consecutive patients who presented to the emergency department for suspected acute coronary syndrome and underwent measurement of ultra-sensitive cardiac troponin I (Singulex) and contemporary cardiac troponin I (Siemens) with levels below the 99th percentile. The clinical characteristics of these patients were analysed, and the efficacy of both analytical methods for predicting cardiovascular events over a 4-year follow-up period was compared.ResultsIn total, 838 patients were analysed (mean age, 62.9 ± 16.6 years; 42.2% women). Their cumulative incidence of the composite cardiovascular event (death, readmission for myocardial infarction, and readmission for heart failure) was 25.9% over the 4-year follow-up. Both Singulex cardiac troponin I (analysed by quartiles) and Siemens cardiac troponin (analysed as detectable/undetectable) improved the predictive efficacy for the combined event over clinical variables [Harrell's C-index (95% confidence interval): 0.77 (0.74–0.80) vs. 0.79 (0.76–0.81) and 0.77 (0.74–0.80) vs. 0.78 (0.75–0.81), respectively; p = 0.018]. However, there were no statistically significant difference between the two predictive models that included the aforementioned troponin assays.ConclusionsDetectable levels of cardiac troponin using a contemporary analytical method or those near the 99th percentile using an ultra-sensitive analytical method improve the predictive efficacy for cardiovascular events, with no differences between the two methods

Unsupervised machine learning model for phenogroup-based stratification in acute type A aortic dissection to identify postoperative acute gastrointestinal injury

ObjectiveWe aimed to explore the application value of unsupervised machine learning in identifying acute gastrointestinal injury (AGI) after extracorporeal circulation for acute type A aortic dissection (ATAAD).MethodsPatients who underwent extracorporeal circulation for ATAAD at the First Hospital of Lanzhou University from January 2016 to January 2021 were included. Unsupervised machine learning algorithm was used to stratify patients into different phenogroups according to the similarity of their clinical features and laboratory test results. The differences in the incidence of perioperative AGI and other adverse events among different phenogroups were compared. Logistic regression was used to analyze the high-risk factors for AGI in each phenogroups and random forest (RF) algorithms were used to construct diagnostic models for AGI in different phenogroups.ResultsA total of 188 patients were included, with 166 males and 22 females. Unsupervised Machine Learning stratified patients into three phenogroups (phenogroup A, B, and C). Compared with other phenogroups, phenogroup B patients were older (P &amp;lt; 0.01), had higher preoperative lactate and D-dimer levels, and had the highest incidence of AGI (52.5%, P &amp;lt; 0.001) and in-hospital mortality (18.6%, P = 0.002). The random forest model showed that the top four risk factors for AGI in phenogroup B were cardiopulmonary bypass time, operation time, aortic clamping time, and ventilator time, which were significantly different from other phenogroups. The areas under the curve (AUCs) for diagnosing postoperative AGI of phenogroup A, B, and C were 0.943 (0.854–0.992), 0.990 (0.966–1.000), and 0.964 (0.899–0.997) using the RF model, respectively.ConclusionPhenogroup stratification based on unsupervised learning can accurately identify high-risk populations for postoperative AGI in ATAAD, providing a new approach for implementing individualized preventive and therapeutic measures in clinical practice.

Effectiveness and safety of full-thickness versus circular muscle myotomy in peroral endoscopic myotomy: a retrospective single-center analysis of 152 patients.

Achalasia is a primary esophageal motility disorder, which shows impaired relaxation of the lower esophageal sphincter (LES) and the absence of peristalsis, leading to dysphagia, weight loss, and chest pain. In recent years, peroral endoscopic myotomy (POEM) has become a popular method for treating achalasia. However, the effectiveness and safety of full-thickness myotomy (FTM) versus circular muscle myotomy (CMM) in POEM require further investigation. This retrospective single-center analysis studied 152 patients who underwent POEM surgery at the General Hospital of the Western Theater Command from May 2014 to May 2023. Patients were divided into two groups based on the depth of myotomy: the FTM group and the CMM group. Parameters such as surgical success rate, procedure time, and myotomy length were evaluated, and treatment efficacy was assessed based on the Eckardt score. Postoperative complications and efficacy were also monitored. Technical success was achieved in both groups, with shorter procedure times in the FTM group (P < 0.05). There were no significant differences in postoperative Eckardt scores and symptom improvement between the FTM and CMM groups. The incidence of adverse events was similar in both groups. The incidence of gastroesophageal reflux disease (GERD) seemed to be higher in the FTM group, although this difference was not statistically significant (P = 0.051). For patients with achalasia, there were no significant differences in short-to-medium-term treatment efficacy and safety between FTM and CMM in POEM. Although FTM significantly reduced procedure time, it may lead to a higher incidence of GERD. More cases are needed in the future to explore the more appropriate myotomy for different achalasia subtypes.

Efficacy and safety of acupuncture monotherapy or combined with pelvic floor muscle training for female stress urinary incontinence: a systematic review and meta-analysis

BackgroundStress urinary incontinence (SUI) is involuntary urine leakage during effort. Pelvic floor muscle training (PFMT) is a common physical therapy for SUI, but has low adherence and its long—term effectiveness is uncertain. Drug therapy has side-effect problems and surgery has risks. Acupuncture’s role in improving SUI is also unclear based on previous studies.ObjectivesThis systematic review and meta-analysis evaluated the efficacy and safety of acupuncture individually or combined with PFMT in improving symptoms and women’s health-related quality of life of SUI.DesignA systematic review and meta-analysis were conducted.PatientsWomen with stress urinary incontinence were treated with electroacupuncture (EA) individually or acupuncture combined with PFMT.ResultsIn the analysis comparing urinary leakage 1 h and the ICIQ-SF score, electroacupuncture (EA) intervention was significantly associated with improvements in both urine leakage (MD = 4.69, 95% CI 2.83 to 6.55, I2 = 62%) and ICIQ-SF (MD = 2.61, 95% CI 1.64 to 3.58, I2 = 65%). The results were robust for the sensitivity analyses. EA was not associated with an increased incidence of adverse events compared to placebo EA (RR = 1.08, 95% CI 0.50 to 2.35, I2 = 0%). When comparing the group receiving pelvic floor muscle training (PFMT) combined with acupuncture to the PFMT only group, the combination therapy was found to improve urine leakage 1 h (MD = 1.91, 95% CI 0.96 to 2.86, I2 = 80%) and improve ICIQ-SF (MD = 2.63, 95% CI 1.60 to 3.65, I2 = 75%) in patients with SUI, despite significant heterogeneity observed. Subgroup analyses based on urine leakage 1 h revealed that subjects with mild stress urinary incontinence showed improvements (MD = 1.46, 95% CI 0.82 to 2.10, I2 = 58%), as did those with moderate stress urinary incontinence (MD = 4.9, 95% CI 1.72 to 8.08, I2 = 77%). There were significant differences between these subgroups (I2 = 77%, p = 0.04). In the subgroup analysis of intervention types, manual acupuncture showed no significant effect when combined (MD = 1.11, 95% CI -0.61 to 2.83, I2 = 86%).ConclusionThe findings from this meta-analysis indicate that EA is more effective at improving the clinical symptoms and quality of life in patients with SUI compared to placebo EA, and it does not increase the risk of adverse events. Moreover, the therapeutic effect of SUI treatment with EA combined with pelvic floor muscle training (PFMT) elicits a more positive response than PFMT alone. This suggests that EA, either as a standalone therapy or as an adjunct to PFMT, can offer beneficial outcomes for individuals with stress urinary incontinence, expanding the range of clinical treatment options available.Systematic Review RegistrationThe meta-analysis was registered in PROSPERO (CRD42022381409).

Triglyceride-glucose index: carotid intima-media thickness and cardiovascular risk in a European population

BackgroundThe triglyceride-glucose (TyG) index is now widely recognized as a marker of insulin resistance and has been linked to the development and prognosis of atherosclerotic cardiovascular diseases (ASCVD) in numerous populations, particularly in the Eastern world. Although there are fewer reports from the Western world, and they are sometimes contradictory, the absence of definitive data on the relationship between a raised TyG index and cardiovascular risk suggested the opportunity of testing this biochemical marker against a well-established vascular marker such as the carotid intima media thickness (c-IMT).MethodsPrimary prevention patients were selected from a cohort of individuals who underwent c-IMT measurement between 1984 and 2018 at the Dyslipidemia Center at the ASST Grande Ospedale Metropolitano Niguarda in Milan, Italy. The TyG index was calculated as the Ln [fasting TG (mg/dL)×fasting glucose (mg/dL)/2]. Carotid ultrasonography was performed using echographic measurements of the far walls of the left and right common, internal carotids, and bifurcations. Patients were followed for up to 20 years with periodic evaluation of biochemical parameters. ASCVD events were monitored through hospital records, where all patients were regularly examined.ResultsThe analysis included 3108 individuals with a mean age of 54.9 ± 13.1 years. Participants were generally non-obese, with an average BMI of 24.6 ± 3.5 Kg/m2. Among the women, 83.1% were postmenopausal. The mean TyG index was 8.65 ± 0.59. There was a significant association between the TyG index and all c-IMT measurements. Those in the highest TyG index quartiles had significantly higher IMTmean and IMTmax compared to those in the lower quartiles. These associations were consistent across all vascular sites examined and remained significant after adjusting for all potential confounders. Kaplan-Meier survival analysis revealed an increased incidence of ASCVD events in the two highest TyG index quartiles.ConclusionsTyG index is a sensitive marker of risk in a European population with moderate ASCVD risk, as assessed by c-IMT measurements, in a large cohort of Lipid Clinic patients.

Evaluating the Safety of Thread-Embedding Acupuncture: Protocol for a Multi-Center, Prospective, Observational Study in Clinical Practice

Background/Objectives: Medical therapies that apply biodegradable materials, such as polydioxanone, are widely used to treat various disorders. Thread-embedding acupuncture (TEA) is a unique form of acupuncture that exerts long-lasting therapeutic effects by inserting absorbable threads at specific acupuncture points, and is widely used to treat various diseases. However, there is currently a lack of research regarding the safety of TEA. This prospective observational trial aims to evaluate the safety of TEA by collecting and analyzing data related to adverse events in patients receiving TEA in actual practice. Methods: A total of 350 eligible participants who undergo TEA at one of three university-affiliated hospitals and two traditional Korean medicine clinics will be systemically observed for post-treatment adverse reactions. The patients will be monitored at three time points: 1 week, 1 month, and 3 months post-treatment. Safety evaluations will assess the incidence of adverse events and treatment discontinuation rates during the 3-month post-treatment period. Conclusions: This study will evaluate the safety of TEA and provide information for decision-making in clinical practice as well as basic data for future large-scale research.

4.5-Year Follow-up with a Novel Corneal Endothelial Prosthesis.

Refractory corneal edema is the foremost reason for endothelial corneal transplantation (EK) in the world. Descemet membrane endothelial keratoplasty (DMEK) and Descemet stripping automated endothelial keratoplasty (DSAEK) offer good clinical outcomes. However, human donor tissue is limited in availability and has a complex logistical chain. Many patients in need do not have access to EK. Success of the human donor tissue depends on its quality, the number of rebubbles, repeat keratoplasties, and patient-related risk factors. The use of an endothelial corneal keratoprosthesis could benefit patients with a high risk for graft failure and human graft rejection, and patients in underserved areas where tissue banking is unavailable. Case cohort series of 10 eyes of 10 patients implanted with the EndoArt, with a follow-up of up to 4.5 years. Outcome measures are device adherence, central corneal thickness, visual acuity, and incidence of adverse events. In the first seven eyes, the EndoArt was implanted in eyes with low visual potential within the first-in-human (FIH) trial, and in the three remaining eyes, implantation was performed because of either guarded posterior or anterior segment prognosis or the patient's wishes. In 9/10 eyes, device adherence was obtained and maintained throughout the follow-up period. Mean corneal thickness decreased from 927 + SD 241 microns to 621 + SD 140 microns. In 6/10 eyes, visual acuity improved from a mean preoperative value of logMAR 1.94 + 0.63 to a mean postoperative value of logMAR 0.8 + 0.64. No pathological thinning or corneal metabolic changes were seen. The surgical technique was developed during the follow-up period. The EndoArt provided a stable decrease in central corneal thickness, improved vision in 60% of eyes, and had no device-related adverse events. The EndoArt is an additional treatment modality for special cases like repeat corneal graft failure in the population of the Western world, or as a primary procedure in underserved areas worldwide.

Posterior Peroral Endoscopic Myotomy With Versus Without Sparing of the Oblique/Sling Fibers: A Meta-analysis.

Several studies have hypothesized that sparing the oblique/sling fibers during posterior peroral endoscopic myotomy (POEM) may reduce the incidence of gastroesophageal reflux disease (GERD) and reflux esophagitis without compromising the established safety and efficacy of the procedure. This study compares perioperative, postoperative motility-related, and postoperative GERD-related outcomes between posterior oblique/sling fibers-sparing POEM (OFS-POEM) and conventional posterior POEM through a pairwise meta-analysis of comparative studies. We conducted a systematic literature review following PRISMA guidelines to identify articles directly comparing posterior OFS-POEM with conventional posterior POEM. A pairwise meta-analysis was performed using a random-effects model. Effect sizes were calculated as odds ratios for dichotomous data and mean differences for continuous data. No significant differences were observed in perioperative outcomes, including mean gastric myotomy length, mean operative time, and incidence of adverse events. Similarly, no significant differences were noted in postoperative motility-related outcomes, such as mean Eckardt score and mean integrated relaxation pressure. However, a statistically significant reduction in the incidence of symptomatic GERD was observed in favor of OFS-POEM, with a number needed to treat (NNT) of 10 (95% CI: 6-49). Interestingly, no significant differences were found in the incidence of objectively diagnosed postoperative GERD, such as the number of patients with DeMeester scores >14 or the incidence of reflux esophagitis. This study suggests that OFS-POEM may reduce the incidence of symptomatic GERD following POEM, without affecting the incidence of GERD diagnosed by pH studies (DeMeester score >14) or by endoscopy (reflux esophagitis). Future studies with larger sample sizes are needed to further investigate the impact of OFS-POEM on GERD incidence as determined by pH studies and endoscopic findings. Given the limitations of this study, no definitive conclusions can be drawn. Multicenter randomized controlled trials with larger sample sizes are required to reach more reliable conclusions. Furthermore, stratifying data according to the type and class of achalasia would provide valuable information on whether there are differences in outcomes among the various types and classes of achalasia.

Association of geriatric nutritional risk index with renal prognosis and all-cause mortality among older patients with chronic kidney disease: a secondary analysis of CKD-ROUTE study

Objectives The aim of the study was to assess the association between the geriatric nutritional risk index (GNRI) and incidence of CKD progression, all-cause mortality, and cardiovascular events in the elderly patients with chronic kidney disease (CKD) before dialysis initiation. Methods We performed a post hoc analysis of the CKD-ROUTE database, which included 538 pre-dialysis CKD patients aged ≥65 years in this prospective cohort study. Associations between GNRI and clinical outcomes were estimated using Cox proportional hazards model analysis. Multivariable linear mixed regression models with random intercepts were used to assess the association between GNRI and estimated glomerular filtration rate (eGFR) decline per year. Results During the median follow-up period of 2.92 years, there were 123 (22.86%) CKD progression events, 44 (8.18%) deaths, and 76 (14.13%) cardiovascular events. After adjusting for multiple confounding factors, the hazard ratios (HRs) for CKD progression in patients with GNRI <92 were 1.99 (95% CI, 1.34–2.97; p < 0.001), when compared with a GNRI of ≥92. Patients with a lower GNRI also had a significantly greater rate of eGFR decline over time than well-nourished patients (mean annual difference, −1.69; 95% CI, −2.62 to −0.77; p < 0.001). In the secondary outcomes, this association was consistent for all-cause mortality. Moreover, the associations were generally consistent across several subgroup and sensitivity analyses. Conclusions The lower GNRI is significantly associated with higher risks of renal prognosis and all-cause mortality in elderly patients with CKD.

Locoregional anesthesia in patients with Brugada syndrome. A retrospective database analysis.

The use of local anesthetics (LA) in individuals with Brugada syndrome (BrS) remains a subject of debate due to the lack of large-scale studies confirming their potential risks. This study primarily aimed to evaluate the incidence of new malignant arrhythmias or defibrillation events in patients diagnosed with BrS during the perioperative period, following the administration of local anesthetics, and within 30 days postoperatively. The secondary objective was to analyze the occurrence of adverse effects during hospitalization, as well as 30-day readmission and mortality rates. A retrospective cohort study was performed on patients with BrS who underwent locoregional anesthesia between January 1, 1996, and September 30, 2020. Anesthetic records and electronic medical records were thoroughly reviewed for up to 30 days following each administration of local anesthetics. A total of 47 procedures involving patients with BrS who underwent locoregional anesthesia were analyzed. The patients were categorized into three groups: 27 in the peripheral nerve block (PNB) group, 13 in the epidural anesthesia group, and 9 in the spinal anesthesia group. One patient in the PNB group experienced intraoperative ventricular fibrillation following the administration of ajmaline. No other adverse events were observed. In this retrospective study, our findings do not indicate an increased arrhythmogenic risk or a higher incidence of adverse events associated with the administration of local anesthetics in patients with BrS. However, the available data are insufficient to confirm the safety of local anesthetic use in this population. Enhanced vigilance is recommended when administering local anesthetics to individuals with BrS. Prospective studies are necessary to further evaluate and establish the safety profile of local anesthetics in this patient group.

Evaluation of the Toxicity and Outcomes of the Combination of Midostaurin and CLAG-M in Patients With FLT3-Mutated Acute Myeloid Leukemia (AML): A Multicenter Retrospective Analysis.

Addition of midostaurin to standard "7+3" (cytarabine and anthracycline) significantly prolongs overall and event-free survival. At University of Washington/Fred Hutchinson Cancer Center (UW/FHCC), the standard regimen for newly diagnosed (ND) and relapsed/refractory (R/R) AML is cladribine, high-dose cytarabine, GCSF, and mitoxantrone (CLAG-M); midostaurin is added if FLT3-mutated. There is limited data on the use of FLT3-inhibitors with high-dose cytarabine regimens in AML. This study aimed to evaluate the safety and efficacy of the combination of midostaurin with CLAG-M versus midostaurin plus 7+3 in FLT3-mutated AML patients. This is a retrospective, multicenter review including FLT3-mutated AML patients undergoing (re)induction chemotherapy with either CLAG-M or 7+3 at UW/FHCC, Oregon Health & Science University, and Swedish Cancer Institute. The primary outcome was incidence of adverse events. Secondary outcomes included disease response per ELN2017 criteria and 28-day mortality. Excluded were patients on clinical trials or who started midostaurin 30 days after chemotherapy. Eighty patients treated from September 2016 to December 2023 were included; 36 patients received CLAG-M, and 44 patients 7+3. Baseline characteristics were similar across all institutions. Adverse event rates were similar between the 2 cohorts, except diarrhea and bleeding which were more common in the 7+3 cohort. The rate of complete remission (CR) plus CR with incomplete blood count recovery did not significantly differ between the 2 cohorts: CLAG-M, 86% versus 7+3, 70% (P = 0.11). The toxicity profile of CLAG-M combined with midostaurin is comparable with the combination of 7+3 with midostaurin, and induces high remissions rates in adults with FLT3-mutated AML.