Abstract Introduction Major depressive disorder (MDD) is a highly prevalent and burdensome condition. This study aims to evaluate the effectiveness, tolerability, and safety of vortioxetine in treating MDD based on real-world data. Methods A systematic search of 8 electronic databases was performed from inception until October 2022 to identify real-world studies, excluding randomized controlled trials. We conducted subgroup, meta-regression, sensitivity analyses, publication bias, and quality assessments using the random-effects model. The effects were summarized by rates or standardized mean difference (SMD) with 95% confidence interval (CI). Results Of the 870 records identified, 11 studies (3139 participants) and 10 case reports or series were eligible for inclusion. Vortioxetine significantly relieved depression symptoms as assessed by both patients (SMD = 2.25, 95% CI = 1.60−2.89) and physicians (SMD = 3.73, 95% CI = 2.78−4.69). Cognitive function (SMD =1.86, 95% CI = 1.11−2.62) and functional disability (SMD =1.71, 95% CI = 1.14−2.29) were similarly markedly improved. Subgroup and meta-regression analyses showed that geographic location and medication regimen (whether combined with other antidepressants) were crucial factors influencing effectiveness (in terms of depression severity and cognitive function), potentially contributing to significant heterogeneity. The estimated response and remission rates were 66.4% (95% CI = 51.2%−81.5%) and 58.0% (95% CI = 48.9%−67.1%), respectively. Vortioxetine was well tolerated, with a pooled dropout rate of 3.5% (95% CI = 1.8%−5.8%), and the most common adverse event was nausea, with an estimated rate of 8.9% (95% CI = 3.8%−15.8%). Limitations The study has some limitations, including significant heterogeneity and limited evidence for some outcomes. Conclusions Vortioxetine is effective, well tolerated, and safe for treating MDD in clinical practice, with significant improvements observed in depressive severity, cognitive function, and functioning. Future studies should directly compare vortioxetine with other antidepressants in real-world settings to further evaluate its clinical utility.
Abstract This study was conducted to compare the differences of the whole blood zinc concentration in patients with chronic kidney disease (CKD) as compared to healthy controls, and to explore the correlations of the whole blood zinc level with coronary artery calcification (CAC) and cardiovascular event (CVE) in CKD patients. 170 CKD patients and 62 healthy controls were recruited . The whole blood zinc concentration were determined in using atomic absorption spectroscopy (AAS) method. The degrees of CAC were evaluated by Agatston score based on computed tomography (CT). Regular follow-up visits were performed to record the incidence of CVE, and risk factors were analyzed by COX proportional hazard model and Kaplan-Meier survival curve. There were statistically significant lower zinc in CKD patients than in healthy population. The prevalence of CAC was 58.82% in CKD patients. Our study found that dialysis duration, iPTH, ALP, 25(OH)D3, neutrophil-lymphocyte ratio (NLR), total cholesterol and Hs-CRP were positively correlated with CAC, while albumin, Hb and zinc were negatively correlated with CAC. A COX proportional hazard model demonstrated that moderate to severe CAC, NLR, phosphate, 25(OH)D 3 , iPTH and HLDL were associated with an increased risk for CVE, while zinc, Hb and albumin was inversely associated with a reduced risk for CVEs. Kaplan-Meier curve showed that low zinc (zinc <86.62μmol/L) patients and moderate to severe CAC patients had lower survival respectively. Our study found the lower levels of zinc and higher prevalence of CAC in CKD patients, the low zinc is involved in the high incidence rate of moderate to severe CAC and CVE in CKD patients.
Objective: The effect of oxygen therapy on the prognosis of chronic obstructive pulmonary disease (COPD) with nocturnal hypoxemia (NOD) has been controversial. Therefore, this study systematically evaluated the relevant literature and included it into randomized controlled studies for meta-analysis to evaluate the efficacy and prognosis. Methods: We searched PubMed, EMBASE, web of science, Cochrane, China HowNet and Wanfang database for the literature on the prognosis of COPD patients with simple NOD from the establishment of the database to 30 June 2022. The outcome indicators were death and aggravation of the disease. The efficacy evaluation measures were pulmonary function and arterial blood gas results. The publication bias and heterogeneity of the included studies were evaluated. Results: A total of 621 patients from 5 studies were included in this meta-analysis, and there was no publication bias in the included studies. The total mortality of long-term oxygen therapy (LTOT) in COPD patients with simple NOD in oxygen therapy group (RR = 1.04; 95% CI: 0.81-1.33, p = 0.77), mortality (RR = 0.87; 95% CI: 0.58-1.31, p = 0.50), risk of progression to LTOT events (RR = 1.07; 95% CI: 0.76-1.51, p = 0.71). PaO2 in patients with COPD and simple NOD in oxygen therapy group was higher than that in non-oxygen therapy group (mean difference (MD) = 13.47; 95% CI: 3.49-23.46, p = 0.008), the decrease of PaCO2 level was not statistically significant (MD = -10.05; 95% CI: -26.36-6.27, p = 0.23). Conclusion: Oxygen therapy can improve the prognosis of blood oxygen partial pressure in COPD patients with simple NOD, but oxygen therapy has no significant effect on the survival rate, controlling the progression of the disease to LTOT and reducing the partial pressure of carbon dioxide.
Percutaneous coronary intervention (PCI) is widely used in clinical treatment of coronary artery disease. However, the effects of PCI on preventing restenosis after revascularization and improving the quality of life were not satisfying. Huxin Formula is formulated by modifying an experienced Chinese medicine formula and has been widely used in clinical practice due to its marked effects on coronary heart disease. A multicentre double-blind randomized controlled clinical trial was designed to evaluate the effects and safety of Huxin Formula in patients undergoing PCI. Our results showed that there was no significant difference between the two groups in main outcomes. For patients with ejection fraction (EF) >50%, score of the quality of life scale was higher in treatment group compared with control group. For patients with unstable angina, score of the quality of life scale in 360 days was significantly higher in treatment group compared with control group (P < 0.05). No obvious adverse reaction was found in the use of Huxin Formula. In conclusion, Huxin Formula, believed to be a safe treatment for patients after PCI, has benefits in improving the quality of life in patients with unstable angina though it failed to show superiority in primary and secondary outcomes.
Introduction: Adult Fontan patients are typically prescribed antiplatelet or anticoagulant therapy to manage increased risk for thrombotic and embolic complications (TECs). There is a Class III recommendation against the use of novel oral anticoagulants (NOACs) in this population due to a paucity of data. We hypothesized that NOACs are potentially non-inferior to warfarin in adult Fontan patients. Methods: We performed a multi-site retrospective review of adult Fontan patients, evaluated at three major academic medical centers (1995-2018), prescribed NOAC, warfarin, or aspirin therapy. Results: We identified 267 adult Fontan patients: 48 on NOACs, 107 on warfarin, and 180 on aspirin (14.4% to 54.2% cross-over amongst groups). Patients were more likely to have clinically significant bleeds (“bleeds”) if on a NOAC (HR=9.3, CI=3.0-28.4) or warfarin (HR=4.1, CI=1.6-10.5) versus aspirin. Bleed hazard ratio differences between NOAC and warfarin patients were not statistically significant (HR=2.3, CI=0.9-5.9). Patients on NOACs were not more likely to suffer TECs than patients on warfarin (HR=1.7, CI=0.4-6.3) or aspirin (HR=2.8, CI=0.7-10.3). Aspirin patients were younger, healthier, and had more favorable Fontan palliation. The traditional scoring systems to predict bleeds (HAS-BLED) and TECs (CHA 2 DS 2 VASc) were not predictive in this patient population. The only risk factor we identified for bleeds was a history of/predisposition to bleeding (OR=10.2, CI=4.4-23.6). Risk factors we identified for TECs included diabetes mellitus (OR=5.0, CI=2.2-11.4), labile international normalized ratio (OR=3.7, CI=1.1-12.4), and CHF (only in the NOAC/warfarin subgroup, OR=4.4, CI=1.2-16.3). Conclusions: NOACs are a potentially noninferior alternative to warfarin for adult Fontan patients. Our findings have laid the groundwork for a randomized control trial comparing the use of NOACs to warfarin in adult Fontan patients to test noninferiority or equivalence.
Background. The first year after heart transplantation (HT) has the highest risk of mortality. We aim to derive and validate a recipient risk prediction tool for early mortality after pediatric HT. Methods. The International Society for Heart and Lung Transplantation (ISHLT) registry was used to identify patients (≤18 y) who underwent primary HT during January 2000–December 2014. Independent predictors of 1-year mortality were identified based on recipient characteristics at HT. Risk scores were assigned based on the magnitude of relative odds of 1-year mortality. The predictive capability of the ISHLT registry derived recipient risk score was externally validated using the Scientific Registry of Transplant Recipients registry data from 2015 to 2017 to ensure a cohort of patients completely exclusive from the derivation cohort. Results. A total of 5045 eligible patients were included in the analysis. The 20-point risk scoring system incorporated 8 recipient variables, including age at HT, diagnosis, pre-HT ventilator use, extracorporeal membrane oxygenation, inhaled nitric oxide use, infection, estimated glomerular filtration rate, and serum bilirubin. Compared with low-risk score group, high-risk group had 7-fold increased risk of 1-year mortality (hazard ratio 7.4; 95% CI [5.2-9.1]; P < 0.001). The C-statistics (0.77) and Hosmer-Lemeshow goodness of fit (0.9) for recipient risk score using derivation cohort from ISHLT registry performed well and was similar to the internal and external validation cohort (C-statistics 0.75, 0.78 and Hosmer-Lemeshow goodness of fit P = 0.4, 0.3, respectively). Conclusions. This study derived and externally validated a simple risk predictive model based on recipient characteristics at HT that has good prediction characteristics for 1-year post-HT mortality. This model may help clinicians identify candidates who are at a higher risk for post-HT mortality and may optimize organ sharing.
Objective Adult Fontan patients are at increased risk for thrombosis and thromboembolic complications leading to increased morbidity and mortality. Most are prescribed antiplatelet or anticoagulant therapy for thromboprophylaxis; novel oral anticoagulants (NOACs) are uncommonly used given lack of data on their use in this population and generalized concerns regarding Fontan patients' abnormal coagulation. We report the largest single-center experience with the use of NOACs for treatment and prophylaxis of thrombosis and thromboembolism in adult Fontan patients. Results A retrospective chart review identified 21 patients (11 female, 10 male), median age 33 years (18-50) at first initiation, who were prescribed a NOAC on 27 different occasions. The main indications for anticoagulation were arrhythmia (N = 12), thrombosis (N = 8), and persistent right to left shunts (N = 2); one patient was initially on anticoagulation for arrhythmia but restarted for thrombosis. The most common indications for initiation of a NOAC over warfarin were patient/provider preference (N = 11), labile international normalized ratio (INR) (N = 5), initiation of therapy elsewhere (N = 3), and history of poor clinical follow-up (N = 2). Over a cumulative 316 months of patient therapy, one new thrombotic event was noted. No major or nonmajor bleeding events occurred, and 10 patients experienced minor bleeding that did not require the cessation of therapy. One patient died from multiorgan system failure following an unwitnessed, out of hospital arrest. At present, 10 patients remain on NOAC therapy in the setting of ongoing arrhythmia (N = 4), history of stroke (N = 2), history of pulmonary embolism (N = 2), history of deep vein thrombosis (N = 1), and history of right ventricle thrombus (N = 1). Conclusions While our study is limited by size, our results suggest that NOACs may be a non-inferior alternative to traditional anticoagulation and that further study is warranted.
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