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First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial.
Gao, RL, Xu, B, Sun, Z, Guan, C, Song, L, Gao, L, Li, C, Cui, J, Zhang, Y, Dou, K, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2023;(3):222-231
Abstract
BACKGROUND The first-generation polymeric bioresorbable scaffolds resulted in higher than acceptable 3-year rates of device-related adverse outcomes. AIMS We aimed to assess the intermediate-term safety and performance of a novel ultrathin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) in non-complex coronary lesions. METHODS The prospective, single-arm, open-label IBS first-in-human study enrolled 45 patients, each with a single de novo lesion. Enrolled patients were randomly assigned to 2 follow-up cohorts. Angiographic and imaging follow-up with intravascular ultrasound and optical coherence tomography (OCT) were conducted at 6 and 24 months in cohort 1 (n=30) and at 12 and 36 months in cohort 2 (n=15). Clinical follow-up was conducted at 1, 6 and 12 months, and annually thereafter up to 5 years. The coprimary outcomes were target lesion failure (TLF) and angiographic late lumen loss (LLL) at 6 months. RESULTS A total of 45 patients were enrolled between April 2018 and January 2019. The mean age was 53.2 years, 77.8% were male, and 26.7% had diabetes. The TLF rates were 2.2% at 6 months and 6.7% at 3 years, which in all cases were due to clinically indicated target lesion revascularisation. No deaths, myocardial infarctions or stent thromboses occurred during 3-year follow-up. In-scaffold LLL was 0.33±0.27 mm at 6 months and 0.37±0.57 mm at 3 years. By OCT, the proportion of covered struts was 99.8% at 6 months and 100% after 1 year. The 3-year strut absorption rate was 95.4%. CONCLUSIONS In this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.
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Effects of Dental Implants and Nutrition on Elderly Edentulous Subjects: Protocol for a Factorial Randomized Clinical Trial.
Qian, SJ, Liu, B, Shi, J, Zhang, X, Deng, K, Shen, J, Tao, Y, Qiao, S, Lai, HC, Yuan, C, et al
Frontiers in nutrition. 2022;:930023
Abstract
BACKGROUND Loss of masticatory function consequent to tooth loss has been associated with changes in food choices and insufficient nutritional intake. To date, interventions based on dental prostheses alone did not significantly improve nutrient intake. Pilot studies have shown positive impacts of interventions combining implant-supported fixed dental prosthesis with brief dietary advice. The relative contribution and the potential synergy of the components of such interventions need to be determined as it has major public health implications for the community-dwelling aging population that continues to disproportionately suffer from tooth loss and its consequences. OBJECTIVE To assess the effect of rehabilitation of masticatory function with fixed implant supported dentures and nutrition education in older subjects with terminal dentition (stage IV periodontitis) or full edentulism. METHODS A 2 × 2 factorial randomized controlled trial with 16-month follow-up of eligible adults (≥60 years) with loss of masticatory function consequent to full arch edentulism or terminal dentition (n = 120) will be conducted to test whether the rehabilitation of masticatory function with fixed implant supported dentures, nutrition education and/or their combination improves intake of fresh fruits and vegetables for aging subjects. The study has been designed to detect changes in fresh fruits and fresh vegetables intake at 4 months using the 24-h dietary recall method. Changes in protein as percentage of total energy, nutritional biomarkers, plasma metabolomics, oral and gut microbiome, quality of life and masticatory function will also be assessed. DISCUSSION We hypothesize that receiving rehabilitation of masticatory function with fixed implant dentures together with nutrition education is the most effective intervention for improving nutrient intake in aging community-dwelling subjects with extensive tooth loss. The results of this study will assist in designing better treatment regimens, guide medical care for individual subjects, and inform public health and policy. CLINICAL TRIALS REGISTRATION NCT05334407.
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Thinner Strut Sirolimus-Eluting BRS Versus EES in Patients With Coronary Artery Disease: FUTURE-II Trial.
Song, L, Xu, B, Chen, Y, Zhou, Y, Jia, S, Zhong, Z, Su, X, Ma, Y, Zhang, Q, Liu, J, et al
JACC. Cardiovascular interventions. 2021;(13):1450-1462
Abstract
OBJECTIVES The aim of the present study was to evaluate the safety and efficacy of thinner strut Firesorb (100/125 μm) sirolimus-eluting bioresorbable scaffolds (BRS) versus cobalt-chromium everolimus-eluting stents (CoCr-EES) in patients with coronary artery disease. BACKGROUND First-generation thicker strut BRS were associated with unexpected device-related adverse outcomes at long-term follow-up. METHODS Eligible patients with 1 or 2 de novo noncomplex coronary lesions were randomized to the Firesorb BRS group or CoCr-EES group in a 1:1 ratio. The primary endpoint was 1-year angiographic in-segment late loss (LL), powered for noninferiority testing. The key secondary endpoint was the 1-year proportion of covered struts assessed on optical coherence tomography, powered for noninferiority and subsequent superiority testing. RESULTS A total of 433 participants from 28 Chinese centers were randomized to the Firesorb BRS group (n = 215) or CoCr-EES group (n = 218). Patient-level 1-year in-segment LL was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.18 ± 0.37 mm in the CoCr-EES group (difference -0.01 mm; 95% confidence interval [CI]: -0.07 to 0.06; pnoninferiority < 0.0001) in the intention-to-treat population and was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.19 ± 0.37 mm in the CoCr-EES group (difference -0.005 mm; 95% CI: -0.07 to 0.06; pnoninferiority < 0.0001) in the per-protocol set. The proportion of covered struts was 99.3% in the Firesorb BRS group and 98.8% in the CoCr-EES group (difference 0.8%; 95% CI: -0.5% to 2.1%; pnoninferiority < 0.0001; psuperiority = 0.21). One-year clinical outcomes were similar between groups. CONCLUSIONS The thinner strut Firesorb BRS was noninferior to the CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL and the key secondary endpoint of 1-year proportion of covered struts by optical coherence tomography. (A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II [FUTURE-II]; NCT02890160).
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Serum Detection of Anti-thyroid Peroxidase and Anti-thyroglobulin Antibodies in Chinese Patients With Pemphigus Vulgaris and Pemphigus Foliaceus and Literature Review.
Wang, HX, Yang, Y, Hu, JY, Zhang, LM, Cai, YF, Guo, H, Xiao, T, Chen, HD, Gao, XH, Qiao, S
Frontiers in immunology. 2021;:653356
Abstract
BACKGROUND Pemphigus is a rare but life-threatening autoimmune skin disease characterized by blistering on skin and/or mucous membranes. The physiological process of blister formation involves IgG antibodies against the desmogleins (Dsgs) and desmocollins (Dscs). Additional autoAbs have also been suggested to mediate the disease heterogeneity, such as anti-thyroid peroxidase (anti-TPO) and antithyroglobulin (anti-Tg) antibodies, the essential culprits of the immune system in autoimmune thyroid diseases. PURPOSE To investigate the levels and antibody positivity of anti-TPO and anti-Tg antibodies in pemphigus patients. METHODS Antibody positivity and levels of anti-TPO and anti-Tg antibodies in pemphigus patients as compared to healthy controls were examined. A meta-analysis was conducted by reviewing six similar studies. RESULTS 98 Chinese pemphigus patients and 65 healthy controls were enrolled in the study. Our meta-analysis revealed a significant correlation between increased presence of positive anti-TPO and anti-Tg antibodies and pemphigus, particularly for pemphigus vulgaris (PV). Such correlation was also observed in our own hospitalized PV patients, but not in pemphigus foliaceus (PF) patients. In addition, the status of anti-TPO and anti-Tg antibodies were also compared between females and males within PV patients, PF patients or controls, as well as compared for females or males between pemphigus patients and controls. In the analysis of T cell counts, we found abnormal low CD3 + T cell counts (< 690 n/µl) were only detected in patients whose thyroid antibody levels were less than 20 IU/ml. CONCLUSION Pemphigus patients showed higher levels and antibody positivity of anti-TPO and anti-Tg antibodies than healthy controls. Further investigations are needed to identify the pathogenic functions of these antibodies in pemphigus, as well as to identify the potential shared susceptibility genes.
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Zinc Finger Proteins in Neuro-Related Diseases Progression.
Bu, S, Lv, Y, Liu, Y, Qiao, S, Wang, H
Frontiers in neuroscience. 2021;:760567
Abstract
Zinc finger proteins (ZNF) are among the most abundant proteins in eukaryotic genomes. It contains several zinc finger domains that can selectively bind to certain DNA or RNA and associate with proteins, therefore, ZNF can regulate gene expression at the transcriptional and translational levels. In terms of neurological diseases, numerous studies have shown that many ZNF are associated with neurological diseases. The purpose of this review is to summarize the types and roles of ZNF in neuropsychiatric disorders. We will describe the structure and classification of ZNF, then focus on the pathophysiological role of ZNF in neuro-related diseases and summarize the mechanism of action of ZNF in neuro-related diseases.
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A preoperative whey protein and glucose drink before hip fracture surgery in the aged improves symptomatic and metabolic recovery.
Deng, Y, Fang, Y, Li, H, Chen, J, An, J, Qiao, S, Wang, C
Asia Pacific journal of clinical nutrition. 2020;(2):234-238
Abstract
BACKGROUND AND OBJECTIVES We investigated the effects of a carbohydrate-whey protein solution on aged patients undergoing hip fracture surgery. METHODS AND STUDY DESIGN Forty patients were randomly assigned to the carbohydrate-whey protein (CHP) group or the control group (CTL). In the CHP group, a mixed solution of CHP was orally administered to patients before surgery: 400 mL was administered on the day before surgery, and 200 mL was administered 3 h before surgery. The size of the liquid dark area in the gastric antrum was measured by ultrasound, and the bleeding volume during surgery was assayed. The incidence of nausea, vomiting, thirst, hunger, and days of hospitalization and the levels of blood glucose, C-reactive protein (CRP) and serum albumin were assessed. RESULTS There was no obvious liquid dark space in the gastric antrum. CHP administration improved postoperative thirst and hunger and resulted in increased albumin levels and decreased CRP concentrations and blood glucose fluctuations. CONCLUSIONS Oral CHP before hip fracture surgery reduces the incidence of postoperative thirst and hunger and improves recovery in the aged.
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iCOPE, a multi-level, cluster randomized, 36-month, parallel-group study to assess the efficacy of HIV disclosure intervention in HIV parental disclosure among parents living with HIV in China.
Li, X, Qiao, S, Zhou, Y
SAGE open medicine. 2020;:2050312120907821
Abstract
OBJECTIVES Parents living with HIV who disclose their HIV status to their children could benefit from the parental HIV disclosure. However, it is also very challenging because of persistent stigma and discrimination against HIV. This report describes the study design and protocol of the "Interactive Communication with Openness, Passion, and Empowerment (iCOPE)" randomized controlled trial aimed at assisting parents living with HIV in conducting culturally and developmentally appropriate disclosure to their uninfected children in China through trainings among both parents living with HIV and healthcare providers. METHODS A total of 791 parents living with HIV with children aged between 6 and 15 years and 357 healthcare providers were randomized into either the intervention group or control group. Intervention package for parents consisted of five 2-h sessions focusing on positive coping, disclosure decision making, developing a developmentally appropriate disclosure plan, and accessing social support and post-disclosure counseling. The intervention for healthcare providers was made up of two 45-min sessions organized around two primary themes: knowledge of child cognitive development and effective parent-child communication skills in the context of parental disclosure. The control group received nutritional education of either five 2-h sessions (parents) or two 45-min sessions (healthcare providers). The outcome assessments were conducted at baseline, 6, 12, 18, 24, 30, and 36 months. CONCLUSION The iCOPE study is among the first efforts to develop and evaluate a theory-based and multi-level intervention to promote culturally and developmentally appropriate parental HIV disclosure in China. It has implications for healthcare providers, social workers, and policy makers as it will provide efficacy data on how to enhance appropriate parental HIV disclosure and will shed light on developing a clinical guideline regarding parental HIV disclosure in China and other low- and middle-income countries.
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Predictors and Periprocedural Myocardial Injury Rate of Small Side Branches Occlusion in Coronary Bifurcation Intervention.
Zhang, D, Xu, B, Yin, D, Li, Y, He, Y, You, S, Qiao, S, Wu, Y, Yan, H, Yang, Y, et al
Medicine. 2015;(25):e992
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Abstract
Occlusion of small side branch (SB) may result in significant adverse clinical events. We aim to characterize the predictors of small SB occlusion and incidence of periprocedural myocardial injury (PMI) in coronary bifurcation intervention.Nine hundred twenty-five consecutive patients with 949 bifurcation lesions (SB ≤ 2.0 mm) treated with percutaneous coronary intervention (PCI) were studied. All clinical characteristics, coronary angiography findings, PCI procedural factors, and quantitative coronary angiographic analysis data were collected. SB occlusion after main vessel (MV) stenting was defined as no blood flow or any thrombolysis in myocardial infarction (TIMI) flow grade decrease in SB after MV stenting. Multivariate logistic regression analysis was performed to identify independent predictors of small SB occlusion. Creatine kinase-myocardial band activity was determined by using an immunoinhibition assay and confirmed by mass spectrometry. Incidence of PMI between no SB occlusion group and SB occlusion group was compared.SB occlusion occurred in 86 (9.1%) of 949 bifurcation lesions. Of SB occlusion, total occlusion occurred in 64 (74.4%) lesions and a decrease in TIMI flow occurred in 22 (25.6%) lesions. True bifurcation lesion, irregular plaque, predilation in SB, preprocedural SB TIMI flow grade, preprocedural diameter stenosis of distal MV, preprocedural diameter stenosis of bifurcation core, bifurcation angle, diameter ratio between MV and SB, diameter stenosis of SB before MV stenting, and MV lesion length were independent risk factors of SB occlusion. We observed a significantly higher incidence of PMI in each cutoff level in patients with SB occlusion compared with those without SB occlusion.True bifurcation lesion, irregular plaque, and 8 other predictors were independent predictors of SB occlusion. Patients with small SB occlusion had significant higher incidence of PMI.