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1.
ObjectivesThe aim of this study was to test whether optical coherence tomographic (OCT) guidance would provide additional useful information beyond that obtained by angiography and lead to a shift in reperfusion strategy and improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) with early infarct artery patency.BackgroundAngiography is limited in assessing the underlying pathophysiological mechanisms of the culprit lesion.MethodsEROSION III (Optical Coherence Tomography–Guided Reperfusion in ST-Segment Elevation Myocardial Infarction With Early Infarct Artery Patency) is an open-label, prospective, multicenter, randomized, controlled study approved by the ethics committees of participating centers. Patients with STEMI who had angiographic diameter stenosis ≤ 70% and TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 at presentation or after antegrade blood flow restoration were recruited and randomized to either OCT guidance or angiographic guidance. The primary efficacy endpoint was the rate of stent implantation.ResultsAmong 246 randomized patients, 226 (91.9%) constituted the per protocol set (112 with OCT guidance and 114 with angiographic guidance). The median diameter stenosis was 54.0% (IQR: 48.0%-61.0%) in the OCT guidance group and 53.5% (IQR: 43.8%-64.0%) in the angiographic guidance group (P = 0.57) before randomization. Stent implantation was performed in 49 of 112 patients (43.8%) in the OCT group and 67 of 114 patients (58.8%) in the angiographic group (P = 0.024), demonstrating a 15% reduction in stent implantation with OCT guidance. In patients treated with stent implantation, OCT guidance was associated with a favorable result with lower residual angiographic diameter stenosis (8.7% ± 3.7% vs 11.8% ± 4.6% in the angiographic guidance group; P < 0.001). Two patients (1 cardiac death, 1 stable angina) met the primary safety endpoint in the OCT guidance group, as did 3 patients (3 cardiac deaths) in the angiographic guidance group (1.8% vs 2.6%; P = 0.67). Reinfarction was not observed in either group. At 1 year, the rates of predefined cardiocerebrovascular events were comparable between the groups (11.6% after OCT guidance vs 9.6% after angiographic guidance; P = 0.66).ConclusionsIn patients with STEMI with early infarct artery patency, OCT guidance compared with angiographic guidance of reperfusion was associated with less stent implantation during primary percutaneous coronary intervention. These favorable results indicate the value of OCT imaging in optimizing the reperfusion strategy of patients with STEMI. (EROSION III: OCT- vs Angio-Based Reperfusion Strategy for STEMI; NCT03571269)  相似文献   
2.
目的:探讨上消化道出血患者急性应激障碍的影响因素。方法:运用病例对照研究法,选取天津市第五中心医院消化内科同期住院的270例患者为研究对象。通过斯坦福急性应激反应问卷(SASRQ)的调查,将发生急性应激障碍(ASD)的144例患者作为病例组,将未发生ASD的126例患者作为对照组。由专业人员对研究对象进行SASRQ、匹兹堡睡眠质量指数量表(PSQI)和疼痛视觉模拟评分尺(VAS)和一般资料的调查。比较病例组与对照组之间上述指标的差异。对ASD的影响因素进行Logistic 回归分析。结果:与对照组相比,病例组性别、年龄、婚姻状况、文化程度、主要照顾者关系、出血量、出血次数、出血诱因、疼痛程度、是否伴有其他症状、睡眠质量、是否恐惧是导致上消化道出血患者发生ASD的重要影响因素;多因素Logistic回归分析显示:性别(OR=0.435,95%CI:0.202~0.938)、文化程度(OR=0.573,95%CI:0.419~0.784)、出血诱因(OR=0.014,95%CI:0.000~0.410)、疼痛程度(OR=0.442,95%CI:0.221~0.886)、睡眠质量(OR=0.531,95%CI:0.379~0.744)为ASD的保护因素,年龄(OR=1.861,95%CI:1.119~3.095)、主要照顾者(OR=1.871,95%CI:1.172~2.987)、是否伴有其他症状(OR=33.219,95%CI:6.069~81.383)是ASD的危险因素。结论:年龄、主要照顾者关系、是否伴有其他症状是导致上消化道出血患者发生ASD的重要危险因素。  相似文献   
3.
目的研究医疗器械上市后风险评估的统计学方法,提高风险管理的科学水平。方法参考欧盟医疗器械新法规中即将实施的趋势报告要求,探索趋势分析方法在医疗器械上市后风险评估中的实践运用,举例说明通过历史数据确定控制限和持续趋势监测的过程,讨论实践中面临的问题。结果趋势分析是科学评估医疗器械上市后风险的方法之一,适于在国内推行。结论企业可运用真实世界风险数据开展趋势分析,提升上市后风险预警能力。  相似文献   
4.
BackgroundIschemia reperfusion (I/R) play an imperative role in the expansion of cardiovascular disease. Sinomenine (SM) has been exhibited to possess antioxidant, anticancer, anti-inflammatory, antiviral and anticarcinogenic properties. The aim of the study was scrutinized the cardioprotective effect of SM against I/R injury in rat.MethodsRat were randomly divided into normal control (NC), I/R control and I/R + SM (5, 10 and 20 mg/kg), respectively. Ventricular arrhythmias, body weight and heart weight were estimated. Antioxidant, inflammatory cytokines, inflammatory mediators and plasmin system indicator were accessed.ResultsPre-treated SM group rats exhibited the reduction in the duration and incidence of ventricular fibrillation, ventricular ectopic beat (VEB) and ventricular tachycardia along with suppression of arrhythmia score during the ischemia (30 and 120 min). SM treated rats significantly (P < 0.001) altered the level of antioxidant parameters. SM treatment significantly (P < 0.001) repressed the level of creatine kinase MB (CK-MB), creatine kinase (CK) and troponin I (Tnl). SM treated rats significantly (P < 0.001) repressed the tissue factor (TF), thromboxane B2 (TXB2), plasminogen activator inhibitor 1 (PAI-1) and plasma fibrinogen (Fbg) and inflammatory cytokines and inflammatory mediators.ConclusionOur result clearly indicated that SM plays anti-arrhythmia effect in I/R injury in the rats via alteration of oxidative stress and inflammatory reaction.  相似文献   
5.
目的提高医疗器械环氧乙烷灭菌的安全性和有效性。方法分析材料的耐受性、灭菌温度、相对湿度、环氧乙烷浓度、作用时间、包装材料等关键质量控制点对医疗器械环氧乙烷灭菌效果的影响。结果环氧乙烷灭菌材料的适应性较好,适宜的灭菌条件为温度30~60℃,相对湿度40%~80%,环氧乙烷浓度300~1 000 mg/L,灭菌时间应至少为医疗器械半周期的2倍,包装材料应根据自身产品特点选择。结论生产企业在采用环氧乙烷对医疗器械进行灭菌时,必须准确把握材料的耐受性、灭菌温度、相对湿度、环氧乙烷浓度、作用时间、物品包装材料等关键质量控制点,才能达到预期的灭菌效果。  相似文献   
6.
《Drug discovery today》2022,27(1):280-291
Positron emission tomography (PET) is an extensively used nuclear functional imaging technique, especially for central nervous system (CNS) and oncological disorders. Currently, drug development is a lengthy and costly pursuit. Imaging with PET radiotracers could be an effective way to hasten drug discovery and advancement, because it facilitates the monitoring of key facets, such as receptor occupancy quantification, drug biodistribution, pharmacokinetic (PK) analyses, validation of target engagement, treatment monitoring, and measurement of neurotransmitter concentrations. These parameters demand careful analyses for the robust appraisal of newly formulated drugs during preclinical and clinical trials. In this review, we discuss the usage of PET imaging in radiopharmaceutical development; drug development approaches with PET imaging; and PET developments in oncological and cardiac drug discovery.  相似文献   
7.
Smoking cessation reduces the risk of death, improves recovery, and reduces the risk of hospital readmission. Evidence and policy support hospital admission as an ideal time to deliver smoking-cessation interventions. However, this is not well implemented in practice. In this systematic review, the authors summarize the literature on smoking-cessation implementation strategies and evaluate their success to guide the implementation of best-practice smoking interventions into hospital settings. The CINAHL Complete, Embase, MEDLINE Complete, and PsycInfo databases were searched using terms associated with the following topics: smoking cessation, hospitals, and implementation. In total, 14,287 original records were identified and screened, resulting in 63 eligible articles from 56 studies. Data were extracted on the study characteristics, implementation strategies, and implementation outcomes. Implementation outcomes were guided by Proctor and colleagues' framework and included acceptability, adoption, appropriateness, cost, feasibility, fidelity, penetration, and sustainability. The findings demonstrate that studies predominantly focused on the training of staff to achieve implementation. Brief implementation approaches using a small number of implementation strategies were less successful and poorly sustained compared with well resourced and multicomponent approaches. Although brief implementation approaches may be viewed as advantageous because they are less resource-intensive, their capacity to change practice in a sustained way lacks evidence. Attempts to change clinician behavior or introduce new models of care are challenging in a short time frame, and implementation efforts should be designed for long-term success. There is a need to embrace strategic, well planned implementation approaches to embed smoking-cessation interventions into hospitals and to reap and sustain the benefits for people who smoke.  相似文献   
8.
AimTo compare the efficacy and safety of folinic acid, fluorouracil and irinotecan (FOLFIRI) plus bevacizumab or aflibercept in metastatic colorectal cancer (mCRC) patients pretreated with oxaliplatin-based chemotherapy.Materials and methodsWe analysed the treatment outcomes of patients receiving FOLFIRI in combination with bevacizumab or aflibercept as second-line treatment for mCRC between October 2017 and March 2020. This analysis included 67 patients receiving FOLFIRI plus aflibercept and 83 receiving FOLFIRI plus bevacizumab.ResultsThe overall response rate (ORR) was 13.6% (95% confidence interval 4.85–22.34) in the FOLFIRI–aflibercept group and 14.7% (95% confidence interval 6.68–22.71) in the FOLFIRI–bevacizumab group. This difference in ORR was not statistically significant. The median progression-free survival was 8.6 months in the FOLFIRI–bevacizumab group and 8.5 months in the FOLFIRI–aflibercept group (P = 0.752). Patients in the FOLFIRI–bevacizumab group showed a median overall survival of 12.4 months, whereas patients in the FOLFIRI–aflibercept group had a median overall survival of 13.7 months (P = 0.276). There were no significant differences in survival between the two treatment groups. The adverse events were also largely similar between the two groups. However, hypertension of grade 3 or more was more frequent in the FOLFIRI–aflibercept group.ConclusionFOLFIRI plus bevacizumab and FOLFIRI plus aflibercept had similar anti-tumour activities and toxicity profiles when used as second-line therapy in mCRC patients. Based on these data, both aflibercept and bevacizumab are suitable anti-angiogenic agents when used in combination with FOLFIRI for mCRC.  相似文献   
9.
10.

Background

Hyperglycaemia is common in patients with acute brain injury admitted to an intensive care unit (ICU). Many studies have found associations between development of hyperglycaemia and increased mortality in hospitalised patients. However, the optimal target for blood glucose control is unknown. We want to conduct a systematic review with meta-analysis and trial sequential analysis to explore the beneficial and harmful effects of restrictive versus liberal glucose control on patient outcomes in adults with severe acute brain injury.

Methods

We will systematically search medical databases including CENTRAL, Embase, MEDLINE and trial registries. We will search the following websites for ongoing or unpublished trials: http://www.controlled-trials.com/ , http://www.clinicaltrials.gov/ , www.eudraCT.com , http://centerwatch.com/ , The Cochrane Library's CENTRAL, PubMed, EMBASE, Science Citation Index Expanded and CINAHL. Two authors will independently review and select trials and extract data. We will include randomised trials comparing levels of glucose control in our analyses and observational studies will be included to address potential harms. The primary outcomes are defined as all-cause mortality, functional outcome and health-related quality of life. Secondary outcomes include serious adverse events including hypoglycaemia, length of ICU stay and duration of mechanical ventilation, and explorative outcomes including intracranial pressure and infection. Trial Sequential Analysis will be used to investigate the risk of type I error due to repetitive testing and to further explore imprecision. Quality of trials will be evaluated using the Cochrane Risk of Bias tool, and quality of evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.

Discussion

The results of the systematic review will be disseminated through peer-reviewed publication. With the review, we hope to inform future randomised clinical trials and improve clinical practice.  相似文献   
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