IVI

IVI
  • 文章类型: Journal Article
    目标:这项研究需要每周对真实世界数据(RWD)进行分析,以了解玻璃体内(IVT)法罗单抗在新生血管性年龄相关性黄斑变性(nAMD)中的安全性和有效性。方法:回顾性分析,单中心临床试验在眼科进行,苏黎世大学医院,苏黎世大学,瑞士,由苏黎世州伦理委员会批准,瑞士。包括nAMD患者。分析来自患者图表和影像学的数据。每周评估第一次法利单抗注射的安全性和有效性,直到注射后4周。结果:纳入63只眼,进行了4周的完整随访。六只眼睛是未经治疗的;57只眼睛从另一种治疗中改用法里单抗。在注射后4周内,两组均未出现视网膜血管炎的迹象。在4周后,在切换组(CST:p=0.00383;CSV:p=0.00702)中,与基线相比,中心子场厚度(CST)和体积(CSV)显示出统计学上显著的降低。两组的矫正视力均恢复至基线水平。两组黄斑新生血管面积均减少,但这没有统计学意义。在接受治疗的患者中,有40%(切换)和75%(未处理)的患者在4周后完全消除了视网膜下和视网膜内流体。结论:每周随访反映了结构-功能关系,从注射后两周内功能快速改善开始,然后在第3周后恢复到近基线水平。在我们的队列中,首次注射法利克单抗显示出较高的安全性,并且在转换的nAMD患者中,黄斑水肿具有统计学上的显着减少。
    Objectives: This study entailed a weekly analysis of real-world data (RWD) on the safety and efficacy of intravitreal (IVT) faricimab in neovascular age-related macular degeneration (nAMD). Methods: A retrospective, single-centre clinical trial was conducted at the Department of Ophthalmology, University Hospital Zurich, University of Zurich, Switzerland, approved by the Cantonal Ethics Committee of Zurich, Switzerland. Patients with nAMD were included. Data from patient charts and imaging were analysed. The safety and efficacy of the first faricimab injection were evaluated weekly until 4 weeks after injection. Results: Sixty-three eyes with a complete 4-week follow-up were enrolled. Six eyes were treatment-naïve; fifty-seven eyes were switched to faricimab from another treatment. Neither group showed signs of retinal vasculitis during the 4 weeks after injection. Central subfield thickness (CST) and volume (CSV) showed a statistically significant decrease compared to the baseline in the switched group (CST: p = 0.00383; CSV: p = 0.00702) after 4 weeks. The corrected visual acuity returned to the baseline level in both groups. The macular neovascularization area decreased in both groups, but this was not statistically significant. A complete resolution of sub- and intraretinal fluid after 4 weeks was found in 40% (switched) and 75% (naïve) of the treated patients. Conclusions: The weekly follow-ups reflect the structure-function relationship beginning with a fast functional improvement within two weeks after injection followed by a return to near-baseline levels after week 3. The first faricimab injection in our cohort showed a high safety profile and a statistically significant reduction in macular oedema in switched nAMD patients.
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  • 文章类型: Journal Article
    药物的玻璃体内注射(IVI)允许活性成分的即时眼内浓度高于通过静脉内注射获得的浓度,同时降低全身副作用的风险。今天,IVI在许多玻璃体视网膜疾病的治疗中起着核心作用。随着人口老龄化和血管内皮生长因子(VEGF)拮抗剂的出现,他们的适应症呈指数增长,创建结构,组织和经济困难。IVI现在是工业化国家中最广泛使用的医疗程序之一,随着新分子的发展,其适应症有望在不久的将来进一步扩大。尽管这种做法的整体安全性得到了证明,IVI使患者面临0.05%的眼内炎风险,其后果往往是戏剧性的。本文详细介绍了当前的建议,特别是关于无菌和防腐,并提出了执行IVI的典型序列。
    Intravitreal injection (IVI) of a drug allows for immediate intraocular concentrations of active ingredients higher than those obtained by intravenous injection while reducing the risk of systemic side effects. Today, IVI\'s play a central role in the treatment of many vitreoretinal diseases. With the aging of the population and the advent of vascular endothelial growth factor (VEGF) antagonists, their indications have increased exponentially, creating structural, organizational and economic difficulties. IVI is now one of the most widely performed medical procedures in industrialized countries, and its indications are expected to expand further in the near future with the development of new molecules. Although the overall safety of this practice is proven, an IVI exposes the patient to a 0.05 % risk of endophthalmitis, the consequences of which are often dramatic. This article details the current recommendations, in particular regarding asepsis and antisepsis, and proposes a typical sequence for performing an IVI.
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  • 文章类型: Journal Article
    静脉内液体给药是在医院环境中广泛实施的最常见的侵入性程序。全球范围内,大约2500万人接受静脉输液治疗。不同的因素影响护士的静脉输液管理实践;它可能影响患者的结果,增加发病率和死亡率。先前的研究表明,尤其是发展中国家的医疗保健提供者在静脉输液管理方面存在技能差距。这项研究的目的是评估在西舍瓦地区公立医院工作的护士和助产士的静脉输液管理实践及其相关因素,埃塞俄比亚中部。
    在西舍瓦地区公立医院的396名护士和助产士中采用了基于机构的横断面研究设计,埃塞俄比亚中部,从2019年3月1日至31日。采用简单随机抽样的方法,使用结构化的自我管理问卷选择研究参与者,和观察检查表。逻辑回归模型用于识别关联,和比值比用于检验与结果变量和预测变量的关联强度.
    在这项研究中,59.3%(95CI=54.7%-64.5%)的参与者静脉输液管理不充分。知识不足(AOR2.1;CI95%=1.36-3.36),未经训练(AOR1.7;95%CI=1.04-2.86),监督不可用(AOR1.8;CI95%=1.14-2.99),护士和助产士缺乏奖励和晋升(AOR2.1;CI95%=1.19-3.62)与结局变量显著相关.
    研究环境中十分之七的参与者静脉输液实践不足。知识不足,培训,缺乏高级职员的监督,护士和助产士缺乏激励和晋升是影响静脉输液管理实践的主要因素。复习课程,监督,需要对护士和助产士进行激励和晋升,以改善静脉输液管理.
    Intravenous fluid administration is the most common invasive procedure widely practiced in hospital settings. Globally, approximately 25 million people receive intravenous fluid therapy. Different factors affect nurse\'s intravenous fluid administration practices; that it may influences on the patient\'s outcome, increase morbidity and mortality. Previous study indicates that healthcare providers especially in developing countries have skills gap related to intravenous fluid administration. The purpose of this study was aimed to assess the intravenous fluid administration practices and its associated factors among nurses and midwives working in public hospitals of West Shewa zone, Central Ethiopia.
    UNASSIGNED: An institution-based cross-sectional study design was employed among 396 nurses and midwives in public hospitals in West Shewa zone, Central Ethiopia, from March 1 to 31, 2019. A Simple random sampling was used to select study participants using structured self-administered questionnaire, and observational checklist. The logistic regression model was used to identify association, and odds ratio was used to test the strength of the associations with outcome variable and predictor variables.
    UNASSIGNED: In this study, 59.3% (95%CI = 54.7%-64.5%) participants was had inadequate intravenous fluid administration practice. Inadequate knowledge (AOR 2.1; CI 95% = 1.36-3.36), being untrained (AOR 1.7; 95% CI = 1.04-2.86), unavailability of supervision (AOR 1.8; CI 95% = 1.14-2.99), and absence of incentives and promotion for nurses and midwives (AOR 2.1; CI 95% = 1.19-3.62) were significantly associated with outcome variable.
    UNASSIGNED: Nearly seven in ten participants in the study setting were inadequate intravenous fluid practice. Inadequate knowledge, training, and absence of supervision by senior staffs, and absence of incentives and promotion for nurses and midwives were the main factors affecting intravenous fluid administration practice. Refresher courses, supervision, incentives and promotions were needed to nurses and midwives for an improvement of the intravenous fluid administration practice.
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  • 文章类型: Journal Article
    Background and Objectives: Intravitreal injections (IVI) of vascular endothelial growth factor (VEGF) inhibitors are guideline-indicated treatments for diabetic macular edema (DME). However, some recent data have suggested that IVI VEGF inhibitors might, through systemic absorption, lead to a reduction in renal function. Our study aims to compare changes in glycated hemoglobin A1c (HbA1c) and estimated glomerular filtration rate (eGFR) between patients who received IVI ranibizumab and aflibercept treatment and patients who have not received IVI treatments. Materials and Methods: There were 17,165 DME patients with documented ophthalmology visits in the China Medical University Hospital-Clinical Research Data Repository. Those with a history of ESRD or bevacizumab treatment history, and those with missing information on HbA1c or eGFR, were excluded. After matching by age (±2 years), gender, and the year of clinical visit, 154 patients with medical treatment (including ranibizumab and aflibercept) and 154 patients without medical treatment were included in the study. The difference between HbA1c and eGFR at baseline and 3 and 12 months after the index date between the two groups was assessed. Results: Mean HbA1c and eGFR decreased between baseline and 12 months after the index date in both groups (p < 0.05). Compared with the non-treatment group, the treatment group had significantly lower HbA1c 3 and 12 months after the index date. There was no significant difference in eGFR between the two groups. In the generalized estimating equations (GEE) model, HbA1c in the treatment group was lower than the non-treatment group (−0.44%, 95% CI = −0.75, −0.14), but eGFR was similar after adjusting for age, gender, and index-year. HbA1c and eGFR decreased with the time in the adjusted GEE model (p < 0.0001) in both groups. Conclusions: This study showed that eGFR decreased with age and time and was not related to IVI anti-VEGF treatments in our tertiary referral hospital. IVI anti-VEGF therapy was also associated with better HbA1c control. It is suggested that DME patients can receive intravitreal VEGF inhibitors without inducing more renal impairment.
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  • 文章类型: Systematic Review
    综合有关用于评估低视力人群与视力相关的生活质量的量表的心理测量特性的信息。
    进行了系统评价。科克伦图书馆,Embase,PubMed,Bireme和Epidemonikos数据库于2020年7月进行了咨询。摘要和全文的资格评估由两名研究者独立进行。使用标准化模板提取有关研究设计的数据,规模和版本,参与者的临床状况,和测量的心理测量特性,使用特定于数据库的受控词汇术语来表示低视力,并使用关键词来表示与视力相关的生活质量和有效性。数据综合考虑了两种量表验证方法,经典测试理论与Rasch分析。
    我们的分析中总共包括了53篇文章。总的来说,40项研究评估了NEIVFQ量表,四个人评估了IVI量表,2人评估了VALVVFQ仪器,7人验证了LVQOL量表。这篇评论发现,VRQoLNEIVFQ,IVI,LVQOL和VALVVFQ-48量表具有足够的心理测量特性,具有良好的内部一致性,当使用CTT方法评估时。NEIVFQ量表还显示出足够的重测信度以及足够的构造和内容效度。使用Rasch分析时,NEIVFQ和LVQOL量表显示项目不足和多维性。IVI量表显示出在为低视力患者提供干预措施后评估HRQoL变化的潜力。
    存在许多问卷来测量低视力人群与视力相关的生活质量,但是问卷的心理测量特性是可变的。
    To synthesize information on the psychometric properties of scales used to assess vision-related quality of life in people with low vision.
    A systematic review was conducted. The Cochrane Library, Embase, PubMed, Bireme and Epistemonikos databases were consulted in July 2020. Eligibility assessment of abstracts and full texts was performed independently by two investigators.A standardized template was used for data extraction regarding study design, scale and version, clinical condition of participants, and psychometric properties measured, using database-specific controlled vocabulary terms for low vision and keywords for vision-related quality of life and validity. Data was synthesized considering two approaches for scales validations, Classical Test Theory and Rasch Analysis.
    A total of 53 articles were included in our analysis. In total, 40 studies evaluated the NEI VFQ scale, four evaluated the IVI scale, two evaluated the VA LV VFQ instrument and seven validated the LVQOL scale. This review found that the VRQoL NEI VFQ, IVI, LVQOL and VA LV VFQ-48 scales have adequate psychometric properties, with good internal consistency, when assessed using the CTT approach. The NEI VFQ scale also showed adequate test-retest reliability and adequate construct and content validity. The NEI VFQ and LVQOL scales showed inadequate items and multidimensionality when Rasch analysis was used. The IVI scale showed potential for assessing change in HRQoL after providing interventions to patients with low vision.
    Many questionnaires exist to measure vision-related quality of life in people with low vision, but the psychometric properties of the questionnaires are variable.
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  • 文章类型: Journal Article
    A series of methods (SDSCI, SDSPT2, iCI, iCIPT2, iCISCF(2), iVI, and iCAS) is introduced to accurately describe strongly correlated systems of electrons. Born from the (restricted) static-dynamic-static (SDS) framework for designing many-electron wave functions, SDSCI is a minimal multireference (MR) configuration interaction (CI) approach that constructs and diagonalizes a [Formula: see text] matrix for [Formula: see text] states, regardless of the numbers of orbitals and electrons to be correlated. If the full molecular Hamiltonian H in the QHQ block (which describes couplings between functions of the first-order interaction space Q) of the SDSCI CI matrix is replaced with a zeroth-order Hamiltonian [Formula: see text] before the diagonalization is taken, we obtain SDSPT2, a CI-like second-order perturbation theory (PT2). Unlike most variants of MRPT2, SDSPT2 treats single and multiple states in the same way and is particularly advantageous in the presence of near degeneracy. On the other hand, if the SDSCI procedure is repeated until convergence, we will have iterative CI (iCI), which can converge quickly from the above to the exact solutions (full CI) even when starting with a poor guess. When further combined with the selection of important configurations followed by a PT2 treatment of dynamic correlation, iCI becomes iCIPT2, which is a near-exact theory for medium-sized systems. The microiterations of iCI for relaxing the coefficients of contracted many-electron functions can be generalized to an iterative vector interaction (iVI) approach for finding exterior or interior roots of a given matrix, in which the dimension of the search subspace is fixed by either the number of target roots or the user-specified energy window. Naturally, iCIPT2 can be employed as the active space solver of the complete active space (CAS) self-consistent field, leading to iCISCF(2), which can further be combined with iCAS for automated selection of active orbitals and assurance of the same CAS for all states and all geometries. The methods are calibrated by taking the Thiel set of benchmark systems as examples. Results for the corresponding cations, a new set of benchmark systems, are also reported.
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  • 文章类型: Journal Article
    BACKGROUND: The aim of the vigilance system in Switzerland is the evaluation and classification of reported suspected adverse reactions of immunological veterinary medicines (IVMP), including suspected lack of expected efficacy. The Institute of Virology and Immunology (IVI) is the competent authority for marketing authorizations of immunological veterinary medicinal products in Switzerland and responsible for the vaccinovigilance system. In 2020, 130 adverse reaction reports were received (5% less compared to 2019). The reports mainly concerned dogs (41%) and cats (25%) followed by cattle (18%) and horses (7%). Many of the reports in dogs involved the application of combined vaccines against canine distemper, hepatitis, parvovirosis and parainfluenza in combination with canine leptospira components, in cats against cat flu and feline panleukopenia in combination with feline leukaemia virus infection. Causality assessments were done according to the international ABON system. In 27% of the reported cases, the causality assessments between the vaccination and the reaction described were evaluated as being probable (ABON A), in 44% as possible (ABON B).
    BACKGROUND: Das Ziel des Vaccinovigilancemeldesystems ist die Erfassung und Klassifizierung von unerwünschten Arzneimittelwirkungen (UAW) nach der Anwendung von immunologischen Tierarzneimitteln (TAM) in der Schweiz. Dazu zählt auch eine vermutete ungenügende Wirksamkeit von Impfstoffen. Als Zulassungsstelle für immunologische TAM ist die Impfstoffkontrolle des Instituts für Virologie und Immunologie (IVI) auch zuständig für das Vaccinovigilancemeldesystem. 130 UAW Meldungen zu zugelassenen immunologischen TAM wurden im Jahr 2020 erfasst (5% weniger als 2019). Am häufigsten betrafen die Meldungen Kleintiere: Hunde (41%) und Katzen (25%), gefolgt von Rindern (18%) und Pferden (7%). Beim Hund basierten die meisten UAW auf der Anwendung von Impfstoffen gegen Staupe, Hepatitis, Parvovirose und Parainfluenza in Kombination mit Leptospirose, bei der Katze waren es Impfstoffe gegen Katzenschnupfen und -seuche kombiniert mit Feliner Leukämievirusinfektion. Die Meldungen wurden gemäss dem internationalen ABON System klassifiziert. In 27% aller eingegangenen Fälle wurde ein kausaler Zusammenhang zwischen der Impfung und der Impfreaktion als wahrscheinlich (ABON A), in 44% als möglich (ABON B) beurteilt.
    BACKGROUND: L’objectif du système de vaccinovigilance en Suisse est l’évaluation et la classification des effets indésirables suspectés signalés en rapport à des médicaments vétérinaires immunologiques, y compris le manque présumé d’efficacité attendue. L’Institut de virologie et d’immunologie (IVI) est l’autorité compétente pour les autorisations de mise sur le marché des médicaments immunologiques vétérinaires en Suisse et est responsable du système de vaccinovigilance. En 2020, 130 déclarations d’effets indésirables ont été reçues (5% de moins par rapport à 2019). Les signalements concernaient principalement les chiens (41%) et les chats (25%) suivis des bovins (18%) et des chevaux (7%). Chez les chiens, ces annonces impliquaient principalement l’application de vaccins combinés contre la maladie de Carré, l’hépatite, la parvovirose et la parainfluenza en combinaison avec la leptospirose, chez les chats contre le coryza et la panleucopénie féline en association avec la leucose féline. Les évaluations de causalité ont été effectuées selon le système international ABON. Dans 27% des cas rapportés, les évaluations de causalité entre la vaccination et la réaction décrite ont été évaluées comme probables (ABON A), dans 44% comme possibles (ABON B).
    BACKGROUND: Lo scopo del sistema di notifica di vaccinovigilanza è di identificare e classificare le reazioni avverse di un farmaco che possono sorgere dopo l’uso di medicamenti veterinari (MVet) immunologici in Svizzera. Questo include anche il sospetto di un’insufficiente efficacia dei vaccini. L’Istituto di Virologia e Immunologia (IVI), in qualità di ufficio di omologazione dei Mvet immunologici, è responsabile anche del sistema di notifica di vaccinovigilanza. Nel 2020 sono state registrate 130 notifiche di Mvet immunologici omologati (5% in meno del 2019). Le notifiche riguardavano per la maggior parte piccoli animali: cani (41%) e gatti (25%), seguiti da bovini (18%) e cavalli (7%). Nei cani la maggioranza delle reazioni avverse erano conseguenti all’uso di vaccini contro cimurro, epatite, parvovirosi e parainfluenza in combinazione con la leptospirosi, nei gatti invece le reazioni avverse erano in relazione a vaccini contro la rinite felina e la gastroenterite felina combinata con l’infezione virale della leucemia felina. Le notifiche sono state classificate secondo il sistema internazionale ABON. Nel 27% dei casi inoltrati è stata considerata una relazione causale tra la vaccinazione e la risposta alla vaccinazione come probabile (ABON A), e nel 44% come possibile (ABON B).
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  • 文章类型: Journal Article
    OBJECTIVE: It is generally accepted that the incidence of birth defects in spontaneously conceived children ranges between 2.0-4.0%. However, several studies have shown that babies born after assisted reproductive technology (ART) procedures tend to present more congenital malformations than naturally conceived children, with 6.5% of the children born after intracytoplasmic sperm injection (ICSI) presenting birth defects. The use of high magnification sperm selection before ICSI was introduced in the early 2000s to allow the identification of spermatozoa with low risk of sperm DNA damage. Intracytoplasmic morphologically selected sperm injection (IMSI) is expected to change the incidence of congenital malformations, although data on the incidence of birth defects in children conceived after IMSI are still scarce.
    METHODS: A systematic review based on searches performed in electronic databases (PubMed, EMBASE, Web of Science, SCOPUS, and Cochrane Central Register of Controlled Trials) including articles published by February 2021 was conducted to identify trials comparing the neonatal outcomes of ICSI and IMSI. The outcome measured was the rate of birth defects in children born after ICSI or IMSI. Three trials were included as targets for data extraction and meta-analysis.
    RESULTS: Our meta-analysis included 3907 children conceived after IMSI (1280) or ICSI (2627). The incidence of birth defects was statistically different, with 2.5% (32/1280) in IMSI and 4.5% (119/2627) in ICSI (RR=0.59; 95% CI=0.40-0.87; p=0.007). The results demonstrated that IMSI decreased the incidence of structural defects compared to ICSI - 2.2% (18/830) vs. 3.8% (78/2049) - in a statistically significant manner (RR=0.58; 95%CI=0.35-0.96; p=0.04). No significant difference was observed in chromosomal abnormalities (Trisomy 13; 18; 21 and Triple X) between children conceived after IMSI (8/830) or ICSI (19/2049) (RR=1.07; 95%CI=0.47-2.43; p=0.87).
    CONCLUSIONS: IMSI seems to be an effective tool at reducing the incidence of structural defects compared to ICSI. However, IMSI does not change the incidence of chromosomal abnormalities.
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  • 文章类型: Journal Article
    UNASSIGNED: To evaluate the incidence rate and outcomes of endophthalmitis after intravitreal injection of in-house compounded bevacizumab.
    UNASSIGNED: In this multicentric study performed from 2014 to 2018, patients who were injected with in-house compounded and sterilized bevacizumab were observed for endophthalmitis. In-house compounded syringes were prepared in compounding pharmacy using sterile standard operating guidelines. All cases of acute endophthalmitis following intravitreal injection were recorded and followed up for final anatomical and visual outcome after management.
    UNASSIGNED: A total of 50,361 bevacizumab injections were administered. Incidence of post-injection endophthalmitis was 0.0377%. Incidence of culture-positive endophthalmitis was 0.0178%, with 55.5% culture positivity for Staphylococcus species. A significant improvement in the final visual outcome was noted (p<0.05), and overall five patients (26.3%) achieved visual acuity of 6/18 or more.
    UNASSIGNED: In-house compounded injections of bevacizumab can reduce post-injection endophthalmitis to a minimum, with maintenance of proper asepsis and strict protocols by the compounding pharmacy.
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  • 文章类型: Journal Article
    生物系统由高度复杂的网络组成,解码各个网络组件的功能意义对于理解健康和疾病状态至关重要。已经设计了几种算法来识别网络中最具影响力的监管点。然而,当前的方法不能解决网络的所有拓扑维度,也不能纠正固有的位置偏差,这限制了它们的适用性。为了克服这种计算缺陷,我们对200个真实世界和模拟网络进行了统计评估,以破译中心性度量之间的关联,并开发了一种称为综合影响值(IVI)的算法,它以无偏见的方式集成了最重要和最常用的网络中心性度量。当与十种不同网络上的其他12种当代有影响力的节点识别方法进行比较时,IVI算法优于所有其他评估方法。使用这种通用方法,网络研究人员现在可以识别最有影响力的网络节点。
    Biological systems are composed of highly complex networks, and decoding the functional significance of individual network components is critical for understanding healthy and diseased states. Several algorithms have been designed to identify the most influential regulatory points within a network. However, current methods do not address all the topological dimensions of a network or correct for inherent positional biases, which limits their applicability. To overcome this computational deficit, we undertook a statistical assessment of 200 real-world and simulated networks to decipher associations between centrality measures and developed an algorithm termed Integrated Value of Influence (IVI), which integrates the most important and commonly used network centrality measures in an unbiased way. When compared against 12 other contemporary influential node identification methods on ten different networks, the IVI algorithm outperformed all other assessed methods. Using this versatile method, network researchers can now identify the most influential network nodes.
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