efficacy

功效
  • 文章类型: Journal Article
    骚扰和虐待是体育运动中普遍存在的关键问题,具有深远的影响。幸存者的见证强调了这些经历对个人的深刻和持久的影响,人际关系,组织和社区层面。他们的许多故事揭示了体育组织中负责任的成年人的痛苦不作为,加重伤害。造成伤害的其他因素包括沉默文化,缺乏对什么构成虐待的知识和理解,不了解报告和支持机制,对潜在后果的恐惧。虽然有效的旁观者干预措施是在运动环境之外开发的,特别是针对高等教育中的学生,这些举措尚未在体育背景下得到广泛调整和评估。为了解决这个差距,SafeSportAlliesErasmus+协作伙伴关系依靠干预映射方法作为指导框架,系统地开发旁观者培训计划(即,安全体育盟友)培训青年体育参与者和青年体育教练充当有效的旁观者。本文介绍了全面的开发过程,并概述了实施和评估的可能性。在整篇论文中,解释了干预映射方法的每个步骤如何塑造安全运动盟友旁观者培训计划。程序开发,并提出了制定的实施和评估计划,揭示遇到的挑战。本文制定的旁观者培训计划以及实施和评估计划可以作为在体育保障这一关键领域内建立未来干预措施的纲要。
    Harassment and abuse represent a pervasive and critical problem in sport with far-reaching consequences. Survivors\' testimonials underscore the profound and enduring impact of these experiences at individual, interpersonal, organizational and community level. Many of their stories reveal painful inaction from responsible adults in the sport organization, aggravating the harm. Other contributing factors to the harm inflicted include a culture of silence, lack of knowledge and understanding of what constitutes abuse, unawareness of reporting and supporting mechanisms, and fear of potential consequences. While effective bystander interventions have been developed outside the sport context, particularly targeting students in higher education, such initiatives have yet to be extensively adapted and assessed within the sport context. To address this gap, the Safe Sport Allies Erasmus+ collaborative partnership relied on the intervention mapping approach as a guiding framework to systematically develop a bystander training program (i.e., Safe Sport Allies) to train youth sport participants and youth sport coaches to act as effective bystanders. The current paper describes the comprehensive development process and provides an overview of implementation and evaluation possibilities. Throughout the paper, it is explained how each step of the Intervention Mapping approach shaped the Safe Sport Allies bystander training program. The program development, and the developed plans for implementation and evaluation are presented, shedding light on challenges encountered. The bystander training program developed in this paper and the implementation and evaluation plans can serve as an outline to build future interventions within this critical domain of safeguarding in sport.
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  • 文章类型: Journal Article
    BempedoicAcid(BA)是一种新型药物,有可能作为他汀类药物的替代品,以降低血脂水平并改善心血管疾病(CVD)结局。特别是对于他汀类药物不耐受的个体。然而,统计能力不足限制了我们对BA疗效和安全性的理解.该荟萃分析利用最新数据提高了我们对BA对脂质和CVD的影响的认识,并增加了统计能力。
    MEDLINE,Embase,CochraneCentral,Clinicaltrials.gov,国家和国际会议的摘要,并搜索了相关研究的参考研究清单。Rayyan被用来筛选搜索结果,采用Revman5.3进行Meta分析和敏感性分析。
    我们的最终分析包括7项随机对照试验(RCT),共有17,782名参与者,BA组(n=9535)为53.6%,安慰剂组(n=8247)为46.4%。BA显著降低主要不良心血管事件(MACE)(OR:0.86;95%CI0.78-0.95;p=0.03),非致死性心肌梗死(OR0.72;95%CI0.61-0.85;p=0.0001),和新发/恶化的糖尿病(OR:0.55;95%CI0.30-0.98,p=0.04),同时将低密度脂蛋白胆固醇(LDL-C)水平降低22.5%(MD:-22.53%;95%CI-25.54至-19.52,p<0.00001)。
    这项荟萃分析的结果表明,BA是他汀类药物治疗的一种有希望且有效的替代药物,特别是他汀类药物不耐受和高CVD风险患者。然而,需要对不同人群进行进一步研究,以量化长期疗效和安全性终点.
    UNASSIGNED: Bempedoic Acid (BA) is a novel drug that has a potential to serve as an alternative to statins to decrease lipid levels and improve cardiovascular disease (CVD) outcomes, particularly for statin-intolerant individuals. However, insufficient statistical power has limited our understanding of the efficacy and safety of BA. This meta-analysis utilizes the latest data to improve our knowledge of BA\'s effects on lipids and CVD with increased statistical power.
    UNASSIGNED: MEDLINE, Embase, Cochrane Central, Clinicaltrials.gov, abstracts of national and international conferences, and reference lists of studies were searched for relevant studies. Rayyan was used to screen the search results, and Revman 5.3 was used for the meta-analysis and sensitivity analysis.
    UNASSIGNED: Our final analysis included seven randomized control trials (RCTs) with 17,782 participants, 53.6 % in the BA group (n = 9535) and 46.4 % in the placebo group (n = 8247). BA significantly decreased major adverse cardiovascular events (MACE) (OR: 0.86; 95 % CI 0.78-0.95; p = 0.03), non-fatal myocardial infarction (OR 0.72; 95 % CI 0.61-0.85; p = 0.0001), and new onset/worsening diabetes (OR:0.55; 95 % CI 0.30-0.98, p = 0.04), while reducing low-density lipoprotein cholesterol (LDL-C) levels by 22.5 % (MD: -22.53 %; 95 % CI -25.54 to -19.52, p < 0.00001).
    UNASSIGNED: The findings of this meta-analysis suggest that BA is a promising and effective alternative to statin therapy, particularly for statin-intolerant and high CVD-risk patients. However, further studies with diverse populations are needed to quantify the long-term efficacy and safety endpoints.
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  • 文章类型: Journal Article
    这项现实世界的研究旨在研究甲abotulinumtoxinA如何影响偏头痛的结果,伴随着焦虑,抑郁症,一组慢性偏头痛(CM)患者中的磨牙症和磨牙症,并确定了良好反应的预测因素。
    被诊断为CM的患者接受了乙酰磺胺醇毒素A,真实世界的回顾性队列研究。每月头痛天数(MHD),每月偏头痛日(MMD),在基线和治疗后12周评估头痛强度(数字评定量表-NRS)和头痛特征.患者报告的结局指标(PROM)包括偏头痛残疾评估量表(MIDAS),头痛影响测试-6(HIT-6)得分,12项异常性疼痛症状清单(ASC-12),贝克焦虑量表(BAI)和贝克抑郁量表(BDI)。还评估了对onabotulinumtoxinA的反应(MHD的减少百分比)和治疗相关的不良事件(TRAEs)。抱怨磨牙症的患者将OnabotulinumA应用于咬肌。
    共72例(平均±SD年龄:36.3±8.5岁;91.7%为女性)被诊断为CM。OnabotulinumtoxinA显示中位数(IQR)MHD显着降低[从基线时的20(15-25)到6(4-10),p<0.001],MMD[从9(6-12)到3(1-6),p<0.001和NRS[从9(8-10)到7(6-8),p<0.001],和MIDAS[从54(30-81)到16(7-24),p<0.001],HIT-6[从67(65-69)到58(54-64),p<0.001],ASC-12[从6(1.5-9)到2(0-9),p=0.002],BAI[从12(6.5-19)到9(3-17),在治疗后12周,p<0.001和BDI[从11(6.5-17)到3(2-7)p<0.001]评分。抱怨磨牙症的患者在最初的n=27(37.5%)和12中接受了乙酰磺胺醇毒素A注射。治疗后一周n=19(70.4%)期。总的来说,70.8%的患者有反应(MHD降低≥50%),而29.2%没有(<50%减少)。两组在人口统计学上表现出相似的特征,偏头痛史,PROM基线分数,合并症,和先前的治疗。
    OnabotulinumtoxinA是一种有效的治疗选择,可以迅速改善偏头痛的结局,残疾,和影响,同时也减轻共病抑郁和/或焦虑。这项研究的值得注意的发现是,在大多数的CM患者是有效的,不管他们以前的治疗史,偏头痛的特点,或并发合并症。此外,我们没有发现对单纯碱毒素A有良好反应的特异性预测因子。将onabotulinumtoxinA应用于咬肌可以缓解并发磨牙症的不适;然而,它不影响偏头痛结局.
    UNASSIGNED: This real-world study aimed to investigate how onabotulinumtoxinA affects the outcome of migraine, along with accompanying anxiety, depression, and bruxism among a group of patients with chronic migraine (CM) and define predictors of good response.
    UNASSIGNED: Patients diagnosed with CM who received onabotulinumtoxinA were included in this single-center, real-world retrospective cohort study. Monthly headache days (MHDs), monthly migraine days (MMDs), headache intensity (numeric rating scale-NRS) and headache characteristics were evaluated at baseline and 12 weeks post-treatment. Patient-reported outcome measures (PROMs) included Migraine Disability Assessment Scale (MIDAS), Headache Impact Test-6 (HIT-6) scores, 12-item Allodynia Symptom Checklist (ASC-12), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI). Response to onabotulinumtoxinA (% reduction in MHDs) and treatment-related adverse events (TRAEs) were also evaluated. OnabotulinumA was applied to the masseter muscles in patients complaining of bruxism.
    UNASSIGNED: A total of 72 patients (mean ± SD age: 36.3 ± 8.5 years; 91.7% were female) diagnosed with CM were included. OnabotulinumtoxinA revealed significant decrease in median (IQR) MHDs [from 20(15-25) at baseline to 6(4-10), p < 0.001], MMDs [from 9(6-12) to 3(1-6), p < 0.001] and NRS [from 9(8-10) to 7(6-8), p < 0.001], and the MIDAS [from 54(30-81) to 16(7-24), p < 0.001], HIT-6 [from 67(65-69) to 58(54-64), p < 0.001], ASC-12 [from 6(1.5-9) to 2(0-9), p = 0.002], BAI [from 12(6.5-19) to 9(3-17), p < 0.001] and BDI [from 11(6.5-17) to 3(2-7) p < 0.001] scores at 12 weeks post-treatment. Patients complaining of bruxism received onabotulinumtoxinA injections in the first n = 27 (37.5%) and 12. week post-treatment n = 19 (70.4%) periods. Overall, 70.8% of patients responded (≥50% reduction in MHDs), while 29.2% did not (<50% reduction). Both groups showed similar characteristics in demographics, migraine history, baseline PROMs scores, comorbidities, and prior treatments.
    UNASSIGNED: OnabotulinumtoxinA is an effective treatment option that rapidly improves migraine outcomes, disability, and impact while also alleviating comorbid depression and/or anxiety. This study\'s noteworthy finding is that onabotulinumtoxinA is effective in a majority of CM patients, irrespective of their prior treatment history, migraine characteristics, or concurrent comorbidities. Furthermore, we identified no specific predictors for a favorable response to onabotulinumtoxinA. Applying onabotulinumtoxinA to the masseter muscles can relieve discomfort associated with concurrent bruxism; however, it does not impact migraine outcomes.
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  • 文章类型: Journal Article
    一些研究表明,单次经颅直流电刺激(tDCS)具有调节健康和运动员运动表现的潜力。据我们所知,先前发表的系统评价既没有全面调查tDCS对身体和心理参数运动表现的影响,也没有调查tDCS对高水平运动员的影响。我们检查了所有可用的研究测试,耐力,运动特定的表现,情绪状态和认知表现,以便更好地应用于国家或国际水平运动员的比赛和赛前训练。在PubMed进行了系统的搜索,WebofScience,EBSCO,Embase,和Scopus直到2023年6月。当参与者至少在州和国家级比赛中有运动经验时,研究就有资格。在没有额外干预的情况下接受了一次tDCS,对照组接受假tDCS或不接受干预。从18篇文章中纳入了20项实验研究(224名参与者)。结果表明,在18项研究中,有12项研究中,一次tDCS会话改善了身体和心理参数。其中,六指TDCS在运动系统上的应用(运动皮层,运动前皮质,小脑),五个在背外侧前额叶皮层,两个在颞叶皮层。对tDCS最敏感的是力量,耐力,和情绪状态,提高了67%,75%,75%的研究,分别。不到一半的研究表明,运动特定任务(40%)和认知表现(33%)有所改善。我们建议tDCS是一种有效的工具,可用于比赛和赛前训练,以提高国家或国际水平运动员的运动成绩。进一步的研究将探索各种参数(运动类型,大脑区域,刺激方案,运动员水平,和测试任务)和提高tDCS干预效果的神经机制研究。系统审查注册:https://www。crd.约克。AC.uk/prospro/display_record.php?ID=CRD4202236989,标识符CRD4202236989。
    Some studies showed that a single session of transcranial direct current stimulation (tDCS) has the potential of modulating motor performance in healthy and athletes. To our knowledge, previously published systematic reviews have neither comprehensively investigated the effects of tDCS on athletic performance in both physical and psychological parameters nor investigated the effects of tDCS on high-level athletes. We examined all available research testing a single session of tDCS on strength, endurance, sport-specific performance, emotional states and cognitive performance for better application in competition and pre-competition trainings of national- or international-level athletes. A systematic search was conducted in PubMed, Web of Science, EBSCO, Embase, and Scopus up until to June 2023. Studies were eligible when participants had sports experience at a minimum of state and national level competitions, underwent a single session of tDCS without additional interventions, and received either sham tDCS or no interventions in the control groups. A total of 20 experimental studies (224 participants) were included from 18 articles. The results showed that a single tDCS session improved both physical and psychological parameters in 12 out of the 18 studies. Of these, six refer to the application of tDCS on the motor system (motor cortex, premotor cortex, cerebellum), five on dorsolateral prefrontal cortex and two on temporal cortex. The most sensitive to tDCS are strength, endurance, and emotional states, improved in 67%, 75%, and 75% of studies, respectively. Less than half of the studies showed improvement in sport-specific tasks (40%) and cognitive performance (33%). We suggest that tDCS is an effective tool that can be applied to competition and pre-competition training to improve athletic performance in national- or international-level athletes. Further research would explore various parameters (type of sports, brain regions, stimulation protocol, athlete level, and test tasks) and neural mechanistic studies in improving efficacy of tDCS interventions. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022326989, identifier CRD42022326989.
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  • 文章类型: Journal Article
    背景:大咯血的特点是危及生命,可能导致气道阻塞和窒息。本研究的目的是评估支气管内填塞联合支气管动脉栓塞(BAE)治疗大咯血的临床疗效。
    方法:在2018年3月至2022年3月期间,共67例接受BAE的大咯血患者分为两组:联合组(n=26)和BAE组(n=41)。评估了技术和临床成功率,治疗后监测不良事件.收集治疗前后血气分析及凝血功能指标,随访期间记录复发率和生存率。
    结果:所有患者均取得技术成功。临床成功率无显著差异,3个月和6个月的复发率,和3个月时的死亡率,6个月,联合组与BAE组之间1年。然而,与BAE组相比,联合组的咯血1年复发率显着降低(15.4%vs.39.0%,P=0.039)。两组均未发生严重不良事件。治疗后,联合组显示较高水平的动脉氧分压(PaO2),氧合指数(PaO2/FiO2),纤维蛋白原(FIB),D-二聚体(D-D)与BAE组比较(P<0.05)。多因素回归分析显示综合治疗与无咯血生存率之间存在显著相关性。
    结论:联合治疗,与单独的栓塞相比,在改善呼吸功能方面表现出卓越的功效,纠正缺氧,止血,并防止复发。它被认为是大咯血的有效和安全的治疗方法。
    BACKGROUND: Massive hemoptysis is characterized by its life-threatening nature, potentially leading to airway obstruction and asphyxia. The objective of this study was to evaluate the clinical effectiveness of combining endobronchial tamponade with bronchial artery embolization (BAE) in the treatment of massive hemoptysis.
    METHODS: Between March 2018 and March 2022, a total of 67 patients with massive hemoptysis who underwent BAE were divided into two groups: the combination group (n = 26) and the BAE group (n = 41). Technical and clinical success rates were assessed, and adverse events were monitored following the treatment. Blood gas analysis and coagulation function indicators were collected before and after the treatment, and recurrence and survival rates were recorded during the follow-up period.
    RESULTS: All patients achieved technical success. There were no significant differences in the clinical success rate, recurrence rates at 3 and 6 months, and mortality rates at 3 months, 6 months, and 1 year between the combination group and the BAE group. However, the hemoptysis recurrence rate at 1 year was significantly lower in the combination group compared to the BAE group (15.4% vs. 39.0%, P = 0.039). No serious adverse events were reported in either group. After treatment, the combination group showed higher levels of arterial partial pressure of oxygen (PaO2), oxygenation index (PaO2/FiO2), fibrinogen (FIB), and D-dimer (D-D) compared to the BAE group (P < 0.05). Multivariate regression analysis demonstrated a significant correlation between combined therapy and hemoptysis-free survival.
    CONCLUSIONS: Combination therapy, compared to embolization alone, exhibits superior efficacy in improving respiratory function, correcting hypoxia, stopping bleeding, and preventing recurrence. It is considered an effective and safe treatment for massive hemoptysis.
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  • 文章类型: Journal Article
    背景:疫苗数量的增加和免疫程序的复杂性,随着传染病流行病学的不断变化,需要一种系统的方法来评估疫苗有效性(VE)。本研究提出了一项初步调查,以建立韩国的VE评估框架,重点是国家免疫计划。
    方法:专家意见是通过针对关键利益相关者的两轮在线调查收集的。第一轮由两个多项选择题和两个开放式问题组成。第二轮是定量调查,通过分析第一轮调查的结果得出了基于五个领域的17份问卷。
    结果:结果强调了政府主导的VE评估系统以及建立多学科评估组织的必要性和紧迫性。关键考虑因素包括人员,预算,数据集成,法律标准,和监控系统增强。
    结论:这些发现为政策制定者提供了有价值的见解,强调合作的必要性,财政支持,和强有力的数据管理,以制定循证疫苗接种政策。
    BACKGROUND: The increasing number of vaccines and the complexity of immunization programs, along with continuous changes in the epidemiology of infectious diseases, necessitate a systematic approach to vaccine effectiveness (VE) evaluation. This study presents a preliminary survey to establish a VE evaluation framework in Korea, focusing on the National Immunization Program.
    METHODS: Experts\' opinions were collected through a two-round online survey targeting key stakeholders. The first round consisted of two multiple-choice questions and two open-ended questions. The second round was a quantitative survey with 17 questionnaires based on five domains derived by analyzing the results of the first-round survey.
    RESULTS: The results emphasize the necessity and urgency of a government-led VE evaluation system and the establishment of a multidisciplinary evaluation organization. Key considerations include personnel, budget, data integration, legal standards, and surveillance system enhancements.
    CONCLUSIONS: These findings provide valuable insights for policymakers, emphasizing the need for collaboration, financial support, and robust data management in developing evidence-based vaccination policies.
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  • 文章类型: Journal Article
    Eribulin是一种非紫杉烷合成类似物,在许多国家被批准作为治疗转移性乳腺癌患者的三线治疗方法。除了其有丝分裂性质,艾瑞布林具有非有丝分裂特性,包括但不限于,它能够诱导上皮向间充质转化的表型逆转,血管重塑,减少免疫抑制肿瘤微环境。自批准以来,在所有乳腺癌亚型中,有大量的研究调查了艾日布林作为早期治疗的应用,以及与其他药物如免疫疗法和靶向治疗的联合应用,包括激素受体阳性,HER2阳性和三阴性乳腺癌,许多展示有希望的活动。本文将重点介绍艾瑞布林在所有亚型转移性乳腺癌治疗中的应用,包括其作为早期药物的作用。它的毒性特征,和潜在的未来方向。
    Eribulin is a non-taxane synthetic analogue approved in many countries as third-line treatment for the treatment of patients with metastatic breast cancer. In addition to its mitotic property, eribulin has non-mitotic properties including but not limited to, its ability to induce phenotypic reversal of epithelial to mesenchymal transition, vascular remodelling, reduction in immunosuppressive tumour microenvironment. Since approval, there has been a surge in studies investigating the application of eribulin as an earlier-line treatment and also in combination with other agents such as immunotherapy and targeted therapy across all breast cancer sub-types, including hormone receptor positive, HER2 positive and triple negative breast cancer, many demonstrating promising activity. This review will focus on the application of eribulin in the treatment of metastatic breast cancer across all subtypes including its role as an earlier-line agent, its toxicity profile, and potential future directions.
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  • 文章类型: Journal Article
    胰腺导管腺癌(PDAC)迫切需要二线或后期治疗策略。我们旨在分析额外安洛替尼的疗效和安全性,特别是安洛替尼与免疫治疗联合使用,一线治疗失败的PDAC患者。
    病理诊断为PDAC的患者接受安洛替尼治疗,一些患者同时接受抗PD-1药物治疗,可以进行回顾性分析。评估额外安洛替尼的疗效和安全性。
    共纳入23例患者。在接受额外安洛替尼治疗的患者中,中位无进展生存期(PFS)为1.8个月,中位总生存期(OS)为6.3个月,无论抗PD-1药物。在接受额外安洛替尼与抗PD-1药物联合治疗的患者中,中位PFS和OS分别为1.8和6.5个月,分别。16例患者(69.6%)发生不良事件。在接受额外安洛替尼治疗的患者中,大多数AE为1-3级。单变量分析显示,基线红细胞分布宽度(RDW)<14%的患者接受额外的安洛替尼联合抗PD-1药物治疗,其OS明显长于基线RDW≥14%的患者(p=0.025)。使用额外的安洛替尼联合抗PD-1药物作为二线治疗的患者比作为后期治疗的患者具有更长的OS(p=0.012)。多因素分析显示,基线RDW是OS的唯一独立危险因素(p=0.042)。
    安洛替尼和免疫疗法的组合是PDAC患者的一种有效的附加疗法,具有可耐受的不良事件,可作为二线或后期治疗,特别是在基线RDW<14%的患者中。
    UNASSIGNED: Pancreatic ductal adenocarcinoma (PDAC) is in urgent need of a second-line or later-line treatment strategy. We aimed to analyze the efficacy and safety of additional anlotinib, specifically anlotinib in combination with immunotherapy, in patients with PDAC who have failed first-line therapy.
    UNASSIGNED: Patients with pathological diagnosis of PDAC were additionally treated with anlotinib, and some patients were treated with anti-PD-1 agents at the same time, which could be retrospectively analyzed. The efficacy and safety of additional anlotinib were evaluated.
    UNASSIGNED: A total of 23 patients were included. In patients treated with additional anlotinib, the overall median progression-free survival (PFS) was 1.8 months and the median overall survival (OS) was 6.3 months, regardless of anti-PD-1 agents. Among patients receiving additional anlotinib in combination with anti-PD-1 agents, median PFS and OS were 1.8 and 6.5 months, respectively. Adverse events (AEs) were observed in 16 patients (69.6%). In patients treated with additional anlotinib, the majority of AEs were grade 1-3. Univariate analysis revealed that patients with baseline red blood cell distribution width (RDW) <14% treated with additional anlotinib plus anti-PD-1 agents had significantly longer OS than patients with baseline RDW ≥14% (p = 0.025). Patients with additional anlotinib plus anti-PD-1 agents as second-line therapy had a longer OS than those treated as later-line therapy (p = 0.012). Multivariate analysis showed that baseline RDW was the only independent risk factor for OS (p = 0.042).
    UNASSIGNED: The combination of anlotinib and immunotherapy represents an effective add-on therapy with tolerable AEs as second- or later-line therapy in patients with PDAC, particularly in patients with baseline RDW <14%.
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  • 文章类型: Journal Article
    这项由内分泌学和肾脏病学专家编写的范围审查旨在解决finenone的重要性,作为一种新颖的治疗选择,糖尿病肾病(DKD),基于非甾体盐皮质激素受体拮抗剂(MRA)特性的心肾益处的生物学前景,以及Finerenone3期临床试验的最新证据。关于MR过度激活在心肾疾病发病机理中的作用以及当前实践模式中未满足的需求,严格审查了fineterone在减缓DKD进展中的重要性。FinerenoneIII期研究计划的疗效和安全性结果,包括FIDELIO-DKD,介绍了FIGARO-DKD和FIDELITY。具体来说,关于纳入具有保留的估计肾小球滤过率(eGFR)或高蛋白尿的患者的观点,同时使用钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)或胰高血糖素样肽1受体激动剂(GLP-1RA),基线糖化血红蛋白(HbA1c)水平和胰岛素治疗,研究了有临床意义的心力衰竭结局和治疗诱导的高钾血症.Finerenone已经成为一种新的治疗剂,可以减缓DKD的进展,降低蛋白尿和心血管并发症的风险,无论基线HbA1c水平和伴随治疗如何(SGLT2i,GLP-1RA,或胰岛素),并具有良好的获益-风险特征。关于SGLT2is和非甾体MRA在减缓或降低心肾风险方面的益处的不断发展的数据似乎为在DKD的管理中使用这些治疗支柱提供了机会。在这个领域长期的治疗稀缺之后。随着人们认识到蛋白尿是检测心肾疾病高危患者的有力标志物,这些重要的发展可能会影响DKD设置中的护理标准选择。
    This scoping review prepared by endocrinology and nephrology experts aimed to address the significance of finerenone, as a novel therapeutic option, in diabetic kidney disease (DKD), based on the biological prospect of cardiorenal benefit due to non-steroidal mineralocorticoid receptor antagonist (MRA) properties, and the recent evidence from the finerenone phase 3 program clinical trials. The importance of finerenone in slowing DKD progression was critically reviewed in relation to the role of MR overactivation in the pathogenesis of cardiorenal disease and unmet needs in the current practice patterns. The efficacy and safety outcomes of finerenone phase III study program including FIDELIO-DKD, FIGARO-DKD and FIDELITY were presented. Specifically, perspectives on inclusion of patients with preserved estimated glomerular filtration rate (eGFR) or high albuminuria, concomitant use of sodium-glucose co-transporter-2 inhibitor (SGLT2i) or glucagon-like peptide 1 receptor agonist (GLP-1 RA), baseline glycated hemoglobin (HbA1c) level and insulin treatment, clinically meaningful heart failure outcomes and treatment-induced hyperkalemia were addressed. Finerenone has emerged as a new therapeutic agent that slows DKD progression, reduces albuminuria and risk of cardiovascular complications, regardless of the baseline HbA1c levels and concomitant treatments (SGLT2i, GLP-1 RA, or insulin) and with a favorable benefit-risk profile. The evolving data on the benefit of SGLT2is and non-steroidal MRAs in slowing or reducing cardiorenal risk seem to provide the opportunity to use these pillars of therapy in the management of DKD, after a long-period of treatment scarcity in this field. Along with recognition of the albuminuria as a powerful marker to detect those patients at high risk of cardiorenal disease, these important developments would likely to impact standard-of-care options in the setting of DKD.
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  • 文章类型: Journal Article
    观察和评估多纳非尼联合经动脉化疗栓塞(TACE)治疗不可切除的肝细胞癌(HCC)的疗效和安全性。
    这个前景,单臂,单中心,II期临床研究纳入了36例初次无法切除的HCC患者,这些患者未接受任何系统治疗.患者接受多纳非尼加TACE(n=26)或多纳非尼加TACE加程序性死亡受体1抑制剂(n=10)。主要终点是短期疗效,次要终点包括无进展生存期(PFS),响应时间(TTR)疾病控制率(DCR),和不良事件。还测量了肿瘤供血动脉直径。
    对所有36例患者的疗效评估显示6例完全缓解,19的部分反应,8稳定的疾病,和3进行性疾病。6名(16.7%)患者成功接受了转换手术,全部实现R0切除,2例(5.6%)达到完全病理反应。客观有效率(ORR)为69.4%,DCR为91.7%。中位PFS为10.7个月,未达到中位总生存期,TTR中位数为1.4个月.6、12和18个月的中位生存率为85.0%,77.6%,和71.3%,分别。6、12和18个月的中位PFS率为65.3%,45.6%,和34.2%,分别。治疗相关不良事件(TRAEs)发生在所有25名受试者中,包括4个(11.3%)3级TRAE。没有发生4级或5级TRAE。治疗后肿瘤供血动脉直径明显下降(P=0.036)。多变量分析显示基线目标病变直径的总和,最佳肿瘤反应,联合免疫疗法是PFS的独立预测因子。
    TACE加多纳非尼可降低不可切除HCC患者的肿瘤供血动脉直径。安全性很好,实现了较高的ORR。
    UNASSIGNED: To observe and assess the efficacy and safety of donafenib combined with transarterial chemoembolization (TACE) to treat unresectable hepatocellular carcinoma (HCC).
    UNASSIGNED: This prospective, single-arm, single-center, phase II clinical study enrolled 36 patients with initial unresectable HCC who had not undergone any systemic treatment. The patients received donafenib plus TACE (n = 26) or donafenib plus TACE plus programmed death receptor 1 inhibitors (n = 10). The primary endpoint was short-term efficacy, with secondary endpoints including progression-free survival (PFS), time to response (TTR), disease control rate (DCR), and adverse events. The tumor feeding artery diameter was also measured.
    UNASSIGNED: Efficacy evaluation of all 36 patients revealed 6 cases of complete response, 19 of partial response, 8 of stable disease, and 3 of progressive disease. Six (16.7%) patients successfully underwent conversion surgery, all achieving R0 resection, and 2 (5.6%) achieved a complete pathological response. The objective response rate (ORR) was 69.4% and the DCR was 91.7%. The median PFS was 10.7 months, the median overall survival was not reached, and the median TTR was 1.4 months. The median survival rates at 6, 12, and 18 months were 85.0%, 77.6%, and 71.3%, respectively. The median PFS rates at 6, 12, and 18 months were 65.3%, 45.6%, and 34.2%, respectively. Treatment-related adverse events (TRAEs) occurred in all 25 subjects, including 4 (11.3%) grade 3 TRAEs. No grade 4 or 5 TRAEs occurred. The tumor feeding artery diameter was significantly decreased following treatment (P = 0.036). Multivariable analysis revealed the sum of baseline target lesion diameters, best tumor response, and combined immunotherapy as independent predictors of PFS.
    UNASSIGNED: TACE plus donafenib reduced the tumor feeding artery diameter in patients with unresectable HCC. The safety profile was good, and a high ORR was achieved.
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