clinical studies

临床研究
  • 文章类型: English Abstract
    BACKGROUND: Digital health applications (DiGA) were included in the German healthcare system in 2020. They are available for prescription and reimbursed by public and private insurance companies. For the specialty of urology, there are currently two DiGA available: for the treatment of erectile dysfunction and benign prostatic hyperplasia/overactive bladder (BPH/OAB). The legal basis, clinical results and practical implementation are presented.
    METHODS: Evaluation of websites and publications to show the regulatory requirements, mode of action, results of clinical trials and prescribing practice with DiGA.
    RESULTS: Since 2020, 63 DiGA have been listed in the register of the Federal Office for Drugs and Medical Devices (BfArM), 35 of them definitively. Two urological DiGA aim to treat erectile dysfunction and BPH/OAB. Randomized, controlled studies have shown a significant and clinically relevant patient benefit for both DiGA. Further urological DiGA are in clinical development.
    CONCLUSIONS: DiGAs offer multimodal therapy combinations that have not yet been used in clinical practice and show a multidimensional benefit for the patient.
    UNASSIGNED: HINTERGRUND UND FRAGESTELLUNG: Digitale Gesundheitsanwendungen (DiGA) wurden 2020 in die Regelversorgung aufgenommen. Sie werden auf Rezept verschrieben und die Kosten von den Krankenkassen übernommen. Für das Fachgebiet Urologie stehen derzeit 2 DiGA zu Behandlung der erektilen Dysfunktion (ED) und der benignen Prostatahyperplasie/überaktiven Blase (BPH/OAB) zur Verfügung. Hier sollen die gesetzlichen Grundlagen, klinische Ergebnisse und die praktische Umsetzung gezeigt werden.
    METHODS: Webseiten und Publikationen zur Darstellung der regulatorischen Voraussetzung, Wirkungsweise, Ergebnissen von klinischen Studien und Verschreibungspraxis mit DiGA werden ausgewertet.
    UNASSIGNED: Seit 2020 wurden 63 DiGA im Verzeichnis des Bundesamts für Arzneimittel und Medizinprodukte (BfArM) gelistet, 35 davon endgültig. Bislang finden sich 2 DiGA im urologischen Fachgebiet: eine betrifft die Behandlung der ED, die andere die der BPH bzw. OAB. Bei beiden DiGA zeigte sich in randomisierten, kontrollierten Studien ein signifikanter und klinisch relevanter Patientennutzen. Weitere urologische DiGA sind in der klinischen Entwicklung.
    UNASSIGNED: Die DiGA bieten multimodale Therapiekombinationen, die so in der klinischen Praxis bisher keine Anwendung fanden und zeigen einen mehrdimensionalen positiven Versorgungseffekt.
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  • 文章类型: Journal Article
    这项研究的目的是评估疗效,特异性,和新发现的生物标志物的预测价值,锌指样蛋白1(称为神经内分泌标志物,NEM)用于检测前列腺癌(PCa)。我们回顾性分析了508名男性的库存血浆样本,年龄中位数为67岁(范围48-97),比较NEM和PSA在预测随后的组织学PCa中的表现。该队列由四组访问泌尿外科诊所的患者组成:(1)未被诊断为良性前列腺疾病或前列腺癌(PCa)的患者被定义为正常;(2)被诊断为良性增生(BPH)而不是PCa的患者;(3)确诊的PCa患者;(4)PCa以外的癌症患者。正常男性显示平均NEM血浆水平为0.948±0.051ng/mL,在男性BPH患者中增加到1.813±0.315ng/mL,男性PCa患者为86.49±15.51ng/mL,和10.47±1.029ng/mL男性与其他钙。这些受试者的前列腺特异性抗原(PSA)的相应浓度为1.787±0.135,5.405±0.699,35.77±11.48ng/mL,和8.036±0.518。进行受试者工作特征(ROC)曲线分析以比较NEM和PSA性能,计算每种生物标志物的Jouden指数以确定每种生物标志物的截止点。预测PCa的ROC曲线下面积NEM为0.99,PSA为0.81(p<0.0001)。NEM的截止值为1.9ng/mL,灵敏度为98%,特异性为97%。相应的PSA值为4.4ng/mL,敏感性为76%,特异性为95%。将患者中每种生物标志物的预测值与其病理数据进行匹配以确定每种生物标志物的准确性。在区分癌症和良性疾病方面,NEM比PSA更准确,如BPH或前列腺炎。总之,在泌尿外科诊所就诊的患者中,NEM比PSA更好地预测PCa。NEM测试,单独或与其他生物标志物结合,提供一个可靠的,非侵入性,和廉价的测试显着减少假阳性,从而减少诊断活检的数量和相关的痛苦程序和生活质量的损失。
    The purpose of this study was to assess the efficacy, specificity, and predictive value of a newly discovered biomarker, Zinc finger-like1 protein (referred to as neuroendocrine marker, NEM) for the detection of prostate cancer (PCa). We retrospectively analyzed banked plasma samples from 508 men, with a median age of 67 years (range 48-97), to compare the performance of NEM and PSA in predicting subsequent histologic PCa. The cohort consisted of four groups of patients visiting a urology clinic: (1) patients not diagnosed with either benign prostatic disease or prostate cancer (PCa) were defined as normal; (2) patients diagnosed with benign hyperplasia (BPH) but not PCa; (3) patients with confirmed PCa; and (4) patients with cancer other than PCa. The normal men displayed a mean NEM plasma level of 0.948 ± 0.051 ng/mL, which increased to 1.813 ± 0.315 ng/mL in men with BPH, 86.49 ± 15.51 ng/mL in men with PCa, and 10.47 ± 1.029 ng/mL in men with other Ca. The corresponding concentrations of prostate-specific antigen (PSA) in these subjects were 1.787 ± 0.135, 5.405 ± 0.699, 35.77 ± 11.48 ng/mL, and 8.036 ± 0.518, respectively. Receiver operating characteristic (ROC) curve analysis was performed to compare NEM and PSA performance, and the Jouden Index for each biomarker was calculated to determine cut-off points for each biomarker. The area under the ROC curve to predict PCa was 0.99 for NEM and 0.81 for PSA (p < 0.0001). The cut-off for NEM was at 1.9 ng/mL, with sensitivity of 98% and specificity of 97%. The corresponding PSA values were 4.4 ng/mL, with sensitivity of 76% and specificity of 95%. The predictive value of each biomarker in a patient was matched with his pathologic data to determine the accuracy of each biomarker. NEM was more accurate than PSA in differentiating cancer from benign conditions, such as BPH or prostatitis. In conclusion, NEM was a better predictor of PCa than PSA in patients visiting urology clinics. NEM tests, either alone or in conjunction with other biomarkers, provide a reliable, non-invasive, and inexpensive test to remarkably reduce false positives and thereby reduce the number of diagnostic biopsies and associated painful procedures and the loss of quality of life.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    这是一名61岁的女士,她出现在脂质诊所,可能患有家族性高胆固醇血症(SimonBroome标准)。她开始服用阿托伐他汀;然而,4周后,她得了肝炎,因此她停用了阿托伐他汀。在此之后,她的肝功能检查恢复正常,她被诊断为他汀类药物诱导的肝炎。三年后,在脂质诊所再次看到她的血脂不受控制,她开始服用alirocumab,前蛋白转化酶枯草杆菌蛋白酶/Kexin9型(PCSK9)抑制剂。几天后,她得了肝炎,随后,alirocumab停用.她做了肝活检,证实她患有自身免疫性肝炎(AIH),并推测为叠加药物损伤。这是第一例报道的与alirocumab相关的自身免疫性肝炎病例。
    This is a case of a 61-year-old lady who presented to the lipid clinic with possible familial hypercholesterolaemia (Simon Broome Criteria). She was commenced on atorvastatin; however, 4 weeks later, she developed hepatitis, and therefore her atorvastatin was discontinued. Following that, her liver function tests normalized, and she was diagnosed with statin-induced hepatitis. Three years later, she was seen again in the lipid clinic with an uncontrolled lipid profile, and she was commenced on alirocumab, a Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor. A few days later, she developed hepatitis, and subsequently, the alirocumab was discontinued. She underwent a liver biopsy, which confirmed that she had Autoimmune Hepatitis (AIH) with presumed superimposed drug injury. This is the first reported case of autoimmune hepatitis associated with alirocumab.
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  • 文章类型: Journal Article
    脑干肿瘤被称为弥漫性脑桥内胶质瘤(DIPG),也被称为脑桥神经胶质瘤,浸润性脑干胶质瘤并不常见,几乎总是影响儿童。脑桥胶质瘤发生在脑干最脆弱的区域(“脑桥”),它调节呼吸和血压等许多重要过程。由于其位置以及它如何侵入健康的脑组织,治疗特别具有挑战性。由于现代医学的进步,寻找解决方案的工作正在不断推进,但是正确的方法仍然难以捉摸。特别关注无法治愈或复发的脑肿瘤,研究正在进行中,以发现新鲜的,针对大脑特定区域的实用方法。
    要成功完成此任务,在像谷歌学者这样的知名数据库中进行了彻底的文献检索,PubMed,和科学直接。
    本文提供了脂质纳米颗粒与替代纳米颗粒制剂相比的显著优点的综合分析。本文深入研究了各种基于脂质的纳米颗粒递送系统的复杂领域,用于弥漫性内在脑桥胶质瘤(DIPG),彻底检查临床前和临床研究,提供对脂质纳米颗粒在推动DIPG治疗进展中的有效性和潜力的全面分析。
    有强大的临床数据支持将基于脂质的纳米颗粒药物递送用于脑癌治疗的有希望的方法,这表明结果有所改善。
    UNASSIGNED: The brainstem tumour known as diffuse intrinsic pontine glioma (DIPG), also known as pontine glioma, infiltrative brainstem glioma is uncommon and virtually always affects children. A pontine glioma develops in the brainstem\'s most vulnerable region (the \"pons\"), which regulates a number of vital processes like respiration and blood pressure. It is particularly challenging to treat due to its location and how it invades healthy brain tissue. The hunt for a solution is continually advancing thanks to advances in modern medicine, but the correct approach is still elusive. With a particular focus on brain tumours that are incurable or recur, research is ongoing to discover fresh, practical approaches to target particular areas of the brain.
    UNASSIGNED: To successfully complete this task, a thorough literature search was carried out in reputable databases like Google Scholar, PubMed, and ScienceDirect.
    UNASSIGNED: The present article provides a comprehensive analysis of the notable advantages of lipid nanoparticles compared to alternative nanoparticle formulations. The article delves into the intricate realm of diverse lipid-based nanoparticulate delivery systems, which are used in Diffuse Intrinsic Pontine Glioma (DIPG) which thoroughly examines preclinical and clinical studies, providing a comprehensive analysis of the effectiveness and potential of lipid nanoparticles in driving therapeutic advancements for DIPG.
    UNASSIGNED: There is strong clinical data to support the promising method of using lipid-based nanoparticulate drug delivery for brain cancer treatment, which shows improved outcomes.
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  • 文章类型: Journal Article
    Joint pain is a common complaint owing to its origin in inflammatory and degenerative joint diseases. Recent research has helped narrow down inadequate angiogenesis as one of the causes. Angioembolization has emerged as a treatment option for this condition when it is refractory to conservative treatment. This review describes angioembolization by elaborating on the mechanism, safety, efficacy, comparative analysis of treatment and the road ahead, in addition to summarizing the existing data on this treatment. The inferences from this review further consolidate transcatheter arterial embolization as one of the prime options for managing joint pain when it is refractory to conservative treatment and label it as one of the most exciting prospects. A limitation of this review is that most of the data were from open label case series or case reports.
    UNASSIGNED: Gelenkschmerzen sind ein weit verbreitetes Beschwerdebild, das seinen Ursprung in entzündlichen und degenerativen Gelenkerkrankungen hat. Durch aktuelle Forschungen konnte die unangemessene Angiogenese als eine der Ursachen ausgemacht werden. Die Angioembolisation hat sich bei Nichtansprechen auf eine konservative Therapie als Behandlungsoption für diese Erkrankung herauskristallisiert. In dieser Übersichtsarbeit wird die Angioembolisation beschrieben, indem der Mechanismus, die Sicherheit, die Wirksamkeit, die vergleichende Analyse der Behandlung und der weitere Weg erläutert und die vorhandenen Daten zu dieser Behandlung zusammengefasst werden. Die Ergebnisse dieser Übersichtsarbeit untermauern die Bedeutung der transkathetergestützten arteriellen Embolisation als eine der wichtigsten Optionen für die Behandlung von Gelenkschmerzen, die auf eine konservative Therapie nicht ansprechen, und bezeichnen sie als einen der bedeutungsvollsten Ansätze. Eine Einschränkung dieses Reviews ist, dass die meisten Daten aus offenen Fallserien oder Fallberichten stammen.
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  • 文章类型: Journal Article
    牙种植体骨折对长期治疗成功构成重大挑战。本系统综述旨在全面检查影响牙种植体骨折(IFs)的临床因素。此外,解决了选择正确类型的植入物和预防这种并发症的策略。在PubMed进行了系统的搜索,Scopus,和WebofScience数据库。符合条件的研究包括回顾性病例对照,前瞻性队列研究,和临床试验。最初的搜索产生了361篇文章,其中312项被排除在这些评论之外,病例报告,无关紧要,或用英语以外的其他语言写的。这留下了49篇文章,只有6人符合深入审查的资格标准。这些研究,所有回顾性病例对照,检查植入物特性,患者人口统计学,手术和假体变量,生物力学和功能因素,临床和程序变量,并发症和维护问题。使用ROBINS-I工具评估偏倚风险较低。主要研究结果表明,植入物直径和结构阻力之间存在相关性,更广泛的植入物显示骨折风险降低。此外,后部区域,尤其是磨牙和前磨牙,由于咀嚼力的增加,对IFs的敏感性更高。植入物的设计和材料可能会显著影响骨折风险,锥形植入物和螺钉保留假体显示出更高的脆弱性。生物力学过载,尤其是磨牙症患者,成为IFs的主要促成因素。假体类型显著影响骨折发生率,悬臂假体由于应力增加而带来更高的风险。种植体周围骨丢失与IFs密切相关,强调需要细致的术前评估和个性化管理策略。未来的研究应该优先考虑更大的和异质的群体与长期随访和标准化的方法,以提高结果的普遍性和可比性。在受控条件下进行随机对照试验和生物力学研究对于阐明导致IFs的复杂相互作用和制定有效的预防策略也至关重要。此外,整合患者报告的结局可以全面了解IFs对生活质量的影响.
    Dental implant fractures pose a significant challenge to long-term treatment success. This systematic review aims to comprehensively examine the clinical factors influencing dental implant fractures (IFs). Furthermore, strategies to choose the right type of implant and prevent this complication are addressed. A systematic search was conducted across PubMed, Scopus, and Web of Science databases. Eligible studies included retrospective case-control, prospective cohort studies, and clinical trials. The initial search yielded 361 articles, of which 312 were excluded being these reviews, case reports, irrelevant, or written in languages other than English. This left 49 articles, with only 6 meeting the eligibility criteria for an in-depth review. These studies, all retrospective case-control, examine implant characteristics, patient demographics, surgical and prosthetic variables, biomechanical and functional factors, clinical and procedural variables, complications and maintenance issues. The risk of bias was assessed as low using the ROBINS-I tool. Key findings suggest a correlation between implant diameter and structural resistance, with wider implants demonstrating reduced fracture risk. Additionally, posterior regions, especially molars and premolars, exhibit higher susceptibility to IFs due to increased masticatory forces. Implant design and material may considerably influence fracture risk, with conical implants and screw-retained prostheses showing higher vulnerability. Biomechanical overload, particularly in patients with bruxism, emerges as a primary contributing factor to IFs. Prosthesis type significantly influences fracture incidence, with cantilever prostheses posing a higher risk due to increased stress. Peri-implant bone loss is strongly associated with IFs, emphasizing the need for meticulous preoperative assessments and individualized management strategies. Future research should prioritize larger and heterogeneous populations with long-term follow-up and standardized methodologies to enhance the generalizability and comparability of findings. Randomized controlled trials and biomechanical studies under controlled conditions are also essential to elucidate the complex interactions contributing to IFs and developing effective prevention strategies. Additionally, integrating patient-reported outcomes may offer a comprehensive understanding of the impact of IFs on quality of life.
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  • 文章类型: Journal Article
    近年来,CRISPR通过使用精确基因编辑来识别特定序列,彻底改变了疾病检测。使用Scopus数据库,这项研究进行了全面的文献计量分析,查看1992年至2023年之间发表的关于CRISPR的学术论文。在使用Zotero筛选了1407篇文章的数据集后,年度出版趋势,引文模式,作者从属关系,使用VOSviewer等分析工具显示关键字共现,RStudio,和MSExcel。根据报告,1992年只有一份CRISPR出版物。到2017年,只有64篇论文。尽管如此,2018年至2023年之间出现了明显的高潮。参与基于CRISPR的疾病检测研究的主要国家包括德国,美国,中国,印度,和英国。重庆大学三峡医院,重庆大学医科大学,和重庆大学生物工程学院是几所顶尖院校。拥有最大的出版物数量(1688和1616)和强大的总链接强度(TLS)分别为42和77,作者刘,C.,李,Y.,站出来。截至2023年,引文最多的领域是布劳顿的2020年《自然生物技术》中基于CRISPR的SARS-CoV-2检测研究。1598次引用。生物传感器和生物电子学占论文的14.99%。研究人员,决策者,和感兴趣的各方可以使用这个全面的总结,以帮助他们做出明智的决定,未来的CRISPR为基础的疾病检测研究。
    CRISPR has revolutionized illness detection by using precision gene editing to identify specific sequences in recent years. Using the Scopus database, this study performs a comprehensive bibliometric analysis, looking at academic papers on CRISPR that were published between 1992 and 2023. After screening a dataset of 1407 articles using Zotero, trends in annual publishing, citation patterns, author affiliations, and keyword co-occurrence are revealed using analysis tools such as VOSviewer, RStudio, and MS Excel. According to the report, there was only one CRISPR publication in 1992. By 2017, there were a meager 64 papers. Nonetheless, there is a notable upsurge between 2018 and 2023. Leading nations involved in CRISPR-based illness detection research include Germany, the United States, China, India, and the United Kingdom. Chongqing University Three Gorges Hospital, Chongqing University Medical University, and Chongqing University Bioengineering College are a few of the top institutions. With the greatest publication numbers (1688 and 1616) and strong total link strengths (TLS) of 42 and 77, respectively, authors Liu, C., and Li, Y., stand out. The field with the greatest citation counts as of 2023 is Broughton\'s 2020 study on CRISPR-based SARS-CoV-2 detection in Nature Biotechnology, with 1598 citations. Biosensors and Bioelectronics comprise 14.99% of papers. Researchers, decision-makers, and interested parties can use this thorough summary to help them make well-informed decisions about future CRISPR-based disease detection studies.
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  • 文章类型: Journal Article
    细胞毒性T淋巴细胞相关抗原4(CTLA-4)作为主要在效应T细胞和调节性T细胞中表达的关键单链跨膜糖蛋白出现。它通过调节T细胞反应在肿瘤免疫中起关键作用。具体来说,CTLA-4通过与B7家族分子的竞争性相互作用抑制T细胞的活化和增殖,同时支持调节性T细胞的存活。从而帮助肿瘤细胞逃避免疫检测。鉴于CTLA-4对肿瘤免疫动力学的显著影响,已经临床开发了一系列抗CTLA-4抗体疗法来对抗各种恶性肿瘤,包括黑色素瘤,肾细胞癌,大肠癌,肝细胞癌,非小细胞肺癌,和胸膜间皮瘤,表现出显著的临床治疗效果。本文旨在深入研究CTLA-4在肿瘤免疫中的重要作用,并综述抗CTLA-4抗体临床研究的最新进展。
    Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) emerges as a key single-chain transmembrane glycoprotein predominantly expressed in effector T cells and regulatory T cells. It plays a crucial role in tumor immunity by modulating T cell responses. Specifically, CTLA-4 dampens T cell activation and proliferation while bolstering the survival of regulatory T cell through its competitive interaction with B7 family molecules, thereby aiding tumor cells in eluding immune detection. Given CTLA-4\'s significant influence on tumor immune dynamics, an array of anti-CTLA-4 antibody therapeutics have been clinically developed to combat various malignancies, including melanoma, renal cell carcinoma, colorectal carcinoma, hepatocellular carcinoma, non-small cell lung carcinoma, and pleural mesothelioma, demonstrating notable clinical therapeutic effects. This paper aims to delve into CTLA-4\'s integral role in tumor immunity and to encapsulate the latest advancements in the clinical research of anti-CTLA-4 antibody.
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  • 文章类型: English Abstract
    BACKGROUND: In recent years intraocular lenses (IOLs) for correcting presbyopia have been significantly improved and diversified. There are currently many different IOL models based on a wide variety of optical designs.
    OBJECTIVE: The wide variety of available IOL solutions to correct presbyopia can be challenging for surgeons and patients. In everyday practice, the question is which IOL is best for which patient.
    METHODS: This overview describes and categorizes the currently available implants. The respective optical properties are analyzed and clinical study results are discussed, in particular those evaluating visual performance and the occurrence of photic phenomena.
    RESULTS: Monofocal-plus IOLs provide improved intermediate visual acuity with optimal distant visual acuity and minimal photic phenomena. Extended depth of field (EDoF) IOLs extend the depth of field through different optical principles and provide good distant and intermediate visual acuity. Trifocal lenses enable the greatest independence from spectacles at the price of a higher probability of dysphotopsia.
    CONCLUSIONS: The selection of the most suitable IOL for correction of presbyopia requires a balance between the patient\'s visual needs and possible side effects. An adequate knowledge of the currently available implants allows a patient-oriented selection of IOLs.
    UNASSIGNED: HINTERGRUND: Presbyopie-korrigierende Intraokularlinsen (IOL) habe in den letzten Jahren deutliche Fortschritte gemacht und sich diversifiziert. Heute existiert eine Vielzahl verschiedener IOL-Modelle, die auf unterschiedlichsten optischen Prinzipien basieren.
    UNASSIGNED: Die Vielfalt der verfügbaren IOL-Lösungen zur Korrektur der Presbyopie kann für Chirurgen und Patienten herausfordernd sein. Im Alltag stellt sich die Frage, welche IOL für welchen Patienten am besten geeignet ist.
    METHODS: Die Übersicht beleuchtet und kategorisiert die heute verfügbaren Implantate. Es werden ihre jeweiligen optischen Eigenschaften analysiert sowie klinische Studienergebnisse betrachtet, die insbesondere die Visusergebnisse und das Auftreten von photischen Phänomenen bewerten.
    UNASSIGNED: Monofokal-Plus-Linsen bieten eine verbesserte Intermediärsehschärfe bei optimalem Fernvisus und minimalen photischen Phänomenen. Intraokularlinsen mit erweiterter Schärfentiefe (EDoF-IOL) erweitern die Schärfentiefe durch verschiedene optische Prinzipien und bieten eine gute Fern- und Intermediärsehschärfe. Die Trifokallinsen ermöglichen die größte Brillenunabhängigkeit zum Preis einer höheren Auftretenswahrscheinlichkeit von Dysphotopsien.
    CONCLUSIONS: Die Auswahl der geeignetsten IOL zur Presbyopiekorrektur erfordert die Abwägung zwischen den Sehbedürfnissen der Patienten und möglichen Nebenwirkungen. Die Vielzahl der heute verfügbaren IOL-Modelle ermöglicht bei angemessenen Kenntnissen über die Implantate eine patientenorientierte IOL-Versorgung.
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