non-invasive markers

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  • 文章类型: Journal Article
    背景:用于评估萎缩性胃炎(AG)的血清生物标志物分析,胃癌前病变,对胃癌风险增加的患者的识别越来越感兴趣。目的是使用另一种方法分析血清胃蛋白酶原检测的诊断性能,化学发光酶免疫分析(CLEIA),以及其他新的潜在生物标志物。
    方法:在我们之前的前瞻性研究中,被认为胃癌风险增加并接受上消化道内窥镜检查的患者的血清,多中心研究检测了胃蛋白酶原I(PGI)和II(PGII),白细胞介素-6(IL-6),人附睾蛋白4(HE-4),脂联素,铁蛋白和KrebsvondenLungen(KL-6)使用CLEIA。以组织学为参考,计算AG检测的诊断性能。
    结果:总计,356名患者(162名男性(46%);平均年龄58.6(±14.2)岁),包括152与AG,包括在内。对于中度至重度语料库AG的检测,胃蛋白酶原I/II比率的敏感性和特异性分别为75.0%(95CI57.8-87.9)和92.6%(88.2-95.8),分别。对于中度至重度胃窦AG的检测,IL-6的敏感性为72.2%(95CI46.5-90.3)。胃蛋白酶原I/II比率或HE-4的组合显示在任何位置检测中度至重度AG的灵敏度为85.2%(95CI72.9-93.4)。
    结论:这项研究表明,通过CLEIA进行的PG检测代表了检测语料库AG的准确方法。此外,IL-6和HE-4可能对胃窦AG的检测感兴趣。
    结论:胃蛋白酶原化学发光酶免疫分析法检测萎缩性胃炎是准确的。IL-6和HE-4可能对胃窦萎缩性胃炎的检测感兴趣。
    BACKGROUND: Analysis of serum biomarkers for the assessment of atrophic gastritis (AG), a gastric precancerous lesion, is of growing interest for identification of patients at increased risk of gastric cancer. The aim was to analyze the diagnostic performance of serum pepsinogen testing using another method, chemiluminescent enzyme immunoassay (CLEIA), as well as of other new potential biomarkers.
    METHODS: The sera of patients considered at increased risk of gastric cancer and undergoing upper endoscopy collected in our previous prospective, multicenter study were tested for pepsinogen I (PGI) and II (PGII), interleukin-6 (IL-6), human epididymal protein 4 (HE-4), adiponectin, ferritin and Krebs von den Lungen (KL-6) using the CLEIA. The diagnostic performance for the detection of AG was calculated by taking histology as the reference.
    RESULTS: In total, 356 patients (162 men (46%); mean age 58.6 (±14.2) years), including 152 with AG, were included. For the detection of moderate to severe corpus AG, sensitivity and specificity of the pepsinogen I/II ratio were of 75.0% (95%CI 57.8-87.9) and 92.6% (88.2-95.8), respectively. For the detection of moderate to severe antrum AG, sensitivity of IL-6 was of 72.2% (95%CI 46.5-90.3). Combination of pepsinogen I/II ratio or HE-4 showed a sensitivity of 85.2% (95%CI 72.9-93.4) for the detection of moderate to severe AG at any location.
    CONCLUSIONS: This study shows that PG testing by CLEIA represents an accurate assay for the detection of corpus AG. Additionally, IL-6 and HE-4 may be of interest for the detection of antrum AG.
    CONCLUSIONS: Pepsinogens testing by chemiluminescent enzyme immunoassay is accurate for the detection of corpus atrophic gastritis. IL-6 and HE-4 maybe of interest for the detection of antrum atrophic gastritis.
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  • 文章类型: Clinical Trial, Phase IV
    至少30%的HIV(PLWH)感染者患有非酒精性脂肪性肝病(NAFLD)。现在已经成为肝纤维化和肝硬化的主要原因。管理主要基于生活方式的改变,这是很难实现的,迫切需要治疗选择。Maraviroc(MVC),通过CCR5受体的拮抗作用,可能减少肝纤维化进展,可能是NAFLD的有效治疗方法。然而,通常每天给药两次,与大多数目前推荐的抗逆转录病毒疗法不同。本研究将探讨在PLWH和NAFLD的联合抗逆转录病毒疗法中添加MVC作为NAFLD治疗的可行性和可接受性。
    这是第四阶段,随机化,开放标签,非侵入性可行性研究。将从英国HIV诊所招募60名控制良好的HIV-1和NAFLD患者,并以1:1的比例随机接受优化的背景治疗(OBT)加MVC或OBT。随访将每24周一次,共96周。主要成果衡量标准将包括征聘和保留率,不良事件和依从性。次要结果将包括肝纤维化标志物的变化,包括增强的肝纤维化评分,Fibroscan的中位肝硬度测量和受控衰减参数评分,和生活质量评估。将根据意向治疗原则进行分析。对于次要结果,使用t方法估计各组之间的差异和95%CIs将用于连续变量,而精确的95%binomialCI将用于分类变量。
    通过伦敦德威英国研究伦理委员会获得伦理批准(参考17/LO/2093)。结果将通过社区团体和同行评审的科学文献传播。试验注册号SRCTN31461655。EudraCT编号2017-004141-24;预结果。
    At least 30% of people living with HIV (PLWH) infection have non-alcoholic fatty liver disease (NAFLD), which has now become a leading cause of hepatic fibrosis and cirrhosis. Management is based largely on lifestyle modifications, which are difficult to achieve, and therapeutic options are urgently needed. Maraviroc (MVC), through antagonism of CCR5 receptors, may reduce hepatic fibrosis progression and could be an effective treatment for NAFLD. However, dosing is usually two times per day, unlike most currently recommended antiretroviral therapies. This study will investigate the feasibility and acceptability of addition of MVC to combination antiretroviral therapy in PLWH and NAFLD as a treatment for NAFLD.
    This is a phase IV, randomised, open-label, non-invasive feasibility study. Sixty individuals with well-controlled HIV-1 and NAFLD will be recruited from UK HIV clinics and randomised 1:1 to receive either optimised background therapy (OBT) plus MVC or OBT alone. Follow-up will be every 24 weeks for 96 weeks. The primary outcome measures will include recruitment and retention rates, adverse events and adherence. Secondary outcomes will include changes in markers of hepatic fibrosis, including the Enhanced Liver Fibrosis score, median liver stiffness measurement and controlled attenuation parameter scores on Fibroscan, and quality of life assessments. Analyses will be performed according to intention-to-treat principles. For secondary outcomes, estimated differences and 95% CIs between the groups using a t-method will be presented for continuous variables and as exact 95% binomial CIs for categorical variables.
    Ethical approval was obtained through the London Dulwich UK Research Ethics Committee (reference 17/LO/2093). Results will be disseminated both through community groups and peer-reviewed scientific literature.Trial registration number SRCTN31461655. EudraCT number 2017-004141-24; Pre-results.
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