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12.
胡山  赵波 《中国临床医学》2020,27(3):899-900
面对来势汹汹的新型冠状病毒肺炎(COVID-19),如何能够正确、快速诊断和筛检出确诊病例显得尤为重要,国内诸多科技工作者都在积极开展相关的诊断试验研究。本文回顾了目前正在开展的十余项诊断试验的注册信息,针对其中存在的共性问题进行了讨论,重点阐述了如何使用PICOS原则构造COVID-19诊断试验的研究问题,还对金标准的设置、受试者的代表性、样本量计算和同步、独立、盲法的测定等诊断试验的设计要点进行了详细说明。旨在为广大研究者提供开展COVID-19诊断试验的设计建议,帮助研究者在顶层设计阶段减少、避免偏倚,完成高质量的临床研究,为临床诊疗提供循证医学证据。  相似文献   
13.
《Clinical neurophysiology》2021,132(12):3104-3115
ObjectiveWe aimed to establish an objective neurophysiological test protocol that can be used to assess the somatosensory nervous system.MethodsIn order to assess most fiber subtypes of the somatosensory nervous system, repetitive stimuli of seven different modalities (touch, vibration, pinprick, cold, contact heat, laser, and warmth) were synchronized with the electroencephalogram (EEG) and applied on the cheek and dorsum of the hand and dorsum of the foot in 21 healthy subjects and three polyneuropathy (PNP) patients. Latencies and amplitudes of the modalities were assessed and compared. Patients received quantitative sensory testing (QST) as reference.ResultsWe found reproducible evoked potentials recordings for touch, vibration, pinprick, contact-heat, and laser stimuli. The recording of warm-evoked potentials was challenging in young healthy subjects and not applicable in patients. Latencies were shortest within Aβ-fiber-mediated signals and longest within C-fibers. The test protocol detected function loss within the Aβ-fiber and Aδ-fiber-range in PNP patients. This function loss corresponded with QST findings.ConclusionIn this pilot study, we developed a neurophysiological test protocol that can specifically assess most of the somatosensory modalities. Despite technical challenges, initial patient data appear promising regarding a possible future clinical application.SignificanceEstablished and custom-made stimulators were combined to assess different fiber subtypes of the somatosensory nervous system using modality-specific evoked potentials.  相似文献   
14.
《The Journal of arthroplasty》2022,37(10):1945-1950
The results of statistical tests in orthopedic studies are typically reported using P-values. If a P-value is smaller than the pre-determined level of significance (eg, < .05), the null hypothesis is rejected in support of the alternative. This automaticity in interpreting statistical results without consideration of the power of the study has been denounced over the years by statisticians, since it can potentially lead to misinterpretation of the study conclusions. In this paper, we review fundamental misconceptions and misinterpretations of P-values and power, along with their connection with confidence intervals, and we provide guidelines to orthopedic researchers for evaluating and reporting study results. We provide real-world orthopedic examples to illustrate the main concepts. Please visit the following https://youtu.be/bdPU4luYmF0 for videos that explain the highlights of the paper in practical terms.  相似文献   
15.
《Primary Care Diabetes》2019,13(6):568-573
AimsTo compare postprandial glucose responses to high-intensity interval exercise (HIE) between obese and lean individuals.MethodsThirty healthy young adult males (15 obese, 15 lean) ate a standardised meal, then performed HIE (4 × 30-s Wingate cycling/4-min rest) or a no-exercise control trial (CON). Blood glucose was measured preprandially and up to 150 min postprandially.ResultsCompared to CON, HIE reduced postprandial glucose concentrations at 120–150 min in obese (p < 0.001) and lean men (p < 0.05), with greater reductions in obese than lean subjects at 120 (−27.0% vs. −8.3%), 135 (−31.9% vs. −15.7%), and 150 min (−21.8% vs. −10.6%). The total glucose area under the curve (AUC) for the testing period was lower with HIE than CON among obese men (p < 0.05), but not lean men (p > 0.05). We found moderate correlations between body mass and postprandial glucose changes (r = 0.39–0.44, p < 0.05), and between glucose AUC and body mass and fat free mass (r = 0.39–0.48, p < 0.05).ConclusionsOur findings suggest that HIE may act as a time-efficient lifestyle intervention strategy for improving obesity-related diabetes risk factors, and might play a role in primary diabetes prevention for the healthy but sedentary population.  相似文献   
16.
This prospective cohort study was conducted to compare the accuracy of QuantiFERON®-TB (QFT) Gold In-Tube test and tuberculin skin test (TST) in diagnosing tuberculosis (TB) in predominantly bacille Calmette–Guerin-vaccinated children with a high incidence of malnutrition. The sensitivity of the QFT versus the TST was 69.6% versus 52.9% for WHO-defined TB, with specificity of 86% versus 78.3%, respectively. The concordance of the TST and QFT was 79% overall (κ = 0.430), 62.5% in those with WHO-defined TB and 85.7% in those without TB. Majority of the QFT+/TST − discordance was seen in children with TB, whereas majority of the TST+/QFT − discordance was seen in those without TB. The TST was more likely to be negative in children with moderate-to-severe malnutrition (P = 0.003) compared to the QFT, which was more likely to be positive in younger children. The significantly better performance of the QFT in malnourished children and those at younger ages supports its use for TB diagnosis in these subpopulations.  相似文献   
17.
《Vaccine》2021,39(45):6601-6613
AKS-452 is a biologically-engineered vaccine comprising an Fc fusion protein of the SARS-CoV-2 viral spike protein receptor binding domain antigen (Ag) and human IgG1 Fc (SP/RBD-Fc) in clinical development for the induction and augmentation of neutralizing IgG titers against SARS-CoV-2 viral infection to address the COVID-19 pandemic. The Fc moiety is designed to enhance immunogenicity by increasing uptake via Fc-receptors (FcγR) on Ag-presenting cells (APCs) and prolonging exposure due to neonatal Fc receptor (FcRn) recycling. AKS-452 induced approximately 20-fold greater neutralizing IgG titers in mice relative to those induced by SP/RBD without the Fc moiety and induced comparable long-term neutralizing titers with a single dose vs. two doses. To further enhance immunogenicity, AKS-452 was evaluated in formulations containing a panel of adjuvants in which the water-in-oil adjuvant, Montanide™ ISA 720, enhanced neutralizing IgG titers by approximately 7-fold after one and two doses in mice, including the neutralization of live SARS-CoV-2 virus infection of VERO-E6 cells. Furthermore, ISA 720-adjuvanted AKS-452 was immunogenic in rabbits and non-human primates (NHPs) and protected from infection and clinical symptoms with live SARS-CoV-2 virus in NHPs (USA-WA1/2020 viral strain) and the K18 human ACE2-trangenic (K18-huACE2-Tg) mouse (South African B.1.351 viral variant). These preclinical studies support the initiation of Phase I clinical studies with adjuvanted AKS-452 with the expectation that this room-temperature stable, Fc-fusion subunit vaccine can be rapidly and inexpensively manufactured to provide billions of doses per year especially in regions where the cold-chain is difficult to maintain.  相似文献   
18.
目的:观察理气中药经验组方对糖尿病大鼠胃排空延迟的干预作用。方法:雌雄各半成年SD大鼠110只,随机分为正常组(A组)、糖尿病中药组(B组)、糖尿病胃复安组(C组)、糖尿病组(D组)。A组、D组1次/d按10 mL/只予0.9%生理盐水灌胃,B组1次/d按8 mL/只予中药煎剂灌胃,C组1次/d按0.5 mg/只予胃复安片灌胃。喂养12周后,行13C胃排空实验及甲基橙水溶液胃排空实验,观察各组大鼠胃排空情况。结果:糖尿病大鼠胃排空较正常大鼠明显延迟(P0.01),糖尿病大鼠胃排空延迟模型制作成功。糖尿病中药组和糖尿病胃复安组大鼠胃排空较糖尿病组快(P0.01);糖尿病中药组大鼠胃排空较糖尿病胃复安组大鼠快(P0.05)。结论:常规喂养12周后糖尿病大鼠出现胃排空延迟。理气中药陈皮、枳实、木香、香附组方煎剂和胃复安均能促进糖尿病大鼠胃排空,理气中药组方煎剂的效果优于胃复安。  相似文献   
19.

Background

The optimal noninvasive test (NIT) for patients with diabetes and stable symptoms of coronary artery disease (CAD) is unknown.

Objectives

The purpose of this study was to assess whether a diagnostic strategy based on coronary computed tomographic angiography (CTA) is superior to functional stress testing in reducing adverse cardiovascular (CV) outcomes (CV death or myocardial infarction [MI]) among symptomatic patients with diabetes.

Methods

PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) was a randomized trial evaluating an initial strategy of CTA versus functional testing in stable outpatients with symptoms suggestive of CAD. The study compared CV outcomes in patients with diabetes (n = 1,908 [21%]) and without diabetes (n = 7,058 [79%]) based on their randomization to CTA or functional testing.

Results

Patients with diabetes (vs. without) were similar in age (median 61 years vs. 60 years) and sex (female 54% vs. 52%) but had a greater burden of CV comorbidities. Patients with diabetes who underwent CTA had a lower risk of CV death/MI compared with functional stress testing (CTA: 1.1% [10 of 936] vs. stress testing: 2.6% [25 of 972]; adjusted hazard ratio: 0.38; 95% confidence interval: 0.18 to 0.79; p = 0.01). There was no significant difference in nondiabetic patients (CTA: 1.4% [50 of 3,564] vs. stress testing: 1.3% [45 of 3,494]; adjusted hazard ratio: 1.03; 95% confidence interval: 0.69 to 1.54; p = 0.887; interaction term for diabetes p value = 0.02).

Conclusions

In diabetic patients presenting with stable chest pain, a CTA strategy resulted in fewer adverse CV outcomes than a functional testing strategy. CTA may be considered as the initial diagnostic strategy in this subgroup. (PROspective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]; NCT01174550)  相似文献   
20.
目的:观察稀土化合物硝酸钇[Y(NO33]亚慢性(90 d)暴露对大鼠学习记忆能力的影响,并探究其可能的机制,为全面评估稀土元素钇的健康风险提供科学依据。方法:选用刚离乳(PND21)SD雌性大鼠,根据质量随机分为4组,分别为对照组(ddH2O),Y(NO33低剂量组[10 mg/(kg·d)]、中剂量组[40 mg/(kg·d)]和高剂量组[160 mg/(kg·d)],每组15只。连续灌胃受试物90 d后进行旷场实验、高架十字迷宫实验、转棒实验、Morris水迷宫实验。水迷宫检测后,每组取5只雌鼠心脏原位灌注,进行脑组织病理学检查。每组剩余10只雌鼠摘取脑组织,紫外分光光度计检测雌鼠大脑皮质和海马中谷氨酸(Glu)的含量;Western blot检测海马组织中N-甲基-D-天冬氨酸(NMDA)受体蛋白表达情况。结果:与对照组相比,硝酸钇90 d暴露后,转棒实验中160 mg/(kg·d)剂量组大鼠在棒时间、在棒圈数、掉落速度明显升高(P<0.05)。在Morris水迷宫定位航向实验第4天时,40、160 mg/(kg·d)剂量组大鼠逃避潜伏期明显降低(P<0.05);Morris水迷宫空间探索实验中,40 mg/(kg·d)剂量组大鼠穿越平台次数、目标象限游泳时间明显增加(P<0.05);160 mg/(kg·d)剂量组穿越平台次数、进入目标象限次数、目标象限游泳时间明显增加(P<0.05);160 mg/(kg·d)剂量组大鼠东北、东南、西南象限的逃避潜伏期明显低于西北象限的逃避潜伏期(P<0.05)。160 mg/(kg·d)剂量组大鼠海马中Glu含量和NMDA受体NR1含量均明显低于对照组(P<0.05)。40和160 mg/(kg·d)剂量组大鼠海马中NMDA受体NR2A含量明显低于对照组(P<0.05)。结论:硝酸钇亚慢性(90 d)暴露可以引起雌性大鼠空间学习记忆能力增强;硝酸钇可能通过降低海马组织神经元细胞外Glu含量,抑制NMDA受体激活,增强雌性大鼠的空间学习记忆能力。  相似文献   
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