多模态超声对侵袭性前列腺癌的诊断价值及ROC曲线分析研究

目的：探讨多模态超声(MUS)对侵袭性前列腺癌(PCa)的诊断价值及受试者工作特征(ROC)曲线分析。方法：选择2018年01月至2021年02月于本院行手术切除并经病理证实的86例PCa患者作为研究对象,根据病理Gleason评分可分为两组,高侵袭组(Gleason＞4+3,共46例),低-中侵袭组(Gleason≤4+3,共40例)。所有患者术前均行MUS检查,包括经直肠常规超声(TRUS)、剪切波弹性成像(SWE)、超声造影(CEUS)。比较两组之间各参数的差异,采用ROC曲线分析其对高侵袭组PCa的诊断效能。结果：高侵袭组与低-中侵袭组的TRUS表现显著不同(P<0.05),其中高侵袭组中TRUS主要表现为弥漫性。高侵袭组SWE中SR比值(23.86±13.67)显著高于低-中侵袭组(12.82±11.95),差异具有统计学意义(P<0.05)。高侵袭组的CEUS参数中初始强度、峰值强度显著高于低-中侵袭组(P<0.05),而两组达峰时间、峰值减半时间无显著差异(P>0.05)。MUS对高侵袭组PCa诊断的ROC曲线下面积最大,敏感度、特异度也最高(P<0.05)。结论：MUS对高侵袭性PCa具有更高的诊断价值,有助于指导临床对治疗方案的选择。     

Use of Alternative Designs and Data Sources for Pediatric Trials

Abstract

Children are considered a vulnerable group and as such are granted additional protection as research subjects. Research projects using children as research subjects are justifiable if the answer to the scientific question of the study cannot be obtained by enrolling adult subjects (cf. scientific necessity). Thus, there is an ethical obligation to explore innovative analytical strategies that seek balance between the feasibility of conducting a trial and maximizing the utilization of data on efficacy and safety. On this note, there is enthusiasm for implementing some less popular but efficient alternative designs for confirmatory pediatric trials. Within the pediatric extrapolation paradigm, examples of such designs, other than purely based on pharmacokinetic/pharmacodynamic data, are described in this article along with their advantages and disadvantages. This article will also discuss how to incorporate alternative data sources in the analysis of pediatric clinical trials. A discussion of existing approaches and a road-map to their utilization will be provided. Real case examples on the use of the approaches are provided.     

Five-year change scores in old age for six neuropsychological tests and normative data for the Useful Field of View (UFOV) test: The influence of physical health

Introduction: Neuropsychological assessment of cognitive change over time is often conducted in clinical settings, but whether neuropsychological change scores are influenced by physical health has, as far as we know, not been examined previously.

Method: In a sample of 153 older Swedish adults (age range, 72–86 years), we evaluated the influence of common age-related diseases, terminal decline pathology, age, education, and gender, to provide (a) preliminary test-specific regression weights and 90% confidence intervals to assess significant change in performance after five years on tests of visual scanning, mental shifting, visual spatial ability, memory, reaction time, and selective attention, and (b) normative data for the Useful Field of View test (UFOV) from a single testing occasion.

Results: Multiple regression analyses showed that test–retest changes were affected by physical health for mental shifting, visual spatial ability, memory, and reaction time, by age for mental shifting and visual reaction time, by education for visual spatial ability, and by Age × Education for auditory reaction time. Gender did not affect any of the change scores. The overall average of variance explained was 2.5%: up to 8.1% for physical health, 4.4% for age, and 3.6% for education. The UFOV scores were mostly influenced by age, but also by physical health and education.

Conclusions: The findings indicate that considering the influence of health on normative change scores in old age in addition to demographic factors leads to more accurate predictions of whether true change has occurred.     

多媒体联合情景教学在急诊医师培训中的应用

目的探讨多媒体联合情景教学在急诊医师培训的应用效果。方法将本院2018年1月-2018年12月的34名急诊医师纳入观察组,应用多媒体联合情景教学法对其进行院内培训,另将本院2017年1月-2017年12月的34名急诊医师纳入对照组,应用传统教学法对其进行培训,对比两组医师的考试成绩、岗位胜任能力以及应急能力。结果观察组理论知识与技术操作的考试成绩均高于对照组,观察组自学、交流、表达、理解、解决问题的能力以及综合能力的评分均高于对照组,观察组急救意识、急救效率、病情评估、团队合作、职业防护的评分均高于对照组(P<0.05)。结论多媒体联合情景教学在急诊医师培训的应用效果显著,可明显提高医师的考试成绩、岗位胜任能力以及应急能力。     

术前低PSA的Gleason 8~10分前列腺癌患者临床特点

背景与目的:前列腺癌的发病率逐渐上升,其中有些患者在诊断为高级别前列腺癌甚至转移性前列腺癌时,其前列腺特异性抗原(prostate-specific antigen,PSA)数值却处于很低的水平。探讨术前低血清PSA的Gleason 8~10分前列腺癌患者临床特点。方法:收集2013年1月-2018年1月江苏省苏北人民医院收治的72例接受前列腺癌根治术的高Gleason评分前列腺癌患者的临床资料。根据术前血清PSA水平分为4组:A组<4.0 ng/mL(9例)、B组4.0~10.0 ng/mL(12例)、C组10.0~20.0 ng/mL(15例)和D组>20.0 ng/mL(36例)。4组平均年龄分别为(68.8±8.6)、(68.9±6.0)、(71.6±6.0)和(68.4±6.4)岁。平均随访时间分别为(21.6±12.1)、(18.8±7.2)、(25.0±13.4)和(24.8±12.5)个月。切缘阳性例数分别为3例(33.3%)、5例(41.7%)、5例(33.0%)和15例(41.7%)。精囊侵犯例数分别为6例(66.7%)、2例(16.7%)、2例(13.3%)和14例(38.9%)。淋巴结转移例数分别为2例(22.2%)、3例(25.0%)、4例(26.7%)和13例(36.1%)。预后评价指标为无生化复发天数(biochemical progression-free day,bPFD)与前列腺癌特异性死亡(prostate cancer-specific death,PCSD)。4组平均PFD分别为(90.00±38.40)、(306.17±79.00)、(223.14±63.30)和(145.03±62.50)d。PCSD例数分别为4例(44.4%)、0例(0.0%)、1例(6.7%)和5例(13.9%)。组间年龄、随访时间、PFD使用单因素方差分析,进一步两两比较采用最小显著差别(least significant difference,LSD)法;组间临床病理学特征采用χ2检验、Fisher精确检验;PCSD使用Kaplan-Meier生存分析,生存曲线间比较使用log-rank检验。结果:A组与其余3组相比,年龄、随访时间、切缘阳性、淋巴结转移的差异均无统计学意义(P>0.05)。A组与B、C两组相比,精囊侵犯、PFD的差异均有统计学意义(P<0.05)。但A组与D组相比,精囊侵犯、PFD的差异无统计学意义(P>0.05)。生存分析显示,A组相较于B组在随访时间内生存状况更差,但差异无统计学意义(P=0.092),A组与C、D两组的生存差异有统计学意义(P<0.05)。结论:具有术前低血清PSA水平的高Gleason评分前列腺癌患者相较于PSA更高水平的患者预后更差,易出现精囊侵犯、术后生化复发快且PCSD例数多。     

加味黄芪建中汤治疗脾阳虚型胃肠功能紊乱临床研究

目的:观察加味黄芪建中汤治疗脾阳虚型功能性胃肠功能紊乱的临床疗效。方法:将患者随机分成2组,对照组用枸橼酸莫沙比利治疗,治疗组运用枸橼酸莫沙比利治疗的基础上加用加味黄芪建中汤治疗,均治疗共4疗程。观察临床疗效及中医症状评分情况。结果:对照组有5例患者失访,疗效结束后显效率治疗组36.0%,对照组20.0%,2组比较,差异有统计学意义(P<0.05);治疗后2组胃脘痞满、食欲减退、神疲乏力评分与治疗前比较,差异有统计学意义(P<0.05),2组胃脘痞满、食欲减退以及神疲乏力等评分分别比较,差异均有统计学意义(P<0.01)。结论:加味黄芪建中汤能改善脾阳虚型胃肠功能紊乱的症状,有良好的临床疗效,优于单纯使用枸橼酸莫沙必利治疗。     

LacdiNAc-Glycosylated Prostate-specific Antigen Density is a Potential Biomarker of Prostate Cancer

BackgroundSerum LacdiNAc-glycosylated prostate-specific antigen (LDN-PSA) and LDN-PSA density together with PSA and PSA density (PSAD) were measured as a diagnostic tool for prostate cancer (PCa).Patients and MethodsWe included 150 patients with PCa without hormonal therapy and 41 patients without PCa obtained from the Kyoto University Hospital between 2012 and 2017. LDN-PSA levels were measured through a WFA–anti-PSA antibody sandwich immunoassay using a highly sensitive surface plasmon field-enhanced fluorescence spectroscopy (SPFS) system. Diagnostic performance of serum LDN-PSA and LDN-PSAD was evaluated by measuring the area under the receiver-operating characteristic curve (AUC).ResultsThe AUCs of LDN-PSA, LDN-PSAD, and PSAD levels (0.780, 0.848, and 0.835, respectively) detected in patients with PCa were significantly higher (P = .0001, P < .0001, and P < .0001, respectively) than that of PSA (0.590). Moreover, among 143 patients with PCa who received radical prostatectomy (RP), the AUCs of LDN-PSA, LDN-PSAD, and PSAD levels (0.750, 0.812, and 0.769, respectively) detected in patients with a pathologic Gleason grade group ≥ 2 were significantly higher (P = .0170, P = .0028, and P = .0003, respectively) than that of PSA (0.578). In the group comprising 35 patients who received RP with a Gleason grade group 1-graded biopsy, the LDN-PSA, LDN-PSAD, and PSAD levels were significantly different (P = .0097, P = .0024, and P = .0312, respectively). However, PSA alone could not discriminate cases with adverse features (P = .454).ConclusionsLDN-PSAD is a potential marker for detecting PCa and selecting candidates for RP.