六西格玛在肿瘤标志物质量目标选择上的应用

目的应用6σ理论对肿瘤标志物项目的分析性能进行评价，并初步确定各项目的质量目标。 方法收集本实验室2018年1至12月室内质控数据和国家卫生健康委临床检验中心室间质量评价结果，以生物学变异导出的质量规范和国家室间质量评价标准作为允许总误差(TEa)计算6项肿瘤标志物的σ水平，并依据质量目标选择流程图和肿瘤标志物分析性能验证图评价肿瘤标志物的分析性能，进而为肿瘤标志物选择合适的质量目标。 结果应用不同层级的生物学变异导出的质量规范和国家室间质量评价标准，肿瘤标志物项目的σ水平存在显著差异；依据质量目标选择流程图：选择生物学变异导出的"适当的"质量规范作为CA125项目的质量目标，选择生物学变异导出的"最低的"质量规范作为t-PSA、CEA、AFP、CA199和CA153项目的质量目标。 结论6σ能够客观评价肿瘤标志物的分析性能，并为实验室质量目标的选择提供重要的参考价值。     

精子冷冻环无保护剂玻璃化冷冻方法的初步研究

目的探讨精子冷冻环无保护剂玻璃化冷冻方法的可行性。方法正常精液标本上游处理后,进行常规冷冻和冷冻环无保护剂的玻璃化冷冻,复苏后分别从活力参数及电镜下超微结构等指标比较两种冷冻方法的效果。结果两种方法冷冻后精子存活率、活动率之间差异无显著性(48%∶48%;44.5%∶43.5%,P>0.05),但均较未冷冻的89%和88.5%明显下降(P<0.001)。超微结构亦较未冷冻时发生了一定的改变,但核结构基本保持完整。结论精子冷冻环无保护剂的玻璃化冷冻是一种简单、方便而行之有效的冷冻方法。     

7例睾丸静脉和2例卵巢静脉变异的解剖学研究

目的：了解睾丸静脉和卵巢静脉的变异。方法：观测了73具（146侧）成人尸体（男58，女15）两种静脉的形态结构。结果：发现两种静脉有变异者7例，其中睾丸静脉5例，卵巢静脉2例，另外，作者还对变异与国内文献作了比较。结论：本研究为探讨睾丸静脉和卵巢静脉曲张发生原因及治疗等提供解剖学资料。     

Kindergarten children's representation and understanding of written number symbols

Two samples of kindergarten children's representation and understanding of written number symbols were examined in two time points in one academic year. About 85% of Chinese five year olds (mean = 5 years 10 months) were able to use conventional number symbols to represent the quantity of 30 or larger. At the end of the kindergarten year, 94% of Chinese six year olds (mean = 6 years 4 months) were able to use conventional number symbols to represent the quantity of 100 or larger. Some Chinese six year olds had problems in representing written addition and subtraction tasks. Children's ability to represent written number symbols, ability to represent written addition and subtraction formula and their performance on written addition and subtraction were closely related. The performance of children in a university-affiliated childcare center was better than that of the center serving working-class families in Time 1, but the performance reversed at the end of the kindergarten year.     

某铜矿山巷道内气溶胶浓度与粒径分布的测量和分析

目的 定性了解矿山巷道内气溶胶的浓度和粒径分布特性。方法 在巷道内的不同区间,分别用凝结核颗粒计数器和个人气溶胶测量仪巡测气溶胶的粒子数和质量浓度,并通过质量浓度的分级测量定性评价微米级气溶胶的粒径分布;在调度室内外,用金属丝网筛扩散法测量亚微米级气溶胶的粒径分布。结果 巷道内可吸入颗粒物(PM10)的平均质量浓度为0.42 mg/m³,其量值大小因工作断面而异,且受人工活动影响变化较大;巷道内粒径大于1.0 μm的颗粒物广泛存在,而粒子直径小于5 nm的气溶胶基本上未被检出。结论 矿山巷道内气溶胶特性因工作断面、人工活动和通风条件的不同而变化明显,在开展内照射剂量评价时应考虑粒径大于1.0 μm放射性气溶胶粒子的剂量贡献。     

Measurement in clinical trials: A neglected issue for statisticians?

Biostatisticians have frequently uncritically accepted the measurements provided by their medical colleagues engaged in clinical research. Such measures often involve considerable loss of information. Particularly, unfortunate is the widespread use of the so‐called ‘responder analysis’, which may involve not only a loss of information through dichotomization, but also extravagant and unjustified causal inference regarding individual treatment effects at the patient level, and, increasingly, the use of the so‐called number needed to treat scale of measurement. Other problems involve inefficient use of baseline measurements, the use of covariates measured after the start of treatment, the interpretation of titrations and composite response measures. Many of these bad practices are becoming enshrined in the regulatory guidance to the pharmaceutical industry. We consider the losses involved in inappropriate measures and suggest that statisticians should pay more attention to this aspect of their work. Copyright © 2009 John Wiley & Sons, Ltd.     

Exhaled nitric oxide and its long‐term variation in healthy non‐smoking subjects

Exhaled nitric oxide (NOexp) is an indicator of inflammation in the airways. Reference values obtained from healthy adults or information on long‐term variation of NOexp are not yet available. The aims of this pilot study were to collect values of NOexp from a selected group of healthy adults and to assess their long‐term variation. We studied 26 healthy subjects (age 21–48, 16 male, 10 female) with normal findings in flow‐volume spirometry, pulmonary diffusing capacity, relative amount of blood eosinophils, chest X‐ray and ECG at rest. NOexp was determined according to the European Respiratory Society guidelines during slow expiration against an airflow resistance. The measurements were repeated after 7 (n=13) and 23 days (n=17). The mean value of NOexp (n=26) was 6·9 ng g^–1 (95% confidence interval, 6·0–7·9 ng g^–1). The upper limit of intra‐individual variation (+2 SD) was 11·9 ng g^–1 and the lower limit (–2 SD) 1·9 ng g^–1, respectively. The mean (SD) value of NO production (NO output) was 39·1 pmol s^–1 (20 pmol s^–1). We found no correlation between NOexp and age (r=–0·06, P=0·78) and no association of NOexp with the gender (male vs. female, P=0·40). The intraindividual coefficient of variation (CoV) was 15·8% of NOexp and 20·7% of NO output within the interval of 7 days. CoV was 16·8% of NOexp and 18% of NO output within the interval 23 days. The results suggest that NOexp values over 12 ng g^–1 are abnormally high in healthy subjects. According to the results the change of NOexp by 30–35% or more within the interval of 1–3 weeks would be abnormal.     

Image processing in digital radiography

Image processing is a critical part of obtaining high-quality digital radiographs. Fortunately, the user of these systems does not need to understand image processing in detail, because the manufacturers provide good starting values. Because radiologists may have different preferences in image appearance, it is helpful to know that many aspects of image appearance can be changed by image processing, and a new preferred setting can be loaded into the computer and saved so that it can become the new standard processing method.Image processing allows one to change the overall optical density of an image and to change its contrast. Spatial frequency processing allows an image to be sharpened, improving its appearance. It also allows noise to be blurred so that it is less visible. Care is necessary to avoid the introduction of artifacts or the hiding of mediastinal tubes.     

Tests of autonomic dysfunction in patients with multiple sclerosis

Autonomic dysfunction is frequent in patients with multiple sclerosis (MS). The sympathetic skin response (SSR) and the R-R interval variation (RRIV) are simple electrophysiologic tests for the assessment of central and peripheral autonomic disturbances. Both tests were performed in 60 patients with clinically definite MS and 30 controls. The SSR was recorded simultaneously from both upper and both lower limbs. In all volunteers normal responses were recorded from the four limbs, but 39 patients (65%) showed abnormal responses in at least one limb. The reduction in amplitude of the response was correlated with patients' EDSS. In individual limbs, the SSR amplitude correlated with weakness, spasticity and cerebellar dysfunction, but was not sufficiently related to the deep sensory loss. The RRIV was abnormal in 48 MS patients (80%), as compared to the controls, but showed no significant relationship either to the EDSS or to the SSR. The sensitivity of SSR and RRIV is high and comparable with that of visual and somatosensory evoked potentials.