Levels of quality management of blood transfusion services in Europe

The European blood legislation has defined several key quality elements to achieve Good Manufacturing Practice (GMP) in the field of blood transfusion. During the recent years, the blood legislation is in the process of implementation throughout its member states. Following the Directive 2002/98/EC, Directive 2005/62/EC has given further requirements for quality-management systems to be fulfilled by blood establishments. In addition, GMP/Good Laboratory Practice (GLP) and ISO standards are used inter alia by blood establishments. In order to support the implementation of the blood legislation, the European Public Health Work Plan (2005/2007) has cofunded two projects, led by the German Red Cross and supported by the European Blood Alliance, delivering a common European Standard Operating Procedure (SOP) methodology (EU-Q-Blood-SOP) and criteria and standards for the inspection of blood establishments (EUBIS). The EU-SOP manual will assist blood establishments in preparing for the inspection of their services related to the implementation of quality relevant elements required by the EU Directive 2002/98/EC and its technical annexes. The standards and criteria for inspection of blood establishments will cross-reference existing quality standards to the directive requirements and define requirements for the structure of quality-management systems based on the directive 2002/98/EC and its technical annexes. Based on these requirements, inspection standards and criteria are developed to assist in the independent assessment of quality systems established by individual blood establishments. These assessments are done in relation to the requirements defined by the European Union legislation on blood, in order to safeguard the quality of blood and to achieve continuous improvement of its quality throughout Europe.     

骨重建数值仿真中的控制方程

人体骨组织有着复杂的结构和生理机制,骨重建理论经历了定性分析、定量计算和计算机定量数值模拟三个阶段。目前,存在力学模型和现象模型两类成熟的骨重建模型,力学模型的共性就是表观密度随一定的力学刺激而变化,现象模型由基本多细胞单元的损伤状态和孔隙度变化来决定。大多数股骨重建仿真模型仍然将骨量的分布看作是各向同性的,这就不能完全反映骨组织微构造的本构关系。本文是对骨重建仿真模型的控制方程进行综述。     

乳腺微浸润癌的临床病理学特征及生物学特性

目的探讨乳腺微浸润癌（microinvasive carcinoma，MIC）的临床病理学特征及生物学特性和其病理诊断标准。方法回顾性研究40例MIC，按文献报道诊断标准分为两个亚型，并对病理学特征、分子生物学指标及预后进行比较。结果MIC占同期乳腺癌的1．5％，乳腺钼靶拍片85．0％的病例（34例／40例）显示不同程度的泥沙样钙化。粉刺型和高核分级的导管内癌更易形成间质浸润。淋巴结转移2．5％（1例／40例）。31例平均8个月随访显示无复发及转移。两亚型各指标比较结果差异均无显著性。结论MIC是一种少见、淋巴结转移率低、预后较好的恶性肿瘤。建议诊断标准：单个浸润灶时，最大径应〈2mm；出现几个浸润灶时，其中单个浸润灶的最大径应〈1mm，且几个浸润灶面积总和不应超过整个肿瘤组织面积的10％。     

Axillary management based on American college of surgeons oncology group Z0011 criteria makes it possible to omit intraoperative diagnosis of sentinel lymph nodes in early breast cancer patients

The ACOSOG Z0011 trial has resulted in the omission of axillary lymph node dissection (ALND) in early breast cancer patients with one or two metastatic sentinel lymph nodes (SLNs). There has been increasing interest in the necessity of intraoperative assessment of SLNs in patients treated based on the Z0011 criteria. We evaluated the utility of intraoperative assessment in these eligible patients. A total of 1396 patients were treated following the Z0011 criteria from April 2012 to December 2019. We examined the proportion and clinicopathological features of patients who underwent ALND due to three or more metastatic SLNs and the sensitivity of intraoperative assessment. Only 16 (1.1%) patients had three or more metastatic SLNs diagnosed by intraoperative assessment, and they immediately underwent ALND. Of the clinicopathological factors, high clinical tumor stage (p = 0.002) and high Ki-67 labeling index value (p = 0.056) were more likely to be associated with the presence of three or more metastatic SLNs. The major independent risk factor for three or more metastatic SLNs was high clinical tumor stage (OR 3.94 [95% CI 1.42–11.0]; p = 0.009). Intraoperative assessment had low sensitivity (70.5%) and a high false-negative rate (29.5%) in detecting SLN metastases. The main finding of our study was the small proportion of patients who required ALND due to three or more metastatic SLNs according to the Z0011 criteria. The Z0011 strategy enables intraoperative assessment of SLNs to be omitted in early breast cancer patients.     

重视供肝机械灌注研究,推动肝移植高质量发展

随着器官捐献数量不断增加和扩大标准供者(ECD)供肝定义不断拓展,供肝质量必然成为影响肝移植高质量发展的突出问题,也是相关领域的研究重点。最大限度解决器官短缺和推动器官移植高质量发展是我国器官捐献与移植事业发展的方向。近年来,利用机械灌注(MP)对供肝进行灌注、保存、评估及修复,已成为当前国际上提高肝移植质量的研究热点。本文针对国内外ECD供肝的不同应用情况,结合国际上MP研究进展和本中心有关研究经验,探讨整合器官保护技术建设器官重症监护室(ICU)的可行性,拟在推动我国器官移植高质量发展同时,进一步丰富器官捐献与移植“中国模式”的技术内涵。     

Parathyroid Carcinoma: A Single-Institution Experience with an Emphasis on Histopathological Features

Parathyroid carcinoma (PC) is a rare malignancy that poses a diagnostic challenge on histologic examination. We analyzed various clinicopathologic features of PC. Pathology reports and slides were reviewed to evaluate the diagnostic histopathologic features of archived cases of PC from the years of 2004–2018. The study cohort comprised twenty cases of PC. The median age was 49 years (range 21–73 years) with equal gender distribution (M:F = 1:1). Most patients presented with symptoms of hypercalcemia (n = 7, 54%). Serum calcium and serum parathyroid hormone were elevated in all but one patient. The right inferior parathyroid was commonly involved (n = 8/14, 57%). The mean tumor size was 2.4 cm (range 0.8–3.5 cm). On frozen section examination, PC was diagnosed in 8 out of 9 cases. Vascular (n = 19/20, 95%) and soft tissue invasion (n = 10/20, 50%) were the most common characteristic histologic findings. Capsular invasion was identified in all cases. Perineural invasion or metastasis at presentation was absent in all cases. Other histological features noted were intratumoral fibrous bands (70%), nodular growth pattern (70%), moderate nuclear atypia (30%), prominent nucleoli (20%), and necrosis (20%). Regional lymph nodes were negative for metastatic disease in all cases (n = 10). Eight out of 16 patients received adjuvant radiotherapy. Follow-up was available in 16 cases (median 21.5 months). Two patients died of disease. Vascular and soft tissue invasion are the most common diagnostic histologic features of PC. Capsular invasion is important to distinguish PC from its benign counterparts. Intraoperative frozen section examination can be used for accurate diagnosis and surgical management.     

Good practices in health promotion for older people – Significance for evidence in health policy

This article is devoted to convincing policy makers to use good practices in encouraging older people to pursue adequate and effective health policies. Long-term scientific research focused on the effects of health promotion programmes is rarely undertaken, although its scope is still expanding. At the same time, it is strongly desirable to form health policy based on scientific evidence. In this situation, an indication of good practices characterised by precisely defined features and their systematic evaluation could be an alternative to an insufficient number of empirical studies. The first step of the methodology was a literature review on health promotion for older people, aimed at defining good practices and criteria used for their selection. The authors searched the following databases: PubMED, Embase and Cochrane Library, as well as international databases dedicated to health promotion programmes for older people (e.g. Age-friendly World ( https://extranet.who.int/agefriendlyworld/age-friendly-practice-database-launched ); HealthProElderly ( www.healthproelderly.com/database/index.php?id=16 ); JA-CHRODIS ( www.chrodis.eu ); EuroHealthNet ( www.eurohealthnet.eu ) and ProFouND; ( www.profound.eu.com ). As relevant health policy information is usually available in national languages, the authors then approached national experts in 10 European countries, who filled in a dedicated survey on health promotion programmes for older people and indicated examples of good practices from their countries. Practical evidence, based on real implemented programmes, is valuable as inspiration for health promotion programmes, their planning and management. Selecting good practices from among implemented and evaluated actions makes it possible to establish their value. The significance of good practices in health promotion is to deliver real benefits and health effects for a target group, which, in the case of evident benefits, renders the practices credible and worthy of further dissemination. The EU already successfully shares good practices in migrant health and environmental protection. Creating databases on good practices helps policy makers promote the sustainability of already implemented activities and enhances their applicability by other organisations and in different settings.     

CCMD-3与DSM-Ⅳ儿童孤独症两种诊断标准的比较

目的：比较中国精神疾病分类方案与诊断标准第三版（CCMD-3）与美国精神障碍诊断和统计手册第四版（DSM-Ⅳ）儿童孤独症诊断的一致性，探讨CCMD-3儿童孤独症诊断中存在的问题，确定诊断标准中各症状条目的出现频率。方法：运用CCMD-3和DSM-Ⅳ儿童孤独症诊断标准对连续首次就诊的255名可疑发育障碍儿童进行诊断。结果：两种诊断系统儿童孤独症、不典型孤独症、非孤独症诊断的总体一致率为96．08％；诊断差异主要来自于儿童孤独症和不典型孤独症的诊断不一致；个别症状在孤独症儿童中出现频率较低。结论：CCMD-3和DSM-Ⅳ儿童孤独症诊断标准具有较好的诊断一致性；为进一步提高诊断一致性，对CCMD-3中个别症状条目予以调整有所必要。