合理选用红细胞流变性指标是诊断血液高黏滞的需要

目的：针对目前国内临床血液流变学指标检测报告单存在指标项目过多的现状,通过分析某医院现行的临床血液流变学指标检测报告单,揭示红细胞流变性检测中报告单所反映的各种存在问题,指出指标设置的不合理之处,从而提供临床血液流变学指标检测规范化建设的原则。方法：通过对现行由厂家提供的某医院的临床血液流变学指标检测报告单的分析,列举报告单中指标设置及其检测结果的各种存在问题,揭示红细胞流变性检测指标设置的混乱性。结果：通过对临床血液流变学指标检测报告单的分析,发现临床血液流变学指标检测报告单的红细胞流变性存在指标过多．指标优劣混杂、指标定义不清的混乱状况。结论：目前临床血液流变学检测报告指标设置混乱的状况．已经对临床医生准确判断血液高黏滞造成严重影响。文章提出改进的必要,并强调指出,有关专家、学者应对临床血液流变学检测报告指标设置加强研究,有关主管部门、学术机构应组织专门的研讨,有针对性地提出切实可行的临床血液流变学指标检测报告的规范化方案,尽早改变临床血液流变学指标检测的混乱状况。     

A portable TDCR system

The triple-to-double-coincidence ratio method (TDCR) is an important method for activity standardization in metrology institutes worldwide. There is an increasing interest in portable systems that allow activity determination outside of specialized laboratories with high accuracy. Within the framework of the EMRP “MetroFission” project, several portable systems using different designs were developed. The PTB system described here is based on channel photomultipliers incorporated in a portable detection module, a separate electronics bin and a computer for data acquisition and storage. This miniature TDCR system was extensively tested and compared to the PTB reference TDCR system that is very well characterized and has been used in several intercomparisons.     

A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies

Near-infrared spectroscopy (NIRS) is a fast and non-destructive analytical method. Associated with chemometrics, it becomes a powerful tool for the pharmaceutical industry. Indeed, NIRS is suitable for analysis of solid, liquid and biotechnological pharmaceutical forms. Moreover, NIRS can be implemented during pharmaceutical development, in production for process monitoring or in quality control laboratories.This review focuses on chemometric techniques and pharmaceutical NIRS applications. The following topics are covered: qualitative analyses, quantitative methods and on-line applications. Theoretical and practical aspects are described with pharmaceutical examples of NIRS applications.     

Review of hemoglobin A(1c) in the management of diabetes

Hemoglobin HbA(1c) (A(1c)) has been used clinically since the 1980s as a test of glycemic control in individuals with diabetes. The Diabetes Control and Complications Trial (DCCT) demonstrated that tight glycemic control, quantified by lower blood glucose and A(1c) levels, reduced the risk of the development of complications from diabetes. Subsequently, standardization of A(1c) measurement was introduced in different countries to ensure accuracy in A(1c) results. Recently, the International Federation of Clinical Chemists (IFCC) introduced a more precise measurement of A(1c) , which has gained international acceptance. However, if the IFCC A(1c) result is expressed as a percentage, it is lower than the current DCCT-aligned A(1c) result, which may lead to confusion and deterioration in diabetic control. Alternative methods of reporting have been proposed, including A(1c) -derived average glucose (ADAG), which derives an average glucose from the A(1c) result. Herein, we review A(1c) , the components involved in A(1c) formation, and the interindividual and assay variations that can lead to differences in A(1c) results, despite comparable glycemic control. We discuss the proposed introduction of ADAG as a surrogate for A(1c) reporting, review imprecisions that may result, and suggest alternative clinical approaches.     

Quantification of immunohistochemistry--issues concerning methods, utility and semiquantitative assessment II

Immunohistochemistry is entering its fourth decade of use on formalin‐fixed paraffin‐embedded tissues. Over this period the method has evolved to become a major part of the practice of diagnostic surgical pathology worldwide. From the beginning immunohistochemistry has been adapted to provide a range of markers of cell lineage and tissue type, with particular application to the diagnosis and classification of tumours. In this modality immunohistochemical methods were employed simply as ‘special stains’, the results of which were evaluated qualitatively by the pathologist, as for any other stain. More recently, attention has shifted to the demonstration of prognostic markers in tumour cells, driven by the advent of molecular biology and the discovery of numerous regulatory molecules, coupled with manufacture of the corresponding specific antibodies. Immunohistochemistry has rapidly adapted to this new use, but in so doing the demand for quantification has become paramount; it is no longer enough that the ‘stain’ is there; rather it is a question of ‘How much is there?’. This review explores the limitations of immunohistochemistry when employed in a semiquantitative mode, and explores the possibility of fulfilling the full potential of immunohistochemistry, as a true quantitative immunoassay applied in a tissue section environment.     

建立中药注射剂综合标准化质量控制体系的思考

目的综合控制中药注射剂的产品质量,降低临床安全风险,探索在药品生产企业中建立中药注射剂综合标准化质量控制体系。方法应用药品质量风险管理的主要工具HACCP原理,对中药注射剂原料、生产、运输、临床使用过程中的各个环节进行危害分析,确定关键控制技术标准。结果与结论建立中药注射剂综合标准化质量控制体系,将极大地加强药品生产企业对中药注射剂产品质量的控制。     

急诊管理标准化的解读和应用框架

推行急诊科管理标准化,为急诊科工作提供了全面有效的改进方法。从以患者为中心,维护患者权利和安全;以急诊医疗护理技术质量和服务质量为关键点;遵循系统原理,改进急诊工作流程;以人为本,规范急诊人力资源管理等方面介绍了急诊管理标准化的原则,指出建立健全急诊规章制度、设定急诊质量监控点是急诊管理标准化的关键要点,认为推行急诊管理标准化,可以建立健全工作程序,取得最佳疗效,可以提高人员适应度,尽快进入工作角色。     

中医药标准化建设与教学

近年来国内外对中医药标准化的需求,已经成为中医药传承、推广和发展的重要问题。因此,培养中医药标准化人才,具有长远、重要的意义。该文建议把中医药标准化建设与教学结合起来,从根本上做起,把今后的每一个中医药从业者,都培养成为中医药标准化建设的实践者,以更好的促进中医药标准化的建设与发展。     

美国药品风险评估与减低计划的简介与启示

目的为发展我国药品风险减低的相关举措提供参考。方法通过对美国药品风险评估与减低计划文献资料的查阅,对文献研究的方法进行研究。结果美国药品风险评估与减低计划的发展已较完善,并逐步标准化、系统化。结论美国药品风险评估与减低计划的运用及标准化措施可为我国药品风险减低相关举措的发展提供参考。     

一例与华法林多药联用致使INR增高的病例分析

1例74岁男性患者因既往有房颤、左房血栓,长期服用华法林0.625mgqd治疗,国际标准化比值(INR)稳定在1.22～2.01。本次因"反复咳嗽咳痰气喘六年,加重三天"入院。后使用哌拉西林钠他唑巴坦钠4.5gbid联合阿奇霉素500mgqd抗感染治疗,入院第5天因恶心呕吐加用注射用奥美拉唑钠40mgqd治疗,入院第10天查INR为5.09,停华法林,加维生素K110mg肌注,第11天INR为4.56,继续予维生素K110mg肌注,第12天开始INR稳定在1.15～1.31,第18天开始恢复使用华法林0.625gqd。