中药标准物质替代测定法技术指导原则

 中药标准物质替代测定法是符合中药特点的多指标质量控制的一种有效模式。为了指导该法的建立,统一并规范该法的研究及在国家药品标准中的应用,并证明采用的方法是否适合于相应的检测要求,探讨并提出本技术指导原则。本指导原则从该法的定义与分类、定量的原理与方法、色谱峰的定位与确认、技术要求四个方面进行论述。当中药指纹图谱(特征图谱)鉴别项或多指标含量测定项采用中药标准物质替代测定法时,按照本原则进行方法学验证研究。     

Clinical Advances in Hemoglobin A1c Measurement: Influence of Variables on Hemoglobin A1c Values and Nonheterogeneity of Hemoglobin A1c Reference Ranges

Introduction

Hemoglobin A1c (HbA1c) values are influenced by analytical interferences such as HbF and hemoglobin variants and clinical factors such as increased red cell turnover. Although less well-known, demographic factors such as race, age, and sex also influence HbA1c values.The HbA1c reference range should be homogenous in the United States based on the use of National Glycohemoglobin Standardization Program certified methods and the recommendations in the National Academy of Clinical Biochemistry guidelines.

Methods

Data on age, race, sex, HbA1c, and glucose values were extracted from the National Health and Nutrition Examination study for a 3 year period. A search for reference range data for laboratories in the United States was performed using the Google search engine.

Results

Extracted data agree with published data on the influence of age, sex, and smoking status on HbA1c values. There is substantial heterogeneity in HbA1c reference ranges in laboratories in the United States.

Conclusion

Age, sex, and smoking status influence HbA1c values. Despite standardization of HbA1c methods and published recommendations, there is wide heterogeneity in HbA1c reference ranges in the United States.     

Comparative assessment of parametric neuroreceptor mapping approaches based on the simplified reference tissue model using [11C]ABP688 PET

In recent years, several linearized model approaches for fast and reliable parametric neuroreceptor mapping based on dynamic nuclear imaging have been developed from the simplified reference tissue model (SRTM) equation. All the methods share the basic SRTM assumptions, but use different schemes to alleviate the effect of noise in dynamic-image voxels. Thus, this study aimed to compare those approaches in terms of their performance in parametric image generation. We used the basis function method and MRTM2 (multilinear reference tissue model with two parameters), which require a division process to obtain the distribution volume ratio (DVR). In addition, a linear model with the DVR as a model parameter (multilinear SRTM) was used in two forms: one based on linear least squares and the other based on extension of total least squares (TLS). Assessment using simulated and actual dynamic [¹¹C]ABP688 positron emission tomography data revealed their equivalence with the SRTM, except for different noise susceptibilities. In the DVR image production, the two multilinear SRTM approaches achieved better image quality and regional compatibility with the SRTM than the others, with slightly better performance in the TLS-based method.     

NORMATIVE VALUES FOR THE FUNCTIONAL MOVEMENT SCREENTM IN ADOLESCENT SCHOOL AGED CHILDREN

Background

International sports programs have established pre‐participation athletic screening procedures as an essential component to identify athletes that are at a high risk of becoming injured. The Functional Movement Screen (FMS™) is a screening instrument intended to evaluate deficiencies in the mobility and stability of an athlete that might be linked to injury. To date, there are no published normative values for the FMS™ in adolescent school aged children. The purpose of this study was to establish normative values for the FMS™ in adolescent school aged children (10 to 17 years). Secondary aims were to investigate whether the performance differed between boys and girls and between those with or without previous history of injury.

Methods

1005 adolescent school students, including both males and females between the ages of 10 and 17 years who fulfilled the inclusion and exclusion criteria, were selected for the study. The test administration procedures, instructions and scoring process associated with the standardized version of the test were followed in order to ensure accuracy in scoring. The components of the FMS™ include the deep squat, hurdle step, in‐line lunge, shoulder mobility, active straight leg raise, trunk stability push up, and rotary stability.

Results

The mean composite FMS™ score was 14.59 (CI 14.43 ‐ 14.74) out of a possible total of 21. There was a statistically significant difference in scores between females and males (p= .000). But no statistically significant difference in scores existed between those who reported a previous injury and those who did not report previous injury (p=.300). The variables like age (r= ‐.038, p=.225), height(r= .065, p= .040), weight (r=.103, p=.001) did not show a strong correlations with the mean composite score.

Conclusion

This study provides normative values for the FMS™ in adolescent school aged children, which could assist in evaluation of functional mobility and stability in this population.

Level of evidence

2c     

Development of Diagnostic Reference Levels Using a Real-Time Radiation Dose Monitoring System at a Cardiovascular Center in Korea

Digital cardiovascular angiography accounts for a major portion of the radiation dose among the examinations performed at cardiovascular centres. However, dose-related information is neither monitored nor recorded systemically. This report concerns the construction of a radiation dose monitoring system based on digital imaging and communications in medicine (DICOM) data and its use at the cardiovascular centre of the University Hospitals in Korea. The dose information was analysed according to DICOM standards for a series of procedures, and the formulation of diagnostic reference levels (DRLs) at our cardiovascular centre represents the first of its kind in Korea. We determined a dose area product (DAP) DRL for coronary angiography of 75.6 Gy cm² and a fluoroscopic time DRL of 318.0 s. The DAP DRL for percutaneous transluminal coronary intervention was 213.3 Gy cm², and the DRL for fluoroscopic time was 1207.5 s.     

对86例寒湿凝滞证原发性痛经患者不同子宫位置与三阴交穴效应关系的分析

目的通过对一项针刺治疗寒湿凝滞证原发性痛经的临床试验的相关数据进行分析,探讨寒湿凝滞证原发性痛经子宫位置与三阴交穴效应的关系。方法按照中央完全随机方案将96例寒湿凝滞证原发性痛经患者随机均等分为期望得气组和期望不得气组,排除子宫位置资料不全者最终纳入86例,于治疗前通过超声对每位受试者子宫位置进行评估,当疼痛视觉模拟量表(VAS-P)值≥40 mm时,取双侧三阴交穴,期望得气组以Φ0.3×40 mm一次性无菌管针直刺1~1.2寸,每10分钟行平补平泻手法30秒;期望不得气组以Φ0.18×13 mm一次性无菌管针弹入即可,不施手法,两组均留针30分钟后缓慢平和的将针渐渐退出,进行疗效检测。采用疼痛视觉模拟评分量表(VAS-P)值评价两组治疗前、起针即刻(针刺30分钟)和起针后10分钟(40分钟)的疼痛情况。并比较各子宫位置反应者比例(治疗前后VAS-P值降低50%及以上患者的比例)、总体有效率、起针即刻效应(治疗前VAS-P值-起针即刻VAS-P值)与起针后效应(治疗前VAS-P值-起针后10分钟VAS-P值)。数据采用重复测量的方差分析、卡方检验、单因素方差分析或非参数检验。结果不同子宫位置间治疗前后各时点VAS-P值、反应者率、总体有效率、起针即刻效应与后效应比较均无显著统计学差异(P≥0.05)。结论现有统计结果提示子宫位置可能与三阴交穴效应无关,其结果有待于前瞻性临床随机对照试验的证实。     

基于文献报道的中药化学成分与CYP450s 相互作用研究

目的：使用复杂网络技术研究中药化学成分与CYP450s的关系,为中药分子机理研究和新药开发提供参考。方法：本文基于120篇文献报道,通过人工摘录的方式收集中药化学成分和CYP450s的相关信息,使用Cytoscape 2.8.2作为分析工具,构建化学成分与CYP450s的复杂网络图,并计算了点度中心度、接近中心度、中间中心度以及中药化学成分节点的相似度。结果：本文采集了169个中药化学成分和25种CYP450s的相关信息。CYP2C19、CYP1A2、CYP3A4等CYP450s和槲皮素、银杏内酯A、黄芩素等化学成分为目前研究的热点酶和热点中药化学成分。相似度较高的欧前胡素和银杏内酯B,槲皮素和黄芩素等化学成分可能存在协同相互作用。结论：复杂网络计算可以很好地辅助中药协同作用机理研究和新药开发工作。     

Pulmonary function testing in New Zealand: the use and importance of reference ranges

BACKGROUND AND OBJECTIVES: The diagnosis, assessment and management of a wide range of respiratory diseases rely on accurate interpretation of lung function tests through the use of reference equations to generate predicted values. This paper ascertains the suitability of reference equations currently used in New Zealand through comparison with newly derived equations from the Wellington Respiratory Survey, and discusses the relevance of the findings to the Asia Pacific region. METHODS: A survey of lung function testing facilities determined the reference equations in common usage. Pulmonary function test results from healthy, lifelong non-smoking subjects (n = 180) were expressed as percentage predicted values, with comparisons made between the currently used and Wellington Respiratory Survey reference equations. Differences in disease severity classification in subjects with COPD (n = 46) and asthma (n = 61) were determined, using the different reference equations. RESULTS: Currently used equations significantly underpredict measured values for FEV(1), PEF, TLC and RV by up to 20%. Severity classification of COPD and asthma based on per cent predicted FEV(1) was substantially altered by the choice of reference equation. CONCLUSION: Many reference equations in current usage in New Zealand are no longer suitable for use. The applicability of reference equations used in other populations and countries within the Asia Pacific region requires further investigation. We recommend that up-to-date reference equations are derived and implemented if those currently used are shown to be unsatisfactory.