中药生产过程质量控制关键技术研究进展

中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。     

Opioid maintenance treatment: trajectories in and out of treatment

Problem: Although efficacy studies of opioid maintenance treatment (OMT) have shown evidence of treatment benefits, there is still need for studies on its effectiveness in natural clinical processes. This study investigates the development in health, substance use and social conditions of those who applied for OMT, including those denied access or discharged.

Method: First, persons assessed for admittance in 2005–2011 (n?=?127) were categorized into four trajectory groups based on whether they were admitted or denied (n?=?19), discharged (n?=?31), readmitted (n?=?21) or had been undergoing OMT without interruption (n?=?56). Second, 99 of these, the analytical sample, were interviewed at follow-up using (a) the Addiction Severity Index (ASI) for seven problem-areas and housing, and (b) self-rated change in 11 problem areas. The ASI was compared to baseline interviews after 55 months (mean). Third, outcomes within groups was studied in relation to alternative interventions.

Results: Within the analytical sample, those denied OMT showed no improvements at group level, those discharged had some improvements, more if readmitted than if not and those with uninterrupted OMT showed the most comprehensive improvements. Those outside OMT, denied and discharged, had considerable mortality risks related to ongoing drug use, especially in lack of well-planned alternative interventions.

Conclusion: Improvements strongly relate to access to OMT. This study underscores that access to OMT improves the situation in all areas investigated and decreases the risk for drug-related death. It underscores the importance of two major risk situations, i.e. being denied OMT and being discharged.     

空间频域成像在皮肤病定量评估中的研究

利用空间频域成像技术搭建的成像系统检测多种皮肤病组织的光学参数和生理参数信息，并对比分析讨论不同类型的皮肤病与光学参数、生理参数之间的关系。实验结果表明，病变皮肤组织与正常皮肤组织之间在光学参数、生理参数上存在较大差异，这将为临床医生对皮肤病诊治提供一种新颖、可靠、科学的评估方法。     

Cured Today,Ill Tomorrow: A Method for Including Future Unrelated Medical Costs in Economic Evaluation in England and Wales

ObjectivesIn many countries, future unrelated medical costs occurring during life-years gained are excluded from economic evaluation, and benefits of unrelated medical care are implicitly included, leading to life-extending interventions being disproportionately favored over quality of life-improving interventions. This article provides a standardized framework for the inclusion of future unrelated medical costs and demonstrates how this framework can be applied in England and Wales.MethodsData sources are combined to construct estimates of per-capita National Health Service spending by age, sex, and time to death, and a framework is developed for adjusting these estimates for costs of related diseases. Using survival curves from 3 empirical examples illustrates how our estimates for unrelated National Health Service spending can be used to include unrelated medical costs in cost-effectiveness analysis and the impact depending on age, life-years gained, and baseline costs of the target group.ResultsOur results show that including future unrelated medical costs is feasible and standardizable. Empirical examples show that this inclusion leads to an increase in the ICER of between 7% and 13%.ConclusionsThis article contributes to the methodology debate over unrelated costs and how to systematically include them in economic evaluation. Results show that it is both important and possible to include future unrelated medical costs.     

Transarterial Chemoembolization vs Radioembolization for Neuroendocrine Liver Metastases: A Multi-Institutional Analysis

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Computer-generated vegan menus: The importance of food composition database choice

Precise data on food chemical composition is crucial for any quantitative nutrition research and indispensable for evaluation and planning of computer-based menus. Moreover, exact food chemical composition is of the utmost importance in composing specific diets that may be low in certain essential nutrients. Therefore, this research evaluated a weekly vegan menu using three different food composition databases (FCDB): the Croatian, the official Danish Food Composition Database and the United States Department of Agriculture (USDA) – National Nutrient Database for Standard Reference. Significant differences (p < 0.05) were determined in evaluated and optimised offers for the same menu when using different FCDBs. Furthermore, in these menus quantities of some nutrients have not reached official daily recommendations needed for prevention of non-communicable diseases. In this research, new vegan menus that can provide adequate quantity of essential nutrients, regardless of FCDB utilized, were created with linear optimisation (LO). This resulted in high quality daily menu offers. However, depending on the FCDB that was used, optimal menus differed in daily meal combinations, and the effectiveness of the optimisation in the minimisation of differences caused by differences of data in FCDBs was tested. Linear optimisation has been proved to be an effective tool in planning of specific diets, such as vegan diets. Nonetheless, the quality of computer-planned menus depends heavily on the quality of FCDB used.     

国内外护理学本科生毕业考核现状与分析

教育测量与评价对实现教育目标具有重要作用。科学的教育评价既促进学生学习,又为教育决策提供依据,以实现持续质量改进。"健康中国2030"的整体目标、医学科学的发展及人民的健康需求,对新时代护理人才的培养提出了更高、更具体的要求。高等护理院校应以国家和社会对护理人才需求、院校培养目标为导向,以测量理论为基础,制定完善的学业评定标准,科学地开展毕业考核,保证人才"出口"质量。毕业考核作为终结性评价,测试内容在评价质量中起核心作用,应符合国家护理学专业培养标准,并与院校培养目标、课程目标契合。院校应关注护理本科生毕业考核质量,在保障测试信度的同时,做到实施公平、评价适当、标准一致,以确保测试的效度。教育管理部门及各院校应优化评价体系,加强对护理本科生毕业管理,在充分开展系统调查与分析的基础上,基于胜任力导向和结果导向,建立综合性评价体系,在教学过程中进行全方位反馈评价管理。文章结合国内外护理学专业本科生毕业考核的现状,从考核目的、内容、方式、评价主体、质量控制等方面进行综述与分析,为我国加强护理学本科教育,完善护理学专业本科生毕业评价体系建设提供借鉴。     

Toxicological evaluation of Yulangsan polysaccharide in Wistar rats: A 26-week oral gavage study

Although numerous studies have proven the medicinal values of Yulangsan polysaccharide (YLSP), the toxicity of this active ingredient is unknown. In the acute toxicity study, a single oral administration of 24 g/kg YLSP caused neither toxicological symptoms nor mortality, and the LD₅₀ was estimated >24 g/kg. In the chronic toxicity study, we administered doses of 0, 0.6, 1.2 and 2.4 g/kg YLSP in rats by oral gavage for 26 weeks followed by a 3-week recovery period. There was no mortality or remarkable clinical signs observed during this 26-week study. Additionally, there were no toxic differences in the following parameters: body weight, food consumption, hematology, clinical biochemistry, organ weight, and macroscopic findings. There were no adverse effects on histopathology observed in males or female rats treated with YLSP. Based on the results, the no-observed-adverse-effect-level of YLSP in rats is greater than 2.4 g/kg when administered orally for 26 consecutive weeks.