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。     

Patient preferences and predicted relative uptake for targeted therapies in metastatic colorectal cancer: a discrete choice experiment

Abstract

Objective

Ras wild-type metastatic colorectal cancers (mCRC) may be treated with anti-vascular endothelial growth factor (VEGF) or anti-epidermal growth factor receptor (EGFR) agents. We aim to estimate patients’ preferences for mCRC treatment and relative importance of cost, efficacy improvement, avoidance of side effects and therapy convenience, and relative uptake between profiles that resemble Bevacizumab (anti-VEGF) and Cetuximab (anti-EGFR), two commonly prescribed mCRC targeted therapies.     

Electronic clinical records in primary care for estimating disease burden and management. An example of COPD

Chronic obstructive pulmonary disease (COPD) is a significant health problem in developed countries. We aimed to estimate the prevalence of COPD in a single Spanish healthcare area. We also aimed to assess if there are any differences in prevalence and spirometry use among primary care services by utilizing already registered information. We designed a cross-sectional study to determine the prevalence of COPD and the performance of spirometries in each primary care service. A total of 8,444 patients were diagnosed with COPD, with a prevalence of 2.6% for individuals older than 39 years. The prevalence increased with age and was much higher in men. Significant heterogeneity was found in the prevalence of COPD and spirometry use among primary care services. COPD was underdiagnosed and there was wide variability in spirometry use in our area. Greater efforts are needed to diagnose COPD in order to improve its clinical outcomes and to refine registries so that they can be used as reliable sources of information     

Optimizing access and configuration of trauma centre care in New South Wales

IntroductionGetting the right patient, to the right place, at the right time is dependent on a multitude of modifiable and non-modifiable factors. One potentially modifiable factor is the number and location of trauma centres (TC). Overabundance of TC dilutes volumes and could be associated with worse outcomes. We describe a methodology that evaluates trauma system reconfiguration without reductions in potential access to care. We used the mature trauma system of New South Wales (NSW) as a model given the perceived overabundance of urban major trauma centres (MTC).MethodsWe first evaluated potential access to TC care via ground and air transport through the use of geographic information systems (GIS) network analysis. Potential access was defined as the proportion of the population living within 60-min transport time from a potential scene of injury to a TC by ground or rotary-wing aircraft. Sensitivity analyses were carried out in order to account for potential pre-hospital interventions and/or transport delays; travel times of 15-, 30-, 45-, 60-, and 90-min were also analyzed. We then evaluated if the current configuration of the system (number of urban MTS in the Sydney basin) could be optimized without reductions in potential access to care using two GIS methodologies: location-allocation and individual removal of MTC.Results86% of the NSW population has potential access to a TC within 60 min ground travel time; potential access improves to 99% with rotary-wing transport. The 1% of the population without potential TC access lives in 48% of the land area (>384,000km2). Utilizing two different methodologies we identified that there was no change in potential access by ground transport after removing 1 or 2 MTC in the Sydney basin at the 30-, 45-, and 60-min transport times. However, 0.02% and 0.5% of the population would not have potential access to MTC care at 15 min after removing one and two MTC respectively.DiscussionRedistribution of the number of MTC in the Sydney basin could be achieved without a significant impact on potential access to care. Our approach can be utilized as an initial tool to evaluate a trauma system where overabundance of coverage is present.     

基于BGP、TGF-β1的表达探究蛇床子素对去卵巢致骨质疏松大鼠的作用

目的观察蛇床子素对去卵巢致骨质疏松大鼠的影响。方法选取3月龄雌性SD大鼠30只,随机分为蛇床子素组(A组)、模型对照组(B组)、假手术组(C组),各10只。A、B 2组摘除卵巢构建去势大鼠骨质疏松模型,C组仅进行手术、不摘除卵巢。造模成功后,分别给予相应药物灌胃,连续给药12周,处死。然后测量骨密度,检测治疗后血清BGP、TGF-β1、钙指标。结果B组大鼠股骨骨密度较C组明显降低(P<0.05);经12周治疗,A组股骨骨密度较B组明显升高(P<0.05)。与C组比较,B组大鼠血清中BGP含量升高、TGF-β1降低(P<0.05);与B组比较,A组大鼠血清中BGP降低、TGF-β1含量升高(P<0.05)。与C组比较,B组大鼠血清Ca水平明显降低(P<0.05);与B组比较,A组大鼠血清Ca水平明显升高(P<0.05)。差异均有统计学意义。结论蛇床子素能够有效通过调节大鼠体内激素分泌改善去卵巢大鼠的骨代谢异常,提高骨密度,对骨质疏松症起到一定的防治作用。     

Prevalence of and factors contributing to anxiety,depression and cognitive disorders among urban elderly in Odisha – A study through the health systems’ Lens

IntroductionGrowing geriatric mental health needs of urban population in India pose several programmatic challenges. This study aimed to assess anxiety, depression and cognitive disorders among urban elderly, and explore availability of social support mechanisms and of a responsive health system to implement the national mental health programme.Methods244 respondents were randomly selected from Berhampur city. We administered a semi-structured interview schedule to assess substance abuse, chronic morbidity, anxiety, depression and cognitive abilities. Further, in-depth interviews were conducted with 25 key informants including district officials, psychiatrists, and programme managers. We used R software and ‘thematic framework’ approach, respectively, for quantitative and qualitative data analysis. Ethical standards were complied with.ResultsAbout half of the respondents were economically dependent; 57.3% had moderate to severe anxiety; 46.7% had moderate to severe depression; while about 25% had severe cognitive impairments. We found association of chewing tobacco (1.34(0.28–2.40)) and depression (0.52(0.37–0.68)) with anxiety; negative perception about elderly-friendly society (1.64(0.75–2.53)) and physical inactivity (2.88(1.60–4.16)) with depression; and age (-0.11(-0.20 – -0.02)) and physical inactivity (-3.44(-5.13 – -1.74)) with cognitive disorders. Qualitative analysis revealed lack of awareness, social stigma, poor availability of trained human resources, and poor political commitment as important systemic barriers to early detection and treatment of mental ailments among the elderly.ConclusionEstablishing tobacco cessation centres, sensitizing community about mental health needs of elderly, incentivizing physical activity of elderly, integrating mental health with primary care, multi-skilling providers and developing a cadre of community counsellors need urgent attention of policy makers and programme implementers.