EMA对药用辅料右旋糖酐新的安全性评价

欧洲药品局（EMA）于2018年11月发布了"人用药品辅料右旋糖酐的包装说明书资料"，该文件引用大量文献全面评价了右旋糖酐的安全性，特别指出含有右旋糖酐辅料的注射和吸入制剂的疫苗与药品，应在说明书中描述有关其过敏反应信息的新要求。介绍该文件的主要内容，期望对我国这类药品说明书的撰写和监管有所帮助。     

Differences in Evidentiary Requirements Between European Medicines Agency and European Health Technology Assessment of Oncology Drugs—Can Alignment Be Enhanced?

ObjectivesNational health technology assessments (HTAs) across Europe show differences in evidentiary requirements from assessments by the European Medicines Agency (EMA), affecting time to patient access for drugs after marketing authorization. This article analyzes the differences between EMA and HTA bodies’ evidentiary requirements for oncology drugs and provides recommendations on potential further alignment to minimize and optimally manage the remaining differences.MethodsInterviews were performed with representatives and drug assessment experts from EMA and HTA bodies to identify evidentiary requirements for several subdomains and collect recommendations for potentially more efficiently addressing differences. A comparative analysis of acceptability of the evidence by EMA and the HTA bodies and for potential further alignment between both authorities was conducted.ResultsAcceptability of available evidence was higher for EMA than HTA bodies. HTA bodies and EMA were aligned on evidentiary requirements in most cases. The subdomains showing notable differences concerned the acceptance of limitation of the target population and extrapolation of target populations, progression-free survival and (other) surrogate endpoints as outcomes, cross-over designs, short trial duration, and clinical relevance of the effect size. Recommendations for reducing or optimally managing differences included joint early dialogues, joint relative effectiveness assessments, and the use of managed entry agreements.ConclusionsDifferences between assessments of EMA and HTA bodies were identified in important areas of evidentiary requirements. Increased alignment between EMA and HTA bodies is suggested and recommendations for realization are discussed.     

药学干预对喹诺酮类药物应用影响

目的 探索药学干预对喹诺酮类药物应用的影响.方法 选取2016年3月—2017年3月到医院接受喹诺酮类药物治疗的患者进行研究,分为药物干预前、干预后两组,喹诺酮类药物使用过程中采用药学干预的方法 进行护理,对比干预前后喹诺酮类药物的耐药率、不合理用药率和不合理使用情况.结果 药学干预后,喹诺酮类药物对肺炎克雷伯菌、大肠埃希菌和铜绿假单胞菌的耐药率降低,且不合理联合用药、不合理用法用量和用药禁忌等不合理用药率也显著降低,不合理使用情况也在逐渐减少(P<0.05).结论 药学干预对喹诺酮类药物的应用效果显著.     

Continuing education in the child health handbook: an educational software for primary care1

ObjectiveTo present, the process of development and evaluation of an educational software on the Child Health Handbook proposed for the continuing education of primary care nurses and physicians.MethodsQuantitative study of methodological development. For software development, the following steps were followed: definition of objectives; determination of the target audience; choice of pedagogical and theoretical reference for content; content selection and structuring; software development and evaluation by experts (five nurses and four physicians). All responded to an instrument that included four domains: pedagogical; content; functionality; system presentation and usability. The evaluation criteria were arranged on a Likert-type scale. The percentage of agreement and Content Validity Index were used for the quantitative analysis of the degree of agreement, considering a Content Validity Index cutoff point equal to 0.80.ResultsThe overall agreement index, calculated by the arithmetic mean of the Contents Validity Index of the evaluated domains, was 0.96, with scores ranging from 0.90 to 1.00. The average percentage of agreement of the experts per domain was 92.86%, with lower agreement in the content (80.95%), presentation, and usability (90.48%) domains. 100% of percentage of agreement was observed in the pedagogical and functionality domains among the evaluated specialists.ConclusionThe percentage of agreement, Content Validity Index and overall agreement index of the Child Health Handbook educational software in the context of primary care disclosed the software adequacy as an educational resource for continuing education of primary care nurses and physicians. Considering the assessed dimensions, it can also be used by other health professionals and undergraduate students.     

The technological imperative in tuberculosis care and prevention in Vietnam

ABSTRACT

A monocausal bacteriological understanding of infectious disease orients tuberculosis control efforts towards antimicrobial interventions. A bias towards technological solutions can leave multistranded public health and social interventions largely neglected. In the context of globalising biomedical approaches to infectious disease control, this ethnography-inspired review article reflects upon the implementation of rapid diagnostic technology in low- and middle-income countries. Fieldwork observations in Vietnam provided a stimulus for a critical review of the global rollout of tuberculosis diagnostic technology. To address local needs in tuberculosis control, health managers in resource-poor settings are readily cooperating with international donors to deploy novel diagnostic technologies throughout national tuberculosis programme facilities. Increasing investment in new diagnostic technologies is predicated on the supposition that these interventions will ameliorate disease outcomes. However, suboptimal treatment control persists even when accurate diagnostic technologies are available, suggesting that promotion of singular technological solutions can distract from addressing systemic change, without which disease susceptibility, propagation of infection, detection gaps, diagnostic delays, and treatment shortfalls persist.     

远程胎儿监护的临床应用

远程胎儿监护是应用互连网及计算机技术，孕妇在家中或远程监护终端将胎心监护图形传输到中央监护站，医生即可通过电脑或手机APP远程判读。对高危孕妇实行远程监护，便于及时发现胎儿宫内缺氧情况和及时处理，改善围产儿结局。     

基于血清代谢组学技术考察通阳化浊方与四妙勇安汤治疗冠心病模型家兔的作用机制＊

目的 通过血清代谢组学技术，考察通阳化浊方与四妙勇安汤在治疗冠心病家兔中的作用机制。方法 40只雄性白兔，随机分为空白组、模型组、通阳化浊方组与四妙勇安汤组4组，每组10只。空白组正常饮食，模型组给予高脂饲料喂养至第8周，于第4周结束后，用球囊法手术损伤实验兔的右侧颈总动脉；在模型组基础上，两个实验组分别在术后，灌胃给予通阳化浊方和四妙勇安汤，连续4周，每日1次。给药结束后，模型组与实验组每组抽取3只家兔，采集全血后，用LC-MS技术进行血清代谢组学检测，运用PCA与OPLS-DA分析法来寻找差异性表达的代谢物和代谢途径。结果 相较于模型组，通阳化浊方与四妙勇安汤组分别存在45和27个差异化合物，通阳化浊方组涉及18条代谢通路，根据Impact值 > 0.05筛选出5条主要代谢通路，包括精氨酸和脯氨酸代谢、组氨酸代谢、牛磺酸和牛磺酸代谢、精氨酸生物合成和α-亚麻酸代谢；四妙勇安汤组涉及11条代谢通路，筛选出2条主要代谢通路分别为牛磺酸和牛磺酸代谢、组氨酸代谢。结论 通阳化浊方与四妙勇安汤在治疗冠心病模型家兔的过程中存在差异性代谢产物，干预相应的代谢通路可能会对药物在模型中的作用产生影响。     

An electronic travel guide for visually impaired – vehicle board recognition system through computer vision techniques

Abstract

Purpose: In the context of assistive technology, mobility takes the meaning of “moving safely, gracefully, and comfortably”.The aim of this article is to provide a system which will be a convenient means of navigation for the Visually Impaired people, in the public transport system.

Method: A blind regular commuter who travels by public transport facility finds difficulty in identifying the vehicle that is nearing the stop. Hence, a real-time system that dynamically identifies the nearing vehicle and informs the commuters is necessary. This paper proposes such a system namely the “Vehicle Board Recognition System” (VBRS). Computer Vision techniques such as segmentation, object recognition, text detection and optical character recognition are utilized to build the system, which will detect, analyze, derive and communicate the information to the passengers.

Results: Thanks to the rapid development in technology, there are several navigation systems both hand held and wearable, available to help visually impaired (VI) people move comfortably both indoor and outdoor. Many blind people are not comfortable in using these devices or they are not affordable for them. Thus the proposed system gives them the comfort of navigation.

Conclusion: This system can be installed in the bus stop to assist the Visually Impaired, from externally rather than their hand held or wearable assistive devices.

• Implications for rehabilitation

• This proposed system will help the visually impaired to

• ensure secure navigation

• be independent of the others

• develop self confidence.

• overcome the training, affordability of wearable/ handheld devices.