Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.     

运动学对线应用于全膝关节置换术的研究进展

全膝关节置换术是目前治疗终末期膝关节骨性关节炎最有效的方法之一，全膝关节置换术后膝关节功能、术后膝关节疼痛与术后下肢力线有着密切的关系。目前膝关节置换术下肢对线方式主要采用机械力学对线方法，该方法可以改善膝关节功能，但是有部分患者也会产生术后膝关节的疼痛、活动受限等并发症，导致术后患者满意度较差。近些年越来越多的研究开始关注运动力学对线技术并应用于临床。运动学对线技术旨在重建患者的解剖结构，将膝关节假体运动轴与膝关节生理性运动轴保持一致，减少膝关节周围软组织和韧带的松解，实现膝关节生理性运动。该文就运动力学对线方法在全膝关节置换术中的应用进展作一综述。     

中日友好医院分型股骨头坏死腓骨植入治疗的三维有限元分析

文题释义：股骨头坏死中日友好医院分型的有限元分析：根据李子荣等提出的中日友好医院分型，建立股骨头坏死三维模型，分为 M型(内侧型)、C型(中央型)和 L型(外侧型)，其中 L型包括L1型(次外侧型)、L2型(极外侧型)和 L3型(全头型)。通过对建立的模型进行有限元分析，为该分型的保髋治疗提供了一定力学依据，显示外侧柱的存留是精准预防塌陷的重要因素，为进一步实现个体化治疗提供力学基础。 腓骨支撑坏死股骨头保髋手术：是对于早中期股骨头坏死需要保留股骨头患者进行的一种手术方式。首先需对股骨头进行髓芯减压，清除一定坏死骨，空腔填塞松质骨(髂骨为主)，打压结实后植入腓骨(异体或自体)支撑，给坏死区的提供力学支撑及生物学修复，预防股骨头进一步坏死及塌陷。 背景：研究报道股骨头坏死的保髋疗效与外侧柱存留密切相关，中日友好医院分型是根据三柱结构确立的，对股骨头塌陷的预测准确性高。 目的：建立股骨头坏死中日友好医院分型各分型仿真的三维有限元模型，通过有限元分析各分型腓骨植入的力学变化，探讨外侧柱存留对保髋疗效的意义，为该分型的塌陷精准预测提供基础。 方法：建立正常股骨头、中日友好医院分型(M型、C型、L1型、L2型、L3型)股骨头坏死及其腓骨植入3组11种三维有限元模型，运用ANSYS软件进行有限元分析计算，观察各组模型的最大应力值、最大位移值及股骨头内部载荷传递模式。 结果与结论：①坏死组位移最大，应变最大，且因坏死分型不同而位移不同，位移变化如下：M型相似文献   

Orthogonally oriented scaffolds with aligned fibers for engineering intestinal smooth muscle

Controlling cellular alignment is critical in engineering intestines with desired structure and function. Although previous studies have examined the directional alignment of cells on the surface (x–y plane) of parallel fibers, quantitative analysis of the cellular alignment inside implanted scaffolds with oriented fibers has not been reported. This study examined the cellular alignment in the x–z and y–z planes of scaffolds made with two layers of orthogonally oriented fibers. The cellular orientation inside implanted scaffolds was evaluated with immunofluorescence. Quantitative analysis of coherency between cell orientation and fiber direction confirmed that cells aligned along the fibers not only on the surface (x–y plane) but also inside the scaffolds (x–z & y–z planes). Our study demonstrated that two layers of orthogonally aligned scaffolds can generate the histological organization of cells similar to that of intestinal circular and longitudinal smooth muscle.     

Association of quadriceps angle with plantar pressure distribution,navicular height and calcaneo-tibial angle

ObjectiveThe aim of study was to analyze the association between Quadriceps Angle (QA) and plantar pressure, navicular height (NH), and calcaneo-tibial angle (CTA).MethodsA total of 64 volunteers (mean age: 22.25 ± 2.54 (range:19–33)) participated in this cross sectional study. EMED-m (Novel GmbH, Germany) electronic pedobarograph was employed for dynamic plantar pressure measurement using two step protocol. The angle between the vertical axis of calcaneus and the long axis of Achilles tendon for CTA. The height of navicular tubercle from the ground was measured while the subject was standing on both feet for NH. QA was measured while the subject was standing in a relaxed posture where both feet bearing equal weight.ResultsThere were significant negative correlations between QA and maximum force (MxF) under the 4th. metatarsal head (MH4). The QA was also significantly correlated with MxF and force-time integral (FTI) under the bigtoe (BT). FTI under the 3rd. metatarsal head (MH3), MH4 and 5th. metatarsal head (MH5) were significantly negatively correlated with QA. Pressure-time integral (PTI) under the MH4 and MH5 were found to be significantly negatively correlated with QA. A significant correlation was also found between QA and NH (p < 0.0001), whilst there was no correlation between QA and CTA. Regression analysis showed that NH was appeared as the major contributor for the QA (β = −0.49, p < 0.001) in the dynamic condition, followed by BT-FTI (β = 0.37, p < 0.001) and MH5-MxF (β = −0.21, p < 0.037).ConclusionThese findings may imply that the NH which can at least be controlled by appropriate shoe inserts may affect QA. This way, loading pattern of both plantar region and whole lower extremity may be altered.Level of evidenceLevel III, Diagnostic Study.     

Why We Need Continuous Pharmaceutical Manufacturing and How to Make It Happen

We make the case for why continuous pharmaceutical manufacturing is essential, what the barriers are, and how to overcome them. To overcome them, government action is needed in terms of tax incentives or regulatory incentives that affect time.     

Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Background

The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

Effect of Day Optimizing Throughput (Dot) Knee Software Implementation on Magnetic Resonance Imaging Workflow Efficiency

PurposeAttempts by magnetic resonance (MR) manufacturers to help imaging centres improve patient throughput has led to the development of more automated acquisition. This software is capable of customizing individual scan alignment; potentially improving imaging efficiency and standardizing protocols. However, substantial investments are required to introduce such systems, potentially deterring their widespread application. This study assessed the implementation costs and reduction in examination durations for automated knee MR imaging (MRI) software.Materials and MethodsResearch activities were performed at a community-based academic centre on a 3-Tesla (3-T) system using Siemens' Day Optimizing Throughput (Dot) knee software. Examination acquisition times were extracted from the system before and after software implementation. Fiscal year 2012/13 finances were used to determine the average hourly cost of MRI utilization. Costs associated with automated software implementation were also calculated. Finally, the number of knee scans required to achieve a positive return on investment using the software was established.Results and DiscussionThe mean (standard deviation, sample size) pre- and post-Dot software scan times were 23.20 (4.18, n = 266) and 21.94 (4.51, n = 59) minutes, respectively, for a routine knee scan and 11.88 (1.60, n = 74) and 11.24 (1.51, n = 27) minutes, respectively, for a fast knee scan. The overall weighted average resulted in a 64-second time savings per automated knee examination. This negligible time savings would be extremely difficult to make use of clinically. Dot simplified 29 unique knee protocols to two, improving the consistency of knee examinations. Current Dot software is not compatible with all patients and therefore has limitations that are a concern among MR technologists.ConclusionAdoption of automated knee systems could assist in standardizing protocols; however, the cost of implementation and difficulty in modifying patient scheduling to reflect the minimal time savings would make a financial return unlikely to occur at small- and medium-sized institutions.     

m6A结合蛋白IGF2BP1在肝细胞癌中的基因调控网络分析

目的 分析m6A阅读器胰岛素样生长因子2-mRNA结合蛋白1（insulin-like growth factor 2 mRNA-binding protein 1，IGF2BP1）在肝细胞癌（hepatocellular carcinoma，HCC）中的表达水平及其对HCC患者预后的影响，并探讨IGF2BP1在HCC发生发展中的作用及其潜在机制。方法 基于5对HCC癌及相应癌旁组织mRNA-seq数据和TCGA数据库LIHC的mRNA-seq数据综合分析IGF2BP1在HCC中的表达情况，同时利用TCGA数据库中343例HCC患者的临床随访资料分析IGF2BP1表达水平对HCC患者总生存期的影响。基于TCGA数据库筛选IGF2BP1的共表达mRNA，并利用m6Avar在线网站预测mRNA的m6A位点及其RNA结合蛋白等信息，最终构建IGF2BP1的基因调控网络。结果 IGF2BP1基因在HCC中表达上调（log2FC HCC转录组数据=10.684，P<0.001；log2FC TCGA-LIHC数据集=7.032，P<0.001）。生存分析显示IGF2BP1低表达的HCC患者中位生存时间为5.84年，IGF2BP1高表达患者为4.44年，高表达患者总生存期缩短（P=0.011）。22个差异表达的mRNA与IGF2BP1存在靶向结合关系，并与其表达水平呈正相关。其中，HMGA2等15个高表达mRNA的HCC患者总生存期缩短。HMGA2、PEG10、CEP55、RHO、CDC6和KIF23基因中的潜在m6A甲基化位点位于mRNA 3'UTR端的miRNA结合区域。结论 IGF2BP1在HCC中高表达且导致患者总生存期缩短。IGF2BP1可能通过m6A甲基化及miRNA抑制作用的方式上调mRNA的表达，促进HCC发生并导致不良预后。