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.     

注射用盐酸柔红霉素的质量评价

目的 按照国家计划抽验要求，评价国内不同企业生产的注射用盐酸柔红霉素的质量。方法 按国家标准检验与探索性研究相结合，对抽验样品进行检验，对检验结果进行统计分析。结果 共抽取样品17批次，按国家标准检验合格率100.0%。探索性研究对主要杂质的来源与结构进行了研究；建立溶液的澄清度检查方法；对包材相容性及稳定性进行了考察。结论 目前国内注射用盐酸柔红霉素总体质量较好；现行标准有待进一步提高，建议现行标准修订有关物质检查方法，增加特定杂质的控制，增加溶液的澄清度检查；建议企业优化生产工艺，以提高产品质量。     

免疫检查点抑制剂应用于晚期胃癌治疗的研究进展

我国属胃癌高发国家,且以进展期胃癌为主。以手术和化疗为主的多学科治疗无法有效改善晚期胃癌患者的预后。近年来,免疫检查点抑制剂类药物的疗效在诸多癌症中得到了证实,因此,该类药物在胃癌中的治疗效果也受到了广泛的关注。本文对近年来的相关研究成果进行综述,全面介绍了免疫检查点抑制剂类药物在胃癌治疗中的临床应用情况、联合用药情况以及不良反应。对于其他治疗均失败的晚期胃癌患者,PD-1抑制剂是一个可行的治疗选项,其代表药物派姆单抗是目前唯一被美国食品药品监督管理局批准应用于胃癌治疗的免疫抑制剂类药物,而我国国家食品药品监督管理总局尚未批准任何此类药物应用于胃癌的临床治疗。如何进一步提高治疗的客观缓解率,将会是后续临床和基础研究的一大焦点。     

An off-the-shelf plasma-based material to prevent pacemaker pocket infection

Bacterial infection of subcutaneous “pockets” housing cardiovascular implantable electronic devices is a significant clinical complication. In this study, pacemakers encapsulated in a blood plasma-based material (PBM) composited with antibiotics were investigated for use as prophylactics against such infections. PBMs, which are made from pooled allogeneic plasma and platelets, are off-the-shelf biomaterials that can be manufactured in the form of complex 3D shapes, extrudable putties, or injectable pastes. In vitro studies with PBM pastes formulated with rifampicin and minocycline demonstrated antibiotic release over 6 days, activity against Escherichia coli, and reduced cytotoxic effects of the antibiotics on fibroblasts. The materials were also evaluated in vivo in a rabbit model in which pacemaker pockets were inoculated with methicillin-resistant Staphylococcus aureus (S. aureus) strain and examined 1 week later. The pockets containing the pacemaker plus S. aureus were grossly purulent and culture positive, whereas pockets into which PBM with antibiotics were injected around the pacemaker were free of purulence and culture negative (p < 0.001). None of the pockets into which PBM without antibiotics were placed demonstrated purulence, but 60% were culture positive. These results demonstrate the potential of PBMs to deliver antibiotics to diminish the incidence of pocket infections for pacemakers and other implantable devices.     

Biomedical microelectromechanical systems (BioMEMS): Revolution in drug delivery and analytical techniques

Advancement in microelectromechanical system has facilitated the microfabrication of polymeric substrates and the development of the novel class of controlled drug delivery devices. These vehicles have specifically tailored three dimensional physical and chemical features which together, provide the capacity to target cell, stimulate unidirectional controlled release of therapeutics and augment permeation across the barriers. Apart from drug delivery devices microfabrication technology’s offer exciting prospects to generate biomimetic gastrointestinal tract models. BioMEMS are capable of analysing biochemical liquid sample like solution of metabolites, macromolecules, proteins, nucleic acid, cells and viruses. This review summarized multidisciplinary application of biomedical microelectromechanical systems in drug delivery and its potential in analytical procedures.