欧洲药物战略（2020）及其对中国医药领域的启示

在当前国际制药技术出现重大创新和变革、药品研发技术信息化和数字化程度不断发展，以及新型冠状病毒肺炎（COVID-19）疫情大流行的背景下，欧盟委员会为满足未竟临床需求、激励行业创新、增强监管系统应变能力、巩固欧盟药品监管体系国际地位，于2020年底发布了《欧洲药物战略》（Pharmaceutical Strategy for Europe，PSE）。PSE被视为欧洲未来5年卫生政策的“基石”，对欧洲制药领域发展和管理具有重要指导意义。通过对PSE制定背景及发展战略目标、具体举措等内容进行梳理分析，并结合中国COVID-19疫情防控与行业发展、药品科学监管与鼓励创新等实际工作提出政策建议。     

Repurposing of parenterally administered active substances used to treat pain both systemically and locally

Pain is a constant in our lives. The efficacy of drug therapy administered by the parenteral route is often limited either by the physicochemical characteristics of the drug itself or its adsorption–distribution–metabolism–excretion (ADME) mechanisms. One promising alternative is the design of innovative drug delivery systems that can improve the pharmacokinetics |(PK) and/or reduce the toxicity of traditionally used drugs. In this review, we discuss several products that have been approved by the main regulatory agencies (i.e., nano- and microsystems, implants, and oil-based solutions), highlighting the newest technologies that govern both locally and systemically the delivery of drugs. Finally, we also discuss the risk assessment of the scale-up process required, given the impact that this approach could have on drug manufacturing.Teaser: The management of pain by way of the parenteral route can be improved using complex drug delivery systems (e.g., micro- and nanosystems) which require high-level assessment and shorten the regulatory pathway.     

淄博市放射工作人员外周血淋巴细胞微核率分析

[摘要]?目的?探讨GeneXpert MTB/RIF检测技术在肺结核诊断中的应用价值。方法?以2020年7月—2021年6月在天门市第一人民医院治疗的疑似肺结核患者107例作为研究对象，所有患者均留取痰标本，进行痰涂片、痰培养、GeneXpert MTB/RIF检测、比例法药敏试验。以培养法和比例法药敏结果为金标准，计算GeneXpert MTB/RIF检测结核分枝杆菌（Mycobacterium tuberculosis，MTB）及其对于利福平耐药性检测的灵敏度、特异度、与金标准的的一致率。结果?107例疑似肺结核患者中，痰涂片阳性39例（36.45%），涂片阴性68例（63.55%）。以痰培养结果为金标准，GeneXpert MTB/RIF检测TBM的灵敏度为85.42%（41/48），特异度为88.14%（52/59）。GeneXpert MTB/RIF与痰培养诊断一致率为86.92%（93/107）；进一步分析，GeneXpert MTB/RIF检测痰涂片阳性患者MTB的灵敏度为97.22%（35/36），特异度为33.33%（1/3），检测涂片阴性患者MTB的灵敏度为50.00%（6/12），特异度为91.07%（51/56）。以比例法药敏结果为金标准，确认痰培养阳性36例患者中利福平耐药有4例（11.11%），敏感的有32例（88.89%）；GeneXpert MTB/RIF检测痰培养阳性患者利福平耐药的灵敏度为75.00%（3/4），特异度为93.75%（30/32）。GeneXpert MTB/RIF与比例法药敏试验一致率为91.67%。结论?GeneXpert MTB/RIF检测技术对于肺结核诊断以及利福平的耐药分析具有重要实用价值，可以作为金标准。     

Local magnetic delivery of adeno-associated virus AAV2(quad Y-F)-mediated BDNF gene therapy restores hearing after noise injury

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Pan-cancer proteomic map of 949 human cell lines

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Top advances of the year: Precision oncology

The advent of precision medicine has changed the landscape of oncologic biomarkers, drug discovery, drug development, and, more importantly, outcomes for patients with cancer. Precision oncology entails the genomic profiling of tumors to detect actionable aberrations. The advances in clinical next-generation sequencing from both tumor tissue and liquid biopsy and availability of targeted therapies has rapidly entered mainstream clinical practice. In this review, recent major developments in precision oncology that have affected outcomes for patients with cancer are discussed. Rapid clinical development was seen of targeted agents across various mutational profiles such as KRASG12C (which was considered “undruggable” for almost 4 decades), Exon 20 insertions, and RET mutations. Approaches to precision chemotherapy delivery by the introduction of antibody drug conjugates in the armamentarium against lung cancer has been appreciated.