Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision

The set of guidelines for good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents was developed following an international consensus conference in Copenhagen in 1996 (Viby-Mogensen et al., Acta Anaesthesiol Scand 1996, 40 , 59–74); the guidelines were later revised and updated following the second consensus conference in Stockholm in 2005 (Fuchs-Buder et al., Acta Anaesthesiol Scand 2007, 51 , 789–808). In view of new devices and further development of monitoring technologies that emerged since then, (e.g., electromyography, three-dimensional acceleromyography, kinemyography) as well as novel compounds (e.g., sugammadex) a review and update of these recommendations became necessary. The intent of these revised guidelines is to continue to help clinical researchers to conduct high-quality work and advance the field by enhancing the standards, consistency, and comparability of clinical studies. There is growing awareness of the importance of consensus-based reporting standards in clinical trials and observational studies. Such global initiatives are necessary in order to minimize heterogeneous and inadequate data reporting and to improve clarity and comparability between different studies and study cohorts. Variations in definitions of endpoints or outcome variables can introduce confusion and difficulties in interpretation of data, but more importantly, it may preclude building of an adequate body of evidence to achieve reliable conclusions and recommendations. Clinical research in neuromuscular pharmacology and physiology is no exception.     

2022年上海市医师协会全科医师分会年会主题报告（一）

本文内容来源于2022年7月22日由上海市医师协会、上海市医师协会全科医师分会主办的"第二届海上全科医师论坛"，主要包括《基层医疗在整合医疗中的作用》《创建全科医学科为国家临床重点专科》《上海市基层卫生发展趋势》《拥抱变化，更好更强》四部分。其中，《基层医疗在整合医疗中的作用》从整合程度、整合层面、整合方向3个维度阐释了"整合医疗"的概念与内涵，并就整合医疗在制度、管理、支付、服务模式、技术应用5个层面的实现路径做了详细介绍；在分析基层医疗和整合医疗共性特征的基础上，阐释基层医疗在上述5个层面对整合医疗的助推作用。《创建全科医学科为国家临床重点专科》从全科医学科在卫生保健改革、满足居民卫生服务需求中的重要作用出发，阐述了创建全科医学科为国家临床重点专科的必要性，认为创建临床重点专科需做到：提高全科医学科学术地位，推进全科医学人才建设，提升全科医学科区域协同能力，形成全方位全周期健康照护专科特色，加快全科医学科研创新发展。《上海市基层卫生发展趋势》肯定了基层卫生对城市健康发展的贡献，提出在"大健康"的背景下进一步的重点工作为推进健康老龄化和实现出生人口提升计划；上海基层卫生的发展趋势在于创新，而基层卫生高质量发展工作的创新需要由全科医生作为推动者和牵头者，创造出新的健康服务模式。《拥抱变化，更好更强》，认为当前社区卫生服务的"薄弱"之处，并非发展之初的硬件或人员配置不足，而是体现在全科学科建设方面。全科医学领域工作者应主动面对和接纳当前国家健康战略的变化、健康需求的变化、医学模式的变化、自身发展/管理的变化，开展主动健康，应对多病共存，加强全-专结合，关注需方角度的服务评价，以助力全科医学学科建设。     

Methodological advances in the design of peptide-based vaccines

The tremendous advances in genomics, recombinant DNA technology, bioengineering and nanotechnology, in conjunction with the development of high-end computations, have been instrumental in the process of rational design of peptide-based vaccines. The use of peptide vaccines was limited owing to their inherent instability when systemically administered; however, advanced formulation techniques have been developed for their systemic delivery, thereby overcoming their degradation, clearance, cellular uptake and off-target effects. With the rise of sophisticated immunological predictors and experimental techniques, several methodological advances have occurred in this field. This review examines contemporary methods to identify and optimize epitopes, engineer their immunogenic properties and develop their safe and efficient delivery into the host.     

Overview of Recognition and Prevention of Child Sex Trafficking in the Primary Care Setting: A Primer for Nurse Practitioners

Child sex trafficking (CST) has become a global public health crisis and is a $150 billion criminal enterprise. Nurse practitioners are key in the recognition and prevention of CST in health care settings. Evidence demonstrates that up to 80% of CST victims have had a recent health care encounter. It is the role of the NP in practice to understand risk factors, screen for CST, and educate parents and caregivers on signs of victimization and prevention.     

青年人群近距离工作后眼部参数的变化及恢复时间

目的：观察青年人群近距离用眼后眼部生理及功能性参数的变化及恢复时间。

方法：前瞻性研究。随机选取2019-12/2020-06在我院进行医学验光的患者69例138眼，根据主觉验光结果分为正视组(+0.75D≤等效球镜度≤-0.50D，18例36眼)、低度近视组(-0.75D≤等效球镜度≤-3.00D，25例50眼)和中度近视组(-3.25D≤等效球镜度≤-6.00D，26例52眼)。所有受试者近距离阅读20min后远眺放松20min，分别于近距离用眼前、近距离用眼20min后、远眺5、10、15、20min时测量受试者眼部生理性参数\〖前房深度(ACD)、眼轴长度(AL)\〗和功能性参数\〖正相对调节(PRA)、调节反应(BCC)\〗，分析各参数的达极时间和恢复时间。

结果：近距离用眼后眼轴变长，前房变浅，PRA绝对值变大，BCC无明显变化，75%(52/69)的受试者AL在近距离用眼20min后达极，87%(60/69)的受试者ACD在远眺5min时达极，96%(66/69)的受试者PRA在近距离用眼20min后达极，且以上参数均在远眺10min后逐渐恢复至初始状态。

结论：近距离用眼后眼部参数发生改变，眼轴变长，前房变浅，PRA绝对值增大，但均在远眺放松过程中逐渐回退，且均需要10min以上才能恢复至初始状态。     

Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial

BackgroundWe evaluated the safety and immunogenicity of NVX-CoV2373, a recombinant SARS-CoV-2 nanoparticle vaccine, in healthy Japanese participants.MethodsThis phase 1/2, randomized, observer-blind, placebo-controlled trial conducted in Japan (two sites), enrolled healthy Japanese adults aged ≥ 20 years with no history/risk of SARS-CoV-2 infection and no prior exposure to other approved/investigational SARS-CoV-2 vaccines or treatments. Participants were stratified by age (< 65 or ≥ 65 years) and randomized to receive two doses of either NVX-CoV2373 (5 μg SARS-CoV-2 rS; 50 μg Matrix-M1) or placebo, 21 days apart. Primary outcomes were safety and immunogenicity assessed by serum IgG antibody levels against SARS-CoV-2 rS protein on day 36. Herein, we report the primary data analysis at 4 weeks after the second dose, ahead of 12-month follow-up completion (data cut-off: 8 May 2021).ResultsBetween 12 February 2021 and 17 March 2021, 326 subjects were screened, and 200 participants enrolled and randomized: NVX-CoV2373, n = 150; placebo, n = 50. Solicited adverse events (AEs) through 7 days after each injection occurred in 121/150 (80.7%) and 11/50 (22.0%) participants in the NVX-CoV2373 and placebo arms, respectively. In the NVX-CoV2373 arm, tenderness and injection site pain were the most frequently reported solicited AEs after each vaccination, irrespective of age. Robust immune responses occurred with NVX-CoV2373 (n = 150) by day 36: IgG geometric mean fold rise (95% confidence interval) 259 (219, 306); seroconversion rate 100% (97.6, 100). No such response occurred with placebo (n = 49).ConclusionTwo doses of NVX-CoV2373 given with a 21-day interval demonstrated acceptable safety and induced robust anti-SARS-CoV-2 immune responses in healthy Japanese adults. Funding: Takeda Pharmaceutical Company Limited and Japan Agency for Medical Research and Development (AMED). ClinicalTrials.gov identifier: NCT04712110.     

活态中医药传统知识数据库的构建与应用意义＊

目的 国家印发《关于促进中医药传承创新发展的意见》指出要依托现有资源建设国家和省级中医药数据中心，以信息化支撑中医药服务体系建设。本文提出活态中医药传统知识数据库的构建思路和具体实施，为推动中医药知识信息化和推广中医药保护提供参考。方法 主要采用文献分析法了解国外数据库进展，梳理国内中医药数据库运行经验，剖析活态中医药传统知识数据库的建设和运行的实际问题，明确数据库建设思路与意义。结果 国家利用资源建立中医药传统知识保护数据库，信息化在知识的保护和传承创新方面发挥一定的作用，但世界上许多传统知识较为丰富的国家和地区，如印度、韩国等已经走在在传统知识数据保护的前列，我国数据库建设和应用仍需要研究、探索和改善，中医药传统知识的保护和分类建设亟需加强，数据信息挖掘与共享合作等规范需要确立。结论 国家高度重视中医药的传承与发展，要以信息化支撑中医药传统知识体系建设，活态中医药传统知识数据库系统帮助数据信息收集整理的同时，也对中医药传统知识的专家人才队伍和技术标准化体系建设有积极作用，以及将来中医药行业规范化建设形成坚实的数据基础。     

一测多评法在中药质量控制中的应用及研究进展＊

一测多评法（quantitative analysis of multi-components by single marker，QAMS）已成熟应用于中药材、中药提取物及中成药领域等中药复杂体系的质量评价研究中，有效解决了因对照品缺乏而导致的多指标质控技术推广难问题。本文查阅近五年的国内外研究文献，重点总结了高效液相色谱、气相色谱和质谱等技术在QAMS法中药质量控制中的应用。高效液相色谱联用紫外检测器（UV）技术应用最为广泛，最适合于中药QAMS法定量，结果稳定、准确；而高效液相色谱联用蒸发光检测器在中药QAMS法应用中，其测定准确性和适用性仍然需进一步探索和验证。液质联用技术虽然具有灵敏度高、线性范围宽等优点，但易受仪器参数、基质效应等的影响。进一步发展HPLC-UV技术在中成药制剂质量评价中的应用，是QAMS法多成分定量值得关注的方向；探索LC-MS和GC技术在中药QAMS质量评价中的稳定性和普适性是未来将面临的挑战。     

玻璃体腔内注射抗血管内皮生长因子治疗早产儿视网膜病复发的危险因素分析

目的 探讨玻璃体腔内注射抗血管内皮生长因子（vascular endothelial growth factor，VEGF）治疗早产儿视网膜病（retinopathy of prematurity，ROP）的效果及复发的危险因素。 方法 回顾性收集2016年1月—2021年12月在郑州大学第一附属医院出生行抗VEGF治疗的ROP患儿159例的临床资料，根据首次抗VEGF治疗后随访周期内ROP复发与否分为复发组（24例）和非复发组（135例），比较分析2组临床资料，采用多因素logistic回归分析探讨抗VEGF治疗ROP复发的危险因素。 结果 经单次抗VEGF治疗后，所有159例患儿均显示附加病变消退。24例（15.1%）抗VEGF治疗后复发，复发平均时间为治疗后（8.4±2.6）周。多因素logistic回归分析显示，术前眼底出血、总用氧时间较长是ROP复发的危险因素（P<0.05），而妊娠高血压是保护因素（P<0.05）。 结论 玻璃体腔内注射抗VEGF治疗ROP是有效的。术前眼底出血和氧疗时间较长可增加ROP复发的风险，而对于妊娠高血压对ROP复发的影响，还需进一步研究证实。