糖尿病前期中医证型及证素特点分析＊

目的 探讨糖尿病前期的中医证型及证素分布特点。方法 检索中国知网、万方及维普三大数据库中收录的自建库以来有关糖尿病前期证型的临床研究文献，对中医证型进行规范整理，建立数据库，提取证素，运用数据挖掘技术中的关联分析、聚类分析探究证素分布规律。结果 共纳入10篇文献，总有效病例1620例，证型经规范处理后整理为18个，主要证型为脾虚痰湿证。共提取证素13个，主要病位证素为脾，主要病性证素为气虚、湿和痰，关联分析显示脾—湿支持度和置信度最高，聚类分析结果可得到3个聚类组。结论 糖尿病前期病位在脾，气虚、脾、痰、湿是常见证素，临床诊治糖尿病前期应注重从脾论治，需辨证施治。     

Adropin 蛋白在多囊卵巢综合征中的研究进展及临床意义

多囊卵巢综合征 (polycystic ovary syndrome, PCOS) 是一种在育龄期女性中常见的疾病, 它的主 要临床表现是月经紊乱、 不孕、 痤疮、 多毛等症状, 可能伴随有糖脂代谢异常。 Adropin 是新近发现的一种 分泌性蛋白, 已证实其在调节糖脂代谢、 改善胰岛素抵抗中发挥着作用, 但具体作用机制及其临床意义尚 未完全明确。 文章简要综述 Adropin 蛋白的作用机理及其在多囊卵巢综合征中的研究进展及临床意义。     

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.     

发热伴血小板减少综合征研究热点的可视化分析

[摘要]　目的　对发热伴血小板减少综合征（severe fever with thrombocytopenia syndrome, SFTS）的相关文献进行文献计量学和可视化分析，探寻近年来的研究现状、热点及趋势，为临床治疗和基础研究提供参考。方法?以Web of Science（WOS）核心合集和中国知网（China national knowledge infrastructure, CNKI）数据库为文献来源，检索2011年1月1日—2021年12月31日有关SFTS的文献，导入CiteSpace.5.7.R2软件，以国家、作者、文献共被引、关键词为节点进行可视化分析，并绘制相关图谱。结果?在WOS核心合集共检索到797篇文献，在CNKI数据库共检索到714篇文献。相关领域发文量总体呈上升趋势，中国发文量居首位，美国和日本之间机构合作密切。研究热点集中在发病机制、抗体、特异性治疗等领域。非结构蛋白、临床预后、血小板减少、SFTS感染的靶细胞等将是未来的研究重点。结论?国内外关于SFTS的研究逐渐成熟，新型布尼亚病毒、免疫功能、预后是研究重点，但是对SFTS发病机制和病毒受体尚不清楚，仍须进一步探索。     

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.     

Efficacy and Safety of Transjugular Intrahepatic Portosystemic Shunt Creation for Budd-Chiari Syndrome: A Systematic Review and Meta-Analysis

PurposeTo assess the critical role of transjugular intrahepatic portosystemic shunt (TIPS) in the management of Budd-Chiari syndrome (BCS), as the data with respect to the safety and outcome of TIPS in patients with BCS are scarce because of the rarity of the disease.Materials and MethodsA comprehensive search of literature of various databases from 2000 to October 2021 was conducted for studies evaluating the outcome of TIPS in patients with BCS. The primary outcomes of the analysis were technical and clinical success, adverse events and mortality associated with TIPS, dysfunction of TIPS, need for TIPS revision, need for liver transplantation (LT), and 1-year survival.ResultsA total of 33 studies (1,395 patients) were included in this meta-analysis. The pooled rates and 95% confidence intervals of various outcomes were 98.6% (97.6–99.7) for technical success, 90.3% (86.0–94.6) for clinical success, 10.0% (6.5–13.6) for major adverse events, 0.5% (0.2–1.0) for TIPS-related mortality, 11.6% (7.8–15.4) for post-TIPS hepatic encephalopathy (HE), 40.1% (32.5–47.7) for TIPS dysfunction, 8.6% (4.9–12.4) for the need for TIPS revision, 4.5% (2.8–6.2) for the need for LT, and 94.6% (93.1–96.1) for 1-year survival. Publication bias was seen with all outcomes except for post-TIPS HE, TIPS dysfunction, and the need for LT.ConclusionsThe existing literature supports the feasibility, safety, and efficacy of TIPS in the treatment of BCS. Deciding the optimal timing of TIPS in BCS needs further studies.     

儿童哮喘与成人慢性阻塞性肺疾病相关性研究进展

儿童哮喘与慢性阻塞性肺疾病(COPD)是儿童期与成人期常见的存在气流受限的慢性气道疾病。研究发现,儿童哮喘会增加成年期罹患COPD的风险,而肺功能变化是预测COPD患病风险的重要指标。针对哮喘患儿建立长期肺功能监测管理,对于评估其成年后存在不可逆气道阻塞的风险有重要意义。文章综述儿童哮喘与COPD相关的研究进展。