Patients suffer from a variety of symptoms after thoracoscopic surgery. However, there is a lack of validated predictive tools to identify potentially high-risk patients. This study is anticipated to include approximately 1,500 lung cancer patients who undergo thoracoscopic surgery. Latent class mixed modeling (LCMM) will be used to dentify subgroups of patients with similar symptom trajectories. Machine learning models were developed to predict postoperative symptom trajectories based on collected information. Effective prediction of postoperative symptoms can help identify high-risk patients and take preventive measures.

开始日期2025-03-01

申办/合作机构

广东省人民医院

NCT06825676

/ Not yet recruitingN/AIIT

Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial (GRAVER)

Study Objective:
To evaluate the impact of guideline-based CKD comprehensive management medical re-education for community healthcare providers on improving cardio-renal outcomes in CKD patients.
Study Design:
A nationwide, multicenter, prospective, cluster-randomized controlled trial.
Inclusion and Exclusion Criteria:
Inclusion Criteria: Chronic kidney disease (CKD) patients meeting the following criteria:
eGFR <60 mL/min/1.73 m² or UACR >30 mg/g on two separate occasions at least 3 months apart.
Exclusion Criteria:
Age <18 years. End-stage renal disease (ESRD) with eGFR <15 mL/min/1.73 m², or patients already on regular dialysis or having received a kidney transplant.
Pregnant or breastfeeding women. Patients participating in any other clinical trials. Patients who exhibit characteristics at the screening stage that suggest they are unable to complete the study.
Intervention:
Control Group: Routine community training and management. Intervention Group: Training for community healthcare providers on guideline-based CKD management, including lifestyle management, risk assessment and referral recommendations, risk factor control, pharmacological treatment, and the application of a CKD management checklist incorporating these components.
Efficacy Evaluation Indicators:
Primary Outcome:
A renal composite endpoint, defined as at least a 25% decline in eGFR, progression to ESRD (dialysis, kidney transplantation, or sustained eGFR <15 mL/min/1.73 m²), or death due to renal or cardiovascular causes.
Secondary Outcomes:
Cardiovascular composite endpoint: cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for heart failure.
Delayed CKD progression, defined as a reduction in the annual eGFR decline rate by 0.5-1 mL/min/1.73 m² or a 30% reduction in UACR per year.
Proportion of patients receiving guideline-recommended pharmacological treatment.
Safety Evaluation Indicators:
Acute deterioration of renal function (serum creatinine increase >30% within 4 weeks).
New-onset hyperkalemia. Symptomatic hypotension. Recurrent hypoglycemia.

开始日期2025-03-01

申办/合作机构

广东省人民医院

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项与广东省人民医院相关的文献（医药）

2025-05-01·TOXICOLOGY IN VITRO

Assessing the safety of midazolam: A comprehensive analysis of adverse events from FAERS

Article

作者: Mao, Songsong ; Wei, Li ; Wang, Zhaojun ; Chen, Jieyuan

Midazolam, a potent sedative from the benzodiazepine class, is widely used in anesthesia and intensive care, but it has been linked to severe and life-threatening cardiopulmonary adverse events (AEs). This study investigated real-world AEs associated with midazolam using data from the U.S. Food and Drug Administration (FDA) adverse event reporting system (FAERS) from 2004 to 2024. Disproportionality analysis was performed using four signal detection methods-reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker-to assess midazolam-related AEs. A total of 2952 AE reports were identified, involving seven system organ classes, with 31 specific AEs meeting criteria across all four algorithms. Unexpected AEs not listed in the product label, such as seizure, coma, respiratory failure, anaphylactic shock, and hypothermia, were also observed, with most AEs occurring within the first 10 days of midazolam use. This pharmacovigilance study highlights the need for increased awareness of serious and unexpected AEs, including respiratory failure, anaphylactic shock, hypothermia, and metabolic acidosis, to promote safer use of midazolam in clinical practice.

2025-01-01·ARQUIVOS BRASILEIROS DE OFTALMOLOGIA

Short-term orthokeratology effects on corneal biomechanics with a focus on SPA1 and stress-strain index (SSI) parameters in pediatric myopia

Article

作者: Niu, Yongyi ; Li, Zheng ; Zeng, Jin ; Yang, Xiyang ; Li, Xue ; Yang, Cheng ; Xie, Wenjuan ; Li, Yingan

PURPOSE:

Although the orthokeratology effects on corneal biomechanics have been proven with clinical trials, reports of stiffness parameter change are scarce. This study investigated the short-term orthokeratology effects in pediatric myopia and compared stiffness parameter changes to those published in recent clinical investigations. This prospective study aimed to investigate corneal biomechanics changes induced by short-term overnight orthokeratology treatment, focusing on stiffness parameter at A1 and stress-strain index.

METHODS:

Twenty-six children aged 8 to 18 were included in this study using orthokeratology lenses for two different durations: 1 day and 1 week. Corneal biomechanics were assessed using corneal visualization (Corvis) Scheimpflug technology. Measurements were taken at baseline and after each wearing session. Changes in corneal stiffness parameters and corneal curvature were analyzed.

RESULTS:

All parameters changed significantly after 1 week of lens wear (p<0.05), except for velocity of corneal apex at the first and second applanation times highest concavity time, radius, stiffness parameter at A1 and stress-strain index. After 1 day, central corneal thickness, first applanation time, second applanation time, deformation amplitude ratio (2 mm), and Corvis biomechanical index (CBI) remained stable (p>0.05). After 1 week, central corneal thickness and first applanation time decreased, whereas second applanation time, deformation amplitude ratio, and Corvis Biomechanical Index significantly increased. With intraocular pressure and central corneal thickness as control variables, no significant correlation was found between stress-strain index and curvature changes (p>0.05). With age as the control variable, no significant correlation was found between stress-strain index and curvature changes (p>0.05).

CONCLUSIONS:

Short-term orthokeratology treatment induced notable changes in several corneal biomechanical parameters. Stiffness parameter at A1 and stress-strain index are unaffected by increasing lens wear duration and do not influence the orthokeratology effect.

2024-12-01·SEIZURE-EUROPEAN JOURNAL OF EPILEPSY

CCDC22 variants caused X-linked focal epilepsy and focal cortical dysplasia

Article

作者: Meng, Heng ; He, Yu-Lei ; Yi, Yong-Hong ; Zhou, Peng ; Gu, Yu-Jie ; Ye, Yi-Chen ; Zhai, Qiong-Xiang ; Liang, Xiao-Yu ; Luo, Sheng ; Zhang, Si-Qi ; Liu, Wen-Hui ; Chi, Qi ; Li, Bing-Mei ; Wang, Peng-Yu ; Han, Dong-Qian

BACKGROUND:

The CCDC22 gene plays vital roles in regulating the NF-κB pathway, an essential pathway for neuroinflammation, neurodevelopment, and epileptogenesis. Previously, variants in CCDC22 were reported to be associated with intellectual disability. This study aimed to explore the association between CCDC22 and epilepsy.

METHODS:

Trios-based whole-exome sequencing (WES) was performed in a cohort of patients with epilepsy of unknown cause recruited from the China Epilepsy Gene 1.0 Project. Damaging effects of variants were analysed using protein modelling.

RESULTS:

Hemizygous missense CCDC22 variants were identified in three unrelated cases. These variants had no hemizygous frequencies in controls. All missense variants identified in this study were predicted to be "damaging" by multiple in silico tools and to alter the hydrogen bonds with surrounding residues and/or protein stability. The three patients presented with focal epilepsy of varying severity, including one with refractory seizures and focal cortical dysplasia (FCD) and two with seizures responding to antiseizure medicine. Notably, the variant associated with the severe phenotype was located in the coiled-coil domain and predicted to alter hydrogen bonding and protein stability, whereas the two variants associated with mild epilepsy were located outside functional domains and had moderate molecular alterations. Analysis of spatiotemporal expression indicated that CCDC22 was expressed in brain subregions with three peaks in the fetal stage, infancy, and early adulthood, especially in the fetal stage, explaining the occurrence of developmental abnormities.

SIGNIFICANCE:

CCDC22 variants are potentially associated with X-linked focal epilepsy and FCD. The molecular subregional effects supported the occurrence of FCD.

项与广东省人民医院相关的新闻（医药）

2024-03-25

·美通社

云康集团公布2023年全年业绩收益达人民币8.92亿元

加大研发投入聚焦精准医疗和智慧化检测领域香港 2024年3月25日 /美通社/ -- 领先的中国医学运营服务供应商云康集团有限公司（「云康」或「集团」；股份代号：2325）公布截至2023年12月31日止年度（「报告期」）之全年业绩。2023年，集团持续拓展全国范围业务网络及服务，集团录得收益人民币891.5百万元。报告期内集团常规检测业务实现同比26.9%的健康稳步增长。由于与成本控制有关的运营及管理能力增强，整体毛利率稳定在36.5%。集团进一步提升运营及管理能力，加强现金流管理，使经营活动所得现金净额较去年明显改善。截至2023年12 月 31 日现金及现金等价物1,244.1百万元人民币。董事会建议宣派截至 2023 年 12 月 31 日止年度末期股息每股0.02港元。持续拓展业务网络，检测服务不断提升为更好地满足客户需求，集团除了拓展业务网络，同时加大于新技术、新产品研发方面的投入，推出多项具有市场竞争力的检测服务，并持续加大对二、三级医院的市场开拓。截至2023年12月31日，集团共有12家独立医学实验室，416家共建现场诊断中心，开展检测项目超过3,000项，年检测总量逾千万例；已形成覆盖国内31个省份及自治区、超过200座城市的客户服务网络。积极助力医联体建设，深度服务赋能医院发展新医改启动以来，集团积极响应政策号召，发挥自身在专业化、标准化及数智化方面的优势，赋能医联体内各级医疗机构提升医学诊断及协同服务能力，形成了独具特色的医联体运营创新模式。同时，在集团与医院的合作当中，集团不仅提供「3+1」肿瘤、感染、遗传及生殖+精准医学的技术体系支撑，还提供深度服务体系的支援，包括区域医联体诊断中心运营、新技术/新产品导入、数字化专科建设服务、医学冷链物流服务、质量控制服务以及供应链服务等，以深度服务更好地赋能医院发展。此外，集团亦快速复制医检联合创新平台模式。年内，集团携手广东省人民医院共同成立医检联合创新平台。推进技术创新，持续加大研发投入报告期内，集团研发投入达55.3百万元，占营业收益的比例提升至截至2023年12月31日止年度的6.2%。截至报告期末，本集团累计已获得319项专利和知识产权，包括授权发明专利、授权实用新型专利、软件著作权专利等。集团通过加强与大学和研究机构合作，积极推进前沿检测技术的研发和市场转化，年内继续与芝加哥大学、多伦多大学、复旦大学、中山大学、南方医科大学、南方科技大学、南昌大学等国内外多家高校保持长期稳定的合作关系，在联合培养、实训实习、科学研究等方面提供广阔的平台与机遇。集团高度重视研、产、服融合创新，积极整合国内外高校、科研机构及优质供应商资源，并借助数字化医疗、人工智能应用等先进技术，协助医院搭建科研创新与成果转化平台。透过研产服一体化服务医疗机构的科研和临床需求，缩短科研成果与产业化距离，提升优质医疗资源的可及性。聚焦客户服务，应用 AI 辅助诊断技术年内，集团专注以客户为导向的数智研发，加速推进「医疗+数字化」工作，构建远程病理平台并持续优化，协助各级医疗机构接入云康远程病理会诊网络。截至2023年12月31日，云康远程病理平台已涵盖536个医学检测项目，并在超过291家共建实验室成功运行，全面提升检验质量和诊断效率，打造高效赋能各级医疗机构的数字化病理会诊系统。集团拥有超过170名国内外病理医生，迄今已累计辅助医生发放70万份数字病理诊断报告，帮助医院提高科室效能约45%。同时，本集团积极与医疗机构建立标杆合作共建应用示范点，打造病理AI共建新模式，赋能医疗机构提升诊断能力和质量。2023年，本集团应用宫颈液基细胞学病理AI诊断，完成数万例宫颈液基细胞检测病例，推动数字化病理技术持续迈进。建设精准医学中心，率先把握行业机遇精准医学是依据患者内在生物学信息以及临牀症状和体征，对患者实施关于健康医疗和临牀决策的量身定制。由于越来越多患者寻求定制化医疗解决方案，精准医疗将呈增长趋势。诊断检测对增强精准医疗至关重要，因为精确的诊断检测可让医生了解患者的病症，从而定制治疗方案。凭借集团于诊断检测领域的经验及市场领导地位，集团率先采取行动以抓住这一行业机遇。截至2023年12月31日，集团自建及与医联体共建精准医学中心12家，覆盖癌症、遗传病和感染性疾病三个重大疾病领域。精益运营，降本增效，提升运营效率集团通过优化内部管理流程、提高运营效率等措施，有效降低了运营成本，并亦积极与供应商建立长期稳定的合作关系，确保了稳定供应和成本控制。报告期内，集团完成「强健工程」项目。通过对集团内部价值创造流程进行梳理，建立流程质量、时效和成本控制点的标准，分析现状与标准之间的差距，并建立避免熵增的规则与机制。积极践行 ESG 理念，企业管治备受认可报告期内，集团积极回应联交所新规要求，建立健全ESG及气候变化管理体系，积极识别并评估重要ESG议题，督促ESG相关目标及日常执行工作的有效落实，不断增强可持续发展管理能力。而在企业管治方面，集团的努力亦获得市场的充分认可。截至报告期末，集团已获得美国传媒专业联盟2022年度「远见奖」四项年报大奖、香港电视广播有限公司《环境、社会及管治大奖》2023之「ESG特别嘉许奖」以及第七届中国卓越投资者关系评选三项大奖等诸多荣誉。未来发展策略集团采取积极发展策略以实现集团的长期目标，助力优化医疗资源配置并加速行业发展。集团计划深化和推广大客户合作之校企合作模式和医检联合创新模式，聚焦客户需求，提高云康价值；此外亦计划继续加大对技术创新和研发的投入，落地新产品开发机制，进一步增强产品竞争力；同时，集团坚持数字化建设，并通过深化共建实验室运营管理，进而提升共建实验室经营效益。集团将加大研发投入，并寻求与行业领先者合作，进一步巩固其在国内市场的领先地位。云康集团有限公司主席及执行董事张勇先生表示，「得益于一系列国家利好政策，医疗服务供给侧结构性改革进一步深化，紧密型县域医疗卫生共同体建设稳步推进，医疗检测服务市场迎来全新机遇。展望未来，集团将继续以『深度服务、精益运营』为经营宗旨，秉承创新驱动、服务至上的理念，积极推进精益运营和数字赋能，顺应国家政策方向，把握医疗检测市场的黄金发展机遇，为各级医疗机构提供更专业、高效、精准、便捷的精准医学检验和病理诊断服务，从而为『健康中国2030』宏伟蓝图的实现贡献力量，并为股东带来长远的回报。」 – 完 – 云康集团有限公司（股份代号： 2325 ）云康集团是中国领先的医学运营服务提供商，早于2008年云康便开始面向各级医疗机构提供标准化的医疗诊断服务，通过利用自身专业的诊断能力以及覆盖全国的医联体服务网络，逐渐发展成为医学运营服务的领先平台。云康也是中国领先的医联体诊断服务供应商，提供涵盖医联体诊断及诊断外包的全方位医疗健康服务。云康向中国医联体内的合作医院提供诊断检测服务，通过现场诊断中心协助其提升临床诊断能力。迄今为止，云康已成功为来自全国416 家共建现场诊断中心提供专业服务，截至2023年12月31日，云康合作的医院分布于中国31个省市。新闻垂询云康集团有限公司赵慧香港办公室总经理;资本市场及企业传讯总经理电邮： zhaohui@yunkanghealth.com 网页： www.yunkanghealth.com

2023-04-18

·BioSpace

Avistone Announces Interim Data Results on PLB1004 in Patients with EGFR mutant NSCLC Patients at AACR 2023

BEIJING--(BUSINESS WIRE)-- Avistone Biotechnology (“Avistone” or “the Company”), a clinical-stage biotechnology company focused on precision oncology therapeutics, today announced interim results from its ongoing phase 1 study on PLB1004. The data were presented today (CT102) at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida USA. PLB1004, a novel mono-anilino-pyrimidine small molecule inhibitor of EGFR, potently and irreversibly targets exon 20 insertion. The molecule also potently targets classical EGFR mutations ExDel19, L858R and T790M with a high degree of selectivity over wild-type EGFR. The study is a multi-center, open-label, dose escalation and expansion study conducted entirely in China, to assess the safety, tolerability, pharmacokinetics, and anti-tumor effect of PLB1004, administered orally, in patients with advanced non-small cell lung cancer. The primary objective of the study is to assess the safety pro PLB1004 and determine the RP2D of the molecule. At the cutoff date for these interim results, July 31, 2022, a total of 65 patients (32 in escalation and 33 in expansion) had received treatment with PLB1004. Dose escalation ranged from a starting dose of 10 mg QD to a top dose of 480 mg QD in 11 cohorts of patients. As of July 31, 2022, dose expansion occurred at two dose levels, 320 mg QD and 400 mg QD. The median age of the patients is 58 years old (range 31 to 77). Most patients are women (60%) with adenocarcinoma (95%) and good performance status (ECOG 0-1 in 98%). The most frequent treatment related adverse events included diarrhea in 75% of patients (19% Grade 3), rash in 60% of patients (11% Grade 3), mouth ulceration in 43% of patients (1.5% Grade 3), elevated serum creatinine in 43% of patients (2% Grade 3) and elevated aspartate aminotransferase in 41% of patients (3% Grade 3). No DLTs were observed at any dose level and thus an MTD was not determined during cycle 1 of drug administration. Beyond Cycle 1, at the highest dose levels, frequent dose interruptions and reductions due to toxicity were observed, and further dose escalation was not attempted above 480 mg QD. Across all dose groups, a total of 38 subjects had EGFR Ex20ins mutations, including 29 at doses ≥ 160 mg QD, among whom 26 completed at least 1 tumor assessment. In these 26 patients the confirmed best response rate was 57.7% (15/26) and the disease control rate (DCR) was 100% (26/26). Among the 26 patients (≥160mg QD dose level) with EGFR Ex20ins mutation who completed at least one tumor evaluation, 8 patients had brain metastases, and 3 of them had a PR (37.5%). “PLB1004 appears to be safe and well-tolerated with promising anti-tumor activity in patients with NSCLC harboring EGFR exon 20 insertion mutations,” said Jin-Ji Yang, M.D., Primary Investigator from Guangdong Provincial People’s Hospital. “Avistone is a science-driven, innovative biotechnology company committed to the discovery and clinical development of first-in-class and best-in-class drugs,” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. “We are proud to share data at this year’s AACR conference for PLB1004 which has best-in-class potential for patients with EGFR NSCLC. We are excited to present these additional data and to highlight the advancements we are achieving for patients with lung cancer.” Electronic copies of the poster presented at the AACR annual meeting are available upon request. About Avistone Biotechnology Avistone is a clinical-stage biotechnology company based in Beijing, China, focusing on researching and developing innovative therapies for patients with significant unmet medical needs globally. The company’s core team comprises experienced drug design and clinical development experts, supported by a scientific advisory committee that includes internationally renowned KOLs. Avistone has an extensive pipeline of targeted therapies for molecular drivers of cancer, including two clinical-stage drug candidates and several ongoing programs in the pre-clinical development stage.

临床结果临床1期AACR会议

2021-11-11

·新浪医药

赛诺菲携手镁信健康打造房颤患者全病程管理项目

2021年11月7日，在第四届中国国际进口博览会现场，赛诺菲带来了全新房颤药物迈达龙®，并与镁信健康正式签订合作意向书，将为中国房颤患者带来第一个创新关爱计划，“迈动心生”。作为赛诺菲建设房颤患者全病程管理生态圈布局的重要部分，赛诺菲与镁信健康将基于各自在慢病管理、中国商业健康险及创新医疗支付模式的深厚经验和专业能力，为中国房颤患者带来全新的解决方案。房颤是一种发病率高、危害严重的慢性疾病，疾病负担沉重，目前在我国有1000万患者1，这一数字仍在持续爬升。虽然临床技术不断发展，房颤诊疗仍然存在节律治疗不规范、现有药物不良反应较重、复发率很高、全病程管理闭环尚未打通等诸多挑战。北京安贞医院心脏内科中心主任马长生教授、广东省人民医院副院长吴书林教授介绍：“房颤症状隐匿性较高，而公众又对房颤缺乏足够认识，这导致我国目前的房颤诊断率相比其它心血管疾病较低。尽管房颤治疗手段不少，节律控制等减少房颤症状的重要方法使用率却不甚理想，治疗规范性方面还有很大的提升空间。房颤还具备易复发的特点，很多患者不坚持随访，致使预后不佳，疾病复发时甚至引发脑卒中等严重心血管事件。此外，房颤患者需要长期服药，药物依从性、用药安全性是亟需解决的问题。” 针对现有房颤诊疗痛点，赛诺菲推出“迈动心生”房颤患者全病程管理项目，涵盖对患者在诊断、治疗、随访和支付各个环节的支持。赛诺菲创新及核心事业部总经理刘菁表示，“作为慢病领域的领导者，赛诺菲正努力加快自身的数字化转型进程，致力于提供解决慢病管理挑战的创新解决方案。赛诺菲与镁信健康达成合作，双方将共同打造专为房颤患者设计的创新支付项目，走出完善全病程管理生态圈的第一步，帮助房颤患者更好地管理疾病。” 作为房颤患者全病程管理项目的重要一环，“迈动心生”项目一方面借力赛诺菲在中国心血管领域的全球资源，一方面深度融合镁信健康“互联网+医+药+险”的闭环生态模式，打通关键的随访和支付环节，为房颤患者联通全病程管理闭环。作为抗心律失常领域的第一个创新团险项目，根据合作意向书，双方将携手为房颤患者搭建一站式服务平台，旨在为患者提供疾病知识教育、复诊提醒和用药提醒、入组患者专属福利权益以及患者随访等服务，从而提高患者的依从性，改善患者的生活质量和长期预后。值得一提的是，赛诺菲房颤重磅创新药盐酸决奈达隆片（商品名：迈达龙®）预计于今年年底在中国获批上市，届时“迈动心生”项目也将同步启动。镁信健康创新支付及患者服务事业部总经理冯昊表示：“我们与赛诺菲合作的商保项目能进一步满足广大房颤患者的用药需求，使他们得到更好的获益和用药保障。” 未来，赛诺菲将在已有布局基础上，继续加速将包括迈达龙®在内的创新药物引入中国，并与行业合作伙伴加速探索心血管疾病全病程管理，布局生态圈建设。通过推进规范治疗和全面管理，赛诺菲致力于让更多患者过上正常生活，助力实现“健康中国2030”的战略目标。参考资料： 1、《中国心房颤动防治现状蓝皮书 2018》

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100 项与广东省人民医院相关的转化医学

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