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推动中国AML精准诊疗规范化进程 首部《吉瑞替尼治疗伴FLT3突变成年人急性髓系白血病临床应用指导原则(2025年版)》发布
Jiang Nan Shi Bao· 2025-12-31 11:34
急性髓系白血病(AML)是恶性程度高、预后差的血液系统肿瘤[1],其中约37%的新诊断AML患者存 在FLT3突变[2],此类患者复发风险显著增高,生存率较低。近年来,靶向FLT3的创新药物吉瑞替尼作 为第二代I型FLT3抑制剂,可通过抑制FLT3受体信号通路诱导白血病细胞凋亡,为患者提供了重要治疗 选择。2021年吉瑞替尼在我国获批用于复发难治性FLT3突变AML,随后在新诊断患者、移植后维持治 疗等领域积累了大量循证医学证据。然而,临床实践中仍存在检测标准化不足、用药方案差异大、维持 治疗时机不明确等问题,亟需统一规范。 《临床应用指导原则》系统梳理了吉瑞替尼的关键临床研究数据,涵盖其单药及联合方案在复发难治和 新诊断AML中的疗效,并首次明确FLT3突变微小残留病(MRD)的检测时机与标准。专家共识指出, 高灵敏度MRD动态监测是指导移植后维持治疗和个体化干预的核心手段。此外,《临床应用指导原 则》还就吉瑞替尼的不良反应管理、特殊人群用药等提出具体建议,为临床医生提供全程管理路径。 ——CSCO白血病专家委员会通信作者马军教授 中国首部《吉瑞替尼治疗伴FLT3突变成年人急性髓系白血病临床应用指导原则(2 ...
肿瘤治疗有哪些突破?专家齐聚分享多癌种诊疗进展
Zhong Guo Jing Ji Wang· 2025-12-24 03:22
12月21日,2025"人民好医生 金山茶花计划"总结交流在北京举行。现场汇集了肺癌、肝胆肿瘤、胃 癌、食管癌、乳腺癌、妇科肿瘤、泌尿肿瘤、淋巴瘤、鼻咽癌等领域专家,共同探讨癌症防控新进展, 助力推进癌症防控事业高质量发展。 中国科学院院士、复旦大学附属中山医院名誉院长樊嘉分享了肝胆肿瘤治疗进展。他说,当前肝胆肿瘤 治疗已迈入免疫主导阶段,免疫治疗与靶向、介入治疗的协同联动,显著延长了患者生存期,还为部分 不可切除肿瘤创造根治机会。2025年,国内外权威指南修订、国内多项专家共识出台,进一步推动肝胆 肿瘤诊疗从"经验型"向"循证型"转变。 "得益于精准诊疗的推广、靶向治疗和免疫治疗的应用等,肺癌患者的生存期和生活质量得到了有效延 长和提升。"广东省人民医院首席专家、广东省肺癌研究所名誉所长吴一龙介绍肺癌领域学术科研创新 进展:"近年来,SCLC(小细胞肺癌)领域迎来突破性变革,全新的T细胞抗体激活类药物,在SCLC 二线治疗中效果显著,为临床提供了新的治疗范式;在NSCLC(非小细胞肺癌)早中期领域,相关研 究显示纳武利尤单抗联合化疗新辅助治疗能有效提升患者5年生存率,多款创新药物及治疗方案的出 现,推动非小 ...
共探癌症防控新路径 “人民好医生·金山茶花计划”在京总结交流
Zhong Guo Qing Nian Bao· 2025-12-23 10:02
中国青年报客户端讯(中青报·中青网记者 余冰玥)癌症是危害公众生命健康、制约居民健康水平提升 的重要因素。12月21日,2025"人民好医生·金山茶花计划"总结交流在北京举行。来自肺癌、胃癌、食 管癌、乳腺癌、妇科肿瘤等领域的专家学者共同探讨癌症防控新进展,助力推进癌症防控事业高质量发 展。 中国科学院院士、复旦大学附属中山医院名誉院长樊嘉介绍,当前,肝胆肿瘤治疗已迈入免疫主导阶 段,免疫治疗与靶向、介入治疗的协同联动,显著延长了患者生存期,还为部分不可切除肿瘤患者创造 了根治机会。2025年,国内外权威指南修订、国内多项专家共识出台,进一步推动肝胆肿瘤诊疗从"经 验型"向"循证型"转变。"未来诊疗需向精准分层、机制协同、全病程管理深化,既要强化高危人群早筛 早诊与科普宣传,优化联合治疗方案,也要鼓励中青年医生投身临床科研创新、紧盯国际前沿。" "得益于精准诊疗的推广、靶向治疗和免疫治疗的应用等,肺癌患者的生存期和生活质量得到了有效延 长和提升。"广东省人民医院首席专家、广东省肺癌研究所名誉所长吴一龙介绍了近年来肺癌领域学术 科研创新进展,在他看来,当前国内研究提供了"中国方案","走向全世界还需要迈出更大的 ...
圣湘生物科技股份有限公司 关于自愿披露相关产品 取得医疗器械注册证的公告
Zheng Quan Ri Bao· 2025-12-17 05:07
在呼吸道领域,本次获批的两款呼吸道"小联检"产品具备高灵敏度、高特异性、操作简便等优势,最快 30分钟即可出具报告。其中,肺炎链球菌、流感嗜血杆菌和卡他莫拉菌是社区获得性肺炎及儿童呼吸道 感染的主要致病菌,大肠埃希菌、鲍曼不动杆菌及嗜麦芽窄食单胞菌多见于医院获得性肺炎及呼吸机相 关肺炎患者,常累及基础疾病多、免疫功能受损或接受侵入性操作的高危人群。在呼吸道感染临床表现 高度相似、经验性用药风险较高的背景下,依托快速、精准的核酸检测尽早明确致病菌,对于实现精准 用药、降低耐药风险并改善患者预后具有重要价值。至此,公司"小联检"系列产品已扩展至10款,进一 步完善了圣湘"6/3+X呼吸道感染核酸快速检测"体系,可更好地应对当前多病原共流行和混合感染等复 杂局面,提供更加灵活、高效的检测选择,为临床精准用药和抗菌药物管理提供有力支撑。 针对EB病毒的普遍感染及潜伏感染特性,在精准监测领域,本次获批上市的EB病毒核酸检测试剂盒 (荧光PCR法)实现了重要技术升级,提升了检测灵敏度,并完善了对血浆、全血等多种标本类型的支 持能力。除引起传染性单核细胞增多症外,EBV还可导致慢性活动性EBV感染、EBV相关噬血细胞性淋 ...
2025“善城”消化论坛暨枣庄市医学会消化病学年会举行
Qi Lu Wan Bao· 2025-12-16 05:52
会上,朱光耀介绍了医院及学科的发展情况,指出消化内科作为枣庄市临床重点专科和枣庄市医药卫生重点学科,此次主办学术活动,既是学科实力的充 分彰显,更是落实健康中国战略、筑牢胃癌防控防线的具体实践,希望以会为媒促进区域医疗资源联动,让前沿诊疗理念与技术惠及更多群众。 首都医科大学附属北京友谊医院王拥军教授受邀致辞,结合自身深耕消化道早癌、胆胰疾病诊疗的丰富经验,围绕学科发展趋势与临床实践重点分享见 解,强调规范化诊疗对提升消化疾病救治效果的核心价值,为整场学术交流奠定了专业且前沿的基调。 专家理论授课环节,王拥军教授、同济医院覃华教授、同济大学附属东方医院段本松教授,以及省内许洪伟教授、左秀丽教授、胡锦华教授、于涛教授、 赵淑磊教授、张锎教授、李国栋教授、魏志教授、卢雪峰教授、孙善明教授等知名专家学者,聚焦四大核心议题,展开系统深入的学术分享。 在胆胰疾病内镜下诊治领域,专家详解ERCP规范化操作技巧及胆胰子镜临床应用进展,为复杂胆胰疾病微创治疗提供新思路;针对消化道肿瘤早诊早 治,重点讲解消化道早癌全链条管理内镜诊断,以及优化肠道准备策略助力结直肠癌筛查等核心技术的应用要点与早癌筛查策略,助力提升肿瘤早期检出 ...
最新!2款创新器械获批上市!
思宇MedTech· 2025-11-07 09:58
Core Insights - The National Medical Products Administration (NMPA) has approved two innovative medical devices: the AI-Rad Companion™ Prostate MR software by Siemens Medical and the G-Branch™ thoracoabdominal aortic stent system by Xianjian Technology, marking a significant advancement in China's medical device industry from "catching up" to "leading" [2][19][27]. Group 1: G-Branch™ Thoracoabdominal Aortic Stent System - The G-Branch™ system is designed for complex vascular conditions, specifically targeting thoracoabdominal aortic aneurysms (TAAA) and thoracoabdominal aortic dissections (TADA), providing a minimally invasive repair solution [7][8]. - This system includes five components: main stent, peripheral stent, extension stent, bifurcated main stent, and iliac extension stent, ensuring safety and effectiveness during surgery [7][12]. - The G-Branch™ system features a unique "dual inner and dual outer" hybrid branch design, which mimics the natural taper of the thoracoabdominal aorta, significantly reducing risks associated with traditional systems [8][9]. - Clinical studies demonstrated a 99.7% success rate in branch reconstruction and a 98.6% overall survival rate, indicating the system's reliability in real-world applications [13]. Group 2: AI-Rad Companion™ Prostate MR Software - The AI-Rad Companion™ Prostate MR software is a localized version of Siemens' global AI-Rad Companion family, designed to assist in the analysis of multiparametric MRI for suspected prostate cancer in men aged 40 and above [19][20]. - This software aims to improve diagnostic accuracy and reduce unnecessary biopsies, with a negative predictive value exceeding 95%, potentially avoiding 20-30% of negative biopsies [20][24]. - The software consists of two main modules: a confirmation module for image loading and patient verification, and a settings module that integrates deep learning for prostate configuration and lesion detection [23]. - Clinical trials showed a sensitivity of 92% and specificity of 88%, with the software enhancing cancer detection rates by 18% and reducing report generation time significantly [24][25]. Group 3: Company Profiles - Xianjian Technology, founded in 2003, is a leading Chinese company in cardiovascular and peripheral vascular intervention medical devices, with a market capitalization exceeding 10 billion HKD [14][16]. - Siemens Medical, a subsidiary of Siemens Healthineers, has been operating in China for over 20 years and plans to launch 20 "China-made" products in 2025, reinforcing its commitment to local innovation [27].
中国首款!自主研发,打破国外垄断
Ke Ji Ri Bao· 2025-10-27 11:56
Core Viewpoint - The article highlights the approval and significance of the uCT Ultima, China's first photon-counting spectral CT developed by United Imaging Healthcare, marking a major advancement in medical imaging technology [5][6]. Group 1: Product Development - The uCT Ultima has received approval from the National Medical Products Administration, representing a significant milestone in the commercialization of photon-counting spectral CT technology in China [5]. - This technology is considered a "crown jewel" in medical devices and is referred to as the "third technological revolution" in CT imaging [5]. Group 2: Technological Advantages - The uCT Ultima features a semiconductor detector that provides higher spatial resolution imaging, direct multi-energy spectrum imaging, and lower radiation dose imaging, significantly enhancing precision diagnosis [6]. - The pixel area of the detector has been reduced to one-ninth of its original size, allowing for the visualization of finer pathological structures and achieving ultra-high resolution imaging with full collimation coverage [6]. - Radiation dose reduction can reach 60% to 70%, and in certain organs, it can be reduced by 80% to 90%, making CT scans safer for patients [6]. Group 3: Market Position - United Imaging Healthcare is now the third company globally and the first in China to successfully commercialize photon-counting CT technology [6]. - The uCT Ultima has already been implemented in clinical research at Fudan University Zhongshan Hospital and Shanghai Jiao Tong University School of Medicine Ruijin Hospital [6].
医学专家:聚焦AML全周期管理 点亮康复希望
Zhong Guo Xin Wen Wang· 2025-10-15 06:54
Core Insights - The increasing societal focus on blood health and support for acute myeloid leukemia (AML) patients is highlighted, with a call for public education on prevention, diagnosis, treatment, and recovery [1][2] - The treatment of AML is evolving towards precision and diversification, with targeted therapies marking the entry into a "precision era" [1] - The application of second-generation FLT3 inhibitors is significantly improving the prognosis for patients with FLT3 mutations, extending median overall survival to 9.3 months while reducing side effects [1] - The widespread use of minimal residual disease (MRD) monitoring technology is aiding in the precise detection of residual cancer cells, allowing for timely treatment adjustments and reduced relapse risk [1] Treatment Recommendations - It is advised that families with a leukemia diagnosis engage actively with healthcare providers to choose appropriate medical institutions based on economic conditions, accessibility, resource allocation, and treatment expectations [2] - The collaboration between the medical community, society, and AML patients' families is expected to enhance the comprehensive management system for AML, making "precision diagnosis and warm recovery" more accessible to families [2]
开立医疗与巴泰医疗正式达成战略合作
Zheng Quan Shi Bao Wang· 2025-09-11 11:32
Core Viewpoint - The strategic cooperation agreement between Kaili Medical and Zhejiang Batai Medical Technology aims to address the growing demand for cardiovascular disease treatment in China by focusing on advanced interventional techniques and providing comprehensive treatment options for coronary heart disease patients [1] Group 1: Company Collaboration - Kaili Medical and Zhejiang Batai Medical have officially signed a strategic cooperation agreement in Hangzhou [1] - The partnership seeks to integrate resources from both companies to enhance the development and promotion of new interventional technologies [1] Group 2: Market Demand - The collaboration is a response to the increasing demand for cardiovascular disease diagnosis and treatment in the Chinese market [1] - The focus will be on "precise diagnosis and treatment" and "intervention without implantation" as key areas of development [1]
国产发力 光子CT连续获批 外资垄断格局被打破
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-27 00:11
Core Insights - The Chinese high-end medical equipment industry has achieved a historic milestone by entering the global forefront in ultra-high-end medical equipment, specifically with the approval of photon-counting spectral CTs by the National Medical Products Administration (NMPA) [1][2] - The approval of the first domestically developed photon-counting spectral CTs by United Imaging Healthcare and Neusoft Medical marks a significant leap from "catching up" to "leading" in next-generation CT technology [2][6] Industry Overview - Photon-counting spectral CT is recognized as a revolutionary direction in CT technology, offering advantages such as higher spatial resolution imaging, direct multi-energy spectrum imaging, and lower radiation doses compared to traditional CT [1][2] - The global market for photon-counting CT is projected to reach approximately $2 billion by 2025, with the simultaneous approval of these two domestic products creating a "dual leader" market structure [2][5] Technological Advancements - Photon-counting CT technology is likened to a leap from "black and white photos" to "color photos," enabling precise identification of energy information from individual X-ray photons, thus providing clearer diagnostic images [3][4] - The new technology can reduce radiation doses by 60% to 70%, and in some cases, up to 80% to 90%, enhancing patient safety during CT scans [4][5] Market Dynamics - Siemens and GE are the only foreign companies that have previously commercialized clinical-grade photon-counting CTs, but their configurations are limited compared to the new domestic offerings [2][4] - The price of Siemens' photon-counting CT is around 50 million RMB, which is 3 to 5 times higher than traditional high-end CTs, indicating a significant market opportunity for domestic manufacturers [5] Clinical Applications - Clinical trials for the new photon-counting CTs have begun in top hospitals, with potential applications in early detection of various diseases, including brain vascular diseases, Alzheimer's, and small tumors in the liver and pancreas [5][6] - Neusoft Medical is collaborating with leading hospitals to explore the clinical applications of its photon-counting CT, further solidifying the position of domestic companies in the medical imaging field [6]