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[Surgical techniques for the safe and rapid resection of primary or secondary sacral tumors located between the second and fourth sacral vertebrae]. [安全快速切除位于第二和第四骶椎之间的原发性或继发性骶骨肿瘤的手术技术]。
Q3 Medicine Pub Date : 2025-10-23 DOI: 10.3760/cma.j.cn112152-20250512-00220
G C Wang, C Q Gao, T Wang, G H Niu, S J Zhang, Z Zhang, W C Ai, L J Li, L L Ding, Z Zhang, G X Zhang, L L Guo
<p><p><b>Objective:</b> To investigate the methods and skills required for the safe and swift removal of primary or secondary sacral tumors located between the second (inclusive) and fourth sacral vertebrae. <b>Methods:</b> The clinical images, pathology reports, surgical procedures, operation durations, intraoperative bleeding volumes, and postoperative functional follow-up data of 26 patients undergoing sacral tumor resection at the First Affiliated Hospital of Zhengzhou University and Xinjiang Production and Construction Corps Hospital between May 2020 and February 2025 were retrospectively examined. Additionally, the safety measures for sacral tumor resection and techniques for expedited specimen removal were evaluated. <b>Results:</b> According to magnetic resonance imaging (MRI) findings, all 26 patients presented with sacral tumors located between the second (inclusive) and fourth sacral vertebrae. Specifically, 9 patients were diagnosed with primary sacral tumors, pathologically confirmed as chordomas, while 17 patients had secondary sacral tumors. Among the secondary tumor cases, 12 were attributed to recurrent rectal cancer invading the sacrum, and 5 were due to malignant teratomas invading the sacrum. The 26 patients underwent a treatment strategy that began with managing the relationship between the internal iliac artery, vein branches, and the tumor, followed by the resection of the sacrum. During surgery, the bilateral sciatic foramina were accurately positioned, and the presacral fascia was dissected subsequent to the fracture of the sacrum. Among the 26 patients, 9 underwent sacral tumor resection directly through the posterior sacral approach. The average operation time for these patients was (71.1±4.9) minutes, with average blood loss of (186.7±72.8) milliliters. On the other hand, 17 patients underwent sacral tumor resection by transitioning from the supine position to the prone knife position through a combined abdominal and sacral approach. The average operation time for this group was (213.5±19.3) minutes, with average blood loss of (480.0±93.0) milliliters, significantly longer than that of the posterior sacral approach. The follow-up period ranged from 1 to 48 months, with a median of 20 months, ending on March 31, 2025. During this time, 26 patients achieved autonomous defecation with the aid of medication. None of the patients reported any functional movement disorders or pain in their lower limbs. It was observed that two out of the 26 patients developed distant metastasis, while the remaining 24 patients survived without any tumors. <b>Conclusion:</b> By pretreated the relationship between the internal iliac vessels and sacral tumors prior to resecting sacral tumors, utilizing the approach of initially fracturing the sacrum followed by rupturing the presacral fascia, the tumor can be entirely eliminated, resulting in a brief surgical procedure, reduced intraoperative bleeding, and minimal postoperative complications.</
目的:探讨安全快速切除位于第二(包括)和第四骶椎之间的原发性或继发性骶骨肿瘤所需的方法和技巧。方法:回顾性分析2020年5月至2025年2月在郑州大学第一附属医院和新疆生产建设兵团医院行骶骨肿瘤切除术的26例患者的临床影像、病理报告、手术方式、手术时间、术中出血量及术后功能随访资料。此外,对骶骨肿瘤切除的安全措施和快速标本切除技术进行了评价。结果:26例患者均表现为位于第二(包括)和第四骶椎之间的骶骨肿瘤。其中原发性骶部肿瘤9例,病理证实为脊索瘤,继发性骶部肿瘤17例。继发性肿瘤中,12例为复发性直肠癌侵犯骶骨,5例为恶性畸胎瘤侵犯骶骨。26名患者接受了治疗策略,首先处理髂内动脉、静脉分支和肿瘤之间的关系,然后切除骶骨。术中准确定位双侧坐骨孔,骶骨骨折后切开骶前筋膜。26例患者中,9例经骶后入路直接行骶骨肿瘤切除术。平均手术时间为(71.1±4.9)分钟,平均失血量为(186.7±72.8)毫升。另一方面,17例患者通过腹骶联合入路由仰卧位过渡到俯卧刀位行骶骨肿瘤切除术。本组平均手术时间为(213.5±19.3)min,平均出血量为(480.0±93.0)ml,明显高于骶后入路。随访时间为1 - 48个月,中位为20个月,截止到2025年3月31日。在此期间,26例患者在药物的帮助下实现了自主排便。没有患者报告有任何功能性运动障碍或下肢疼痛。据观察,26名患者中有2名发生了远处转移,而其余24名患者没有任何肿瘤。结论:在切除骶骨肿瘤前,对髂内血管与骶骨肿瘤的关系进行预处理,采用先破骶骨后破骶前筋膜的方法,可完全切除肿瘤,手术时间短,术中出血少,术后并发症少。
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引用次数: 0
[Interpretation of the Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2025 edition)]. 【中华医学会肺癌临床诊疗指南(2025年版)解读】。
Q3 Medicine Pub Date : 2025-10-23 DOI: 10.3760/cma.j.cn112152-20250819-00408
B Zhang, R B Zhong, H Zhong

The "Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2025 edition)" was collaboratively completed under the leadership of Professor Han Baohui from the Department of Pulmonary and Critical Care Medicine at Shanghai Chest Hospital and Professor Wang Jie from the Department of Medical Oncology at the Cancer Hospital of the Chinese Academy of Medical Sciences & Peking Union Medical College. The guideline involved the cooperation of more than 50 lung cancer diagnosis and treatment institutions and over 100 experts across China. Since the completion of the first edition in 2018, the guideline is typically revised annually to promptly incorporate the latest advancements in the field of lung cancer. The most distinctive feature of these guidelines is that they exclusively reference the indications approved by the National Medical Products Administration of China. At the same time, particular emphasis is placed on integrating clinical research data from Chinese scholars based on Chinese patients, thereby enhancing the guidelines' authority, applicability, and drug accessibility. The "Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2025 edition)" was officially published in September 2025. To better introduce the key points of the guidelines to peers, this interpretation has been prepared.

《中华医学会肺癌临床诊疗指南(2025年版)》由上海胸科医院肺重症医学科韩宝辉教授与中国医学科学院、北京协和医学院肿瘤医院肿瘤内科王杰教授共同完成。该指南涉及全国50多家肺癌诊疗机构和100多名专家的合作。自2018年第一版完成以来,该指南通常每年修订一次,以及时纳入肺癌领域的最新进展。本指南最大的特点是专门参考中国国家药品监督管理局批准的适应症。同时,特别注重整合中国学者基于中国患者的临床研究数据,从而提高指南的权威性、适用性和药物可及性。《中华医学会肺癌临床诊疗指南(2025年版)》于2025年9月正式发布。为更好地向同行介绍指南的要点,特编写本解读。
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引用次数: 0
[Establishment of a clinical risk scoring model for patients undergoing curative resection of pulmonary metastases from colorectal cancer based on primary tumor lymph node indices]. [基于原发肿瘤淋巴结指数的结直肠癌肺转移根治性切除患者临床风险评分模型的建立]。
Q3 Medicine Pub Date : 2025-10-23 DOI: 10.3760/cma.j.cn112152-20250302-00081
R S Xiang, Q Zhang, S B Lu, W J Yang, D Y Kong, Y Sun, H R Zhang, J L Fan, L Feng, H Z Zhang

Objective: To analyze the clinicopathological factors affecting the prognosis of patients after curative resection of lung metastases (LMs) from colorectal cancer (CRC) and to construct a clinical risk scoring (CRS) model. Methods: This study retrospectively collected clinicopathological data and follow-up information on 132 patients who underwent radical resection of LMs from CRC at the Cancer Hospital of the Chinese Academy of Medical Sciences between January 2010 and December 2020. We analyzed the clinicopathological factors influencing patient prognosis using univariate and multivariate Cox proportional hazards regression models, and we developed a risk stratification model for prognostic prediction. Results: The median follow-up duration for the cohort of 132 patients was 54.2 months. During this period, 61 patients (46.2%) experienced recurrence or distant metastasis, resulting in a 5-year DFS rate of 54.1%. Additionally, 33 patients (25.0%) died, corresponding to a 5-year overall survival (OS) rate of 76.7%. Univariate Cox proportional hazards regression model analysis indicated that ten clinicopathological factors were significantly associated with OS (all P<0.05). These factors include the total number of lymph nodes (LNs) dissected from the primary tumor (PT) <16, the number of negative LNs from the PT <13, pN(+) of the PT, logarithmic odds of positive lymph nodes (LODDS) of the PT ≥-1.1, lymph nodes ratio (LNR) of the PT ≥0.02, preoperative carcinoembryonic antigen (CEA) level before LMs resection ≥10 ng/ml, the presence of hilar/mediastinal LN metastasis, the number of LMs ≥2, the maximum diameter of LMs ≥2.5 cm, and the necessity for hilar/mediastinal lymphadenectomy. Multivariate Cox proportional hazards regression analysis identified the number of negative LNs <13 (HR=3.01, 95% CI: 1.28-7.03, P=0.011), pN(+) of the PT (HR=5.04, 95% CI: 1.51-16.84, P=0.009), preoperative CEA level before LMs resection ≥10 ng/ml (HR=5.39, 95% CI: 1.80-16.19, P=0.003), the number of LMs ≥2 (HR=2.47, 95% CI: 1.09-5.60, P=0.030), and the necessity for hilar/mediastinal lymphadenectomy (HR=2.74, 95% CI: 1.15-6.52, P=0.023) as independent prognostic risk factors. Patients were categorized based on independent risk factors, revealing statistically significant differences in OS across the groups with CRS scores of ≤2, 3~4, and ≥5 (P<0.001). Conclusions: Independent risk factors associated with LMs from CRC patients include the number of negative LNs <13, pN(+) of the PT, preoperative CEA level before LMs resection ≥10 ng/ml, the number of LMs ≥2, and the necessity for hilar/mediastinal lymphadenectomy. Patients scoring 3 or higher on the CRS model may warrant cautious assessment for the appropriateness of direct surgical treatment.

目的:分析影响结直肠癌(CRC)肺转移瘤根治性切除术后预后的临床病理因素,建立临床风险评分(CRS)模型。方法:本研究回顾性收集2010年1月至2020年12月在中国医学科学院肿瘤医院行大肠癌LMs根治术的132例患者的临床病理资料和随访资料。我们使用单因素和多因素Cox比例风险回归模型分析了影响患者预后的临床病理因素,并建立了预后预测的风险分层模型。结果:132例患者的中位随访时间为54.2个月。在此期间,61例患者(46.2%)出现复发或远处转移,5年DFS率为54.1%。此外,33例(25.0%)患者死亡,对应的5年总生存率(OS)为76.7%。单因素Cox比例风险回归模型分析显示,10个临床病理因素与OS有显著相关(均P<0.05)。这些因素包括原发肿瘤(PT)中淋巴结清扫总数(LNs), HR=3.01, 95% CI: 1.28-7.03, P=0.011), PT的pN(+) (HR=5.04, 95% CI: 1.51-16.84, P=0.009), LMs切除术前术前CEA水平≥10 ng/ml (HR=5.39, 95% CI: 1.80-16.19, P=0.003), LMs数量≥2 (HR=2.47, 95% CI: 1.09-5.60, P=0.030),以及是否需要行肝门/纵隔淋巴结切除术(HR=2.74, 95% CI: 1.15-6.52, P=0.023)作为独立预后危险因素。根据独立危险因素对患者进行分类,CRS评分≤2分、3~4分和≥5分组的OS差异有统计学意义(P<0.001)。结论:与结直肠癌患者LMs相关的独立危险因素包括阴性LNs的数量
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引用次数: 0
[Clinicopathological features and surgery-related outcomes of duodenal adenocarcinoma: a multicenter retrospective study]. [十二指肠腺癌的临床病理特征和手术预后:一项多中心回顾性研究]。
Q3 Medicine Pub Date : 2025-10-23 DOI: 10.3760/cma.j.cn112152-20250120-00030
Q F Xiao, X Wu, C H Yuan, Z T Gu, X L Tang, F B Meng, D Wang, R Lang, G Zhai, X D Tian, Y Zhang, E H Zhao, X D Zhao, F Cao, J Y Xu, Y Xing, J S Wei, S M Gou, C F Wang, J W Zhang

Objective: This multicenter retrospective study aimed to analyze the clinicopathological features of duodenal adenocarcinoma (DA) and identify prognostic factors for postoperative survival. Methods: Demographic characteristics, clinicopathological features, treatment outcomes and survival of DA patients undergoing surgical treatment at 18 Chinese medical centers from January 2012 to December 2023 were retrospectively analyzed. Results: Among the 2 056 DA patients included, 46.8% (963) had extra-ampullary DA (EA-DA), and 53.2% (1 093) had peri-ampullary DA (PA-DA). The 1-, 3-, and 5-year overall survival (OS) rates for patients who underwent radical surgery were 93.2%, 71.0%, and 57.2%, respectively. The median overall survival was 76 months, and the median progression-free survival (PFS) was 65 months. No differences in survival were observed between the laparotomy group and minimally invasive surgery (MIS) group either before or after propensity score matching (OS: 76 vs. 75 months before PSM, P=0.986; OS: 75 vs. 75 months after PSM, P=0.602). Furthermore, there were no significant differences between-group in operation time and postoperative complications (P>0.05). The MIS group experienced less intraoperative blood loss and shorter hospital stays. The multivariate Cox regression analysis revealed that advanced age (HR=1.43,95% CI:1.18-1.73), elevated carbohydrate antigen 19-9 levels (HR=1.24,95% CI:1.02-1.51), perineural invasion (HR=1.44,95% CI:1.14-1.81), vascular invasion (HR=1.35,95% CI:1.07-1.71), advanced T stage (T3-4 vs. T1-2:HR=1.86,95% CI:1.49-2.31), regional lymph node metastasis (HR=1.93,95% CI:1.58-2.36), preoperative biliary drainage (HR=1.26,95% CI:1.04-1.53), intraoperative blood loss (HR=1.34,95% CI:1.11-1.62), clinically significant postoperative pancreatic fistulas (HR=1.53,95% CI:1.12-2.09), and postoperative hemorrhage (HR=1.62,95% CI:1.14-2.29) were independent risk factors for poor prognosis after surgery (all P<0.05). Conclusions: Radical surgery is associated with favorable overall survival among DA patients, and no difference in survival is observed between EA-DA and PA-DA patients. MIS is a reliable alternative for DA treatment.

目的:本多中心回顾性研究旨在分析十二指肠腺癌(DA)的临床病理特征,并确定影响术后生存的预后因素。方法:回顾性分析2012年1月至2023年12月在中国18家医疗中心接受手术治疗的DA患者的人口学特征、临床病理特征、治疗结果和生存率。结果:纳入的2056例DA患者中,46.8%(963例)为壶腹外DA (EA-DA), 53.2%(1093例)为壶腹周围DA (PA-DA)。根治性手术患者的1年、3年和5年总生存率(OS)分别为93.2%、71.0%和57.2%。中位总生存期为76个月,中位无进展生存期(PFS)为65个月。在倾向评分匹配前后,剖腹手术组和微创手术(MIS)组的生存率均无差异(PSM前76个月vs. 75个月,P=0.986; PSM后75个月vs. 75个月,P=0.602)。两组手术时间及术后并发症比较,差异无统计学意义(P < 0.05)。MIS组术中出血量少,住院时间短。多变量Cox回归分析显示,高龄(HR = 1.43, 95% CI: 1.18—-1.73),碳水化合物抗原波水平升高(HR = 1.24, 95% CI: 1.02—-1.51),神经周的入侵(HR = 1.44, 95% CI: 1.14—-1.81),血管侵犯(HR = 1.35, 95% CI: 1.07—-1.71),先进的T台(T3-4 vs T1-2: HR = 1.86, 95%置信区间CI: 1.49 - -2.31),区域淋巴结转移(HR = 1.93, 95% CI: 1.58—-2.36),术前胆道引流(HR = 1.26, 95% CI: 1.04—-1.53),术中失血(HR = 1.34, 95%置信区间CI: 1.11 - -1.62),临床显著的术后胰瘘(HR=1.53,95% CI:1.12-2.09)和术后出血(HR=1.62,95% CI:1.14-2.29)是术后预后不良的独立危险因素(P均<0.05)。结论:根治性手术与DA患者良好的总生存率相关,EA-DA和PA-DA患者的生存率无差异。MIS是一种可靠的DA治疗方法。
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引用次数: 0
[Design principles and statistical considerations in oncological non-inferiority clinical trials]. [肿瘤学非劣效性临床试验的设计原则和统计学考虑]。
Q3 Medicine Pub Date : 2025-10-23 DOI: 10.3760/cma.j.cn112152-20250304-00086
Y M Liu, T Chen, Y Wang, C Li

Non-inferiority clinical trials are a research paradigm that employs randomized controlled methods to evaluate whether the treatment effect of the experimental group is not inferior to that of the active control group within a predefined acceptable margin. This article systematically summarizes the applicable conditions, key design elements, and statistical analysis methods for non-inferiority trials. By integrating representative case studies in the field of oncology, it elucidates the unique value of non-inferiority designs in balancing benefits and risks and in optimizing therapeutic decisions. Through reviewing theoretical frameworks and addressing common misconceptions in methodological practices, this study aims to provide clear guidance for the standardized design and scientific interpretation of non-inferiority trials, thereby promoting their high-quality application in clinical research.

非劣效性临床试验是一种研究范式,它采用随机对照的方法,在预先确定的可接受范围内评价实验组的治疗效果是否不劣于积极对照组。本文系统总结了非劣效性试验的适用条件、关键设计要素和统计分析方法。通过整合肿瘤学领域的代表性案例研究,它阐明了非劣效性设计在平衡收益和风险以及优化治疗决策方面的独特价值。本研究旨在通过对非劣效性试验的理论框架进行梳理,纠正方法学实践中常见的误区,为非劣效性试验的规范化设计和科学解释提供明确的指导,从而促进其在临床研究中的高质量应用。
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引用次数: 0
[Guidelines on clinical practice of molecular tests in breast cancer in China (2025 edition)]. [中国乳腺癌分子检测临床实践指南(2025年版)]。
Q3 Medicine Pub Date : 2025-10-23 DOI: 10.3760/cma.j.cn112152-20250627-00298

Breast cancer is one of the most prevalent malignancies among women globally and ranks second in the incidence of malignant tumors among Chinese women. It has become a significant public health issue that seriously threatens women's health, highlighting the urgent need to establish a precision prevention and treatment system. Currently, the diagnosis and treatment of breast cancer have transitioned from traditional histological classification to a precision medicine phase centered on molecular characteristics, significantly enhancing the specificity and effectiveness of clinical treatments. With the rapid development of molecular biology techniques, the continuous discovery and application of new biomarkers have fueled the growing demand for molecular pathological testing in clinical settings. The widespread use of various molecular testing platforms has driven clinical decision-making from population-based and standardized approaches to individualized and refined strategies. This shift enables clinicians to more accurately assess patient prognosis and predict treatment responses, thereby formulating more appropriate treatment plans. However, the emergence of new technologies and biomarkers has also increased the requirements for standardization, normalization of testing procedures, and the establishment of quality control. While this trend brings new opportunities for precision diagnosis and treatment of breast cancer, it also poses higher demands on clinical and pathological practices, necessitating the establishment of unified precision diagnosis and treatment pathways and consensus. The "Guidelines on clinical practice of molecular tests in breast cancer in China (2025 edition)" was developed through a multidisciplinary collaboration among experts in molecular pathology and breast oncology, integrating domestic clinical realities with international advancements. We systematically evaluated evidence quality (GRADE criteria) and recommendation strength based on global clinical studies and practical experiences. The guideline aims to harmonize localized molecular diagnostic expertise with global insights, addressing critical needs in precision therapeutics, hereditary susceptibility assessment, and prognostic recurrence risk stratification. It proposes optimized clinical testing algorithms, emphasizes multidisciplinary integration, and establishes standardized protocols to ensure robust implementation of molecular diagnostics in China. This document serves as an authoritative reference for clinicians and pathologists to refine individualized patient management and jointly promotes the realization of the "Healthy China 2030" strategic goal.

乳腺癌是全球女性最常见的恶性肿瘤之一,在中国女性恶性肿瘤发病率中排名第二。它已成为严重威胁妇女健康的重大公共卫生问题,迫切需要建立精准防治体系。目前,乳腺癌的诊断和治疗已经从传统的组织学分类过渡到以分子特征为中心的精准医学阶段,显著提高了临床治疗的特异性和有效性。随着分子生物学技术的快速发展,新的生物标志物的不断发现和应用,推动了临床对分子病理检测的需求不断增长。各种分子检测平台的广泛使用推动了临床决策从基于人群和标准化的方法到个性化和精细的策略。这种转变使临床医生能够更准确地评估患者预后并预测治疗反应,从而制定更合适的治疗计划。然而,新技术和生物标志物的出现也增加了对标准化、规范化测试程序和建立质量控制的要求。这一趋势在为乳腺癌精准诊疗带来新机遇的同时,也对临床和病理实践提出了更高的要求,需要建立统一的精准诊疗路径和共识。《中国乳腺癌分子检测临床实践指南(2025年版)》是由分子病理学和乳腺肿瘤学专家多学科合作,结合国内临床实际和国际先进成果制定的。我们系统地评估了证据质量(GRADE标准)和基于全球临床研究和实践经验的推荐强度。该指南旨在协调局部分子诊断专业知识与全球见解,解决精确治疗,遗传易感性评估和预后复发风险分层方面的关键需求。提出优化临床检测算法,强调多学科整合,建立标准化方案,确保分子诊断在中国的稳健实施。为临床医生和病理学家完善个体化患者管理提供权威参考,共同推动“健康中国2030”战略目标的实现。
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引用次数: 0
[Epidemiology, prevention and control of cervical cancer in middle-aged and elderly women in China]. [中国中老年妇女宫颈癌流行病学及防治]。
Q3 Medicine Pub Date : 2025-09-23 DOI: 10.3760/cma.j.cn112152-20250121-00031
Z Wang, S M Wang, H K Wang, J Yin, Y L Qiao

Cervical cancer is one of the most common malignant tumors among women worldwide and represents a significant public health issue threatening women's health. In recent years, the disease burden of cervical cancer in China has been increasing, with women aged 45 and older bearing a particularly heavy burden. This population not only has the highest incidence and mortality rates but also represents the second peak age group for high-risk human papilloma virus (HR-HPV) infection, with the HR-HPV infection rate remaining consistently high. The causes of this situation are multifaceted. On one hand, the target group for HPV vaccination in China is women aged 9-45, which has resulted in very limited vaccination rates among middle-aged and older women when they were within the recommended age range. Additionally, this demographic has relatively low awareness of the HPV vaccine. On the other hand, aging-related declines in immune function and hormonal changes increase the risk of persistent HR-HPV infection in this group. The latent nature of HPV infection further complicates the early detection of the disease. At the same time, cervical cancer screening coverage among middle-aged and older women in China remains low and shows significant regional disparities, with screening rates in economically disadvantaged areas being markedly lower than those in more affluent regions. Furthermore, physiological changes associated with aging reduce the accuracy of conventional screening methods in this population, leading to insufficient early detection and intervention for cervical cancer. As a result, many patients are diagnosed at an advanced stage of the disease, significantly increasing treatment difficulty and disease burden. This article reviewed the burden of cervical cancer and HR-HPV infection among middle-aged and older women in China, the associated influencing factors, and the status of comprehensive prevention and control measures, aiming to provide a reference for improving cervical cancer prevention strategies for middle-aged and older women in China and contribute to the country's efforts to eliminate cervical cancer.

宫颈癌是全世界妇女中最常见的恶性肿瘤之一,是威胁妇女健康的重大公共卫生问题。近年来,中国宫颈癌的疾病负担不断增加,其中45岁及以上的女性负担尤为沉重。这一人群不仅发病率和死亡率最高,而且是高危人乳头瘤病毒(HR-HPV)感染的第二高峰年龄组,HR-HPV感染率一直很高。造成这种情况的原因是多方面的。一方面,中国HPV疫苗接种的目标群体是9-45岁的女性,这导致中老年女性在推荐年龄范围内的疫苗接种率非常有限。此外,这一人群对HPV疫苗的认识相对较低。另一方面,与年龄相关的免疫功能下降和激素变化增加了这一群体持续感染HR-HPV的风险。HPV感染的潜伏性进一步使疾病的早期检测复杂化。与此同时,中国中老年妇女宫颈癌筛查覆盖率仍然较低,且存在明显的地区差异,经济落后地区的筛查率明显低于较富裕地区。此外,与衰老相关的生理变化降低了传统筛查方法在这一人群中的准确性,导致宫颈癌的早期发现和干预不足。因此,许多患者在疾病的晚期被诊断出来,大大增加了治疗难度和疾病负担。本文综述了中国中老年妇女宫颈癌及HR-HPV感染负担、影响因素及综合防治措施现状,旨在为完善中国中老年妇女宫颈癌预防策略提供参考,为国家消除宫颈癌做出贡献。
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引用次数: 0
[Expert consensus on diagnosis and treatment of advanced non-small cell lung cancer with HER-2 alterations (2025 edition)]. 【晚期非小细胞肺癌HER-2改变诊治专家共识(2025年版)】。
Q3 Medicine Pub Date : 2025-09-23 DOI: 10.3760/cma.j.cn112152-20250414-00163
<p><p>Mutations in the human epidermal growth factor receptor 2 (HER-2) gene are recognized as significant but relatively rare driver alterations in non-small cell lung cancer (NSCLC). These mutations predominantly manifest as gene mutation, amplification, and protein overexpression, with an estimated prevalence from 2.8% to 15.4% among NSCLC patients in China. Research indicates that HER-2 mutations, particularly exon 20 insertions (ex20ins), are strongly correlated with aggressive tumor biology, poor prognosis, and limited responsiveness to immunotherapy, thereby exhibiting characteristics of "cold tumors". Overexpression and amplification of HER-2 are also indicative of a heightened risk of chemotherapy resistance and unfavorable survival outcomes, suggesting a distinct molecular subtype with unique biological behaviors. In recent years, novel antibody-drug conjugates (ADCs), particularly trastuzumab deruxtecan (T-DXd), have demonstrated groundbreaking efficacy in HER-2-mutant advanced NSCLC patients. These ADCs have shown significant clinical benefits, including high objective response rates and progression-free survival advantages, making T-DXd the first targeted therapy approved for this patient population globally. Additionally, ADCs have exhibited therapeutic potential in patients with HER-2 overexpression, thus broadening the scope of their indications. To standardize the clinical diagnosis and treatment of HER-2 variant NSCLC, the Chinese Anti-cancer Association convened multidisciplinary experts from oncology, pulmonology, thoracic surgery, pathology, and molecular diagnostics to develop this consensus based on the latest evidences from both domestic and international studies, coupled with China's clinical practice experience. This consensus focuses on the molecular characteristics, clinical significance, diagnostic strategies, treatment options, and safety management of HER-2 alterations, addressing ten critical clinical questions in a systematic manner. It is recommended that HER-2 status be routinely tested at initial diagnosis, disease progression, or recurrence in NSCLC. Mutation detection should prioritize next-generation sequencing (NGS), while protein overexpression may be assessed using immunohistochemistry (IHC) standards for gastric cancer. Fluorescence in situ hybridization (FISH) is recommended for detecting HER-2 amplification. Regarding treatment, for HER-2-mutant patients, first-line therapy may involve chemotherapy with or without immune checkpoint inhibitors (ICIs), similar to treatment approaches for driver-gene negative populations. Upon failure of first-line treatment, trastuzumab deruxtecan, may be considered as alternative therapeutic options. For patients with HER-2 overexpression, ADCs should be considered after failure of standard systemic therapy. However, the management of HER-2 amplification remains insufficiently supported by evidence, necessitating a cautious, individualized approach. The consensus also i
人表皮生长因子受体2 (HER-2)基因突变被认为是非小细胞肺癌(NSCLC)中重要但相对罕见的驱动改变。这些突变主要表现为基因突变、扩增和蛋白质过表达,在中国的NSCLC患者中估计患病率为2.8%至15.4%。研究表明,HER-2突变,特别是外显子20插入(ex20ins),与肿瘤的侵袭性、预后差和对免疫治疗的反应性有限密切相关,从而表现出“冷肿瘤”的特征。HER-2的过表达和扩增也预示着化疗耐药风险的增加和不利的生存结果,这表明HER-2是一种具有独特生物学行为的独特分子亚型。近年来,新型抗体-药物偶联物(adc),特别是曲妥珠单抗德鲁西替康(T-DXd),在her -2突变晚期NSCLC患者中显示出突破性的疗效。这些adc已显示出显著的临床益处,包括高客观缓解率和无进展生存优势,使T-DXd成为全球首个批准用于该患者群体的靶向治疗。此外,adc在HER-2过表达患者中显示出治疗潜力,从而扩大了其适应症的范围。为了规范HER-2变异型非小细胞肺癌的临床诊断和治疗,中国抗癌协会召集肿瘤学、肺科、胸外科、病理学、分子诊断等多学科专家,结合国内外最新研究证据,结合中国临床实践经验,形成了这一共识。这一共识集中在HER-2改变的分子特征、临床意义、诊断策略、治疗选择和安全管理上,以系统的方式解决了十个关键的临床问题。建议在非小细胞肺癌的初始诊断、疾病进展或复发时常规检测HER-2状态。突变检测应优先考虑下一代测序(NGS),而蛋白质过表达可使用免疫组织化学(IHC)标准评估胃癌。荧光原位杂交(FISH)被推荐用于检测HER-2扩增。关于治疗,对于her -2突变患者,一线治疗可能包括使用或不使用免疫检查点抑制剂(ICIs)的化疗,类似于驱动基因阴性人群的治疗方法。在一线治疗失败时,曲妥珠单抗德鲁德替康可作为替代治疗方案。对于HER-2过表达的患者,在标准全身治疗失败后应考虑adc。然而,HER-2扩增的管理仍然没有足够的证据支持,需要采取谨慎的个体化方法。共识还包括筛选和管理与adc相关的不良反应的详细建议,例如间质性肺疾病(ILD),强调安全管理在确保治疗效果方面的关键作用。该共识的发表旨在推动HER-2变异型NSCLC分子诊断和治疗途径的标准化,改善患者的临床结果和生活质量,促进个性化精准治疗策略的实施。
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引用次数: 0
[Expert consensus on the diagnosis and treatment of advanced non-small cell lung cancer with EGFR PACC mutations (2025 edition)]. 【EGFR PACC突变晚期非小细胞肺癌诊治专家共识(2025年版)】。
Q3 Medicine Pub Date : 2025-09-23 DOI: 10.3760/cma.j.cn112152-20250529-00247
<p><p>Lung cancer is the malignancy with the highest incidence and mortality burden globally, ranking first in both morbidity and mortality among all types of malignant tumors. Pathologically, lung cancer is classified into non-small cell lung cancer (NSCLC) and small cell lung cancer, with NSCLC accounting for approximately 85% of cases. Due to the often subtle or nonspecific clinical manifestations in early-stage disease, many patients are diagnosed at a locally advanced or metastatic stage, where treatment options are limited and prognosis remains poor. Therefore, molecular targeted therapy focusing on driver genes has become a key strategy to improve the survival outcomes of patients with advanced NSCLC. The epidermal growth factor receptor (EGFR) is one of the most common driver genes in NSCLC. While EGFR mutations occur in approximately 12% of advanced NSCLC patients globally, the incidence rises to 55.9% in Chinese patients. Among EGFR mutations, P-loop and αC-helix compressing (PACC) mutations account for about 12.5%. Currently, EGFR tyrosine kinase inhibitors (TKIs) have become the first-line standard treatment for advanced NSCLC patients with classical EGFR mutations, with efficacy well-established through clinical studies and real-world evidence. However, with rapid advancements in NSCLC precision medicine and deeper exploration of the EGFR mutation spectrum, EGFR PACC mutations have emerged as a key clinical focus. The structural characteristics of these mutations lead to significant variability in responses to EGFR TKIs, leaving therapeutic options still limited, while detection challenges persist due to the sensitivity constraints of current testing technologies, driving increasing demand for improved diagnostic and treatment approaches. The current clinical evidence primarily stems from retrospective analyses and small-scale exploratory studies, while prospective, large-scale, high-level evidence-based medical research specifically targeting this mutation subtype remains notably insufficient. This evidence gap has consequently led to the absence of standardized guidelines or expert consensus regarding optimal treatment strategies for advanced NSCLC with EGFR PACC mutations. As a clinical consensus specifically addressing EGFR PACC-mutant NSCLC, this document provides a comprehensive framework encompassing the clinical rationale for EGFR PACC mutation testing, therapeutic strategies for advanced-stage disease, management of treatment-related adverse events, and follow-up protocols. The consensus underscores the pivotal role of EGFR PACC mutation detection in precision medicine implementation while offering evidence-based recommendations to guide personalized therapeutic decision-making. By establishing clear clinical pathways encompassing molecular testing, therapeutic intervention, and long-term monitoring for EGFR PACC-mutant NSCLC, this consensus aims to meaningfully improve patient survival outcomes while serving as a robust, ev
肺癌是全球发病率和死亡率负担最高的恶性肿瘤,在各类恶性肿瘤中发病率和死亡率均居首位。肺癌在病理学上分为非小细胞肺癌(NSCLC)和小细胞肺癌,其中NSCLC约占85%。由于早期疾病的临床表现往往微妙或非特异性,许多患者被诊断为局部晚期或转移期,治疗选择有限,预后仍然很差。因此,针对驱动基因的分子靶向治疗已成为改善晚期NSCLC患者生存结局的关键策略。表皮生长因子受体(EGFR)是NSCLC中最常见的驱动基因之一。EGFR突变发生在全球约12%的晚期NSCLC患者中,而中国患者的发生率上升至55.9%。在EGFR突变中,p环和α c -螺旋压缩(PACC)突变约占12.5%。目前,EGFR酪氨酸激酶抑制剂(TKIs)已成为经典EGFR突变晚期NSCLC患者的一线标准治疗,其疗效已通过临床研究和现实证据得到证实。然而,随着NSCLC精准医学的快速发展和对EGFR突变谱的深入探索,EGFR PACC突变已成为临床关注的重点。这些突变的结构特征导致对EGFR TKIs的反应存在显著差异,使得治疗选择仍然有限,而由于当前检测技术的敏感性限制,检测挑战仍然存在,推动了对改进诊断和治疗方法的需求不断增加。目前的临床证据主要来自回顾性分析和小规模的探索性研究,而专门针对这种突变亚型的前瞻性、大规模、高水平的循证医学研究仍然明显不足。因此,这一证据差距导致缺乏关于EGFR - PACC突变晚期非小细胞肺癌最佳治疗策略的标准化指南或专家共识。作为专门针对EGFR - PACC突变NSCLC的临床共识,本文件提供了一个全面的框架,包括EGFR - PACC突变检测的临床依据、晚期疾病的治疗策略、治疗相关不良事件的管理和随访方案。该共识强调了EGFR PACC突变检测在精准医疗实施中的关键作用,同时为指导个性化治疗决策提供了循证建议。通过建立明确的临床途径,包括分子检测、治疗干预和EGFR pacc突变NSCLC的长期监测,这一共识旨在有意义地改善患者的生存结果,同时为开发个性化的临床管理方法奠定坚实的循证基础。
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引用次数: 0
[Combination of hyaluronidase and pH-responsive, IR780-loaded photosensitive micelle enhanced anticancer effect in triple-negative breast cancer]. [透明质酸酶与ph反应性、负载ir780光敏胶束的联合应用增强了三阴性乳腺癌的抗癌作用]。
Q3 Medicine Pub Date : 2025-09-23 DOI: 10.3760/cma.j.cn112152-20240726-00307
R Yang, Q H Wang, L Ming, S Li, Z Jia, J D Zhao, D Z Chen
<p><p><b>Objectives:</b> To investigate the enhancement of tumor penetration and photodynamic therapy (PDT) efficacy in triple-negative breast cancer by hyaluronidase (HAase) using a novel pH-responsive IR780-loaded photosensitive micelle. <b>Methods:</b> The pH-responsive IR780-loaded photosensitive micelles were prepared using the nanoprecipitation method, and their morphology, size, and encapsulation efficiency were characterized. The <i>in vitro</i> stability and pH-responsive drug release of the micelles were also evaluated. The cytotoxicity of the micelles on triple-negative breast cancer cells (MDA-MB-231) was assessed using a cell counting kit. A nude mouse breast cancer model was established, and HAase was injected intratumorally 24 hours before intravenous injection of the photosensitive micelles. The effect of HAase on the biodistribution and tumor uptake of the micelles was detected using small animal <i>in vivo</i> imaging. CD31 and HIF-1α immunofluorescence staining were performed to investigate the mechanism of HAase-enhanced tumor penetration. The body weight and tumor volume of the mice were measured, and necrosis and apoptosis of tumor tissues were assessed using HE staining and TUNEL staining, respectively. <b>Results:</b> Transmission electron microscopy showed that the micelles had a uniform particle size of approximately 60-70 nm, with a hydrated particle size of (98.03±0.22) nm. The IR780 encapsulation efficiency was 74.15%, with a drug loading content of 2.07%. After 7 days at 4 ℃, there was no significant change in hydrated particle size (<i>P=</i>0.062). The 24-hour release rates of the micelles in PBS at pH 7.4 and 6.5 were (2.41±0.21)% and (43.69±2.09)%, respectively, showing a significant difference (<i>P</i><0.000 1). The cytotoxicity assay revealed that the cell viability in the micelles group without light exposure was significantly higer than that in the micelles group under light exposure [(97.00±5.38)% <i>vs.</i> (53.27±9.00)%, <i>P=</i>0.000 2]. The micelles were able to target and accumulate in the tumor tissue, and this accumulation increased significantly with HAase treatment. CD31 and HIF-1α immunofluorescence staining indicated that the CD31 signal was enhanced [(0.27±0.05)% <i>vs.</i> (4.57±0.27)%, <i>P</i><0.000 1] and the HIF-1α signal was reduced [(5.14±0.38)% <i>vs.</i> (0.08±0.04)%, <i>P</i><0.000 1] in the HAase-treated group compared to that in the micelle-only group. After 11 days of treatment with HAase combined with photosensitive micelles, there was no statistically significant difference in mouse body weight (<i>P></i>0.05). However, the tumor volume inhibition rate in the HAase-micelle-mediated PDT group was significantly higher than that in the micelle-mediated PDT group [(87.66±6.37)% <i>vs.</i> (25.34±12.63)%, <i>P=</i>0.002]. Histological staining showed a significant increase in tumor cell necrosis and apoptosis in the HAase-micelle-mediated PDT group. <b>Conclusion:</b> HAase enhances t
目的:研究透明质酸酶(HAase)在三阴性乳腺癌中对肿瘤穿透和光动力治疗(PDT)效果的增强作用。方法:采用纳米沉淀法制备ph响应型负载ir780光敏胶束,并对其形貌、尺寸和包封效率进行表征。并对胶束的体外稳定性和ph响应性药物释放进行了评价。使用细胞计数试剂盒评估胶束对三阴性乳腺癌细胞(MDA-MB-231)的细胞毒性。建立裸鼠乳腺癌模型,在静脉注射光敏胶束前24小时瘤内注射HAase。利用小动物体内成像技术检测HAase对胶束生物分布和肿瘤摄取的影响。采用CD31和HIF-1α免疫荧光染色研究haase增强肿瘤穿透的机制。测定小鼠体重和肿瘤体积,分别采用HE染色和TUNEL染色观察肿瘤组织坏死和凋亡情况。结果:透射电镜显示,胶束粒径均匀,约为60 ~ 70 nm,水合粒径为(98.03±0.22)nm, IR780包封率为74.15%,载药量为2.07%。4℃处理7 d后,水化颗粒大小无显著变化(P=0.062)。pH为7.4和6.5时,胶束在PBS中的24小时释放率分别为(2.41±0.21)%和(43.69±2.09)%,差异有统计学意义(P<0.000 1)。细胞毒性试验结果显示,未光照胶束组细胞活力显著高于光照胶束组[(97.00±5.38)% vs(53.27±9.00)%,P=0.000 2]。胶束能够靶向并在肿瘤组织中积累,并且这种积累在HAase治疗后显著增加。CD31和HIF-1α免疫荧光染色结果显示,与单纯胶束组相比,haase治疗组CD31信号增强[(0.27±0.05)%比(4.57±0.27)%,P<0.000 1], HIF-1α信号减弱[(5.14±0.38)%比(0.08±0.04)%,P<0.000 1]。HAase联合光敏胶束治疗11 d后,小鼠体重差异无统计学意义(P < 0.05)。然而,haase -胶束介导PDT组的肿瘤体积抑制率明显高于胶束介导PDT组[(87.66±6.37)% vs(25.34±12.63)%,P=0.002]。组织学染色显示,haase -胶束介导的PDT组肿瘤细胞坏死和凋亡明显增加。结论:HAase增强了ph响应性ir780负载光敏胶束的肿瘤深度穿透和靶向蓄积,显著提高了光动力治疗三阴性乳腺癌的疗效。
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中华肿瘤杂志
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