境外医学信息网 · 2026-10-05
东京节点自动汇总：指南共识 / 顶级期刊目次 / 药监动态 / 临床试验。时间窗为近 7 天，只列新出现的条目（已见过的自动过滤）。每条中文在前、英文原文随后（药名与批号保留英文）。本文与当日《医学文献雷达》一并存入腾讯文档。
一、指南与共识（PubMed · 近 7 天）
二、顶级期刊目次
NEJM
- Andes Virus — 临床综述 ｜ Andes Virus — A Clinical Review ｜ 原文
- 帕博利珠单抗联合Belzutifan辅助治疗肾细胞癌 ｜ Adjuvant Pembrolizumab plus Belzutifan for Renal-Cell Carcinoma ｜ 原文
- 头孢唑林用于甲氧西林敏感金黄色葡萄球菌菌血症 ｜ Cefazolin for Methicillin-Susceptible Staphylococcus aureus Bacteremia ｜ 原文
- 再论狼疮中的NETs ｜ More on NETs in Lupus ｜ 原文
Lancet
- 财富再分配能否抵消援助崩溃？ ｜ Can wealth redistribution offset the collapse of aid? ｜ 原文01814-3/fulltext?rss=yes)
- 埃博拉病毒病患者的姑息关怀 ｜ Compassionate care for patients with Ebola virus disease ｜ 原文01770-8/fulltext?rss=yes)
- 高质量导师制可改善医师-科学家的招募、留任与职业满意度 ｜ High-quality mentorship can improve physician-scientist recruitment, retention, and career satisfaction ｜ 原文01707-1/fulltext?rss=yes)
- 离线：时间能否被驯服？ ｜ Offline: Can time be tamed? ｜ 原文01979-3/fulltext?rss=yes)
JAMA
- 体能评估可有助于指导老年人照护 ｜ Physical Fitness Assessments Could Help Guide Older Adult Care ｜ 原文
- 新研究提示高血压普遍治疗不足 ｜ Hypertension Widely Undertreated, New Study Suggests ｜ 原文
- 将衰老纳入心血管照护 ｜ Expanding Cardiovascular Care to Incorporate Aging ｜ 原文
- 外文来信 ｜ Foreign Letters ｜ 原文
Nat Rev Urol
- 寡转移性前列腺癌——弥合局限性与转移性疾病之间的差距 ｜ Oligometastatic prostate cancer - bridging the gap between localized and metastatic disease. ｜ 原文
- 肾细胞癌辅助免疫治疗：理解复杂性、拥抱不确定性、有所作为 ｜ Adjuvant immunotherapy for renal cell carcinoma: understanding complexity, embracing uncertainty, making a difference. ｜ 原文
- 女性膀胱癌预后较男性更差——偏倚、生物学还是两者兼有？ ｜ Worse bladder cancer outcomes in women than in men - bias, biology or both? ｜ 原文
Eur Urol
- 越来越多的证据支持NECTIN4作为Enfortumab Vedotin的预测性生物标志物： compartment仍重要 ｜ Accumulating Evidence Supports NECTIN4 as a Predictive Biomarker for Enfortumab Vedotin: The Compartment Still Matters ｜ 原文
- 回复Paolo Zaurito致编辑的信，关于Robert M. Meier、Nima Aghdam、Alan C. Beckman等：前列腺癌立体定向体部放疗的10年生存与毒性结局：一项非随机临床试验。Eur Urol。印刷中。http://dx.doi.org/10.1016/j.eururo.2026.04.029 ｜ Reply to Paolo Zaurito’s Letter to the Editor re: Robert M. Meier, Nima Aghdam, Alan C. Beckman, et al. 10-yr Survival and Toxicity Outcomes of Stereotactic Body Radiotherapy for Prostate Cancer: A Nonrandomized Clinical Trial. Eur Urol. In press. http://dx.doi.org/10.1016/j.eururo.2026.04.029 ｜ 原文
- 回复Riccardo Lombardo致编辑的信，关于Bi-Ming He、Keqin Zhang、Zhien Zhou等：认知融合与软件融合靶向前列腺活检诊断临床显著性前列腺癌：一项多中心、随机、非劣效性试验（IMAGINATION）。Eur Urol。印刷中。http://dx.doi.org/10.1016/j.eururo.2026.06.020 ｜ Reply to Riccardo Lombardo’s Letter to the Editor re: Bi-Ming He, Keqin Zhang, Zhien Zhou, et al. Cognitive Versus Software-based Fusion targeted Biopsy for the Diagnosis of Clinically Significant Prostate Cancer: A Multicenter, Randomized, Noninferiority Trial (IMAGINATION). Eur Urol. In press. http://dx.doi.org/10.1016/j.eururo.2026.06.020 ｜ 原文
- 回复：Pierre-Etienne Gabriel, Alec Zhu, Paolo Gontero, Morgan Rouprêt, Evanguelos Xylinas, John P Sfakianos. BCG无应答NMIBC：在多模式及不断演进的治疗格局中一个过时的定义。Eur Urol。出版中。http://dx.doi.org/10.1016/j.eururo.2026.03.028 ｜ Re: Pierre-Etienne Gabriel, Alec Zhu, Paolo Gontero, Morgan Rouprêt, Evanguelos Xylinas, John P Sfakianos. BCG-unresponsive NMIBC: An Obsolete Definition in a Multimodal and Evolving Therapeutic Landscape. Eur Urol. In press. http://dx.doi.org/10.1016/j.eururo.2026.03.028 ｜ 原文
BJU Int
- 早发性前列腺癌中母系和父系亲属的三代家族风险 ｜ Three‐generation familial risks in early‐onset prostate cancer with maternal and paternal relatives ｜ 原文
- 迈向可持续的多学科肾癌肿瘤委员会：重新设计转诊路径 ｜ Towards sustainable multidisciplinary renal cancer tumour boards: redesigning the referral pathway ｜ 原文
- 选定STAMPEDE定义的高危前列腺癌中保留神经机器人辅助根治性前列腺切除术后的肿瘤学和控尿结局 ｜ Oncological and continence outcomes after nerve‐sparing robot‐assisted radical prostatectomy in selected STAMPEDE‐defined high‐risk prostate cancer ｜ 原文
J Urol
- 理解新辅助治疗现代时代的膀胱保留策略。 ｜ Understanding Bladder-Sparing Approach in the Modern Era of Neoadjuvant Therapy. ｜ 原文
- 交替膀胱内灌注吉西他滨和卡介苗（GemBCG）化学免疫治疗用于BCG暴露的高级别非肌层浸润性膀胱癌的I期临床试验。 ｜ A Phase I Clinical Trial of Chemoimmunotherapy with Alternating Intravesical Gemcitabine and Bacillus Calmette-Guérin (GemBCG) for BCG-Exposed High-Grade Non-Muscle-Invasive Bladder Cancer. ｜ 原文
- 门诊泌尿外科、围手术期护理、尿流改道。 ｜ Office Urology, Perioperative Care, Urinary Diversions. ｜ 原文
三、药监动态
FDA 新药原始批准（NDA/BLA，近 30 天）
- （近 30 天无 NDA/BLA 原始批准；仿制药 24 个未列）
FDA 药品召回/质量警示（openFDA，近 30 天）
- Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufacture ｜ 溶出度不合格（Failed Dissolution Specifications） ｜ 召回日 20260923
- Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Indust ｜ 稳定性不合格（Failed Stability Specifications） ｜ 召回日 20260923
- Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per t ｜ 无菌保证缺失（Lack of Assurance of Sterility） ｜ 召回日 20260923
- fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% ｜ 标签：未另行分类：2026年8月31日收到投诉（Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 r） ｜ 召回日 20260916
- Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dro ｜ 效价不足药品（Subpotent Drug） ｜ 召回日 20260916
- Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx O ｜ 存在颗粒物及无菌保证缺失。（Presence of Particulate Matter and Lack of Assurance of Sterility. Par） ｜ 召回日 20260916
- Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Market ｜ 杂质/降解不合格：（OOS）有机杂质（Failed impurities/degradation specifications: (OOS) for Organic Impuri） ｜ 召回日 20260916
- Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporat ｜ 存在颗粒物：颗粒物鉴定为污渍（Presence of Particulate Matter: particulate matter identified as stain） ｜ 召回日 20260916
EMA 新药（新意见）
- Zeydovio（glepaglutide） ｜ 状态：意见（Status: Opinion） ｜ 原文
- Xervyteg（Allogeneic faecal microbiota） ｜ 汇总，状态：意见（pooled, Status: Opinion） ｜ 原文
- VaxRabeo（rabies vaccine (inactivated) for human） ｜ 状态：意见（Status: Opinion） ｜ 原文
- Qezzaqar（catequentinib） ｜ 状态：意见（Status: Opinion） ｜ 原文
EMA 新闻
- 人用药品委员会（CHMP）2026年9月14-17日会议要点 ｜ Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026 ｜ 原文
- 兽用药品委员会（CVMP）2026年9月8-10日会议要点 ｜ Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 September 2026 ｜ 原文
- 新欧盟供应链将终结Visudyne短缺 ｜ New EU supply chain to end Visudyne shortage ｜ 原文
四、临床试验（ClinicalTrials.gov · 近 7 天有更新）
- [212Pb]VMT-Alpha-NET用于转移性或不可手术的生长抑素受体阳性胃肠神经内分泌肿瘤 ｜ [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, ｜ RECRUITING ｜ PHASE1 · National Cancer Institute (NCI) ｜ 更新 2026-10-02 ｜ 原文
- 经双侧、3D超声引导下前列腺局灶热消融术后功能结局评估 ｜ Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Trans ｜ TERMINATED ｜ PHASE2 · Assistance Publique - Hôpitaux de Paris ｜ 更新 2026-10-01 ｜ 原文
- 术前盆底物理治疗以减少钬激光前列腺剜除术后压力性尿失禁 ｜ Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of th ｜ ACTIVE_NOT_RECRUITING ｜ NA · The Cleveland Clinic ｜ 更新 2026-09-30 ｜ 原文
- 经会阴前列腺活检与消融同步进行（Bioblation）治疗前列腺癌 ｜ Concomitant Trans-Perineal Prostate Biopsy and Ablation (Bioblation) for Prostate Cancer ｜ RECRUITING ｜ NA · Benha University ｜ 更新 2026-09-30 ｜ 原文
- 前列腺癌合并BPH患者Urolift术前SBRT以降低泌尿毒性 ｜ Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer. ｜ RECRUITING ｜ NA · Northwell Health ｜ 更新 2026-09-29 ｜ 原文
- 前列腺切除术后早期停用α受体阻滞剂（CLEAR试验） ｜ Ceasing Alpha-blockers Early After Resection of the Prostate (The CLEAR Trial) ｜ NOT_YET_RECRUITING ｜ PHASE4 · Shanghai East Hospital ｜ 更新 2026-09-29 ｜ 原文
- 上市后研究评估iTind与UroLift的安全性比较 ｜ Post-Market Study to Assess iTind Safety in Comparison to UroLift ｜ RECRUITING ｜ NA · Olympus Corporation of the Americas ｜ 更新 2026-09-29 ｜ 原文
- 门诊长时程尿动力学评估 ｜ Ambulatory Long Length URodynamics Evaluation ｜ RECRUITING ｜ NA · Bright Uro ｜ 更新 2026-09-28 ｜ 原文
- 阴道普拉睾酮与雌三醇用于盆底功能障碍女性的比较 ｜ Vaginal Prasterone Versus Estriol in Women With Pelvic Floor Disorders ｜ COMPLETED ｜ NA · Poznan University of Medical Sciences ｜ 更新 2026-10-02 ｜ 原文
- 尿动力学系统可靠性试验 ｜ Trial for Reliability of Urodynamics SysTem ｜ COMPLETED ｜ NA · Bright Uro ｜ 更新 2026-10-01 ｜ 原文
- Voro泌尿支架关键性研究 ｜ Pivotal Study of Voro Urologic Scaffold ｜ ACTIVE_NOT_RECRUITING ｜ PHASE3 · Levee Medical, Inc. ｜ 更新 2026-09-30 ｜ 原文
- 多模式多维干预对年轻未产女性运动员尿失禁的影响 ｜ Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes. ｜ RECRUITING ｜ NA · Centre Hospitalier Universitaire de Saint Etienne ｜ 更新 2026-09-30 ｜ 原文
- NASHA Dx尿道填充系统试验 ｜ Trial of NASHA Dx Urethral Bulking System ｜ NOT_YET_RECRUITING ｜ NA · Palette Life Sciences, Inc. ｜ 更新 2026-09-30 ｜ 原文
- 盆底肌训练与普拉提运动治疗尿失禁的比较 ｜ Pelvic Floor Muscle Training vs. Pilates Exercises for Urinary Incontinence ｜ COMPLETED ｜ NA · Universidade Estadual do Norte do Parana ｜ 更新 2026-09-30 ｜ 原文
- 睾酮治疗勃起功能障碍与多发性硬化症 ｜ Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis ｜ WITHDRAWN ｜ PHASE4 · Tulane University ｜ 更新 2026-10-02 ｜ 原文
- 冲击波治疗保留神经根治性前列腺切除术后勃起功能障碍 ｜ Shockwave Therapy on Treating Erectile Dysfunction Following Nerve-sparing Radical Prostatectomy. ｜ NOT_YET_RECRUITING ｜ NA · University of Manitoba ｜ 更新 2026-09-30 ｜ 原文
- VERTICA® RF设备治疗ED的安全性与有效性 ｜ Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED ｜ ACTIVE_NOT_RECRUITING ｜ NA · OHH-MED Medical Ltd ｜ 更新 2026-09-29 ｜ 原文
- AIM-TEST：微生物组靶向营养治疗功能性继发性性腺功能减退症 ｜ AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism ｜ ENROLLING_BY_INVITATION ｜ NA · Varol TUNALI ｜ 更新 2026-09-29 ｜ 原文
- 弥散张量成像引导的前列腺癌保留神经术 ｜ Tractography-Guided Nerve-Sparing in Prostate Cancer ｜ RECRUITING ｜ NA · Massimo Valerio ｜ 更新 2026-09-29 ｜ 原文
- PLEASURE（Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon） ｜ PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon) ｜ SUSPENDED ｜ PHASE4 · University of Miami ｜ 更新 2026-09-28 ｜ 原文
- 超声在RIRS中检测残留碎片的准确性 ｜ Accuracy of Ultrasound for Detecting Residual Fragments During RIRS ｜ TERMINATED ｜ NA · University of California, San Francisco ｜ 更新 2026-10-01 ｜ 原文