Intrauterine device (IUD) insertion is a common contraceptive procedure often associated with moderate to severe pain, particularly among nulliparous individuals. Current pain management strategies, such as over-the-counter analgesics, are frequently inadequate. Methoxyflurane, a short-acting, self-administered inhaled analgesic, has been shown to provide rapid and effective pain relief in acute and procedural settings. This study aims to evaluate whether 3 mL of inhaled Methoxyflurane (via Penthrox inhaler) improves patient satisfaction by reducing pain and anxiety during IUD insertion.

开始日期2026-02-01

申办/合作机构

Women's College Hospital

TCTR20250920004

/ Not yet recruiting临床3期IIT

Efficacy of methoxyflurane on Tourniquet pain and intra-operative pain relief in endoscopic carpal tunnel release: a randomized controlled trial

开始日期2025-09-15

申办/合作机构-

NCT07017452

/ Not yet recruiting临床3期

Methoxyflurane + Lorazepam + Percocet (Per os) vs Deep Intravenous Sedation: A Non-inferiority Randomized Controlled Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia

The primary aim of the study is to show that methoxyflurane-lorazepam-percocet combination administrated 'per os' is non inferior to deep intravenous sedation in achieving analgesia during Rezum convective radiofrequency water vapor thermal therapy for the management of benign prostate hyperplasia (BPH). We propose to conduct a single-centered, unblinded, randomized controlled trial designed after consulting ICH Guidelines for Good Clinical Practice as well the regulations set by the Biomedical Research Ethics Board, University of Manitoba.

开始日期2025-08-01

申办/合作机构

University of Manitoba

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100 项与甲氧氟烷相关的转化医学

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100 项与甲氧氟烷相关的专利（医药）

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项与甲氧氟烷相关的文献（医药）

2026-02-01·REGULATORY TOXICOLOGY AND PHARMACOLOGY

Methoxyflurane exposure in ambulances: a controlled laboratory study on paramedic safety

Article

作者: MacLeod, Jonathan ; Cantor, Zachary ; Austin, Michael A ; Mao, Somalin

Methoxyflurane, a self-administered fluorinated hydrocarbon, provides rapid, relief for traumatic pain. While low-dose methoxyflurane poses minimal risk, paramedics may experience intermittent exposure. This study assesses occupational risks to enhance paramedic safety, health standards, and patient care directives. Active air sampling was conducted in a Ministry of Health-approved ambulance, in the driver and patient compartment, under controlled conditions, both with and without ventilation. Twelve healthy participants inhaled for 15 min, with samples collected per EPA and ISO standards. Results were adjusted for time weighted average (TWA) exposure. Twenty-four air samples were collected (median age 30.5 years, 50 % female). Exposure concentrations remained below 8-h TWA occupational limits and NIOSH 60-min ceiling limits. With ventilation, 8-h TWA levels were 0.001 ppm (driver) and 0.033 ppm (patient compartment), rising to 0.017 ppm and 0.057 ppm without ventilation. Maximum TWA levels for 22 transports (30-min duration) reached 0.019 ppm (driver) and 0.736 ppm (patient) with ventilation, increasing to 0.377 ppm and 1.254 ppm without. These were based upon worst-case assumptions of 22 treatment and transport events, each lasting 30 min, over a 12 h work shift. Ventilation significantly reduced exposure, with 99.1 % protocol adherence and no adverse events. This controlled study confirms methoxyflurane's safe use in ambulances with exposure well below safety thresholds. Ventilation minimizes potential risk(s), ensuring paramedic safety and uninterrupted pain management.

2025-12-01·REGIONAL ANESTHESIA AND PAIN MEDICINE

Analgesic effectiveness of methoxyflurane inhaler during genicular nerve block in knee osteoarthritis: a randomized controlled trial

Article

作者: Seangrung, Rattaphol ; Kimpee, Pretimon ; Cohen, Steven Paul ; Itthichaikulthol, Wichai ; Limpoon, Suwimon ; Sawang, Saowanee ; Pasutharnchat, Koravee ; Tontisirin, Nuj

Background:

Up to 30% of patients with knee osteoarthritis (KOA) have evidence of sensitization, with a similar proportion experiencing severe pain during procedures. Most patients with KOA are elderly and often develop side effects from intravenous sedation. Our study investigated the effectiveness of a methoxyflurane inhaler combined with local anesthesia in reducing procedural pain from genicular nerve block compared with local anesthesia alone.

Methods:

42 adults with refractory KOA were randomized into two groups. Methoxyflurane group received a self-titrated methoxyflurane inhaler with local anesthesia whereas lidocaine group received local anesthesia only. The primary outcome was pain score on a 0–10 verbal numerical rating scale (VNRS) during the procedure. Secondary outcomes included changes in VNRS and behavioral pain scale (critical care pain observational tool) during the procedure, hemodynamic changes, anxiety level, sedation score, and adverse events.

Results:

42 patients with a mean age of 66±12 years participated in this study. There were no significant baseline differences. During the procedure, the methoxyflurane group experienced a significantly greater VNRS pain reduction from baseline (2 (1, 4) vs −1 (−2, 0); p<0.01) and greater VNRS reduction over time (p=0.01) compared with the lidocaine group, with a higher sedation score (p<0.01). Immediately postprocedure, anxiety levels were lower in the methoxyflurane group compared with the lidocaine group (median State-Trait Anxiety Inventory score 21 (IQR 20, 24) vs 27 (23, 29); p=0.02), but the median reduction in anxiety level was not significant (6 (1, 12) vs 5 (0, 14); p=0.61). There were no differences in behavioral pain scores, hemodynamic parameters, recovery or discharge times, and adverse effects between the two groups.

Conclusion:

A methoxyflurane inhaler combined with local anesthesia provided better procedural pain control than local anesthesia alone with no observable differences in adverse effects. Future studies evaluating the impact of a methoxyflurane inhaler on different types of painful procedures are warranted.

2025-12-01·LANCET

Comparison of inhalational methoxyflurane, intranasal fentanyl, and intravenous morphine for treatment of prehospital acute pain in Norway (PreMeFen): a randomised, non-inferiority, three-arm, phase 3 trial

Article

作者: Heyerdahl, Fridtjof ; Smalberget, Live ; Simensen, Randi ; Rehn, Marius ; Hagemo, Jostein ; Thorsen, Kjetil ; Fjose, Lars Olav ; Olsen, Inge Christoffer

BACKGROUND:

Adequate pain control is essential; however, acute pain is often undertreated in prehospital care. This study aimed to evaluate three analgesic regimens for treating acute pain in an ambulance setting.

METHODS:

PreMeFen is a randomised, open-label, non-inferiority, three-arm, phase 3 trial conducted in the working areas of the ground ambulance service of the Innlandet Hospital Trust, Norway. Patients aged 18-69 years and 70 years and older with traumatic or medical acute pain scoring 4 or higher on the Numeric Rating Scale (NRS) were randomly assigned (1:1:1) to receive in titration doses 3 mL inhalational methoxyflurane, 50 μg or 100 μg intranasal fentanyl, or 0·05 mg/kg or 0·1 mg/kg intravenous morphine, respectively, depending on the age group. The primary endpoint was change in pain NRS score from baseline to 10 min after treatment start and was analysed per protocol. The non-inferiority margin was 1·3. This trial is registered with ClinicalTrials.gov (NCT05137184) and is completed.

FINDINGS:

Between Nov 12, 2021, and April 22, 2023, 632 patients were assessed for eligibility, and 338 were randomly assigned to methoxyflurane (n=112), fentanyl (n=115), or morphine (n=111). 281 patients were included in the per-protocol population. 145 (52%) of 281 patients were female and 136 (48%) were male. Median age was 61 years (IQR 47-75). The baseline NRS score was 7·6 (SD 1·8). Mean NRS score changes after 10 min were -3·31 (SD 2·67) for methoxyflurane, -1·98 (2·28) for fentanyl, and -2·74 (2·12) for morphine. Comparing changes in mean NRS score while adjusting for baseline showed that methoxyflurane was non-inferior to fentanyl (-1·33 [95% CI -2·01 to -0·64]) and morphine (-0·36 [-1·03 to 0·31]). Intranasal fentanyl was not non-inferior to morphine at 10 min (0·91 [0·27 to 1·55]). Adverse events occurred in 26 (24%) of 109 patients in the morphine group, 27 (24%) of 112 in the fentanyl group, and 24 (22%) of 111 in the methoxyflurane group. Two serious adverse events, respiratory depression (grade 2) and loss of consciousness (grade 3), occurred in the same patient in the methoxyflurane group. There were no treatment-related deaths.

INTERPRETATION:

Inhalational methoxyflurane is non-inferior to intranasal fentanyl and intravenous morphine for acute pain management in the prehospital environment, assessed 10 min after administration. Inhalational methoxyflurane serves as a valuable non-intravenous alternative in the early phase of treatment and might bridge the gap to longer-acting analgesics.

FUNDING:

Norwegian Air Ambulance Foundation and Innlandet Hospital Trust.

项与甲氧氟烷相关的新闻（医药）

2025-12-24

·誉文学术翻译润色

《The Lancet》20251220日最新4篇前沿研究导读(译文)

The Lancet Dec 20, 2025 Volume 406Number 10522 https://www.thelancet.com/journals/lancet/issue/current Table of contents (目录) 1. The Lancet最新：用于治疗2型糖尿病患者肥胖症的口服小分子胰高血糖素样肽-1受体激动剂奥福格利普隆（ATTAIN-2）：3期、双盲、随机、多中心、安慰剂对照试验 1 Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial 1 Prof Deborah B Horn, Prof Donna H Ryan 1 2. The Lancet最新：术前mFOLFIRINOX与PAXG对I–III期可切除和边缘可切除的胰腺导管腺癌患者的效果对比（PACT-21 CASSANDRA）：随机、开放标签、2×2析因、3期试验的首次随机分析结果 2 Preoperative mFOLFIRINOX versus PAXG for stage I–III resectable and borderline resectable pancreatic ductal adenocarcinoma (PACT-21 CASSANDRA): results of the first randomisation analysis of a randomised, open-label, 2 × 2 factorial phase 3 trial 2 Michele Reni, Marina Macchini 2 3. The Lancet对比：吸入性甲氧氟烷、鼻内芬太尼、静脉注射吗啡对挪威院前急性疼痛的疗效比较（PreMeFen）：随机、非劣效性、三臂、3期试验 3 Comparison of inhalational methoxyflurane, intranasal fentanyl, and intravenous morphine for treatment of prehospital acute pain in Norway (PreMeFen): a randomised, non-inferiority, three-arm, phase 3 trial 3 Randi Simensen, Lars Olav Fjose 3 4. The Lancet揭示：异基因CD19嵌合抗原受体自然杀伤细胞疗法在系统性红斑狼疮中的疗效与安全性：中国病例系列研究 4 Efficacy and safety of allogeneic CD19 CAR NK-cell therapy in systemic lupus erythematosus: a case series in China 4 Jie Gao, Mengtao Li 4 1. The Lancet最新：用于治疗2型糖尿病患者肥胖症的口服小分子胰高血糖素样肽-1受体激动剂奥福格利普隆（ATTAIN-2）：3期、双盲、随机、多中心、安慰剂对照试验 Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial Prof Deborah B Horn, Prof Donna H Ryan https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02165-8/abstract 摘要背景肥胖是一种慢性疾病，会显著增加罹患2型糖尿病（T2D）及其并发症的风险。本研究旨在评估口服小分子（非肽类）GLP-1受体激动剂奥福格利普隆对T2D成年患者的肥胖治疗效果。方法在10个国家136个研究点进行为期72周的3期、双盲、安慰剂对照试验。参与者体重指数（BMI）为27 kg/m2以上、糖化血红蛋白（HbA1c）为7–10%（53–86 mmol/mol）。随机分配参与者（1：1：1：2），分别接受奥福格利普隆（6 mg、12 mg、36 mg）或安慰剂治疗，每日一次。主要终点指标为第72周时体重相对于基线的平均变化百分比。基于所有随机分配的参与者数据，评估治疗方案估值（不考虑是否发生并发事件），作为主要估计指标，而疗效估值有一定支持作用。在所有至少接受一剂研究药物的患者中评估安全性。试验已在ClinicalTrials.gov注册（NCT05872620），现已完成。发现 2023年6月5日至2024年2月15日，共筛查2859名参与者，随机分配其中1613人（女性757人【46.9%】），按剂量递增阶段，分别采用6-mg（n = 329）、12-mg（n = 332）、36-mg（n = 322）奥福格利普隆或安慰剂（n = 630），通过调整生活方式进行辅助治疗。共1444人（89.5%）完成研究。基线体重为101.4 kg（SD：22.5），BMI为35.6 kg/m2（SD：6.6），HbA1c为8.05%（SD：0.75；64.4 mmol/mol【SD：8.2】）。对于治疗方案估值，从基线到第72周，与安慰剂组的体重平均百分比变化–2.5%（–3.0至–1.9）相比，6-mg、12-mg、36-mg奥福格利普隆组分别为–5.1%（95%CI：–6.0至–4.2）（估计治疗差异【ETD】：–2.7%【95%CI：–3.7至–1.6】；p < 0.0001）、–7·0%（–7.8至–6.2）（ETD：–4.5【–5.5至–3.6】；p < 0.0001）、–9.6%（–10.5至–8.7）（ETD：–7.1【–8.2至–6.1】；p < 0.0001）。使用奥福格利普隆治疗后，所有预设体重和心血管代谢指标（HbA1c等）均有显著改善。不良事件主要为胃肠道相关事件，奥福格利普隆组因不良事件而停止治疗的患者比例（6.1–9.9%）高于安慰剂组（4.1%）。奥福格利普隆治疗的最常见不良反应为轻中度胃肠道症状，主要发生在剂量递增期间。研究期间，共报告10例死亡病例：奥福格利普隆组6例，安慰剂组4例。除安慰剂组一例和12-mg奥福格利普隆组一例外，其他死亡病例均与研究治疗无关。奥福格利普隆组的死亡病例与治疗无关。解释对于肥胖或超重T2D成年患者，每日一次奥福格利普隆，可通过调整生活方式进行辅助治疗。与安慰剂相比，其减重效果具有显著的统计学优势，且安全性与其他GLP-1受体激动剂相似。 2. The Lancet最新：术前mFOLFIRINOX与PAXG对I–III期可切除和边缘可切除的胰腺导管腺癌患者的效果对比（PACT-21 CASSANDRA）：随机、开放标签、2×2析因、3期试验的首次随机分析结果 Preoperative mFOLFIRINOX versus PAXG for stage I–III resectable and borderline resectable pancreatic ductal adenocarcinoma (PACT-21 CASSANDRA): results of the first randomisation analysis of a randomised, open-label, 2 × 2 factorial phase 3 trial Michele Reni, Marina Macchini https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01685-X/abstract 摘要背景围手术期化疗是可切除及边缘可切除胰腺导管腺癌（PDAC）患者的常规治疗手段。本研究旨在评估PAXG（顺铂、白蛋白紫杉醇、卡培他滨和吉西他滨）相对于mFOLFIRINOX（改良的氟尿嘧啶、亚叶酸钙、伊立替康和奥沙利铂）对PDAC患者的优越性。方法 CASSANDRA是在意大利17家学术医院进行的随机、开放标签、2×2析因、3期临床试验。符合条件的患者年龄在18–75岁之间，且病理确诊为可切除或边缘可切除的PDAC。采用中央网络系统进行随机分组，系统使用带有计算机算法的R代码列表进行操作。设计采用1:1随机分组，同时按中心和糖类抗原19-9进行分层。首先随机分配参与者，分别接受PAXG或mFOLFIRINOX治疗，为期4个月。具体而言，PAXG组卡培他滨总日剂量为 1250 mg/m2，每日分两次服用，单次剂量625 mg/m2；每14天静脉注射一次顺铂（30 mg/m2）、白蛋白紫杉醇（150 mg/m2）、吉西他滨（800 mg/m2）。在mFOLFIRINOX组，每14天静脉注射一次氟尿嘧啶（2400 mg/m2）、亚叶酸钙（400 mg/m2）、伊立替康（150 mg/m2）、奥沙利铂（85 mg/m2）。随后进行第二次随机分组，在手术前或手术后进行为期2个月的额外化疗。主要终点指标为意向性治疗人群的无事件生存期（EFS），安全性人群包括至少接受过一次指定治疗的患者。本研究报告了首次随机分组的结果。试验已在ClinicalTrials.gov（NCT04793932）、及EudraCT（2020-003080-26和2024-519031-42-00）注册。试验已完成入组工作，完成了首次随机分组后初步分析所需的必要事件，但总体生存随访仍在进行中。发现 2020年11月3日至2024年4月24日，132名符合条件的患者分配至PAXG组，128名患者分配至mFOLFIRINOX组。PAXG组患者的中位年龄为65岁（IQR：60–70岁），132名患者中，女性68名（52%），男性64名（48%）。mFOLFIRINOX组患者的中位年龄为63岁（IQR：57–69岁），128名患者中，女性62名（48%），男性66名（52%）。所有260名患者均接受至少一次指定化疗。PAXG组患者的中位无进展生存期显著长于mFOLFIRINOX组（16.0个月【95%CI：12.4–19.8】vs 10.2个月【8.6–13.5】；风险比0.63【0.47–0.84】；p = 0.0018）。PAXG组87名（66%）患者、mFOLFIRINOX组78名（61%）患者至少出现一次3级或更严重不良反应，包括1例致命事件。解释与mFOLFIRINOX方案相比，PAXG方案显著提高了可切除或边缘可切除PDAC患者的EFS。术前PAXG治疗是可切除或边缘可切除胰腺癌的标准治疗方案。术前PAXG应作为未来相关试验的标准对照组。 3. The Lancet对比：吸入性甲氧氟烷、鼻内芬太尼、静脉注射吗啡对挪威院前急性疼痛的疗效比较（PreMeFen）：随机、非劣效性、三臂、3期试验 Comparison of inhalational methoxyflurane, intranasal fentanyl, and intravenous morphine for treatment of prehospital acute pain in Norway (PreMeFen): a randomised, non-inferiority, three-arm, phase 3 trial Randi Simensen, Lars Olav Fjose https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01575-2/abstract 摘要背景疼痛的有效控制至关重要；但在院前急救中，急性疼痛往往无法充分缓解。本研究旨在评估救护车中用于治疗急性疼痛的三种镇痛方案。方法在挪威Innlandet医院信托机构的地面急救服务工作区域开展随机、开放标签、非劣效性、三臂、3期临床试验PreMeFen。患者年龄18岁以上，在数字评分量表（NRS）上的急性创伤或医疗性疼痛评分达4分或更高。随机分配患者（1：1：1），在滴定剂量下接受吸入性甲氧氟烷（3 mL）、鼻内芬太尼（50 μg或100 μg）或静脉注射吗啡（0.05或0.1 mg/kg），具体剂量依据年龄组确定。主要终点指标为治疗10分钟后疼痛NRS评分相对于基线的变化情况，并按方案进行分析。非劣效性界值为1.3。试验已在ClinicalTrials.gov（NCT05137184）注册，现已完成。发现 2021年11月12日至2023年4月22日，共对632名患者进行资格评估，随机分配其中338名患者，分别接受甲氧氟烷（n=112）、芬太尼（n=115）或吗啡（n=111）治疗。将281名患者纳入符合方案集。其中女性145名（52%），男性136名（48%）。中位年龄为61岁（IQR：47–75岁）。基线NRS评分为7.6分（SD：1.8）。10分钟后，甲氧氟烷组平均NRS评分变化为–3.31（SD：2.67），芬太尼组为–1.98（2.28），吗啡组为–2.74（2.12）。在调整基线因素后，比较平均NRS评分的变化后发现，甲氧氟烷不劣于芬太尼（–1.33【95%CI：–2.01至–0.64】）和吗啡（–0.36【–1.03至0.31】）。10分钟时，鼻内芬太尼不劣于吗啡（0.91【0.27至1.55】）。吗啡组26名（24%）患者、芬太尼组27名（24%）患者、甲氧氟烷组24名（22%）患者发生不良事件。甲氧氟烷组1名患者出现严重不良事件，即呼吸抑制（2级）和意识丧失（3级）。未发生治疗相关死亡。解释根据给药10分钟后的评估结果，在急救环境中，吸入式甲氧氟烷在急性疼痛处理方面不逊于鼻内芬太尼和静脉用吗啡。在治疗初期，吸入式甲氧氟烷是一种非常有效的非静脉替代疗法，或许能填补长效镇痛药的空白。 4. The Lancet揭示：异基因CD19嵌合抗原受体自然杀伤细胞疗法在系统性红斑狼疮中的疗效与安全性：中国病例系列研究 Efficacy and safety of allogeneic CD19 CAR NK-cell therapy in systemic lupus erythematosus: a case series in China Jie Gao, Mengtao Li https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01671-X/abstract 摘要背景近来，靶向自体CD19的嵌合抗原受体（CAR）T细胞在治疗自身免疫疾病方面具有极佳的效果，但同时也存在感染等诸多安全性问题。本研究旨在评估异基因CD19 CAR自然杀伤（NK）细胞疗法在复发或难治性系统性红斑狼疮（SLE）患者中的安全性、耐受性和疗效。方法在中国某研究机构开展开放、单臂、前瞻性、首次人体病例系列研究，评估了异基因CD19 CAR NK细胞疗法对复发或难治性SLE成年患者（18–65岁之间）的疗效。符合纳入条件的患者为先前至少接受两种标准全身性治疗、仍表现中重度疾病活动的患者。研究包括方案升级和剂量递增，从第7天开始进行方案升级，从第0天开始进行剂量递增，初始剂量为0.75×109 CAR NK细胞。从第–5天到第–3天，每天使用氟达拉滨（每天25 mg/m2）和环磷酰胺（每天300 mg/m2）对所有患者进行淋巴细胞清除预处理。随后，在单个治疗周期内，以相同剂量进行三次CAR NK细胞输注，每次输注时间间隔相同。监测了患者在28天内的剂量限制性不良事件。主要终点指标为安全性和耐受性，包括根据国家癌症研究所不良事件通用术语标准5.0版报告的剂量限制性毒性及不良事件发生率。本研究已在ClinicalTrials.gov（NCT06010472）注册，目前仍在进行后续随访工作。发现 2023年8月21日至2024年6月16日，共纳入18名中重度复发或难治性SLE患者。在这18名患者中，女性17人（94%）；中位年龄为37.5岁（IQR：32.0–39.8岁），中位病程为10.5年（IQR：4.5–14.8年）。患者均接受至少两种标准全身性治疗，其中14名（78%）患者使用生物制剂（贝利尤单抗和泰它西普）、1名患者接受血浆置换治疗。18名患者中，1名患者（6%）出现细胞因子释放综合征（1级）。未观察到神经毒性及其他CAR NK细胞治疗相关严重不良事件，且未出现剂量限制性毒性。18名患者中，9名患者随访超12个月，其中6名（67%）达到了DORIS缓解和狼疮低疾病活动状态。解释本研究表明，异基因CAR NK细胞疗法是治疗自身免疫性疾病的有效手段，这种疗法或许能解决当前自体CAR T细胞疗法所面临的问题，如生产规模和时间、可及性、安全性以及成本等。 pl : 13年资深纯人工论文翻译、英美母语润色经验，降AI率，誉文编辑，持续专注于以更加严谨而专业的人工学术翻译和英美润色，降重修改，降AI率，助作者语言通过期刊要求。近期有需要英美语言润色修改或论文翻译的老师，可在誉文编辑(http://www.youwinedit.com/)官网上单或通过官网联系:QQ:1162362299; Weixin: KWN3689。

临床结果临床3期细胞疗法

2025-12-21

·道道之道

【本周医刊】2025年第51周医学期刊更新

2025年第51周（2025.12.14-2025.12.20）重要医学期刊论著更新如下： 1.综合期刊 LANCET 题目：Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial 翻译：口服小分子胰高糖素样肽 - 1 受体激动剂奥福格列肽治疗2 型糖尿病合并肥胖症：ATTAIN-2Ⅲ期、双盲、随机、多中心、安慰剂对照临床试验题目：Preoperative mFOLFIRINOX versus PAXG for stage I–III resectable and borderline resectable pancreatic ductal adenocarcinoma (PACT-21 CASSANDRA): results of the first randomisation analysis of a randomised, open-label, 2 × 2 factorial phase 3 trial 翻译：可切除及交界可切除Ⅰ-Ⅲ期胰腺导管腺癌术前改良氟尿嘧啶+ 亚叶酸钙+ 伊立替康+ 奥沙利铂方案（mFOLFIRINOX）对比帕博利珠单抗+ 白蛋白结合型紫杉醇+ 吉西他滨方案（PAXG）：PACT-21 CASSANDRA 随机、开放标签、2×2析因设计Ⅲ期临床试验首次随机分析结果题目：Comparison of inhalational methoxyflurane, intranasal fentanyl, and intravenous morphine for treatment of prehospital acute pain in Norway (PreMeFen): a randomised, non-inferiority, three-arm, phase 3 trial 翻译：吸入用甲氧氟烷、鼻用芬太尼与静脉用吗啡治疗挪威院前急性疼痛的疗效对比：PreMeFen随机、非劣效性、三臂Ⅲ期临床试验题目：Efficacy and safety of allogeneic CD19 CAR NK-cell therapy in systemic lupus erythematosus: a case series in China 翻译：异基因 CD19 嵌合抗原受体自然杀伤细胞（CAR-NK）疗法治疗系统性红斑狼疮的有效性与安全性：中国病例系列研究 NEW ENGLAND JOURNAL OF MEDICINE 题目：ctDNA-Guided Adjuvant Atezolizumab in Muscle-Invasive Bladder Cancer 翻译：循环肿瘤 DNA 指导的阿替利珠单抗辅助治疗肌层浸润性膀胱癌题目：Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes 翻译：替尔泊肽对比度拉糖肽治疗 2 型糖尿病的心血管结局题目：Noninferiority of One HPV Vaccine Dose to Two Doses 翻译：人乳头瘤病毒疫苗单剂接种非劣效于两剂接种题目：Trial of High-Dose Oral Rifampin in Adults with Tuberculous Meningitis 翻译：大剂量口服利福平治疗成人结核性脑膜炎的临床试验 BMJ-BRITISH MEDICAL JOURNAL 题目：Changes in hospital financial performance and quality of care after real estate investment trust acquisition 翻译：房地产投资信托基金收购后医院财务绩效与医疗质量的变化 JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 题目：An AI-Powered Lifestyle Intervention vs Human Coaching in the Diabetes Prevention Program: A Randomized Clinical Trial 翻译：人工智能驱动的生活方式干预对比人工指导在糖尿病预防项目中的应用：一项随机临床试验题目：Development and Validation of the Sequential Organ Failure Assessment (SOFA)-2 Score 翻译：序贯器官衰竭评估（SOFA）-2评分的建立与验证题目：Arsenic Exposure Reduction and Chronic Disease Mortality 翻译：砷暴露水平降低与慢性病死亡风险的关联 NATURE MEDICINE 题目：Detection of undiagnosed liver cirrhosis via AI-enabled electrocardiogram: a pragmatic, cluster-randomized clinical trial 翻译：基于人工智能心电图的未确诊肝硬化筛查：一项务实性整群随机临床试验 LANCET DIGITAL HEALTH 题目：Label-efficient computational tumour infiltrating lymphocyte assessment in breast cancer (ECTIL): multicentre validation in 2340 patients with breast cancer 翻译：乳腺癌低标注量计算法肿瘤浸润淋巴细胞评估（ECTIL研究）：基于2340 例乳腺癌患者的多中心验证题目：The impact of artificial intelligence-driven decision support on uncertain antimicrobial prescribing: a randomised, multimethod study 翻译：人工智能驱动决策支持系统对不确定性抗菌药物处方行为的影响：一项随机化多方法研究题目：Automated retinal image analysis systems to triage for grading of diabetic retinopathy: a large-scale, open-label, national screening programme in England 翻译：自动视网膜图像分析系统用于糖尿病视网膜病变分级分诊：一项英格兰大规模开放标签全国性筛查项目题目：Efficacy of standalone smartphone apps for mental health: an updated systematic review and meta-analysis 翻译：独立智能手机心理健康应用程序的效能：一项更新的系统综述与荟萃分析 NPJ DIGITAL MEDICINE 题目：Interpretable deep learning for multicenter gastric cancer T staging from CT images 翻译：基于可解释性深度学习的多中心胃癌计算机断层扫描（CT）T分期评估题目：Predicting Invasiveness of Lung Adenocarcinoma from Chest CT with Few-shot Vision-Language Ternary Classification Model 翻译：基于小样本视觉 - 语言三元分类模型的胸部CT 预测肺腺癌侵袭性题目：The structure-preserving spectral graph neural network for dual kinase inhibitors and synergy scoring in gastric cancer 翻译：用于胃癌双激酶抑制剂筛选及协同评分的结构保留谱图神经网络题目：Bridging clinical knowledge and AI: an interpretable transformer framework for ECG diagnosis 翻译：融合临床知识与人工智能：一种用于心电图诊断的可解释性Transformer 框架题目：RMS: a ML-based system for ICU respiratory monitoring and resource planning 翻译：RMS 系统：基于机器学习的重症监护病房（ICU）呼吸监测与资源规划系统题目：Systematic review and meta-analysis of regulator-approved deep learning systems for fundus diabetic retinopathy detections 翻译：监管机构批准的深度学习眼底糖尿病视网膜病变检测系统的系统综述与荟萃分析题目：An AI-powered tongue image model for home-based monitoring of liver fibrosis 翻译：基于人工智能舌象模型的居家肝纤维化监测题目：Artificial intelligence-driven multivariate integration for pulmonary arterial pressure prediction in pulmonary hypertension 翻译：人工智能驱动的多变量整合模型预测肺动脉高压患者肺动脉压力题目：Effects of app delivered self hypnosis on stress management 翻译：应用程序介导的自我催眠对压力管理的效果题目：An Automated Classifier of Harmful Brain Activities for Clinical Usage Based on a Vision-Inspired Pre-trained Framework 翻译：基于视觉启发预训练框架的临床用有害脑电活动自动分类器 2.肿瘤学 CA-A CANCER JOURNAL FOR CLINICIANS 题目：Bridging the cancer divide: Policy and structural solutions for equity in the United States 翻译：弥合癌症医疗鸿沟：美国实现医疗公平的政策与结构性解决方案 ANNALS OF ONCOLOGY 题目：Capivasertib plus paclitaxel as first-line treatment for metastatic triple-negative breast cancer: Results from the randomised, global phase III CAPItello-290 trial 翻译：卡匹沙替尼联合紫杉醇一线治疗转移性三阴性乳腺癌：全球多中心Ⅲ期随机对照CAPItello-290 试验结果题目：The Achilles heel of precision AKT-targeted therapies in advanced prostate cancer: therapeutic promise constrained by the test 翻译：晚期前列腺癌精准靶向 AKT 治疗的阿喀琉斯之踵：检测方法限制治疗潜力发挥题目：Local and locoregional prostate cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up 翻译：局限性及局部区域性前列腺癌：欧洲肿瘤内科学会（ESMO）诊断、治疗与随访临床实践指南题目：Germline alterations in patients with lung cancer 翻译：肺癌患者的胚系基因变异特征题目：Next-Generation Multicenter Studies: Using Artificial Intelligence to Automatically Process Unstructured Health Records of Patients with Lung Cancer across Multiple Institutions 翻译：新一代多中心研究：基于人工智能自动化处理多中心肺癌患者非结构化健康医疗记录 JOURNAL OF CLINICAL ONCOLOGY 题目：Addition of Carboplatin to Sequential Taxane-Anthracycline Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer: A Phase III Randomized Controlled Trial 翻译：三阴性乳腺癌新辅助化疗在紫杉类 - 蒽环类序贯方案基础上加用卡铂的疗效：一项Ⅲ期随机对照试验题目：Efficacy and Safety of Neoadjuvant TQB2102 in Locally Advanced or Early Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: A Randomized, Open-Label, Multicenter, Phase II Trial 翻译：新辅助药物 TQB2102 治疗局部晚期或早期人表皮生长因子受体2 阳性乳腺癌的有效性与安全性：一项随机、开放标签、多中心Ⅱ期试验题目：Individual Patient Data Meta-Analysis of Consensus Molecular Subtypes as Biomarkers of First-Line Treatment in RAS Wild-Type Metastatic Colorectal Cancer 翻译：共识分子亚型作为 RAS 野生型转移性结直肠癌一线治疗生物标志物的个体患者数据荟萃分析题目：Quizartinib for Newly Diagnosed FLT3-Internal Tandem Duplication–Negative AML: The Randomized, Double-Blind, Placebo-Controlled, Phase II QUIWI Study 翻译：奎扎替尼治疗初诊 FLT3 基因内部串联重复阴性急性髓系白血病：随机、双盲、安慰剂对照Ⅱ期QUIWI 研究题目：Amivantamab Plus Lazertinib in Atypical EGFR-Mutated Advanced Non–Small Cell Lung Cancer: Results From CHRYSALIS-2 翻译：阿米万他单抗联合拉泽替尼治疗罕见表皮生长因子受体（EGFR）突变晚期非小细胞肺癌：CHRYSALIS-2研究结果 LANCET ONCOLOGY（本周无更新） NATURE CANCER（本周无更新） JAMA ONCOLOGY 题目：Prostate-Specific Membrane Antigen PET-Guided Intensification of Salvage Radiotherapy After Radical Prostatectomy: A Phase 2 Randomized Clinical Trial 翻译：前列腺特异性膜抗原正电子发射断层显像引导的前列腺癌根治术后挽救性放疗剂量强化：一项Ⅱ期随机临床试验题目：The Definition of Cure in Colon Cancer: A Pooled Analysis of 15 Randomized Clinical Trials 翻译：结肠癌治愈的定义界定：基于 15 项随机临床试验的汇总分析题目：Risk Factors for Valvulopathy Among Childhood Cancer Survivors 翻译：儿童癌症幸存者心脏瓣膜病的危险因素题目：Pathogenic Variants, Family History, and Cumulative Risk of Breast Cancer in US Women 翻译：致病性基因变异、家族史与美国女性乳腺癌的累积发病风险题目：Artificial Intelligence–Detected Tumor-Infiltrating Lymphocytes and Outcomes in Anti–PD-1–Based Treated Melanoma 翻译：人工智能检测的肿瘤浸润淋巴细胞与程序性死亡受体1（PD-1）抑制剂治疗黑色素瘤的预后关联题目：Risk Prediction Model for Development of Heart Failure or Cardiomyopathy After Breast Cancer Treatment 翻译：乳腺癌治疗后心力衰竭或心肌病发病风险预测模型题目：Consistent Adherence to Physical Activity Guidelines and Digestive System Cancer Risk and Mortality 翻译：坚持遵循体力活动指南与消化系统癌症发病及死亡风险的关联题目：Hormonal Contraceptive Formulations and Breast Cancer Risk in Adolescents and Premenopausal Women 翻译：激素避孕药剂型与青少年及绝经前女性乳腺癌发病风险 CANCER RESEARCH 题目：The Prolyl Isomerase PIN1 Affects Fibroblast Differentiation States and Cross-talk in Pancreatic Cancer 翻译：脯氨酰异构酶 PIN1 调控胰腺癌成纤维细胞分化状态及细胞间互作题目：Interaction and Reciprocal Stabilization of H3.3 and PARP1 Promote DNA Damage Repair and Tumor Progression in Small Cell Lung Cancer 翻译：H3.3 与PARP1 的相互作用及双向稳定促进小细胞肺癌DNA 损伤修复与肿瘤进展题目：The Microbial Bile Acid Metabolite 3-Oxo-LCA Inhibits Colorectal Cancer Progression 翻译：微生物胆汁酸代谢产物 3 - 氧代- 石胆酸抑制结直肠癌进展题目：Quantitative Cell Type–Specific Immunopeptidome Analysis of Macrophage and Tumor Coevolution Reveals Therapeutic MHC-I Peptides in Glioblastoma 翻译：巨噬细胞与肿瘤共进化的细胞类型特异性定量免疫肽组分析揭示胶质母细胞瘤的治疗性MHC-Ⅰ类分子结合肽题目：circADAMTS12 Inhibits the Antitumor Activity of Microglia to Enable Metastatic Colonization in the Brain 翻译：环状 RNA ADAMTS12 抑制小胶质细胞抗肿瘤活性以促进结肠癌脑转移定植题目：Surgery-Induced Neutrophil Extracellular Traps Promote Tumor Metastasis by Reprogramming Cancer Cell Lipid Metabolism 翻译：手术诱导的中性粒细胞胞外陷阱通过重编程癌细胞脂质代谢促进肿瘤转移题目：An Olive Oil–Based High-Fat Diet Promotes Obesity-Driven Metastasis of Triple-Negative Breast Cancer 翻译：橄榄油基高脂饮食促进肥胖相关三阴性乳腺癌转移题目：Parkin Induces Ubiquitination and Large Extracellular Vesicle Release of HMGB1 to Activate Antitumor Immunity 翻译：帕金蛋白诱导高迁移率族蛋白 B1 泛素化及大细胞外囊泡释放以激活抗肿瘤免疫题目：Inhibition of GSK3 and TSC2 Mediates the Oncogenic Activity of AKT in Hepatocellular Carcinoma 翻译：抑制 GSK3 与TSC2 介导AKT 在肝细胞癌中的促癌活性题目：Distinct Cellular and Molecular Patterns in Pretreatment Peripheral Blood Are Associated with CAR T-cell Outcomes in Diffuse Large B-cell Lymphoma 翻译：弥漫大 B 细胞淋巴瘤患者治疗前外周血中独特的细胞与分子特征与嵌合抗原受体T 细胞（CAR-T）治疗疗效相关题目：Spatially Discontinuous Mutation Topographies in Ductal Carcinoma In Situ Reveal Noncompetitive Growth Dynamics 翻译：导管原位癌中空间非连续的突变图谱揭示非竞争性生长动力学特征题目：Path2Omics Enhances Transcriptomic and Methylation Prediction Accuracy from Tumor Histopathology 翻译：Path2Omics 工具基于肿瘤组织病理学特征提升转录组与甲基化预测精度题目：Mathematical Modeling Quantifies “Just-Right” APC Inactivation for Colorectal Cancer Initiation 翻译：数学建模量化结直肠癌发生过程中腺瘤性息肉病基因（APC）的“适度”失活效应题目：Artificial Intelligence and Multimodality Data Integration Decipher Tertiary Lymphoid Structure Maturity in Gastric Cancer 翻译：人工智能与多模态数据整合解析胃癌三级淋巴结构成熟度题目：Large-Scale T-cell Receptor Repertoire Profiling Unveils Tumor-Specific Signals for Diagnosing Indeterminate Pulmonary Nodules 翻译：大规模 T 细胞受体库测序揭示用于诊断性质待定肺结节的肿瘤特异性信号 CLINICAL CANCER RESEARCH 题目：Addition of Ianalumab (VAY736) to Ibrutinib in Patients with Chronic Lymphocytic Leukemia on Ibrutinib Therapy: Results from a Phase Ib Study 翻译：伊布替尼治疗慢性淋巴细胞白血病患者中联合伊纳鲁单抗（VAY736）的疗效：一项Ⅰb期研究结果题目：Extracellular Matrix–MYCAF Signatures Correlate with Resistance to Neoadjuvant aPD-L1 Immune Checkpoint Inhibition with Durvalumab + Metformin in HPV+ HNSCC 翻译：细胞外基质 - 髓源性癌症相关成纤维细胞特征与HPV 阳性头颈部鳞状细胞癌患者对度伐利尤单抗联合二甲双胍新辅助程序性死亡配体1（PD-L1）免疫检查点抑制剂治疗耐药相关题目：Prognostic Significance and Predictive Value of Circulating Tumor Cells in Invasive Lobular Breast Carcinoma—An Exploratory Analysis of the STIC CTC Trial 翻译：循环肿瘤细胞在浸润性小叶乳腺癌中的预后意义及预测价值——STIC CTC 试验的探索性分析题目：ctDNA Longitudinal Analysis during Total Neoadjuvant Therapy and Nonoperative Management for Locally Advanced Rectal Cancer: A Biomarker Study from the NOMINATE Trial 翻译：局部晚期直肠癌全程新辅助治疗及非手术治疗期间循环肿瘤DNA 的纵向分析：NOMINATE试验的生物标志物研究题目：LRP1bLoss Predicts Sensitivity to Immunotherapy in Patients with NSCLC: An Analysis of the Phase III CheckMate-026 Randomized Trial 翻译：LRP1b基因缺失预测非小细胞肺癌患者对免疫治疗的敏感性：Ⅲ期CheckMate-026 随机试验分析题目：Radiogenomic Profiling of Prostate Tumors prior to External Beam Radiotherapy Converges on a Transcriptomic Signature of TGF-β Activity Driving Tumor Recurrence 翻译：前列腺癌外照射放疗前的放射基因组学分析发现转化生长因子-β（TGF-β）活性相关转录组特征驱动肿瘤复发题目：Tumor miRNA Signatures Associate with Outcomes of Patients with Stage II/III Melanoma 翻译：肿瘤微小 RNA 特征与Ⅱ/Ⅲ期黑色素瘤患者预后相关题目：Diagnosis and Treatment Response Monitoring of Liver Cancer Using Glypican-3–Targeted Single-Domain Antibody PET 翻译：基于磷脂酰肌醇蛋白聚糖 3 靶向单域抗体正电子发射断层显像的肝癌诊断及疗效监测题目：Targeting KRAS Inhibitor–Resistant Pancreatic Cancer with an MUC1-C Antibody–Drug Conjugate 翻译：以黏蛋白 1-C 抗体- 药物偶联物靶向治疗对KRAS 抑制剂耐药的胰腺癌题目：Derivation of AZD5335, a Novel FRα-Targeted TOP1i-Loaded ADC, for the Treatment of FRα-Expressing Cancers 翻译：新型叶酸受体α靶向拓扑异构酶1 抑制剂偶联抗体药物AZD5335 的研发：用于治疗叶酸受体α阳性癌症题目：D3-GPC2–Directed CAR T Cells Are Safe and Efficacious in Preclinical Models of Neuroblastoma and Small Cell Lung Cancer 翻译：靶向 D3 - 神经节苷脂- 神经母细胞瘤癌基因同源物2 的嵌合抗原受体T 细胞在神经母细胞瘤及小细胞肺癌临床前模型中兼具安全性与有效性题目：The Impact of JAK1Pathogenic Variants and MHC-I Expression on Response to Immune Checkpoint Inhibition in Endometrial Cancer 翻译：JAK1致病性基因变异及主要组织相容性复合体Ⅰ类分子表达对子宫内膜癌患者免疫检查点抑制剂治疗应答的影响题目：Prognosis and Biological Characteristics of ER-Low Metastatic Breast Cancer: Results from a Multicenter Cohort and the TONIC Trial 翻译：雌激素受体低表达转移性乳腺癌的预后及生物学特征：一项多中心队列研究与TONIC 试验结果 JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE（本周无更新） 3.内分泌学与代谢 LANCET DIABETES & ENDOCRINOLOGY（本周无更新） 4.呼吸病学 LANCET RESPIRATORY MEDICINE（本周无更新） 5.心血管病学 EUROPEAN HEART JOURNAL 题目：Atrial fibrillation in former world-class rowers: role of environmental and genetic factors 翻译：前世界级赛艇运动员的心房颤动：环境与遗传因素的作用题目：Hypokalaemia and atrial fibrillation detected by implanted loop recorders 翻译：植入式循环记录仪检出的低钾血症与心房颤动题目：Transient anticholinergic burden and out-of-hospital cardiac arrest: a case-crossover study 翻译：一过性抗胆碱能药物负荷与院外心脏骤停的关联性：一项病例交叉研究题目：Circadian patterns of atrial fibrillation and disease progression assessed by implanted loop recorders 翻译：基于植入式循环记录仪评估心房颤动的昼夜节律模式及疾病进展题目：Atrial fibrillation and atherosclerosis cause different vascular brain lesions on magnetic resonance imaging 翻译：心房颤动与动脉粥样硬化在磁共振成像中所致脑血管病变的差异特征 CIRCULATION 题目：Oxidized Phospholipids, Lipoprotein(a), and Cardiovascular Outcomes After Acute Coronary Syndrome 翻译：氧化磷脂、脂蛋白（a）与急性冠状动脉综合征患者的心血管结局题目：Leveraging a Genetic Proxy to Investigate the Effects of Lifelong Cardiac Sodium Channel Blockade 翻译：利用遗传替代标志物探究终身心脏钠通道阻滞的效应题目：High-Voltage Focal Pulsed Field Ablation to Treat Scar-Related Ventricular Tachycardia: The First-in-Human VCAS Trial 翻译：高压局灶性脉冲电场消融治疗瘢痕相关性室性心动过速：首个人体VCAS 试验题目：Hypercontractility and Oxidative Stress Drive Creatine Kinase Dysfunction in Hypertrophic Cardiomyopathy 翻译：心肌过度收缩与氧化应激导致肥厚型心肌病患者肌酸激酶功能异常 JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY（本周无更新） 6.传染病学 LANCET INFECTIOUS DISEASES 题目：Dynamics of endemic virus re-emergence in children in the USA following the COVID-19 pandemic (2022–23): a prospective, multicentre, longitudinal, immunoepidemiological surveillance study 翻译：新冠疫情后美国儿童地方性病毒再流行的动态变化（2022—2023年）：一项前瞻性、多中心、纵向免疫流行病学监测研究题目：Sotrovimab versus usual care in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial 翻译：索托维单抗对比常规治疗用于新冠病毒感染住院患者的疗效：RECOVERY随机、对照、开放标签平台试验题目：A 3-month clofazimine–rifapentine-containing regimen for drug-susceptible tuberculosis versus standard of care (Clo-Fast): a randomised, open-label, phase 2c clinical trial 翻译：含氯法齐明 - 利福喷丁的3 个月方案治疗药物敏感性结核病与标准治疗的对比：Clo-Fast随机、开放标签2c 期临床试验题目：Global policy responses to antimicrobial resistance, 2021–22: a systematic governance analysis of 161 countries and territories 翻译：2021—2022年全球应对抗菌药物耐药性的政策措施：一项覆盖161 个国家和地区的系统性治理分析题目：Efficacies of artemether–lumefantrine, artesunate–amodiaquine, dihydroartemisinin–piperaquine, and artesunate–pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in children aged 6 months to 10 years in Uganda: a randomised, open-label, phase 4 clinical trial 翻译：蒿甲醚 - 苯芴醇、青蒿琥酯- 阿莫地喹、双氢青蒿素- 哌喹及青蒿琥酯- 咯萘啶治疗乌干达6 月龄至10 岁儿童无并发症恶性疟原虫疟疾的疗效：一项随机、开放标签4 期临床试验题目：Safety, tolerability, and protective efficacy of a radiation-attenuated, whole sporozoite malaria vaccine in children in Gabon: a randomised, double-blind, placebo-controlled, phase 2 trial 翻译：辐射减毒全子孢子疟疾疫苗在加蓬儿童中的安全性、耐受性及保护效力：一项随机、双盲、安慰剂对照2 期试验题目：Effectiveness of the TAK-003 dengue vaccine in adolescents during the 2024 outbreak in São Paulo, Brazil: a test-negative, case–control study 翻译：TAK-003 登革热疫苗在2024 年巴西圣保罗登革热疫情中对青少年的保护效果：一项阴性病例对照研究题目：Rifasutenizol-based triple therapy versus bismuth plus clarithromycin-based triple therapy for first-line treatment of Helicobacter pylori infection in China (EVEREST-HP): a phase 3, multicentre, randomised, triple-dummy, double-blind, controlled, non-inferiority trial 翻译：利福舒替尼三联疗法对比铋剂联合克拉霉素三联疗法一线治疗中国幽门螺杆菌感染：EVEREST-HPⅢ期、多中心、随机、三模拟、双盲、对照、非劣效性试验 CLINICAL MICROBIOLOGY AND INFECTION 题目：Penicillin V as first-line treatment of pneumonia in primary care: a registry-based study 翻译：青霉素 V 作为基层医疗机构肺炎一线治疗方案的疗效：一项基于登记数据库的研究题目：Towards model-informed precision dosing of intravenous linezolid: a multicentre external evaluation of pharmacokinetic models in critically ill adults 翻译：迈向静脉用利奈唑胺的模型指导精准给药：针对危重症成人患者药代动力学模型的多中心外部验证题目：Diagnostic performance of Xpert MTB/RIF Ultra assay with pulmonary and extrapulmonary specimens: a retrospective evaluation in a low-incidence setting in Finland 翻译：Xpert MTB/RIF Ultra 检测在肺部及肺外标本中的诊断效能：芬兰低发病率地区的回顾性评价题目：Defining epidemiological cutoff values for Brucella melitensis: an European multicentre study 翻译：羊布鲁氏菌流行病学折点的界定：一项欧洲多中心研究题目：In vitroactivity and resistance mechanisms of sulbactam/durlobactam against Acinetobacter baumannii clinical isolates in China (2019–2020) 翻译：舒巴坦 / 杜洛巴坦对中国鲍曼不动杆菌临床分离株的体外抗菌活性及耐药机制研究（2019—2020年）题目：Complex pathways to ceftolozane-tazobactam resistance in clinical Pseudomonas aeruginosaisolates: a genomic epidemiology study 翻译：铜绿假单胞菌临床分离株对头孢洛扎 - 他唑巴坦耐药的复杂通路解析：一项基因组流行病学研究题目：Frailty predicts in-hospital and 1-year outcomes in patients with infective endocarditis 翻译：衰弱状态对感染性心内膜炎患者住院期及1 年预后的预测价值题目：Efficacy and safety of a China-developed live attenuated herpes zoster vaccine in Chinese healthy adults aged 40 years and older: a multicentre, randomized, double-blind, placebo-controlled, phase 3 clinical trial 翻译：国产减毒活带状疱疹疫苗在中国 40 岁及以上健康成人中的有效性与安全性：一项多中心、随机、双盲、安慰剂对照Ⅲ期临床试验题目：Current situation of solid organ transplantation from HIV-positive donors to HIV-positive recipients in Europe: the Spanish perspective 翻译：欧洲 HIV 阳性供体向HIV 阳性受体开展实体器官移植的现状：西班牙视角题目：The effect of remdesivir and nirmatrelvir/ritonavir on mortality in patients hospitalized with COVID-19 during the Omicron era: an emulated target trial 翻译：奥密克戎流行期间瑞德西韦与奈玛特韦/ 利托那韦对新冠病毒感染住院患者死亡率的影响：一项仿真目标试验题目：Randomized clinical trial to evaluate the longitudinal HIV-1 reservoir and inflammation in treatment-naïve people starting dolutegravir/lamivudine versus dolutegravir plus tenofovir alafenamide/emtricitabine 翻译：初治 HIV-1 感染者接受多替拉韦/ 拉米夫定方案与多替拉韦联合丙酚替诺福韦/ 恩曲他滨方案治疗后，病毒储存库及炎症水平的纵向评估：一项随机临床试验题目：Safety and immunogenicity of adjuvanted respiratory syncytial virus vaccine in high-risk transplant recipients: an interventional cohort study 翻译：佐剂呼吸道合胞病毒疫苗在高危移植受者中的安全性与免疫原性：一项干预性队列研究题目：Immune reconstitution in very advanced HIV patients treated with dolutegravir vs. darunavir-based triple antiretroviral therapy: the Advanz-4 randomized clinical trial 翻译：晚期 HIV 感染者接受多替拉韦方案与达芦那韦为基础的三联抗逆转录病毒治疗的免疫重建效果对比：Advanz-4随机临床试验 7.胃肠肝病学 LANCET GASTROENTEROLOGY & HEPATOLOGY（本周无更新） JOURNAL OF HEPATOLOGY 题目：Healthy eating and physical activity significantly lower sex-specific alcohol-attributable liver mortality in the United States 翻译：健康饮食与规律运动可显著降低美国不同性别人群中酒精归因性肝脏疾病死亡率题目：Somatic loss-of-function mutations in CIDEB reduce hepatic steatosis by increasing lipolysis and fatty acid oxidation 翻译：CIDEB基因体细胞功能缺失突变通过增强脂解作用与脂肪酸氧化减轻肝脏脂肪变性题目：Enhanced surveillance, subtyping, and host adaptation analysis reveal genotype-wide zoonotic potential of rat hepatitis E virus 翻译：强化监测、亚型分析及宿主适应性研究揭示鼠戊型肝炎病毒全基因型的人畜共患病潜在风险题目：Engineered monoclonal antibody tobevibart enhances HBsAg capture by Fc receptor-positive cells and activates HBV-specific T cells 翻译：工程化单克隆抗体托贝韦巴特增强 Fc 受体阳性细胞对乙肝表面抗原的捕获并激活乙肝病毒特异性T 细胞题目：Safety and efficacy of elafibranor in primary sclerosing cholangitis: The ELMWOOD phase II randomized-controlled trial 翻译：依折麦布醇治疗原发性硬化性胆管炎的安全性与有效性：ELMWOODⅡ期随机对照试验题目：Phase II INTEGRIS-PSC trial of bexotegrast, an αvβ6/αvβ1integrin inhibitor, in primary sclerosing cholangitis 翻译：αvβ6/αvβ1整合素抑制剂贝索替格拉斯特治疗原发性硬化性胆管炎的Ⅱ期INTEGRIS-PSC 试验题目：Identification and validation of RIPK3 as a novel biomarker to predict outcomes in patients with acute decompensation of cirrhosis 翻译：受体相互作用蛋白激酶 3（RIPK3）作为预测肝硬化急性失代偿患者预后的新型生物标志物的鉴定与验证题目：Phase I trial of ADP-A2AFP TCR T-cell therapy in patients with advanced hepatocellular or gastric hepatoid carcinoma 翻译：ADP-A2AFP TCR-T 细胞疗法治疗晚期肝细胞癌或胃肝样腺癌的Ⅰ期临床试验题目：Proteogenomic profiling predicts outcomes of adjuvant chemotherapy in extrahepatic cholangiocarcinoma 翻译：蛋白质基因组学图谱预测肝外胆管癌辅助化疗的疗效题目：Patient-derived liver organoids recapitulate liver epithelial heterogeneity and enable precision modeling of alcohol-related liver disease 翻译：患者来源肝类器官可重现肝脏上皮细胞异质性，为酒精相关性肝病提供精准建模工具题目：Restoration of N-glycosylation via leucine-activated leucyl-tRNA synthetase 1 overcomes chemoresistance in intrahepatic cholangiocarcinoma 翻译：通过亮氨酸激活的亮氨酰 - tRNA 合成酶1 恢复N - 糖基化，逆转肝内胆管癌的化疗耐药性题目：Decreased LONP1 expression exacerbates MASH-induced liver fibrosis via elevated orotic acid levels 翻译：LONP1 表达下调通过升高乳清酸水平加重代谢相关脂肪性肝炎（MASH）诱导的肝纤维化 GASTROENTEROLOGY 题目：Chemical Perturbations Impacting Histone Acetylation Govern Colorectal Cancer Differentiation 翻译：影响组蛋白乙酰化的化学扰动调控结直肠癌分化进程题目：Selective Urokinase Inhibition Plus Chemotherapy: A Novel Approach to Pancreatic Cancer Treatment via Enhanced Antitumor Immunity and Decreased Metastasis 翻译：选择性尿激酶抑制联合化疗：通过增强抗肿瘤免疫与减少转移治疗胰腺癌的新策略题目：Risk of Pancreatic Cancer in Glycemically Defined New-Onset Diabetes: A Prospective Cohort Study 翻译：血糖定义的新发糖尿病患者胰腺癌发病风险：一项前瞻性队列研究题目：Early Infliximab Levels and Clearance Predict Outcomes After Infliximab Rescue in Acute Severe Ulcerative Colitis: Results From PREDICT-UC 翻译：英夫利昔单抗早期血药浓度及清除率预测重症急性溃疡性结肠炎英夫利昔单抗挽救治疗的疗效：PREDICT-UC研究结果题目：Low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet Improves Colonic Barrier Function and Mast Cell Activation in Patients With Diarrhea-Predominant Irritable Bowel Syndrome: A Mechanistic Trial 翻译：低可发酵低聚糖、双糖、单糖及多元醇饮食改善腹泻型肠易激综合征患者结肠屏障功能与肥大细胞活化：一项机制性试验题目：Enhancement of Inpatient Mortality Prognostication With Machine Learning in a Prospective Global Cohort of Patients With Cirrhosis With External Validation 翻译：机器学习模型提升全球肝硬化前瞻性队列患者住院死亡风险预测效能及外部验证题目：A Randomized Trial of Endoscopic Submucosal Dissection vs Transanal Minimally Invasive Surgery in Early Rectal Neoplasms: DSETAMIS-2018 Study 翻译：内镜黏膜下剥离术对比经肛微创手术治疗早期直肠肿瘤的随机对照试验：DSETAMIS-2018研究题目：GastroNet-5M: A Multicenter Dataset for Developing Foundation Models in Gastrointestinal Endoscopy 翻译：GastroNet-5M 数据集：用于开发胃肠内镜基础模型的多中心数据集题目：The Natural History of Gastroesophageal Varices in Children With Portal Hypertension 翻译：门静脉高压症儿童患者食管胃底静脉曲张的自然病程研究 GUT 题目：Circulating HBV RNA and HBsAg seroconversion in patients with chronic HBV infection: a long-term follow-up study starting from childhood in Taiwan 翻译：中国台湾地区慢性乙型肝炎病毒感染患者循环乙肝病毒RNA 与乙肝表面抗原血清学转换：一项始于儿童期的长期随访研究题目：Tracking B cell immunity during perturbation of hepatitis B infection induced by treatment withdrawal 翻译：停药诱导乙型肝炎感染状态扰动过程中B 细胞免疫功能的动态监测题目：Hereditary chronic pancreatitis induced plasticity cooperates with mutant Kras in early pancreatic carcinogenesis 翻译：遗传性慢性胰腺炎诱导的细胞可塑性与突变型Kras 协同促进胰腺癌早期发生题目：Secondary bile acid production by gut bacteria promotes Western diet-associated colorectal cancer 翻译：肠道细菌产生的次级胆汁酸促进西式饮食相关结直肠癌的发生发展题目：Effects of a probiotic fermented dairy product on hippocampal metabolites, structure and function: an 8-week randomised, placebo-controlled trial in healthy women 翻译：益生菌发酵乳制品对健康女性海马代谢物、结构及功能的影响：一项8 周随机安慰剂对照试验题目：PCK1 deficiency promotes MASH-HCC progression by 12-HETE-induced CD8+ T cell dysfunction 翻译：磷酸烯醇式丙酮酸羧激酶 1（PCK1）缺失通过12 - 羟基二十碳四烯酸（12-HETE）诱导的CD8⁺ T 细胞功能障碍促进代谢相关脂肪性肝炎相关肝细胞癌（MASH-HCC）进展 HEPATOLOGY 题目：Early screening, diagnosis and recurrence monitoring of hepatocellular carcinoma in patients with chronic hepatitis B based on serum N-glycomics analysis: A cohort study 翻译：基于血清 N - 糖组学分析的慢性乙型肝炎患者肝细胞癌早期筛查、诊断及复发监测：一项队列研究题目：Spatial single-cell proteomics landscape decodes the tumor microenvironmental ecosystem of intrahepatic cholangiocarcinoma 翻译：空间单细胞蛋白质组图谱解析肝内胆管癌的肿瘤微环境生态系统题目：Higher level of HBsAg associated with delayed development of HCC in immune-tolerant patients 翻译：免疫耐受期患者乙肝表面抗原（HBsAg）高水平与肝细胞癌（HCC）发病延迟相关题目：Increased risk of HCC in HBeAg-negative indeterminate phase compared with HBeAg-negative chronic infection 翻译：乙肝 e 抗原（HBeAg）阴性不确定期患者相比HBeAg 阴性慢性感染期患者肝细胞癌发病风险升高 CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 题目：Diagnosis of Retrograde Cricopharyngeus Dysfunction Using High Resolution Impedance Manometry and Comparison With Control Subjects 翻译：基于高分辨率阻抗测压的环咽肌功能障碍诊断及与健康对照者的对比研究题目：Comparative Effectiveness of Empiric Treatment for Helicobacter pylori in a Large, Diverse Population in the United States 翻译：美国大规模多样化人群中幽门螺杆菌经验性治疗的疗效对比题目：Long-Term Mortality After Cholecystectomy in a Nationwide Cohort of Swedish Individuals Between 1969 and 2016 翻译：瑞典全国队列研究：1969—2016年胆囊切除术患者的远期死亡率分析题目：Nasal Continuous Positive Airway Pressure to Reduce Hypoxia in Patients With Obesity Undergoing Sedated Upper Gastrointestinal Endoscopy: A Prospective Randomized Trial 翻译：经鼻持续气道正压通气改善肥胖患者镇静状态下上消化道内镜检查的缺氧状况：一项前瞻性随机试验题目：Association of Metabolic Comorbidities With Fibrosis Severity and Fibrosis Regression in Patients With Chronic Hepatitis B 翻译：代谢合并症与慢性乙型肝炎患者肝纤维化严重程度及纤维化逆转的相关性题目：The Vasopressin Biomarker Copeptin Is Linked to Systemic Inflammation and Refines Prognostication in Decompensated Cirrhosis 翻译：血管升压素生物标志物和肽素与全身炎症相关，并可优化失代偿期肝硬化患者的预后评估题目：Transferrin Saturation and Serum Ferritin Are Main Predictors of Liver Iron Content in Subjects With Hyperferritinemia 翻译：转铁蛋白饱和度与血清铁蛋白是高铁蛋白血症患者肝脏铁含量的主要预测指标题目：Microbiological Profile of Bacterial Infections in Patients With Cirrhosis Over Time: A 20-year Territory-wide Study 翻译：肝硬化患者细菌感染的病原谱变迁：一项为期20 年的全区域研究题目：Efficacy of 6-mm and 8-mm Transjugular Intrahepatic Portosystemic Shunt for Variceal Bleeding: A Randomized Controlled Trial 翻译：6mm 与8mm 经颈静脉肝内门体分流术治疗食管胃底静脉曲张破裂出血的疗效对比：一项随机对照试验题目：Comparative Effectiveness of Infliximab vs Ustekinumab for Endoscopic and Transmural Remission in Biologic Naïve Crohn’s Disease 翻译：英夫利昔单抗对比乌司奴单抗治疗初治生物制剂的克罗恩病患者内镜下及透壁缓解的疗效题目：Liver Transplantation Is Associated With a Reduced Risk of Colorectal Dysplasia in Patients With IBD and Concomitant PSC 翻译：肝移植可降低炎症性肠病合并原发性硬化性胆管炎患者的结直肠异型增生风险题目：Defining Radiological Healing in Perianal Fistulizing Crohn’s Disease: A TOpClass Global Expert Delphi Consensus 翻译：肛周瘘管型克罗恩病影像学愈合标准的界定：TOpClass全球专家德尔菲共识题目：Proactive Drug Monitoring Versus Clinically Based Dosing for Endoscopic Healing in Pediatric Crohn’s Disease Receiving Infliximab 翻译：英夫利昔单抗治疗儿童克罗恩病时，主动药物浓度监测对比临床经验给药对内镜下愈合的影响题目：Efficacy of Etrasimod in Ulcerative Colitis: Analysis of ELEVATE UC 52 and ELEVATE UC 12 by Baseline Endoscopic Severity 翻译：依曲莫德治疗溃疡性结肠炎的疗效：基于基线内镜严重程度分层的ELEVATE UC 52 与ELEVATE UC 12 研究分析题目：Symptoms of Constipation: Relationship Between Questionnaires and Diaries and Impact on Quality of Life 翻译：便秘症状：问卷与日记记录的一致性及其对生活质量的影响题目：Multicenter Validation of Video-based Deep Learning to Evaluate Defecation Patterns on 3-dimensional High-definition Anorectal Manometry 翻译：基于视频的深度学习评估三维高分辨率肛门直肠测压排便模式的多中心验证题目：Performance of a Smartphone-based Stool Test for Use in Colorectal Cancer Screening: Population-based Study 翻译：基于智能手机的粪便检测用于结直肠癌筛查的效能：一项人群研究 8.公共卫生和流行病学 LANCET PUBLIC HEALTH（本周无更新） LANCET PLANETARY HEALTH（本周无更新） LANCET GLOBAL HEALTH（本周无更新） 9.微生物学 FUNGAL DIVERSITY（本周无更新） LANCET MICROBE（本周无更新） NATURE MICROBIOLOGY 题目：A Plasmodium-derived nanoparticle vaccine elicits sterile protection against malaria in mice 翻译：疟原虫来源纳米颗粒疫苗诱导小鼠产生抗疟疾无菌保护作用题目：Pneumococcal S protein coordinates cell wall modification and repair to resist host antimicrobials 翻译：肺炎链球菌 S 蛋白协同调控细胞壁修饰与修复以抵抗宿主抗菌防御题目：Streptococcus pneumoniaeS protein activates PBP1a to regulate peptidoglycan remodelling and cell division 翻译：肺炎链球菌 S 蛋白激活青霉素结合蛋白1a（PBP1a）调控肽聚糖重塑与细胞分裂题目：Zoonotic Streptococcusimports glucose to inhibit stringent response and promote growth during meningitis 翻译：人畜共患链球菌摄取葡萄糖以抑制严紧反应并促进脑膜炎发病期的菌株增殖 MICROBIOME 题目：Bacillus amyloliquefaciens PP19 regulation of microbial communities and suppression of Peronophythora litchii 翻译：解淀粉芽孢杆菌 PP19 对微生物群落的调控作用及对荔枝霜疫霉菌的抑制效果题目：Sodium butyrate modulates ocular surface microbiome and attenuates inflammation of meibomian gland dysfunction in ApoE−/− mice 翻译：丁酸钠调控载脂蛋白 E 基因敲除（ApoE⁻/⁻）小鼠眼表微生物组并减轻睑板腺功能障碍相关炎症题目：Synthetic microbial community in pristine environment promotes the growth of the endangered plant Lilium tsingtauense 翻译：原生环境合成微生物群落促进珍稀濒危植物青岛百合生长题目：Gut microbiome-derived indole-3-carboxaldehyde promotes intestinal development via AHR-NRF2 signaling in the early-life of chicks 翻译：雏鸡早期肠道微生物组来源的吲哚 - 3 - 甲醛通过芳香烃受体- 核因子E2 相关因子2（AHR-NRF2）信号通路促进肠道发育题目：Dysbiosis of the gut microbiota in calcium oxalate nephrolithiasis is associated with impaired short-chain fatty acid production and systemic metabolomic disruptions 翻译：草酸钙肾结石患者肠道菌群失调与短链脂肪酸生成受损及全身代谢组紊乱相关题目：Unraveling the interaction between the phageome and bacteriome in the rumen and its role in influencing metabolome dynamics in dairy cows at different lactation stages 翻译：奶牛不同泌乳期瘤胃噬菌体组与细菌组的互作解析及其对代谢组动态变化的影响 10.内科学 JAMA INTERNAL MEDICINE（本周无更新） ANNALS OF INTERNAL MEDICINE 题目：Trends in Cancer Incidence in Younger and Older Adults 翻译：青老年人群癌症发病率变化趋势题目：Primary Care Physician Time Spent in Patient Care: An Observational Study Using Electronic Health Record Logs 翻译：基层医生用于患者诊疗的时间占比：一项基于电子健康记录日志的观察性研究题目：Trends in and Predictors of Physician Attrition From Clinical Practice Across Specialties 翻译：不同专科医生临床执业流失趋势及影响因素分析题目：The Mediterranean Diet for Irritable Bowel Syndrome 翻译：地中海饮食在肠易激综合征中的应用题目：Step Accumulation Patterns and Risk for Cardiovascular Events and Mortality Among Suboptimally Active Adults 翻译：低活动量成年人的步数累积模式与心血管事件及死亡风险的关联题目：Effectiveness of Recombinant Herpes Zoster Vaccine in the U.S. Medicare Population, 2018 to 2019, by Immunocompetence and Prior Receipt of Live Zoster Vaccine 翻译：2018—2019年美国医疗保险人群重组带状疱疹疫苗的保护效力：基于免疫功能状态及既往减毒活疫苗接种史的分层分析题目：Palliative Care Educational App for Family Caregivers of Homebound Patients With Incurable Cancer 翻译：面向居家晚期癌症患者家庭照护者的姑息治疗教育应用程序 11.牙科与口腔外科 JOURNAL OF CLINICAL PERIODONTOLOGY（本周无更新）

细胞疗法免疫疗法并购临床2期临床3期

2023-03-10

·BioSpace

Endo Launches First Generic Version of Pylera® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) Capsules

DUBLIN, March 10, 2023 /PRNewswire/ --Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping the first generic version of Allergan's Pylera® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) 140 mg, 125 mg and 125 mg capsules in the U.S., following final approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application. "We're proud to be a reliable, quality supplier providing choices to healthcare professionals and their appropriate patients," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "This first-to-market generic product strengthens our portfolio and is a lower-cost option for people who need the medication." Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules, in combination with omeprazole, are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past five years) to eradicate H. pylori. According to IQVIA™, Pylera® sales were approximately $30 million for the 12 months ended December 31, 2022. Pylera® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate. IMPORTANT SAFETY INFORMATION FOR BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE CAPSULES CONTRAINDICATIONS Methoxyflurane: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. the concurrent use of tetracycline hydrochloride, a component of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride reported to result in fatal renal toxicity. Disulfiram: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride psychotic reactions have been reported in alcoholic patients who are using metronidazole, a component of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. Alcohol: Alcoholic beverages or other products containing propylene glycol should not be consumed during and for at least 3 days after therapy with bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride occur due to the interaction between alcohol or propylene glycol and metronidazole, a component of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. Cockayne Syndrome: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is contraindicated in patients with Cockayne Syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne Syndrome. Severe Renal Impairment: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is contraindicated in patients with severe renal impairment. The antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (bun). In patients with significantly impaired renal function, higher serum concentrations of tetracyclines may lead to azotemia, hyperphosphatemia, and acidosis. Pregnancy: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is contraindicated during pregnancy. Hypersensitivity Reactions: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is contraindicated in patient with known hypersensitivity (e.g. urticaria, erythematous rash, flushing and fever) to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, or tetracyclines. WARNINGS AND PRECAUTIONS Fetal Toxicity: Tetracycline can cause fetal harm when administered to a pregnant woman. Based on animal data, use of drugs of the tetracycline class during the second and third trimester of pregnancy can cause permanent discoloration of the teeth (yellow-gray brown) and possibly inhibit bone development. If bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is used during pregnancy, or if the patient becomes pregnant while taking bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride, advise the patient of the potential risk to the fetus. Maternal Toxicity: Tetracycline, a component of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride, administered during pregnancy at high doses (> 2 g iv) was associated with rare but serious cases of maternal hepatotoxicity. This syndrome may result in stillborn or premature birth due to maternal pathology. Tooth Enamel Discoloration and Hypoplasia: The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug, but has been observed following repeated short-term courses. Central and Peripheral Nervous System Effects: Metronidazole: convulsive seizures, encephalopathy, aseptic meningitis and peripheral neuropathy (including optic neuropathy) have been reported. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible. Aseptic meningitis symptoms may occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued. Tetracycline: intracranial hypertension (IH), including pseudotumor cerebri, has been associated with the use of tetracyclines. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin should be avoided because isotretinoin is also known to cause IH. Bismuth-containing products: cases of neurotoxicity associated with excessive doses of various bismuth-containing products have been reported. Effects have been reversible with discontinuation of bismuth therapy. Development of Potential for Microbial Overgrowth: Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with metronidazole and requires treatment with an antifungal agent. As with other antibacterial drugs, use of tetracycline hydrochloride may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride and institute appropriate therapy. Photosensitivity: Photosensitivity, manifested by an exaggerated sunburn reaction, has been observed in patients taking tetracycline. Instruct patients taking bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride to avoid exposure to the sun or sun lamps. Discontinue treatment at the first evidence of skin erythema. Darkening of the Tongue and/or Black Stool: Bismuth subcitrate potassium may cause temporary and harmless darkening of the tongue and/or black stools, generally reversible within several days after treatment [see Adverse Reactions]. Stool darkening should not be confused with melena. Use in Patients with Blood Dyscrasias: Metronidazole is a nitroimidazole, and should be used with care in patients with evidence of or history of blood dyscrasia. Total and differential leukocyte counts are recommended before and after therapy. Increased Drug Plasma Concentrations in Patients with Hepatic Impairment: Patients with mild to moderate hepatic impairment should be monitored for metronidazole associated adverse events. Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is not recommended in patients with severe hepatic impairment. Cutaneous Reactions: Skin and subcutaneous disorders including Stevens-Johnson Syndrome, toxic epidermal necrolysis and dress syndrome (drug rash with eosinophilia and systemic symptoms) have been reported. Discontinue treatment at the first evidence of a cutaneous reaction. ADVERSE REACTIONS Most frequently reported adverse reactions (>5o): abnormal feces, diarrhea, nausea, and headache. DRUG INTERACTIONS Methoxyfurane: risk of fatal renal toxicity; do not co-administer. Disulfram: psychotic reactions can occur; do not take concurrently or within the last 2 weeks of disulfram. Alcohol: abdominal cramps, nausea, vomiting, headaches, and flushing can occur; do not consume during therapy and for at least 3 days afterwards. Oral contraceptives: decreased efficacy possibly resulting in pregnancy; use a different or additional form of contraception. Anticoagulants: potentiation of the anticoagulant effect; prothrombin time, international normalized ratio (INR), or other suitable anticoagulation tests should be closely monitored. Lithium: increased lithium serum concentrations; measure serum lithium and serum creatinine concentrations during therapy. Antacids, multivitamins or dairy products: decreased absorption of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride; do not take concomitantly. Busulfan: increased busulfan serum concentrations; avoid concomitant use, monitor for busulfan toxicity. CYP inducers and CYP inhibitors: prolonged or accelerated half-life of metronidazole or concomitant medications; use with caution. INDICATION Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence. Please see Full Prescribing Information, including Boxed Warning, for bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. About Par Pharmaceutical Par Pharmaceutical develops, manufactures and markets innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patients' lives. Par, among the top leaders in the U.S. generics industry, possesses an expanding portfolio that includes sterile injectables, alternative dosage forms and other differentiated products. Par Pharmaceutical is an Endo company. Learn more at . Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, the statements by Mr. Sims, any statements relating to product launch, shipments, sales potential, quality, safety or cost. and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. Copies of the Company's press releases and additional information about the Company are available at or you can contact the Company's Investor Relations Department at relations.investor@endo.com. Company Codes: OTC-BB:ENDPQ, OTC-PINK:ENDPQ

上市批准

100 项与甲氧氟烷相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00544	甲氧氟烷	N02BG09	DB01028

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
疼痛	加拿大	Purdue Pharma LP	2018-04-07
麻醉	美国	Abbott Laboratories	1962-05-04

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适应症	最高研发状态	国家/地区	公司	日期
急性疼痛	临床3期	英国	Medical Developments International Ltd.	2011-08-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03215056 (MAGPIE, Pubmed \| Injury)	临床3期	-	192	Methoxyflurane 3 mL	廠簾繭製齋製構繭顧鹽(膚鏇觸繭餘積鏇醖夢廠) = 鬱淵鑰選觸築選憲製淵憲遞獵鏇築願壓鹽製鹹 (壓簾襯簾構範夢膚願獵 ) 更多	积极	2025-12-01
				Placebo (normal saline, 5 mL)	廠簾繭製齋製構繭顧鹽(膚鏇觸繭餘積鏇醖夢廠) = 膚憲獵鹽範簾餘鏇鹹鑰憲遞獵鏇築願壓鹽製鹹 (壓簾襯簾構範夢膚願獵 ) 更多
NCT05137184 (PreMeFen, Pubmed \| Nephron Clin Pract)	临床3期	急性疼痛	281	Inhalational methoxyflurane	鏇鬱觸淵鏇鹹淵壓壓觸(網構衊壓積蓋鏇獵鏇餘) = 鏇壓範簾膚蓋襯築獵遞簾鹽鏇鬱繭鑰鹹餘積糧 (窪糧選淵憲鹽齋淵鬱壓 ) 更多	积极	2025-12-01
				Intranasal fentanyl	鏇鬱觸淵鏇鹹淵壓壓觸(網構衊壓積蓋鏇獵鏇餘) = 淵蓋壓廠壓膚鏇鹽願醖簾鹽鏇鬱繭鑰鹹餘積糧 (窪糧選淵憲鹽齋淵鬱壓 )
NCT03256903 (InMEDIATE, Pubmed \| Ann Emerg Med) 人工标引	临床3期	创伤后疼痛一线	305	Methoxyflurane	衊積鏇鹹襯簾鬱簾齋選(鏇顧觸構鬱糧顧製齋鏇) = 觸醖淵齋製齋膚構繭願繭積鑰醖積繭築鹹窪構 (蓋淵襯夢遞範蓋構觸鬱 ) 更多	积极	2020-03-01
				standard analgesic treatment	衊積鏇鹹襯簾鬱簾齋選(鏇顧觸構鬱糧顧製齋鏇) = 願鹽醖醖範餘窪網鬱齋繭積鑰醖積繭築鹹窪構 (蓋淵襯夢遞範蓋構觸鬱 ) 更多
NCT03585374 (MEDITA, Pubmed \| Adv Ther) 人工标引	临床3期	创伤和损伤	272	Methoxyflurane	獵範憲廠願憲膚鬱醖簾(襯築簾艱願糧衊選範積) = 獵願鹽遞窪淵憲獵鏇繭窪窪獵艱膚廠夢願觸築 (艱網窪築觸遞獵積製築 ) 更多	优效	2019-11-01
				Standard Analgesic Treatment	獵範憲廠願憲膚鬱醖簾(襯築簾艱願糧衊選範積) = 衊廠夢簾壓襯壓鬱鏇夢窪窪獵艱膚廠夢願觸築 (艱網窪築觸遞獵積製築 ) 更多
NCT01420159 (STOP!, Pubmed \| J Pain Res)	临床3期	疼痛	300	Methoxyflurane	繭膚獵衊淵遞獵鏇鹽獵(鏇獵鹽構衊鑰繭醖獵築) = 餘膚築壓鹹製廠衊繭蓋憲夢鏇顧憲選願顧鹽選 (齋簾憲遞壓齋觸選齋窪 ) 更多	-	2019-01-01
				Placebo	繭膚獵衊淵遞獵鏇鹽獵(鏇獵鹽構衊鑰繭醖獵築) = 鏇選鹹廠鬱壓蓋淵淵淵憲夢鏇顧憲選願顧鹽選 (齋簾憲遞壓齋觸選齋窪 ) 更多
NCT01420159 (Pubmed \| Adv Ther)	临床3期	-	300	Methoxyflurane	觸餘襯築艱鹽醖鬱衊繭(艱艱鹹淵獵鹹顧淵衊網) = Treatment-related adverse events (mostly dizziness/headache) were reported by 42.2% of patients receiving methoxyflurane and 14.9% of patients receiving placebo 獵壓壓壓鹽醖壓繭蓋簾 (夢窪願繭糧淵顧鬱鬱構 ) 更多	-	2016-11-01
				Placebo
NCT01420159 (STOP!, Pubmed \| Emerg Med J)	临床3期	急性疼痛	300	Methoxyflurane	築製餘艱選醖積淵獵獵(齋襯構鑰願構構壓憲觸) = 網蓋壓鑰糧糧製鑰艱衊夢鏇糧獵網艱繭鬱積簾 (淵衊積糧製鏇製糧鏇鑰 )	积极	2014-08-01
NCT03894800 (Pubmed \| Anesthesiology)	临床4期	急性疼痛 \| 创伤和损伤 \| 血容量不足	12	Methoxyflurane	積壓網鏇醖選鹹蓋壓鏇(餘積齋願鑰蓋範觸窪鹹) = 衊壓襯蓋簾齋衊窪膚鬱醖積艱選顧蓋蓋餘觸淵 (夢網築艱蓋餘範築遞夢 )	-	2006-10-01