New England Journal of Medicine最新文献

{"title":"Vaccinating against <i>Clostridioides difficile</i> Infection.","authors":"Vincent B Young","doi":"10.1056/NEJMcibr2413794","DOIUrl":"https://doi.org/10.1056/NEJMcibr2413794","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 12","pages":"1237-1240"},"PeriodicalIF":96.2,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143733207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Severe HDL Cholesterol Reduction with Bempedoic Acid and Fenofibrate.","authors":"Francesco Sbrana, Federico Bigazzi, Beatrice Dal Pino","doi":"10.1056/NEJMc2413726","DOIUrl":"https://doi.org/10.1056/NEJMc2413726","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 12","pages":"1241-1242"},"PeriodicalIF":96.2,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143733202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intensive Blood-Pressure Control in Patients with Type 2 Diabetes.","authors":"Yufang Bi, Mian Li, Yan Liu, Tingzhi Li, Jieli Lu, Peng Duan, Fengmei Xu, Qijuan Dong, Ailiang Wang, Tiange Wang, Ruizhi Zheng, Yuhong Chen, Min Xu, Xiaohu Wang, Xinhuan Zhang, Yanbo Niu, Zhiqiang Kang, Chunru Lu, Jing Wang, Xinwen Qiu, An Wang, Shujing Wu, Jingya Niu, Jingya Wang, Zhiyun Zhao, Huanfeng Pan, Xiaohua Yang, Xiaohong Niu, Shuguang Pang, Xiaoliang Zhang, Yuancheng Dai, Qin Wan, Shihong Chen, Qidong Zheng, Shaoping Dai, Juan Deng, Leshan Liu, Guixia Wang, Huiqi Zhu, Weidong Tang, Haixia Liu, Zhenfang Guo, Guang Ning, Jiang He, Yu Xu, Weiqing Wang","doi":"10.1056/NEJMoa2412006","DOIUrl":"10.1056/NEJMoa2412006","url":null,"abstract":"<p><strong>Background: </strong>Effective targets for systolic blood-pressure control in patients with type 2 diabetes are unclear.</p><p><strong>Methods: </strong>We enrolled patients 50 years of age or older with type 2 diabetes, elevated systolic blood pressure, and an increased risk of cardiovascular disease at 145 clinical sites across China. Patients were randomly assigned to receive intensive treatment that targeted a systolic blood pressure of less than 120 mm Hg or standard treatment that targeted a systolic blood pressure of less than 140 mm Hg for up to 5 years. The primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes. Multiple imputation was used for missing outcome data, with an assumption that the data were missing at random.</p><p><strong>Results: </strong>Of 12,821 patients (6414 patients in the intensive-treatment group and 6407 in the standard-treatment group) enrolled from February 2019 through December 2021, 5803 (45.3%) were women; the mean (±SD) age of the patients was 63.8±7.5 years. At 1 year of follow-up, the mean systolic blood pressure was 121.6 mm Hg (median, 118.3 mm Hg) in the intensive-treatment group and 133.2 mm Hg (median, 135.0 mm Hg) in the standard-treatment group. During a median follow-up of 4.2 years, primary-outcome events occurred in 393 patients (1.65 events per 100 person-years) in the intensive-treatment group and 492 patients (2.09 events per 100 person-years) in the standard-treatment group (hazard ratio, 0.79; 95% confidence interval, 0.69 to 0.90; P<0.001). The incidence of serious adverse events was similar in the treatment groups. However, symptomatic hypotension and hyperkalemia occurred more frequently in the intensive-treatment group than in the standard-treatment group.</p><p><strong>Conclusions: </strong>Among patients with type 2 diabetes, the incidence of major cardiovascular events was significantly lower with intensive treatment targeting a systolic blood pressure of less than 120 mm Hg than with standard treatment targeting a systolic blood pressure of less than 140 mm Hg. (Funded by the National Key Research and Development Program of the Ministry of Science and Technology of China and others; BPROAD ClinicalTrials.gov number, NCT03808311.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1155-1167"},"PeriodicalIF":96.2,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142648992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tezepelumab in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps.","authors":"Brian J Lipworth, Joseph K Han, Martin Desrosiers, Claire Hopkins, Stella E Lee, Joaquim Mullol, Oliver Pfaar, Ting Li, Claudia Chen, Gun Almqvist, Mary Kay Margolis, Julie McLaren, Shankar Jagadeesh, Jamie MacKay, Ayman Megally, Åsa Hellqvist, Vaishali S Mankad, Lila Bahadori, Sandhia S Ponnarambil","doi":"10.1056/NEJMoa2414482","DOIUrl":"10.1056/NEJMoa2414482","url":null,"abstract":"<p><strong>Background: </strong>Treatment with tezepelumab has been effective for sinonasal symptoms in patients with severe, uncontrolled asthma and a history of chronic rhinosinusitis with nasal polyps, but its efficacy and safety in adults with severe, uncontrolled chronic rhinosinusitis with nasal polyps is unknown.</p><p><strong>Methods: </strong>We randomly assigned adults with physician-diagnosed, symptomatic, severe chronic rhinosinusitis with nasal polyps to receive standard care and either tezepelumab (at a dose of 210 mg) or placebo subcutaneously every 4 weeks for 52 weeks. The coprimary end points were the changes from baseline in the total nasal-polyp score (range, 0 to 4 [for each nostril]; higher scores indicate greater severity) and the mean nasal-congestion score (range, 0 to 3; higher scores indicate greater severity) at week 52. Key secondary end points assessed in the overall population were the loss-of-smell score, the total score on the Sinonasal Outcome Test (SNOT-22; range, 0 to 110; higher scores indicate greater severity), the Lund-Mackay score (range, 0 to 24; higher scores indicate greater severity), the total symptom score (range, 0 to 24; higher scores indicate greater severity), and the first decision to treat with nasal-polyp surgery or use of systemic glucocorticoid therapy, or both, assessed in time-to-event analyses (individual and composite).</p><p><strong>Results: </strong>In total, 203 patients were assigned to receive tezepelumab and 205 to receive placebo. At week 52, the patients who received tezepelumab had significant improvements in the total nasal-polyp score (mean difference vs. placebo, -2.07; 95% confidence interval [CI], -2.39 to -1.74) and the mean nasal-congestion score (-1.03; 95% CI, -1.20 to -0.86) (P<0.001 for both scores). Tezepelumab significantly improved the loss-of-smell score (mean difference vs. placebo, -1.00; 95% CI, -1.18 to -0.83), SNOT-22 total score (-27.26; 95% CI, -32.32 to -22.21), Lund-Mackay score (-5.72; 95% CI, -6.39 to -5.06), and total symptom score (-6.89; 95% CI, -8.02 to -5.76) (P<0.001 for all scores). Surgery for nasal polyps was indicated in significantly fewer patients in the tezepelumab group (0.5%) than in the placebo group (22.1%) (hazard ratio, 0.02; 95% CI, 0.00 to 0.09); there was significantly less use of systemic glucocorticoids with tezepelumab (5.2%) than with placebo (18.3%) (hazard ratio, 0.12; 95% CI, 0.04 to 0.27) (P<0.001 for both time-to-event analyses).</p><p><strong>Conclusions: </strong>Tezepelumab therapy led to significantly greater reductions in the size of nasal polyps, the severity of nasal congestion and sinonasal symptoms, and the use of nasal-polyp surgery and systemic glucocorticoids than placebo in adults with severe, uncontrolled chronic rhinosinusitis with nasal polyps. (Funded by AstraZeneca and Amgen; WAYPOINT ClinicalTrials.gov number, NCT04851964.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1178-1188"},"PeriodicalIF":96.2,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143665381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disappearing Data at the U.S. Federal Government.","authors":"Janet Freilich, W Nicholson Price, Aaron S Kesselheim","doi":"10.1056/NEJMp2502567","DOIUrl":"https://doi.org/10.1056/NEJMp2502567","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143733244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes.","authors":"Yogish C Kudva, Dan Raghinaru, John W Lum, Timothy E Graham, David Liljenquist, Elias K Spanakis, Francisco J Pasquel, Andrew Ahmann, David T Ahn, Grazia Aleppo, Thomas Blevins, Davida Kruger, Sue A Brown, Carol J Levy, Ruth S Weinstock, Devin W Steenkamp, Tamara Spaic, Irl B Hirsch, Frances Broyles, Michael R Rickels, Michael A Tsoukas, Philip Raskin, Betul Hatipoglu, Donna Desjardins, Adrienne N Terry, Lakshmi G Singh, Georgia M Davis, Caleb Schmid, Jelena Kravarusic, Kasey Coyne, Luis Casaubon, Valerie Espinosa, Jaye K Jones, Kathleen Estrada, Samina Afreen, Camilla Levister, Grenye O'Malley, Selina L Liu, Sheryl Marks, Amy J Peleckis, Melissa-Rosina Pasqua, Vanessa Tardio, Corey Kurek, Ryan D Luker, Jade Churchill, Farbod Z Tajrishi, Ariel Dean, Brittany Dennis, Evelyn Fronczyk, Jennifer Perez, Shereen Mukhashen, Jasmeen Dhillon, Aslihan Ipek, Suzan Bzdick, Astrid Atakov Castillo, Marsha Driscoll, Xenia Averkiou, Cornelia V Dalton-Bakes, Adelyn Moore, Lin F Jordan, Amanda Lesniak, Jordan E Pinsker, Ravid Sasson-Katchalski, Tiffany Campos, Charles Spanbauer, Lauren Kanapka, Craig Kollman, Roy W Beck","doi":"10.1056/NEJMoa2415948","DOIUrl":"https://doi.org/10.1056/NEJMoa2415948","url":null,"abstract":"<p><strong>Background: </strong>Automated insulin delivery (AID) systems have been shown to be beneficial for patients with type 1 diabetes, but data are needed from randomized, controlled trials regarding their role in the management of insulin-treated type 2 diabetes.</p><p><strong>Methods: </strong>In this 13-week, multicenter trial, adults with insulin-treated type 2 diabetes were randomly assigned in a 2:1 ratio to receive AID or to continue their pretrial insulin-delivery method (control group); both groups received continuous glucose monitoring (CGM). The primary outcome was the glycated hemoglobin level at 13 weeks.</p><p><strong>Results: </strong>A total of 319 patients underwent randomization. Glycated hemoglobin levels decreased by 0.9 percentage points (from 8.2±1.4% at baseline to 7.3±0.9% at week 13) in the AID group and by 0.3 percentage points (from 8.1±1.2% to 7.7±1.1%) in the control group (mean adjusted difference, -0.6 percentage points; 95% confidence interval [CI], -0.8 to -0.4; P<0.001). The mean percentage of time that patients were in the target glucose range of 70 to 180 mg per deciliter increased from 48±24% to 64±16% in the AID group and from 51±21% to 52±21% in the control group (mean difference, 14 percentage points; 95% CI, 11 to 17; P<0.001). All other multiplicity-controlled CGM outcomes reflective of hyperglycemia that were measured were significantly better in the AID group than in the control group. The frequency of CGM-measured hypoglycemia was low in both groups. A severe hypoglycemia event occurred in one patient in the AID group.</p><p><strong>Conclusions: </strong>In this 13-week, randomized, controlled trial involving adults with insulin-treated type 2 diabetes, AID was associated with a greater reduction in glycated hemoglobin levels than CGM alone. (Funded by Tandem Diabetes Care; 2IQP ClinicalTrials.gov number, NCT05785832.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143659644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sentinel-Lymph-Node Biopsy in Early-Stage Breast Cancer - Is It Obsolete?","authors":"Monica Morrow","doi":"10.1056/NEJMe2414899","DOIUrl":"10.1056/NEJMe2414899","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1134-1136"},"PeriodicalIF":96.2,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pembrolizumab in Early-Stage Triple-Negative Breast Cancer.","authors":"Patrick Neven, Giuseppe Floris, Christine Desmedt","doi":"10.1056/NEJMc2416491","DOIUrl":"https://doi.org/10.1056/NEJMc2416491","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 11","pages":"1140-1141"},"PeriodicalIF":96.2,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incidence of Scrub Typhus in Rural South India.","authors":"Carol Devamani, Neal Alexander, Daniel Chandramohan, John Stenos, Mary Cameron, Kundavaram P P Abhilash, Punam Mangtani, Stuart Blacksell, Huong Thi Thu Vu, Winsley Rose, Wolf-Peter Schmidt","doi":"10.1056/NEJMoa2408645","DOIUrl":"10.1056/NEJMoa2408645","url":null,"abstract":"<p><strong>Background: </strong>Hospital studies suggest that scrub typhus is a leading cause of severe undifferentiated fever in regions across Asia where the disease is endemic, but the population-based incidence of infection and illness has been little studied.</p><p><strong>Methods: </strong>We conducted a population-based cohort study to assess epidemiologic and clinical characteristics of scrub typhus in 37 villages in Tamil Nadu, India, where the disease is highly endemic. Study participants were visited every 6 to 8 weeks over a period of 2 years; a venous blood sample was obtained from those who had had fever since the last visit. A subcohort of participants underwent blood sampling to estimate the incidence of serologically confirmed <i>Orientia tsutsugamushi</i> infection.</p><p><strong>Results: </strong>We systematically assessed 32,279 participants from 7619 households for acute febrile illness. During 54,588 person-years of follow-up, we observed 6175 episodes of fever. A blood sample was obtained in 4474 episodes (72.5%), of which 328 (7.3%) met the clinical case definition of scrub typhus (detection of IgM against <i>O. tsutsugamushi</i> on enzyme-linked immunosorbent assay [ELISA] or detection of <i>O. tsutsugamushi</i> on polymerase-chain-reaction assay). The incidence of clinical infection was 6.0 cases per 1000 person-years (95% confidence interval [CI], 4.8 to 7.5). A total of 71 clinical cases (21.6%) resulted in hospitalization (incidence, 1.3 events per 1000 person-years; 95% CI, 1.0 to 1.7). A total of 29 clinical cases (8.8%) were severe, as indicated by the presence of organ dysfunction or adverse pregnancy outcomes (incidence, 0.5 cases per 1000 person-years; 95% CI, 0.4 to 0.8). Among 2128 participants in the subcohort who provided samples at the beginning and end of a study year, the incidence of seroconversion independent of any symptoms was 81.2 events per 1000 person-years (95% CI, 70.8 to 91.6). The incidence of clinical infection was higher in older age groups than in younger age groups and higher among female participants than among male participants. By contrast, the age-adjusted rate of severe infection was similar among male and female participants. Among 5602 participants assessed at the start of the first year of the study, the seroprevalence of IgG as assessed with ELISA was 42.8% (95% CI, 35.8 to 50.2). IgG seropositivity at the beginning of years 1 or 2 did not protect against clinical illness during the subsequent year but was associated with less severe disease than IgG seronegativity.</p><p><strong>Conclusions: </strong>We describe the burden of scrub typhus, including the incidence of asymptomatic infection, in a region of Asia where the disease is endemic. (Funded by the U.K. Medical Research Council; ClinicalTrials.gov number, NCT04506944.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 11","pages":"1089-1099"},"PeriodicalIF":96.2,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7617504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Smooth Transition.","authors":"Ole-Petter Riksfjord Hamnvik, Anand Vaidya, Jenny Siegel, Michael S Irwig","doi":"10.1056/NEJMimc2404250","DOIUrl":"https://doi.org/10.1056/NEJMimc2404250","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 11","pages":"e30"},"PeriodicalIF":96.2,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}