NEJM evidence最新文献

{"title":"Transfusion Strategies in Myocardial Ischemia - Treat Patients, Not Numbers.","authors":"Sheharyar Raza, Jeremy W Jacobs","doi":"10.1056/EVIDe2400366","DOIUrl":"https://doi.org/10.1056/EVIDe2400366","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 2","pages":"EVIDe2400366"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143054486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Proof-of-Concept Study of Ulipristal Acetate for Early Medication Abortion.","authors":"Beverly Winikoff, Manuel Bousiéguez, Jorge Salmerón, Karina Robles-Rivera, Sonia Hernández-Salazar, Angélica Martínez-Huitrón, María Laura García-Martínez, Lucía Aguirre-Antonio, Ilana G Dzuba","doi":"10.1056/EVIDoa2400209","DOIUrl":"10.1056/EVIDoa2400209","url":null,"abstract":"<p><strong>Background: </strong>The current regimen for early medication abortion in many countries is mifepristone and misoprostol, but mifepristone is relatively expensive and limited in many regions. Ulipristal acetate, with a similar chemical profile, might be an alternative. This proof-of-concept study evaluated ulipristal acetate and misoprostol for medication abortion through 63 days of gestation.</p><p><strong>Methods: </strong>We conducted a two-stage clinical study to choose an effective and acceptable ulipristal-misoprostol regimen. First, we undertook a dose-finding study. Sixty-six participants were randomly assigned to either 60 mg or 90 mg of oral ulipristal, followed by 800 μg of buccal misoprostol. Because the two groups had similar efficacy and safety profiles, we opted for the 60-mg ulipristal dose for an open-label study with 100 additional participants, resulting in a total of 133 participants using the same regimen. To evaluate acceptability, we applied a structured questionnaire at the end of the follow-up visit.</p><p><strong>Results: </strong>Pregnancy termination occurred with the combination of oral ulipristal 60 mg and buccal misoprostol 800 μg in 129 out of 133, or 97.0%, (95% confidence interval [CI], 94.1 to 99.9%), of participants. Among those for whom this regimen did not result in pregnancy termination, one participant had a completion with sharp curettage, two received manual vacuum aspiration, and one underwent a repeat medication abortion with misoprostol alone. Side effects included chills (77.4%; 95% CI, 70.3 to 84.5%), diarrhea (66.9%; 95% CI, 59.0 to 74.8%), and nausea (48.1%; 95% CI, 39.7 to 56.5%). No serious adverse events were reported. The regimen was deemed \"acceptable\" or \"highly acceptable\" by 97.7% (95% CI, 95.2 to 100.0%) of participants.</p><p><strong>Conclusions: </strong>This study suggests that ulipristal acetate followed by misoprostol is an effective and acceptable medication abortion regimen with no reported serious adverse events. (This project is supported by the OPTions Initiative. The study registered as ISRCTN35625202.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":" ","pages":"EVIDoa2400209"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143030367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiopulmonary Exercise Testing.","authors":"Tiffany L Brazile, Benjamin D Levine, Keri M Shafer","doi":"10.1056/EVIDra2400390","DOIUrl":"https://doi.org/10.1056/EVIDra2400390","url":null,"abstract":"<p><p>AbstractBecause symptoms of cardiopulmonary disease often occur with exertion, cardiopulmonary exercise testing (CPET) has a unique role in the assessment of patient symptoms, disease severity, prognosis, and response to therapy. In addition to the evaluation of cardiovascular and pulmonary physiology, CPET provides an assessment of the interaction of the cardiovascular and pulmonary systems with the musculoskeletal, nervous, and hematological systems. In this article, we review key CPET variables, protocols, and clinical indications.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 2","pages":"EVIDra2400390"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143054399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New Data on Ulipristal Acetate and Misoprostol for Medication Abortion - A Step Forward?","authors":"Daniel Grossman","doi":"10.1056/EVIDe2400460","DOIUrl":"10.1056/EVIDe2400460","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":" ","pages":"EVIDe2400460"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143030373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Restrictive versus Liberal Transfusion in Myocardial Infarction - A Patient-Level Meta-Analysis.","authors":"Jeffrey L Carson, Dean A Fergusson, Helaine Noveck, Ranjeeta Mallick, Tabassome Simon, Sunil V Rao, Howard Cooper, Simon J Stanworth, Gerard T Portela, Gregory Ducrocq, Marnie Bertolet, Andrew P DeFilippis, Andrew M Goldsweig, Sarang Kim, Darrell J Triulzi, Mark A Menegus, J Dawn Abbott, Renato D Lopes, Maria Mori Brooks, John H Alexander, Paul C Hébert, Shaun G Goodman, P Gabriel Steg","doi":"10.1056/EVIDoa2400223","DOIUrl":"10.1056/EVIDoa2400223","url":null,"abstract":"<p><strong>Background: </strong>Clinical guidelines have concluded that there are insufficient data to provide recommendations for the hemoglobin threshold for the use of red cell transfusion in patients with acute myocardial infarction (MI) and anemia. After the recent publication of the Myocardial Infarction and Transfusion (MINT) trial, we performed an individual patient-level data meta-analysis to evaluate the effect of restrictive versus liberal blood transfusion strategies.</p><p><strong>Methods: </strong>We conducted searches in major databases. Eligible trials randomly assigned patients with MI and anemia to either a restrictive (i.e., transfusion threshold of 7-8 g/dl) or liberal (i.e., transfusion threshold of 10 g/dl) red cell transfusion strategy. We used individual patient data from each trial. The primary outcome was a composite of 30-day mortality or MI.</p><p><strong>Results: </strong>We included 4311 patients from four trials. The primary outcome occurred in 334 patients (15.4%) in the restrictive strategy and 296 patients (13.8%) in the liberal strategy (relative risk [RR] 1.13, 95% confidence interval [CI], 0.97 to 1.30). Death at 30 days occurred in 9.3% of patients in the restrictive strategy and in 8.1% of patients in the liberal strategy (RR 1.15, 95% CI, 0.95 to 1.39). Cardiac death at 30 days occurred in 5.5% of patients in the restrictive strategy and in 3.7% of patients in the liberal strategy (RR 1.47, 95% CI, 1.11 to 1.94). Heart failure (RR 0.89, 95% CI, 0.70 to 1.13) was similar in the transfusion strategies. All-cause mortality at 6 months occurred in 20.5% of patients in the restrictive strategy compared with 19.1% of patients in the liberal strategy (hazard ratio 1.08, 95% CI, 1.05 to 1.11).</p><p><strong>Conclusions: </strong>Pooling individual patient data from four trials did not find a definitive difference in our primary composite outcome of MI or death at 30 days. At 6 months, a restrictive transfusion strategy was associated with increased all-cause mortality. (Partially funded by a grant from the U.S. National Heart, Lung, and Blood Institute [R01HL171977].).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":" ","pages":"EVIDoa2400223"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PIVOTing the Course of HbSC Disease.","authors":"Abena Appiah-Kubi, Banu Aygun","doi":"10.1056/EVIDe2400449","DOIUrl":"https://doi.org/10.1056/EVIDe2400449","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 2","pages":"EVIDe2400449"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143054483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Should Low-Risk Pregnant Patients be Screened for Asymptomatic Bacteriuria?","authors":"Prachi Ray, Kellie E Murphy, Vanessa G Allen","doi":"10.1056/EVIDtt2400088","DOIUrl":"https://doi.org/10.1056/EVIDtt2400088","url":null,"abstract":"<p><p>AbstractScreening and treatment of asymptomatic bacteriuria is generally not recommended due to a lack of clinical benefit and potential harm. A notable exception is the recommendation for routine screening during pregnancy. In this Tomorrow's Trial, the authors review the relevant evidence and propose a trial to address the question, \"should low-risk pregnant patients be screened for asymptomatic bacteriuria?\"</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 2","pages":"EVIDtt2400088"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143054484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"On \"Blood Pressure Targets for Adults with Vasodilatory Shock\".","authors":"Rob Mac Sweeney, C Corey Hardin, François Lamontagne","doi":"10.1056/EVIDe2400444","DOIUrl":"https://doi.org/10.1056/EVIDe2400444","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 1","pages":"EVIDe2400444"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"BNC210, an α7 Nicotinic Receptor Modulator, in Post-Traumatic Stress Disorder.","authors":"Spyridon Papapetropoulos, Elizabeth Doolin, Susan O'Connor, Dharam Paul, Michael Odontiadis, Mark Jaros, Paul Rolan, Murray B Stein","doi":"10.1056/EVIDoa2400380","DOIUrl":"10.1056/EVIDoa2400380","url":null,"abstract":"<p><strong>Background: </strong>Post-traumatic stress disorder (PTSD) is a serious, debilitating, and prevalent psychiatric condition occurring in people who are traumatized and experience intense, disturbing thoughts and feelings that persist. BNC210 is a novel α7 nicotinic acetylcholine receptor-negative allosteric modulator developed to treat PTSD.</p><p><strong>Methods: </strong>ATTUNE was a randomized, double-blind, phase 2b, placebo-controlled trial. Patients between 18 and 75 years of age with a current PTSD diagnosis and a Clinician-Administered PTSD Scale for DSM-5 (<i>Diagnostic and Statistical Manual of Mental Disorders</i>, Fifth Edition) (CAPS-5) total symptom severity score of 30 or more were eligible (range: 0 to 80; in all scales used in this trial a higher score indicates a more severe condition). We randomly assigned patients 1:1 to a BNC210 dose of 900 mg twice daily or placebo for 12 weeks. The primary end point was a change from baseline to week 12 in CAPS-5 total score for BNC210 versus placebo.</p><p><strong>Results: </strong>In the modified intent-to-treat population (n=182), an improvement in the CAPS-5 total score was observed with BNC210 compared with placebo (least squares [LS] mean difference: -4.03; Cohen's d effect size: 0.40; P=0.048) at week 12. A LS mean difference in CAPS-5 score of -4.11 was observed as early as week 4. The LS mean difference to week 12 for depressive symptoms measured on the Montgomery-Åsberg Depression Rating Scale (range: 0 to 60; minimal clinically important difference [MCID] ≥2]) was -3.19 and for sleep measured on the Insomnia Severity Index (range: 0 to 28; MCID 6) was -2.19. Treatment-emergent adverse events (AEs) occurred in 70 (66.7%) patients in the BNC210 group and 56 (53.8%) in the placebo group, most commonly headache, nausea, fatigue, and hepatic enzyme elevations. In the BNC210 treatment group, 21 patients withdrew from treatment for AEs, while 10 did so in the placebo group. There were no serious AEs or deaths reported for the BNC210 group.</p><p><strong>Conclusions: </strong>BNC210 improved PTSD symptom severity at week 12 with indications of effect as early as week 4. Our trial establishes equipoise for additional larger trials that are needed to determine the clinical utility of BNC210 for the treatment of PTSD. (Funded by Bionomics Limited; ClinicalTrials.gov number, NCT04951076.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":" ","pages":"EVIDoa2400380"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142796519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diabetes Care for the Aging Population in the Digital Age.","authors":"Medha Munshi, Elena Toschi","doi":"10.1056/EVIDe2400389","DOIUrl":"https://doi.org/10.1056/EVIDe2400389","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 1","pages":"EVIDe2400389"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}