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Compared with What? Measuring AI against the Health Care We Have 与什么相比?用我们现有的医疗保健衡量人工智能
IF 158.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-26 DOI: 10.1056/nejmp2404691
Isaac S. KohaneFrom the Department of Biomedical Informatics, Harvard Medical School, and Boston Children’s Hospital — both in Boston.
Large numbers of patients are already using AI tools to obtain medical advice. Rigorous trials of these tools will be important. But what will they be measured against?
大量患者已经在使用人工智能工具获取医疗建议。对这些工具进行严格的试验非常重要。但是,衡量这些工具的标准是什么呢?
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引用次数: 0
Chvostek’s Sign in Familial Hypoparathyroidism 家族性甲状旁腺功能减退症的 Chvostek 征
IF 158.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-26 DOI: 10.1056/nejmicm2406864
Zhigang YangHenan Children’s Hospital, Zhengzhou, ChinaJie DengBeijing Children’s Hospital, Beijing, China
A 2-year-old boy was brought to the ED after he had had four generalized seizures in the previous week. Physical examination was notable for brisk tendon reflexes and Chvostek’s sign (shown in a vi...
一名两岁的男孩在一周前出现了四次全身性癫痫发作,随后被送到急诊室。体格检查结果显示,他有轻快的腱反射和Chvostek征(如图...
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引用次数: 0
“Blessed Be the Fruit” — The Contemporary Rise of Pronatalism "有福之果"--当代产婆主义的兴起
IF 158.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-26 DOI: 10.1056/nejmp2410208
Rasadokht Forati, and Deborah BartzFrom Harvard Medical School (R.F., D.B.) and the Department of Obstetrics and Gynecology, Brigham and Women’s Hospital (D.B.) — both in Boston.
Pronatalist policies like those being increasingly promoted in the United States threaten the health and well-being of women and marginalized people, as well as progress toward gender equity.
美国日益推行的产前主义政策威胁着妇女和边缘化人群的健康和福祉,也威胁着实现性别平等的进程。
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引用次数: 0
APOL1 Bi- and Monoallelic Variants and Chronic Kidney Disease in West Africans 西非人的 APOL1 双等位基因和单等位基因变异与慢性肾病
IF 158.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-26 DOI: 10.1056/nejmoa2404211
Rasheed A. Gbadegesin, Ifeoma Ulasi, Samuel Ajayi, Yemi Raji, Timothy Olanrewaju, Charlotte Osafo, Adebowale D. Ademola, Adanze Asinobi, Cheryl A. Winkler, David Burke, Fatiu Arogundade, Ivy Ekem, Jacob Plange-Rhule, Manmak Mamven, Michael Matekole, Olukemi Amodu, Richard Cooper, Sampson Antwi, Adebowale A. Adeyemo, Titilayo O. Ilori, Victoria Adabayeri, Alexander Nyarko, Anita Ghansah, Toyin Amira, Adaobi Solarin, Olugbenga Awobusuyi, Paul L. Kimmel, Frank Chip Brosius, Muhammad Makusidi, Uzoma Odenigbo, Matthias Kretzler, Jeffrey B. Hodgin, Martin R. Pollak, Vincent Boima, Barry I. Freedman, Nicholette D. Palmer, Bernard Collins, Milind Phadnis, Jill Smith, Celia I. Agwai, Ogochukwu Okoye, Aliyu Abdu, Jillian Wilson, Winfred Williams, Babatunde L. Salako, Rulan S. Parekh, Bamidele Tayo, Dwomoa Adu, and Akinlolu Ojothe H3Africa Kidney Disease Research Network*From the Department of Pediatrics, Duke University Medical Center, Durham (R.A.G.), and the Departments of Medicine (..
Apolipoprotein L1 gene (APOL1) variants are risk factors for chronic kidney disease (CKD) among Black Americans. Data are sparse on the genetic epidemiology of CKD and the clinical association of A...
载脂蛋白 L1 基因 (APOL1) 变异是美国黑人患慢性肾病 (CKD) 的风险因素。关于慢性肾脏病的遗传流行病学和载脂蛋白 L1 基因变异与慢性肾脏病的临床关联的数据很少。
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引用次数: 0
Long-Term Effects of Empagliflozin in Patients with Chronic Kidney Disease. 恩格列净对慢性肾病患者的长期影响
IF 158.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-25 DOI: 10.1056/nejmoa2409183
,William G Herrington,Natalie Staplin,Nikita Agrawal,Christoph Wanner,Jennifer B Green,Sibylle J Hauske,Jonathan R Emberson,David Preiss,Parminder Judge,Doreen Zhu,Rejive Dayanandan,Ryoki Arimoto,Kaitlin J Mayne,Sarah Y A Ng,Emily Sammons,Michael Hill,Will Stevens,Karl Wallendszus,Susanne Brenner,Alfred K Cheung,Zhi-Hong Liu,Jing Li,Lai Seong Hooi,Wen Liu,Takashi Kadowaki,Masaomi Nangaku,Adeera Levin,David Z I Cherney,Aldo P Maggioni,Roberto Pontremoli,Rajat Deo,Shinya Goto,Xavier Rossello,Katherine R Tuttle,Dominik Steubl,Dan Massey,Martina Brueckmann,Martin J Landray,Colin Baigent,Richard Haynes
BACKGROUNDIn the EMPA-KIDNEY trial, empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, had positive cardiorenal effects in patients with chronic kidney disease who were at risk for disease progression. Post-trial follow-up was designed to assess how the effects of empagliflozin would evolve after the discontinuation of the trial drug.METHODSIn the active trial, patients with chronic kidney disease were randomly assigned to receive either empagliflozin (10 mg once daily) or matching placebo and were followed for a median of 2 years. All the patients had an estimated glomerular filtration rate (eGFR) of at least 20 but less than 45 ml per minute per 1.73 m2 of body-surface area or an eGFR of at least 45 but less than 90 ml per minute per 1.73 m2 with a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of at least 200. Subsequently, surviving patients who consented were observed for 2 additional years. No trial empagliflozin or placebo was administered during the post-trial period, but local practitioners could prescribe open-label SGLT2 inhibitors, including open-label empagliflozin. The primary composite outcome was kidney disease progression or cardiovascular death as assessed from the start of the active-trial period to the end of the post-trial period.RESULTSOf the 6609 patients who had undergone randomization in the active trial, 4891 (74%) were enrolled in the post-trial period. During this period, the use of open-label SGLT2 inhibitors was similar in the two groups (43% in the empagliflozin group and 40% in the placebo group). During the combined active- and post-trial periods, a primary-outcome event occurred in 865 of 3304 patients (26.2%) in the empagliflozin group and in 1001 of 3305 patients (30.3%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.72 to 0.87). During the post-trial period only, the hazard ratio for a primary-outcome event was 0.87 (95% CI, 0.76 to 0.99). During the combined periods, the risk of kidney disease progression was 23.5% in the empagliflozin group and 27.1% in the placebo group; the risk of the composite of death or end-stage kidney disease was 16.9% and 19.6%, respectively; and the risk of cardiovascular death was 3.8% and 4.9%, respectively. There was no effect of empagliflozin on death from noncardiovascular causes (5.3% in both groups).CONCLUSIONSIn a broad range of patients with chronic kidney disease at risk for progression, empagliflozin continued to have additional cardiorenal benefits for up to 12 months after it was discontinued. (Funded by Boehringer Ingelheim and others; EMPA-KIDNEY ClinicalTrials.gov number, NCT03594110; EuDRACT number, 2017-002971-24.).
背景在EMPA-KIDNEY试验中,钠-葡萄糖共转运体2(SGLT2)抑制剂empagliflozin对有疾病进展风险的慢性肾病患者具有积极的心肾作用。试验后随访的目的是评估停用试验药物后,empagliflozin 的疗效将如何发展。方法在积极试验中,慢性肾病患者被随机分配接受empagliflozin(10 毫克,每天一次)或匹配的安慰剂,并接受中位 2 年的随访。所有患者的估计肾小球滤过率(eGFR)为每分钟每 1.73 平方米体表面积至少 20 毫升但小于 45 毫升,或 eGFR 为每分钟每 1.73 平方米体表面积至少 45 毫升但小于 90 毫升,尿白蛋白与肌酐比值(白蛋白以毫克为单位,肌酐以克为单位)至少为 200。随后,对同意接受治疗的存活患者进行了为期两年的观察。试验后期间不使用试验用的恩格列净或安慰剂,但当地医生可开具开放标签的SGLT2抑制剂处方,包括开放标签的恩格列净。主要的综合结果是肾病进展或心血管死亡,评估时间为活动试验开始至试验后结束。在此期间,两组患者使用开放标签 SGLT2 抑制剂的比例相似(empagliflozin 组为 43%,安慰剂组为 40%)。在活动期和试验后的综合阶段,在3304例患者中,有865例(26.2%)服用了恩格列净;在3305例患者中,有1001例(30.3%)服用了安慰剂(危险比为0.79;95%置信区间[CI]为0.72至0.87)。仅在试验后阶段,主要结果事件的危险比为 0.87(95% 置信区间 [CI],0.76 至 0.99)。在综合期间,恩格列净组肾病进展风险为23.5%,安慰剂组为27.1%;死亡或终末期肾病综合风险分别为16.9%和19.6%;心血管死亡风险分别为3.8%和4.9%。结论 在有进展风险的慢性肾病患者中,empagliflozin在停药后长达12个月内仍具有额外的心肾益处。(由勃林格殷格翰等公司资助;EMPA-KIDNEY ClinicalTrials.gov 编号:NCT03594110;EuDRACT 编号:2017-002971-24)。
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引用次数: 0
Alternative Complement Pathway Inhibition with Iptacopan in IgA Nephropathy. 用Iptacopan抑制IgA肾病的替代补体途径
IF 158.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-25 DOI: 10.1056/nejmoa2410316
Vlado Perkovic,Jonathan Barratt,Brad Rovin,Naoki Kashihara,Bart Maes,Hong Zhang,Hernán Trimarchi,Dmitrij Kollins,Olympia Papachristofi,Severina Jacinto-Sanders,Tobias Merkel,Nicolas Guerard,Ronny Renfurm,Thomas Hach,Dana V Rizk
BACKGROUNDThe alternative complement pathway plays a key role in the pathogenesis of IgA nephropathy. Iptacopan specifically binds to factor B and inhibits the alternative pathway.METHODSIn this phase 3, double-blind, randomized, placebo-controlled trial, we enrolled adults with biopsy-confirmed IgA nephropathy and proteinuria (defined as a 24-hour urinary protein-to-creatinine ratio of ≥1 [with protein and creatinine both measured in grams]) despite optimized supportive therapy. Patients were randomly assigned, in a 1:1 ratio, to receive oral iptacopan (200 mg) or placebo twice daily for 24 months while continuing to receive supportive therapy. The primary objective of this prespecified interim analysis was to assess the efficacy of iptacopan as compared with that of placebo in reducing proteinuria at month 9; the primary end point was the change from baseline in the 24-hour urinary protein-to-creatinine ratio at month 9. The proportion of patients who had a 24-hour urinary protein-to-creatinine ratio of less than 1 at month 9 without receiving rescue or alternative medication or undergoing kidney-replacement therapy (dialysis or transplantation) was a secondary end point. Safety was also assessed. The effect of iptacopan on kidney function will be assessed at the end of the 2-year double-blind treatment period.RESULTSThe main trial population included 222 patients in the iptacopan group and 221 in the placebo group. The interim efficacy analysis included the first 250 patients who underwent randomization in the main trial population (125 patients in each group) and who remained in the trial until month 9 or discontinued the trial by month 9. Safety was assessed in all the patients in the main trial population. At month 9, the adjusted geometric mean 24-hour urinary protein-to-creatinine ratio was 38.3% (95% confidence interval, 26.0 to 48.6; two-sided P<0.001) lower with iptacopan than with placebo. The reduction in proteinuria was supported by consistent results in secondary end point analyses. There were no unexpected safety findings with iptacopan. The incidence of adverse events that occurred during the treatment period was similar in the two groups; most events were mild to moderate in severity and reversible. No increased risk of infection was observed.CONCLUSIONSAmong patients with IgA nephropathy, treatment with iptacopan resulted in a significant and clinically meaningful reduction in proteinuria as compared with placebo. (Funded by Novartis; APPLAUSE-IgAN ClinicalTrials.gov number, NCT04578834.).
背景替代补体途径在 IgA 肾病的发病机制中起着关键作用。在这项 3 期、双盲、随机、安慰剂对照试验中,我们招募了经活检证实患有 IgA 肾病且在接受优化支持疗法后仍有蛋白尿(定义为 24 小时尿蛋白与肌酐比值≥1[蛋白和肌酐均以克为单位])的成人患者。患者按 1:1 的比例被随机分配到接受口服依帕可潘(200 毫克)或安慰剂治疗,每天两次,持续 24 个月,同时继续接受支持疗法。这项预设中期分析的主要目的是评估与安慰剂相比,依帕可潘在第9个月时减少蛋白尿的疗效;主要终点是第9个月时24小时尿蛋白与肌酐比值与基线相比的变化。次要终点是第9个月时24小时尿蛋白与肌酐比值小于1且未接受抢救或替代药物治疗或接受肾脏替代疗法(透析或移植)的患者比例。此外,还对安全性进行了评估。在为期 2 年的双盲治疗期结束时,将评估依帕可潘对肾功能的影响。结果主要试验人群包括依帕可潘组 222 名患者和安慰剂组 221 名患者。中期疗效分析包括在主要试验人群中接受随机分组的前250名患者(每组125名患者),这些患者在第9个月前仍在试验中,或在第9个月前中止了试验。第9个月时,调整后的24小时尿蛋白与肌酐的几何平均比值为38.3%(95%置信区间为26.0至48.6;双侧P<0.001),伊帕考潘比安慰剂低。次要终点分析的一致结果也证明了蛋白尿的减少。伊帕可潘没有出现意外的安全性结果。两组患者在治疗期间的不良反应发生率相似;大多数不良反应的严重程度为轻度至中度,并且是可逆的。结论与安慰剂相比,IgA肾病患者接受依帕可潘治疗后,蛋白尿明显减少,且具有临床意义。(由诺华公司资助;APPLAUSE-IgAN ClinicalTrials.gov 编号:NCT04578834)。
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引用次数: 0
Atrasentan in Patients with IgA Nephropathy 阿曲生坦在 IgA 肾病患者中的应用
IF 158.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-25 DOI: 10.1056/nejmoa2409415
Hiddo J.L. Heerspink, Meg Jardine, Donald E. Kohan, Richard A. Lafayette, Adeera Levin, Adrian Liew, Hong Zhang, Amit Lodha, Todd Gray, Yi Wang, Ronny Renfurm, and Jonathan Barrattthe ALIGN Study Investigators*From the Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (M.J.), the Division of Nephrology, University of Utah Health, Salt Lake City (D.E.K.), Stanford University, Stanford, CA (R.A.L.), the University of British Columbia, Vancouver, Canada (A. Levin), Mount Elizabeth Novena Hospital, Singapore (A. Liew), Peking University First Hospital, Beijing (H.Z.), Chinook Therapeutics, Seattle (T.G.), Novartis, East Hanover, NJ (A. Lodha, Y.W.), Novartis, Basel, Switzerland (R.R.), and the University of Leicester, Leicester, United Kingdom (J.B.).
Patients with IgA nephropathy and severe proteinuria have a high lifetime risk of kidney failure. The efficacy and safety of the selective endothelin type A receptor antagonist atrasentan in reduci...
患有IgA肾病和严重蛋白尿的患者终生面临肾衰竭的高风险。选择性内皮素 A 型受体拮抗剂阿曲生坦(astrasentan)在降低 IgA 肾病患者蛋白尿方面的疗效和安全性,以及对肾衰竭患者的治疗效果都具有重要意义。
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引用次数: 0
Way Stations in Progress - Burgeoning Treatment Options for IgA Nephropathy. 前进中的驿站--IgA 肾病的新兴治疗方案。
IF 158.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-25 DOI: 10.1056/nejme2413288
Julie R Ingelfinger
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引用次数: 0
Navigating Clinicians' Conscience-Based Refusals to Provide Lawful Medical Care. 引导临床医生基于良心拒绝提供合法医疗服务。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-24 Epub Date: 2024-10-19 DOI: 10.1056/NEJMp2403935
Douglas B White, Mark Wicclair
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引用次数: 0
The Opportunity Costs of Medicare Advantage Plan Rebates. 医疗保险优势计划回扣的机会成本。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-24 Epub Date: 2024-10-19 DOI: 10.1056/NEJMp2405572
Cori Uccello, Gretchen Jacobson, Melinda J B Buntin
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引用次数: 0
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