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Intensive Blood-Pressure Control in Patients with Type 2 Diabetes. 强化 2 型糖尿病患者的血压控制。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-16 DOI: 10.1056/NEJMoa2412006
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

Background: Effective targets for systolic blood-pressure control in patients with type 2 diabetes are unclear.

Methods: 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.

Results: 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.

Conclusions: 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.).

背景:2 型糖尿病患者收缩压控制的有效目标尚不明确:2型糖尿病患者收缩压控制的有效目标尚不明确:我们在全国 145 个临床基地招募了 50 岁或以上、患有 2 型糖尿病、收缩压升高和心血管疾病风险增加的患者。患者被随机分配接受以收缩压低于120毫米汞柱为目标的强化治疗或以收缩压低于140毫米汞柱为目标的标准治疗,疗程长达5年。主要结果是非致死性中风、非致死性心肌梗死、心力衰竭治疗或住院或心血管原因导致的死亡的复合结果。对缺失的结果数据采用多重估算,假设数据是随机缺失的:在2019年2月至2021年12月期间入组的12821名患者(强化治疗组6414名,标准治疗组6407名)中,5803名(45.3%)为女性;患者的平均年龄(±SD)为63.8±7.5岁。随访一年时,强化治疗组的平均收缩压为121.6毫米汞柱(中位数为118.3毫米汞柱),标准治疗组的平均收缩压为133.2毫米汞柱(中位数为135.0毫米汞柱)。在中位 4.2 年的随访期间,强化治疗组有 393 名患者(每 100 人年发生 1.65 例)发生了主要结果事件,标准治疗组有 492 名患者(每 100 人年发生 2.09 例)发生了主要结果事件(危险比为 0.79;95% 置信区间为 0.69 至 0.90;PConclusions:在2型糖尿病患者中,以收缩压低于120毫米汞柱为目标的强化治疗比以收缩压低于140毫米汞柱为目标的标准治疗的主要心血管事件发生率要低得多。(由中国科技部国家重点研发计划等资助;BPROAD ClinicalTrials.gov 编号:NCT03808311)。
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引用次数: 0
Health Equity Rounds - Root-Cause and Solutions-Oriented Discussions of Medical Racism. 健康公平查房--以根源和解决方案为导向的医学种族主义讨论。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-14 Epub Date: 2024-11-09 DOI: 10.1056/NEJMp2410910
Katherine A Nash, Joanna Perdomo, Heather E Hsu
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引用次数: 0
Out of Breath. 喘不过气来
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-14 DOI: 10.1056/NEJMimc2400356
Meron Teklu, Anand Vaidya, Merve Yonar, June-Ho Kim, Edy Y Kim
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引用次数: 0
The Menstrual Health Equity Initiative - Access to Menstrual Products for People Experiencing Homelessness. 月经健康公平倡议--无家可归者获得月经用品。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-14 Epub Date: 2024-11-09 DOI: 10.1056/NEJMp2409709
Sarah Revak, Karen Cuttin, Bianca Nfonoyim Bernhard, Shelby H Davies
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引用次数: 0
Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. 可手术膀胱癌围手术期Durvalumab与新辅助化疗的联合应用
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-14 Epub Date: 2024-09-15 DOI: 10.1056/NEJMoa2408154
Thomas Powles, James W F Catto, Matthew D Galsky, Hikmat Al-Ahmadie, Joshua J Meeks, Hiroyuki Nishiyama, Toan Quang Vu, Lorenzo Antonuzzo, Pawel Wiechno, Vagif Atduev, Ariel G Kann, Tae-Hwan Kim, Cristina Suárez, Chao-Hsiang Chang, Florian Roghmann, Mustafa Özgüroğlu, Bernhard J Eigl, Niara Oliveira, Tomas Buchler, Moran Gadot, Yousef Zakharia, Jon Armstrong, Ashok Gupta, Stephan Hois, Michiel S van der Heijden

Background: Neoadjuvant chemotherapy followed by radical cystectomy is the standard treatment for cisplatin-eligible patients with muscle-invasive bladder cancer. Adding perioperative immunotherapy may improve outcomes.

Methods: In this phase 3, open-label, randomized trial, we assigned, in a 1:1 ratio, cisplatin-eligible patients with muscle-invasive bladder cancer to receive neoadjuvant durvalumab plus gemcitabine-cisplatin every 3 weeks for four cycles, followed by radical cystectomy and adjuvant durvalumab every 4 weeks for eight cycles (durvalumab group), or to receive neoadjuvant gemcitabine-cisplatin followed by radical cystectomy alone (comparison group). Event-free survival was one of two primary end points. Overall survival was the key secondary end point.

Results: In total, 533 patients were assigned to the durvalumab group and 530 to the comparison group. The estimated event-free survival at 24 months was 67.8% (95% confidence interval [CI], 63.6 to 71.7) in the durvalumab group and 59.8% (95% CI, 55.4 to 64.0) in the comparison group (hazard ratio for progression, recurrence, not undergoing radical cystectomy, or death from any cause, 0.68; 95% CI, 0.56 to 0.82; P<0.001 by stratified log-rank test). The estimated overall survival at 24 months was 82.2% (95% CI, 78.7 to 85.2) in the durvalumab group and 75.2% (95% CI, 71.3 to 78.8) in the comparison group (hazard ratio for death, 0.75; 95% CI, 0.59 to 0.93; P = 0.01 by stratified log-rank test). Treatment-related adverse events of grade 3 or 4 in severity occurred in 40.6% of the patients in the durvalumab group and in 40.9% of those in the comparison group; treatment-related adverse events leading to death occurred in 0.6% in each group. Radical cystectomy was performed in 88.0% of the patients in the durvalumab group and in 83.2% of those in the comparison group.

Conclusions: Perioperative durvalumab plus neoadjuvant chemotherapy led to significant improvements in event-free survival and overall survival as compared with neoadjuvant chemotherapy alone. (Funded by AstraZeneca; NIAGARA ClinicalTrials.gov number, NCT03732677; EudraCT number, 2018-001811-59.).

背景:新辅助化疗后进行根治性膀胱切除术是符合顺铂治疗条件的肌层浸润性膀胱癌患者的标准治疗方法。增加围手术期免疫疗法可改善疗效:在这项3期开放标签随机试验中,我们以1:1的比例将符合顺铂条件的肌浸润性膀胱癌患者分配到接受新辅助杜瓦单抗加吉西他滨-顺铂治疗,每3周1次,共4个周期,然后进行根治性膀胱切除术和辅助杜瓦单抗治疗,每4周1次,共8个周期(杜瓦单抗组),或接受新辅助吉西他滨-顺铂治疗,然后仅进行根治性膀胱切除术(对比组)。无事件生存期是两个主要终点之一。总生存期是关键的次要终点:共有533名患者被分配到durvalumab组,530名患者被分配到对比组。估计24个月的无事件生存率,durvalumab组为67.8%(95%置信区间[CI],63.6至71.7),对比组为59.8%(95% CI,55.4至64.0)(进展、复发、未接受根治性膀胱切除术或任何原因死亡的危险比为0.68;95% CI,0.56至0.82;PC结论:与单纯新辅助化疗相比,围手术期使用durvalumab加新辅助化疗可显著提高无事件生存率和总生存率。(由阿斯利康资助;NIAGARA ClinicalTrials.gov 编号:NCT03732677;EudraCT 编号:2018-001811-59)。
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引用次数: 0
Case 35-2024: A Newborn with Hypoxemia and a Lung Opacity. 病例 35-2024:新生儿低氧血症和肺不张。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-14 DOI: 10.1056/NEJMcpc2402487
T Bernard Kinane, Evan J Zucker, Katherine A Sparger, Cassandra M Kelleher, Angela R Shih
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引用次数: 0
Lessons from England's National Health Service. 英格兰国民健康服务的经验教训。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-14 DOI: 10.1056/NEJMhpr2407495
Timothy G Ferris, Jennifer Dixon, David Blumenthal
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引用次数: 0
Inebilizumab for Treatment of IgG4-Related Disease. 伊奈珠单抗用于治疗 IgG4 相关疾病。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-14 DOI: 10.1056/NEJMoa2409712
John H Stone, Arezou Khosroshahi, Wen Zhang, Emanuel Della Torre, Kazuichi Okazaki, Yoshiya Tanaka, J Matthias Löhr, Nicolas Schleinitz, Lingli Dong, Hisanori Umehara, Marco Lanzillotta, Zachary S Wallace, Mikael Ebbo, George J Webster, Fernando Martinez Valle, Manu K Nayar, Cory A Perugino, Vinciane Rebours, Xinxin Dong, Yanping Wu, Qing Li, Nishi Rampal, Daniel Cimbora, Emma L Culver

Background: IgG4-related disease is a multiorgan, relapsing, fibroinflammatory, immune-mediated disorder with no approved therapy. Inebilizumab targets and depletes CD19+ B cells and may be effective for treating patients with IgG4-related disease.

Methods: In this phase 3, multicenter, double-blind, randomized, placebo-controlled trial, adults with active IgG4-related disease underwent randomization in a 1:1 ratio to receive inebilizumab (300-mg intravenous infusions on days 1 and 15 and week 26) or placebo for a 52-week treatment period. Participants in both groups received identical glucocorticoid tapers. Glucocorticoids were allowed to treat disease flares, but background immunosuppressants were not permitted. The primary end point was the first treated, adjudicated disease flare during the treatment period, assessed in a time-to-event analysis. Key secondary end points were the annualized flare rate and treatment-free and glucocorticoid-free complete remission.

Results: A total of 135 participants with IgG4-related disease underwent randomization: 68 participants were assigned to receive inebilizumab and 67 were assigned to receive placebo. Treatment with inebilizumab reduced flare risk; 7 participants (10%) in the inebilizumab group had at least one flare, as compared with 40 participants (60%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.06 to 0.28; P<0.001). The annualized flare rate was lower with inebilizumab than with placebo (rate ratio, 0.14; 95% CI, 0.06 to 0.31; P<0.001). More participants in the inebilizumab group than in the placebo group had flare-free, treatment-free complete remission (odds ratio, 4.68; 95% CI, 2.21 to 9.91; P<0.001) and flare-free, glucocorticoid-free complete remission (odds ratio, 4.96; 95% CI, 2.34 to 10.52; P<0.001). Serious adverse events occurred during the treatment period in 12 of the participants (18%) who received inebilizumab and 6 of the participants (9%) who received placebo.

Conclusions: Inebilizumab reduced the risk of flares of IgG4-related disease and increased the likelihood of flare-free complete remission at 1 year, confirming the role of CD19-targeted B-cell depletion as a potential treatment for IgG4-related disease. (Funded by Amgen; MITIGATE ClinicalTrials.gov number, NCT04540497.).

背景IgG4相关疾病是一种多器官、复发性、纤维炎症性、免疫介导的疾病,目前尚无获批疗法。伊奈珠单抗能靶向消耗 CD19+ B 细胞,可能对治疗 IgG4 相关疾病患者有效:在这项3期、多中心、双盲、随机、安慰剂对照试验中,患有活动性IgG4相关疾病的成人按1:1的比例随机接受伊奈珠单抗(第1天、第15天和第26周静脉注射300毫克)或安慰剂,治疗期为52周。两组患者均接受相同的糖皮质激素减量治疗。允许使用糖皮质激素治疗疾病复发,但不允许使用背景免疫抑制剂。主要终点是在治疗期间首次出现经治疗和判定的疾病复发,以时间到事件分析法进行评估。主要次要终点是年复发率以及无治疗和无糖皮质激素完全缓解率:共有135名IgG4相关疾病患者接受了随机分配:68名参与者被分配接受伊维单抗治疗,67名参与者被分配接受安慰剂治疗。伊维单抗治疗降低了复发风险;伊维单抗组有7人(10%)至少复发一次,而安慰剂组有40人(60%)复发(危险比为0.13;95%置信区间[CI]为0.06至0.28;PConclusions.):伊尼单抗降低了IgG4相关疾病复发的风险,并增加了1年后无复发完全缓解的可能性,证实了CD19靶向B细胞清除作为IgG4相关疾病潜在治疗方法的作用。(由安进公司资助;MITIGATE ClinicalTrials.gov 编号:NCT04540497)。
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引用次数: 0
Activity of Research-Grade Pemivibart against Recent SARS-CoV-2 JN.1 Sublineages. 研究级 Pemivibart 对近期 SARS-CoV-2 JN.1 亚系的活性。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-14 DOI: 10.1056/NEJMc2410203
Qian Wang, Yicheng Guo, Jerren Ho, David D Ho
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引用次数: 0
Immunobridging for Pemivibart, a Monoclonal Antibody for Prevention of Covid-19. 用于预防 Covid-19 的单克隆抗体 Pemivibart 的免疫桥接。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-14 DOI: 10.1056/NEJMc2404555
Pete Schmidt, Yong Li, Myra Popejoy
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引用次数: 0
期刊
New England Journal of Medicine
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