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10 years of civil war in Yemen. 也门十年内战。
IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-21 DOI: 10.1016/S0140-6736(24)02073-7
Sharmila Devi
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引用次数: 0
Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. 在治疗新发冠状动脉病变患者时,药物涂层球囊血管成形术联合支架植入术与预定支架植入术(REC-CAGEFREE I):一项开放标签、随机、非劣效试验。
IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-14 Epub Date: 2024-09-02 DOI: 10.1016/S0140-6736(24)01594-0
Chao Gao, Xingqiang He, Fan Ouyang, Zhihui Zhang, Guidong Shen, Mingxing Wu, Ping Yang, Likun Ma, Feng Yang, Zheng Ji, Hua Wang, Yanqing Wu, Zhenfei Fang, Hong Jiang, Shangyu Wen, Yi Liu, Fei Li, Jingyu Zhou, Bin Zhu, Yunpeng Liu, Ruining Zhang, Tingting Zhang, Ping Wang, Jianzheng Liu, Zhiwei Jiang, Jielai Xia, Robert-Jan van Geuns, Davide Capodanno, Scot Garg, Yoshinobu Onuma, Duolao Wang, Patrick W Serruys, Ling Tao
<p><strong>Background: </strong>The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions.</p><p><strong>Methods: </strong>REC-CAGEFREE I was an open-label, randomised, non-inferiority trial conducted at 43 sites in China. After successful lesion pre-dilatation, patients aged 18 years or older with de novo, non-complex coronary artery disease (irrespective of target vessel diameter) and an indication for percutaneous coronary intervention were randomly assigned (1:1), via a web-based centralised system with block randomisation (block size of two, four, or six) and stratified by site, to paclitaxel-coated balloon angioplasty with the option of rescue stenting due to an unsatisfactory result (DCB group) or intended deployment of second-generation thin-strut sirolimus-eluting stents (DES group). The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation) assessed at 24 months in the intention-to-treat (ITT) population (ie, all participants randomly assigned to treatment). Non-inferiority was established if the upper limit of the one-sided 95% CI for the absolute risk difference was smaller than 2·68%. Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT04561739. It is closed to accrual and extended follow-up is ongoing.</p><p><strong>Findings: </strong>Between Feb 5, 2021, and May 1, 2022, 2272 patients were randomly assigned to the DCB group (1133 [50%]) or the DES group (1139 [50%]). Median age at the time of randomisation was 62 years (IQR 54-69), 1574 (69·3%) of 2272 were male, 698 (30·7%) were female, and all patients were of Chinese ethnicity. 106 (9·4%) of 1133 patients in the DCB group received rescue DES after unsatisfactory DCB angioplasty. As of data cutoff (May 1, 2024), median follow-up was 734 days (IQR 731-739). At 24 months, the DoCE occurred in 72 (6·4%) of 1133 patients in the DCB group and 38 (3·4%) of 1139 in the DES group, with a risk difference of 3·04% in the cumulative event rate (upper boundary of the one-sided 95% CI 4·52; p<sub>non-inferiority</sub>=0·65; two-sided 95% CI 1·27-4·81; p=0·0008); the criterion for non-inferiority was not met. During intervention, no acute vessel closures occurred in the DCB group and one (0·1%) of 1139 patients in the DES group had acute vessel closure. Periprocedural myocardial infarction occurred in ten (0·9%) of 1133 patients in the DCB group and nine (0·8%) in the DES group.</p><p><strong>Interpretation: </strong>In patients with de novo, non-complex coronary artery disease, irrespective of vessel diameter, a strateg
背景:药物涂层球囊(DCB)血管成形术治疗新发冠状动脉病变患者的长期效果仍不确定。我们的目的是评估在新发、非复杂冠状动脉病变患者中,DCB血管成形术加支架置入术与药物洗脱支架(DES)置入术的非劣效性:REC-CAGEFREE I 是一项开放标签、随机、非劣效试验,在中国 43 个地点进行。在成功进行病变预扩张后,年龄在 18 岁或以上、患有新发、非复杂性冠状动脉疾病(不考虑靶血管直径)且有经皮冠状动脉介入治疗指征的患者被随机分配(1:1),通过基于网络的集中系统进行分块随机分配(分块大小为 2、4 或 6),并按部位进行分层,将患者分配到紫杉醇涂层球囊血管成形术组(DCB 组),如果效果不理想,可选择进行支架置入术(DCB 组)或打算部署第二代薄支架西罗莫司洗脱支架组(DES 组)。主要结果是在意向治疗(ITT)人群(即所有随机分配接受治疗的参与者)中,在24个月时评估以设备为导向的复合终点(DoCE,包括心血管死亡、靶血管心肌梗死以及临床和生理学指示的靶病变血运重建)。如果绝对风险差异的单侧 95% CI 上限小于 2-68%,则确定为非劣效性。安全性在 ITT 群体中进行评估。该研究已在 ClinicalTrials.gov 登记,编号为 NCT04561739。该研究已经结束,目前正在进行延长随访:2021年2月5日至2022年5月1日期间,2272名患者被随机分配到DCB组(1133人[50%])或DES组(1139人[50%])。随机分配时的中位年龄为 62 岁(IQR 54-69),2272 例患者中有 1574 例(69-3%)为男性,698 例(30-7%)为女性,所有患者均为华裔。DCB组1133名患者中有106名(9-4%)在DCB血管成形术不满意后接受了DES治疗。截至数据截止日(2024年5月1日),中位随访时间为734天(IQR为731-739)。24个月时,DCB组1133例患者中有72例(6-4%)发生DoCE,DES组1139例患者中有38例(3-4%)发生DoCE,累积事件发生率的风险差异为3-04%(单侧95% CI上限为4-52;非劣效性=0-65;双侧95% CI上限为1-27-4-81;p=0-0008);未达到非劣效性标准。在干预期间,DCB 组未发生急性血管闭塞,而 DES 组的 1139 名患者中有 1 名(0-1%)发生急性血管闭塞。DCB组1133例患者中有10例(0-9%)发生了围手术期心肌梗死,DES组有9例(0-8%):在新发、非复杂性冠状动脉疾病患者中,无论血管直径大小,DCB血管成形术加支架植入术的策略与DES植入术相比,在2年后的DoCE方面没有达到非劣效性,这表明DES仍应是这一患者群体的首选治疗方法:资助:西京医院和神启医疗:摘要中译文见补充材料部分。
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引用次数: 0
Department of Error. 错误部。
IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-14 Epub Date: 2024-09-02 DOI: 10.1016/S0140-6736(24)01827-0
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引用次数: 0
How feasible is a cage-free solution for de novo coronary artery disease? 新发冠状动脉疾病的无笼型解决方案有多大可行性?
IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-14 Epub Date: 2024-09-02 DOI: 10.1016/S0140-6736(24)01696-9
Margaret B McEntegart, Ajay J Kirtane
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引用次数: 0
Optimal patient and mechanical circulatory support device selection in acute myocardial infarction cardiogenic shock. 急性心肌梗死心源性休克患者和机械循环支持装置的最佳选择。
IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-14 Epub Date: 2024-09-02 DOI: 10.1016/S0140-6736(24)01588-5
Jacob C Jentzer, Benjamin Hibbert
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引用次数: 0
Enhancing mpox response in Africa with implementation science. 通过科学实施加强非洲应对麻风病的能力。
IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-14 Epub Date: 2024-08-30 DOI: 10.1016/S0140-6736(24)01807-5
Abdu A Adamu, Joseph Okeibunor, Reena H Doshi, Charles S Wiysonge
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引用次数: 0
Primary biliary cholangitis. 原发性胆汁性胆管炎
IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-14 Epub Date: 2024-08-28 DOI: 10.1016/S0140-6736(24)01303-5
Atsushi Tanaka, Xiong Ma, Atsushi Takahashi, John M Vierling

Primary biliary cholangitis is a chronic, autoimmune, cholestatic disease that mainly affects women aged 40-70 years. Recent epidemiological studies have shown an increasing incidence worldwide despite geographical heterogeneity and a decrease in the female-to-male ratio of those the disease affects. Similar to other autoimmune diseases, primary biliary cholangitis occurs in genetically predisposed individuals upon exposure to environmental triggers, specifically xenobiotics, smoking, and the gut microbiome. Notably, the diversity of the intestinal microbiome is diminished in individuals with primary biliary cholangitis. The intricate interplay among immune cells, cytokines, chemokines, and biliary epithelial cells is postulated as the underlying pathogenic mechanism involved in the development and progression of primary biliary cholangitis, and extensive research has been dedicated to comprehending these complex interactions. Following the official approval of obeticholic acid as second-line treatment for patients with an incomplete response or intolerance to ursodeoxycholic acid, clinical trials have indicated that peroxisome proliferator activator receptor agonists are promising additional second-line drugs. Future dual or triple drug regimens might reach a new treatment goal of normalisation of alkaline phosphatase levels, rather than a decrease to less than 1·67 times the upper limit of normal levels, and potentially improve long-term outcomes. Improvement of health-related quality of life with better recognition and care of subjective symptoms, such as pruritus and fatigue, is also an important treatment goal. Promising clinical investigations are underway to alleviate these symptoms. Efforts to facilitate better access to medical care and dissemination of current knowledge should enable diagnosis at an earlier stage of primary biliary cholangitis and ensure access to treatments based on risk stratification for all patients.

原发性胆汁性胆管炎是一种慢性、自身免疫性胆汁淤积性疾病,主要影响 40-70 岁的女性。最近的流行病学研究表明,尽管存在地域差异,但该病在全球范围内的发病率却在不断上升,而且患病人群的男女比例也在下降。与其他自身免疫性疾病类似,原发性胆汁性胆管炎也会发生在有遗传易感性的人身上,他们暴露于环境诱因,特别是异种生物、吸烟和肠道微生物组。值得注意的是,原发性胆汁性胆管炎患者肠道微生物群的多样性减少。免疫细胞、细胞因子、趋化因子和胆道上皮细胞之间错综复杂的相互作用被推测为原发性胆汁性胆管炎发生和发展的潜在致病机制,人们一直致力于对这些复杂的相互作用进行深入研究。在官方批准将顺苯乙醇酸作为熊去氧胆酸不完全反应或不耐受患者的二线治疗药物后,临床试验表明过氧化物酶体增殖激活剂受体激动剂是很有前景的二线治疗药物。未来的双药或三药治疗方案可能会达到新的治疗目标,即使碱性磷酸酶水平恢复正常,而不是降至正常水平上限的 1-67 倍以下,并有可能改善长期预后。通过更好地识别和护理瘙痒和疲劳等主观症状,改善与健康相关的生活质量也是一个重要的治疗目标。目前正在开展前景看好的临床研究,以缓解这些症状。为更好地获得医疗服务和传播现有知识所做的努力应能使原发性胆汁性胆管炎得到早期诊断,并确保所有患者都能获得基于风险分层的治疗。
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引用次数: 0
Temporary mechanical circulatory support in infarct-related cardiogenic shock: an individual patient data meta-analysis of randomised trials with 6-month follow-up. 心梗相关性心源性休克的临时机械循环支持:对随访 6 个月的随机试验进行的个体患者数据荟萃分析。
IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-14 Epub Date: 2024-09-02 DOI: 10.1016/S0140-6736(24)01448-X
Holger Thiele, Jacob E Møller, Jose P S Henriques, Margriet Bogerd, Melchior Seyfarth, Daniel Burkhoff, Petr Ostadal, Richard Rokyta, Jan Belohlavek, Steffen Massberg, Marcus Flather, Matthias Hochadel, Steffen Schneider, Steffen Desch, Anne Freund, Hans Eiskjær, Norman Mangner, Janine Pöss, Amin Polzin, P Christian Schulze, Carsten Skurk, Uwe Zeymer, Christian Hassager
<p><strong>Background: </strong>Percutaneous active mechanical circulatory support (MCS) devices are being increasingly used in the treatment of acute myocardial infarction-related cardiogenic shock (AMICS) despite conflicting evidence regarding their effect on mortality. We aimed to ascertain the effect of early routine active percutaneous MCS versus control treatment on 6-month all-cause mortality in patients with AMICS.</p><p><strong>Methods: </strong>In this individual patient data meta-analysis, randomised controlled trials of potential interest were identified, without language restriction, by querying the electronic databases MEDLINE via PubMed, Cochrane Central Register of Controlled Trials, and Embase, as well as ClinicalTrials.gov, up to Jan 26, 2024. All randomised trials with 6-month mortality data comparing early routine active MCS (directly in the catheterisation laboratory after randomisation) versus control in patients with AMICS were included. The primary outcome was 6-month all-cause mortality in patients with AMICS treated with early routine active percutaneous MCS versus control, with a focus on device type (loading, such as venoarterial extracorporeal membrane oxygenation [VA-ECMO] vs unloading) and patient selection. Hazard ratios (HRs) of the primary outcome measure were calculated using Cox regression models. This study is registered with PROSPERO, CRD42024504295.</p><p><strong>Findings: </strong>Nine reports of randomised controlled trials (n=1114 patients) were evaluated in detail. Overall, four randomised controlled trials (n=611 patients) compared VA-ECMO with a control treatment and five randomised controlled trials (n=503 patients) compared left ventricular unloading devices with a control treatment. Two randomised controlled trials also included patients who did not have AMICS, who were excluded (55 patients [44 who were treated with VA-ECMO and 11 who were treated with a left ventricular unloading device]). The median patient age was 65 years (IQR 57-73); 845 (79·9%) of 1058 patients with data were male and 213 (20·1%) were female. No significant benefit of early unselected MCS use on 6-month mortality was noted (HR 0·87 [95% CI 0·74-1·03]; p=0·10). No significant differences were observed for left ventricular unloading devices versus control (0·80 [0·62-1·02]; p=0·075), and loading devices also had no effect on mortality (0·93 [0·75-1·17]; p=0·55). Patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality with MCS use (0·77 [0·61-0·97]; p=0·024). Major bleeding (odds ratio 2·64 [95% CI 1·91-3·65]) and vascular complications (4·43 [2·37-8·26]) were more frequent with MCS use than with control.</p><p><strong>Interpretation: </strong>The use of active MCS devices in patients with AMICS did not reduce 6-month mortality (regardless of the device used) and increased major bleeding and vascular complications. However, patients with ST-elevation cardiogenic shock withou
背景:经皮主动机械循环支持(MCS)装置越来越多地用于急性心肌梗死相关性心源性休克(AMICS)的治疗,尽管有关其对死亡率影响的证据相互矛盾。我们旨在确定早期常规主动经皮 MCS 与对照治疗对 AMICS 患者 6 个月全因死亡率的影响:在这项患者个体数据荟萃分析中,通过查询电子数据库 MEDLINE(通过 PubMed)、Cochrane Central Register of Controlled Trials(对照试验中央注册)和 Embase 以及 ClinicalTrials.gov(截至 2024 年 1 月 26 日),确定了可能感兴趣的随机对照试验,没有语言限制。研究纳入了所有随机试验,这些试验提供了 AMICS 患者 6 个月的死亡率数据,比较了早期常规积极 MCS(随机化后直接在导管室进行)与对照试验。主要结果是接受早期常规主动经皮MCS治疗的AMICS患者的6个月全因死亡率,重点是设备类型(加载,如静脉体外膜肺氧合[VA-ECMO]与非加载)和患者选择。主要结局指标的危险比(HRs)采用 Cox 回归模型进行计算。本研究已在 PROSPERO 注册,编号为 CRD42024504295:详细评估了九项随机对照试验报告(n=1114 名患者)。总体而言,四项随机对照试验(样本数=611名患者)将VA-ECMO与对照治疗进行了比较,五项随机对照试验(样本数=503名患者)将左心室负重装置与对照治疗进行了比较。两项随机对照试验还包括未接受AMICS治疗的患者,这些患者被排除在外(55名患者[44名接受VA-ECMO治疗,11名接受左心室负荷装置治疗])。患者年龄中位数为 65 岁(IQR 57-73);在有数据的 1058 例患者中,845 例(79-9%)为男性,213 例(20-1%)为女性。早期使用非选择性 MCS 对 6 个月死亡率无明显益处(HR 0-87 [95% CI 0-74-1-03];P=0-10)。左心室卸载装置与对照组相比无明显差异(0-80 [0-62-1-02];P=0-075),加载装置对死亡率也无影响(0-93 [0-75-1-17];P=0-55)。无缺氧性脑损伤风险的ST段抬高型心源性休克患者使用MCS后死亡率降低(0-77 [0-61-0-97];P=0-024)。与对照组相比,使用 MCS 时大出血(几率比 2-64 [95% CI 1-91-3-65])和血管并发症(4-43 [2-37-8-26])的发生率更高:AMICS患者使用主动MCS装置并不能降低6个月死亡率(无论使用何种装置),反而会增加大出血和血管并发症。然而,ST 段抬高型心源性休克患者在使用 MCS 后死亡率有所降低,但无缺氧性脑损伤风险。因此,MCS 的使用应仅限于某些患者:莱比锡大学莱比锡心脏中心和 Herzinfarktforschung 基金会。
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引用次数: 0
Advancing the economics of health for all. 推进全民健康经济学。
IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-14 Epub Date: 2024-09-05 DOI: 10.1016/S0140-6736(24)01873-7
Mariana Mazzucato, Tedros Adhanom Ghebreyesus
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引用次数: 0
Mpox in eastern Democratic Republic of the Congo: challenges and prospects for vaccination. 刚果民主共和国东部的麻风病:疫苗接种的挑战与前景。
IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-14 Epub Date: 2024-09-02 DOI: 10.1016/S0140-6736(24)01806-3
Harry César Kayembe Ntumba, Bien-Aimé Makasa Mandja
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引用次数: 0
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The Lancet
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