The Lancet最新文献

英文中文

Clarity in gender-inclusive language in reproductive health care. 明确生殖保健中包含性别的语言。

IF 88.5 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

The Lancet

Pub Date : 2025-08-23 Epub Date: 2025-08-18 DOI: 10.1016/S0140-6736(25)01628-9

Sally Pezaro, John Pendleton, Isaac Samuels

引用次数: 0

Building community capacity in mental health care with the Strong Minds-Strong Communities programme: a randomised controlled trial in the USA. 通过“强大的思想-强大的社区”项目建设社区精神卫生保健能力：美国的一项随机对照试验。

IF 88.5 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

The Lancet

Pub Date : 2025-08-23 DOI: 10.1016/S0140-6736(25)00859-1

Margarita Alegría, Gabriela Livas Stein, Mario Cruz-Gonzalez, Irene Falgas-Bague, Sheri Lapatin Markle, Kari M Eddington, Andrew Supple, Larimar Fuentes, Claire Poindexter, Patrick E Shrout

Background: Provider shortages and lack of culturally responsive care limit mental health services in reaching multicultural populations worldwide. We examined the effectiveness of a psychoeducational intervention aimed at building community capacity to address depression and anxiety among racial, ethnic, and linguistic minoritised adults.Methods: Strong Minds-Strong Communities (SM-SC) was a 6-month, multicentre, longitudinal, randomised trial done in 37 community-based organisations and clinics in two US sites (Massachusetts and North Carolina). Adults aged 18 years and older speaking English, Spanish, Mandarin, or Cantonese, with moderate to severe depression or anxiety symptoms assessed using the Computerized Adaptive Test for Mental Health (CAT-MH), were eligible for inclusion. Participants were randomly assigned (1:1) to a psychoeducational intervention provided by community health workers or a usual care condition, which constituted receiving a US National Institutes of Health booklet about anxiety and depression. Both conditions included referrals for social determinants of health needs. Randomisation was stratified by site using computer-generated blocks of size 2. Investigators and participants were not masked to treatment allocation, but outcome assessors were. Primary outcomes were changes from baseline at months 6 and 12 in self-reported depression and anxiety symptoms using the Hopkins Symptom Checklist-25 (HSCL-25), level of functioning using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2·0), and perceived quality of care using the Global Evaluation of Care domain of the Perceptions of Care Outpatient Survey (PoC-OP) in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT04092777, and has been completed.Findings: From Sept 4, 2019, to March 3, 2023, 5265 potential participants were approached for study inclusion. 2681 were excluded and 2584 were assessed for eligibility. A further 1417 were excluded, and 1167 were deemed eligible for study inclusion. 1044 participants were randomly assigned, 524 to the SM-SC intervention and 520 to the usual care group. The mean age of participants was 42·6 years (SD 13·3) and 875 (83·8%) were female, 165 (15·8%) were male, and four (0·4%) were other. Between baseline and 6 months, intervention participants reported greater improvements in depression and anxiety symptoms (standardised effect size, 0·39 [95% CI 0·27-0·52]), functioning (standardised effect size, 0·28 [0·16-0·39]), and perceived quality of care (standardised effect size, 0·47 [0·31-0·62]). These greater improvements in depression and anxiety symptoms, functioning, and perceived quality of care attenuated but remained significant 6 months post-intervention (standardised effect sizes of 0·28 [95% CI 0·16-0·40] for depression and anxiety, 0·21 [0·08-0·33]) for functioning, and 0·33 [0·16 -0·50] for perceived

背景：提供者短缺和缺乏文化响应性护理限制了精神卫生服务向全世界多文化人群提供服务。我们检查了心理教育干预的有效性，旨在建立社区能力，以解决种族，民族和语言少数的成年人的抑郁和焦虑。方法：Strong Minds-Strong Communities （SM-SC）是一项为期6个月、多中心、纵向、随机的试验，在美国两个地点（马萨诸塞州和北卡罗来纳州）的37个社区组织和诊所进行。年龄在18岁及以上，说英语、西班牙语、普通话或广东话的成年人，使用计算机化心理健康适应测试（CAT-MH）评估有中度至重度抑郁或焦虑症状，符合纳入条件。参与者被随机（1:1）分配到由社区卫生工作者提供的心理教育干预或通常的护理条件，其中包括接受美国国立卫生研究院关于焦虑和抑郁的小册子。这两种情况都包括转诊健康需求的社会决定因素。随机化按地点分层，使用计算机生成的大小为2的块。研究者和参与者没有被隐瞒治疗分配，但结果评估者被隐瞒。主要结局是在第6个月和第12个月时使用霍普金斯症状清单-25 （HSCL-25）自我报告的抑郁和焦虑症状的基线变化，使用世界卫生组织残疾评估表2.0 （WHODAS 2.0）的功能水平，以及使用意向治疗人群的护理感知门诊调查（PoC-OP）的全球护理评估域的感知护理质量。该研究已在ClinicalTrials.gov注册，编号NCT04092777，并已完成。研究结果：2019年9月4日至2023年3月3日，5265名潜在受试者被纳入研究。2681人被排除，2584人被评估为合格。另有1417例被排除，1167例被认为符合纳入研究的条件。1044名参与者被随机分配，524人被分配到SM-SC干预组，520人被分配到常规护理组。参与者的平均年龄为42.6岁（SD 13.3），女性875人（83.8%），男性165人（15.8%），其他4人（0.4%）。在基线至6个月期间，干预参与者报告抑郁和焦虑症状（标准化效应量，0.39 [95% CI 0.27 - 0.52]）、功能（标准化效应量，0.28[0.16 - 0.39]）和感知护理质量（标准化效应量，0.47[0.31 - 0.62]）均有较大改善。干预后6个月，抑郁和焦虑症状、功能和感知护理质量的显著改善有所减弱，但仍具有显著性（抑郁和焦虑的标准化效应量为0.28 [95% CI 0.16 - 0.40]，功能的标准化效应量为0.21 [95% CI 0.08 - 0.33]），感知护理质量的标准化效应量为0.33[0.16 - 0.50])。解释：该干预表明，适应文化的干预可以改善黑人、拉丁裔和亚洲人群的抑郁和焦虑症状，并通过建立社区能力为精神卫生保健短缺提供了另一种选择。资助：国家心理健康研究所。翻译：关于摘要的西班牙语和中文翻译，请参阅补充资料部分。

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引用次数: 0

Antisense oligonucleotide DGAT-2 inhibitor, ION224, for metabolic dysfunction-associated steatohepatitis (ION224-CS2): results of a 51-week, multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. 反义寡核苷酸DGAT-2抑制剂ION224治疗代谢功能障碍相关脂肪性肝炎（ION224- cs2）：一项为期51周、多中心、随机、双盲、安慰剂对照的2期试验的结果。

IF 88.5 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

The Lancet

Pub Date : 2025-08-23 DOI: 10.1016/S0140-6736(25)00979-1

Rohit Loomba, Erin Morgan, Keyvan Yousefi, Dan Li, Richard Geary, Sanjay Bhanot, Naim Alkhouri

Background: ION224, a liver-directed antisense inhibitor of diacylglycerol O-acyltransferase 2 (DGAT2), suppresses de novo lipogenesis, an important metabolic pathway associated with lipotoxicity and the underlying inflammation, hepatocellular injury, and fibrosis in metabolic dysfunction-associated steatohepatitis (MASH). This study aimed to prospectively assess the safety and efficacy of ION224 in patients with MASH and fibrosis.

Methods: ION224-CS2 was an adaptive, two-part, multicentre, randomised, double-blind, placebo-controlled, phase 2 trial conducted at 43 clinical sites in the USA and Puerto Rico in patients aged 18-75 years with biopsy-confirmed MASH and fibrosis (stages F1, F2, and F3) and baseline liver steatosis ≥10%. In part 1, participants were randomly assigned (1:1:1) to subcutaneous injections of ION224 60 mg, 90 mg, or 120 mg, or placebo, once per month. In part 2, participants were randomly assigned (2:1) to ION224 90 mg and 120 mg or placebo after a pre-specified interim analysis of safety and efficacy (liver steatosis). The primary endpoint was ≥2-point reduction in Non-Alcoholic Fatty Liver Disease Activity Score Activity Score (NAS) with ≥1-point improvement in hepatocellular ballooning or lobular inflammation, and without worsening of fibrosis at week 51. The primary analysis was in a predefined per-protocol set that included patients who received at least ten of 13 doses of the study drug without missing three consecutive doses and completed the final liver biopsy at the end of treatment. ION224-CS2 was registered at ClinicalTrials.gov (NCT04932512) and is closed.

Findings: Between June 8, 2021, and Dec 27, 2022, 160 participants were randomly assigned to receive ION224 60 mg (n=23), 90 mg (n=45), or 120 mg (n=46), or placebo (n=46), of whom 123 were included in the per-protocol set. The primary endpoint was met in 18 (46%) of 39 participants in the 90-mg group (predicted risk 46·2% [95% CI 30·5-61·8]; risk difference 27·4% [95% CI 6·7-48·1], p=0·0094) and 20 (59%) of 34 in the 120-mg group (58·8% [42·3-75·4]; 40·1% [18·7- 61·4], p=0·0002) compared with six (19%) of 32 in the placebo group (predicted risk 18·7% [95% CI 5·2-32·3]). ION224 was safe and well tolerated. Adverse events were reported in 107 (94%) of participants treated with ION224 and 41 (89%) of 46 participants treated with placebo. There were no deaths and no treatment-related serious adverse events.

Interpretation: This study provides the first clinical evidence that antisense-mediated inhibition of DGAT2 with ION224 could be a safe and efficacious strategy for the treatment of MASH. The observed histological improvements were independent of changes in bodyweight, suggesting potential to combine with other therapies such as GLP-1 based treatments.

Funding: Ionis Pharmaceuticals.

背景：ION224是一种肝脏定向的二酰基甘油o -酰基转移酶2 （DGAT2）的反义抑制剂，可抑制新生脂肪生成，这是代谢功能障碍相关脂肪性肝炎（MASH）中与脂肪毒性和潜在炎症、肝细胞损伤和纤维化相关的重要代谢途径。本研究旨在前瞻性评估ION224在MASH和纤维化患者中的安全性和有效性。方法：ion244 - cs2是一项适应性、两部分、多中心、随机、双盲、安慰剂对照的2期临床试验，在美国和波多黎各的43个临床站点进行，患者年龄为18-75岁，活检证实为MASH和纤维化（F1、F2和F3期），基线肝脂肪变性≥10%。在第一部分中，参与者被随机分配（1:1:1）到皮下注射ION224 60mg， 90mg或120mg，或安慰剂，每月一次。在第2部分中，在预先指定的安全性和有效性（肝脂肪变性）的中期分析后，参与者被随机分配（2:1）到ION224 90mg和120mg或安慰剂组。主要终点是非酒精性脂肪性肝病活动度评分（NAS）降低≥2分，肝细胞球囊或小叶炎症改善≥1分，且在第51周无纤维化恶化。主要分析是在一个预定义的方案集中进行的，该方案集包括接受了13剂研究药物中至少10剂的患者，没有连续错过3剂，并在治疗结束时完成了最终的肝活检。ION224-CS2已在ClinicalTrials.gov （NCT04932512）注册，并已关闭。研究结果：在2021年6月8日至2022年12月27日期间，160名参与者被随机分配接受ION224 60mg （n=23）、90mg （n=45）、120mg （n=46）或安慰剂（n=46），其中123人被纳入每个方案集。90毫克组39名受试者中有18名（46%）达到主要终点（预测风险为46.2% [95% CI 30.5 - 61.8]；风险差为27.4% [95% CI 6.7 - 48.1], p= 0.0094）， 120毫克组34名受试者中有20名（59%）达到主要终点（58.8% [43.2 - 75.4];40.1% [18.7 - 64.1],p= 0.0002），安慰剂组32名受试者中有6名（19%）达到主要终点（预测风险为18.7% [95% CI 5.2 - 33.2]）。ION224是安全且耐受性良好的。在接受ION224治疗的参与者中，有107人（94%）报告了不良事件，46名接受安慰剂治疗的参与者中有41人（89%）报告了不良事件。无死亡，无治疗相关的严重不良事件。解释：本研究首次提供了临床证据，证明ION224反义介导的DGAT2抑制可能是治疗MASH的一种安全有效的策略。观察到的组织学改善与体重变化无关，提示可能与其他疗法（如基于GLP-1的治疗）联合使用。资金来源：Ionis Pharmaceuticals。

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引用次数: 0

Efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy versus Roux-en-Y gastric bypass in France (SADISLEEVE): results of a randomised, open-label, superiority trial at 2 years of follow-up. 法国单吻合术十二指肠回肠旁路与套筒胃切除术相比（SADISLEEVE）的有效性和安全性：一项随机、开放标签、2年随访的优势试验的结果。

IF 88.5 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

The Lancet

Pub Date : 2025-08-23 DOI: 10.1016/S0140-6736(25)01070-0

Maud Robert, Tigran Poghosyan, Nicolas Romain-Scelle, Sebastien Czernichow, Dominique Delaunay, Adrien Sterkers, Litavan Khamphommala, Andrea Lazzati, Claire Blanchard, Robert Caiazzo, François Pattou, Emmanuel Disse

Background: Since 2007, single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) has been proposed as an alternative to Roux-en-Y gastric bypass (RYGB) in the treatment of obesity. We conducted a multicentre randomised trial, with the hypothesis that SADI-S could be more effective than RYGB at 2-year follow-up.

Methods: This multicentre, open-label, individually randomised superiority trial was conducted in France; patients were recruited from 22 bariatric institutions, mostly public academic hospitals. Key inclusion criteria were patients with a BMI ≥40 kg/m² or ≥35 kg/m² with obesity-related comorbidities (type 2 diabetes, hypertension, dyslipidaemia, sleep apnoea, or osteoarthrosis), and a candidate for SADI-S or RYGB gastric bypass as a primary surgery or after a sleeve gastrectomy. Main key exclusions included previous bariatric surgery (other than sleeve gastrectomy), inflammatory bowel disease, type 1 diabetes, and untreated Helicobacter pylori infection. Participants were randomly assigned (1:1) to SADI-S or RYGB, stratified by centre, failure of sleeve gastrectomy, and presence of type 2 diabetes. The primary endpoint was percentage excess weight loss (%EWL) at 2 years (%EWL=[(weight at 2 years - initial weight)/(initial weight - ideal weight)] × 100). The study is registered with ClinicalTrials.gov, NCT03610256 and is completed.

Findings: Between Nov 8, 2018, and Sept 29, 2021, a total of 381 patients were randomly assigned (intention-to-treat population) and included in the primary analysis (SADI-S: 190, RYGB: 191). Mean age was 44·4 years (SD 10·64), mean BMI was 46·2 kg/m² (6·40), 265 (70%) were female, and 79 (21%) had a primary sleeve gastrectomy. 43 (12%) of 370 participants were lost to follow-up. At 2 years, the mean %EWL was statistically significantly higher in the SADI-S group compared with the RYGB group (-76·0% [SD 26·7] vs -68·1% [28·7], confirming the superiority of SADI-S (mean difference -6·72% [95% CI -12·64 to -0·80], p=0·026). The primary outcome was missing for 78 (20%) of 381 participants, with 46 (59%) of 78 participants in the SADI-S group and 32 (41%) of 78 in the RYGB group, p=0·09. The number of serious adverse events related to the surgical technique in the safety population, including all operated patients, was 40 in the SADI-S group including three anastomotic leaks and eight severe diarrhoea compared with 35 in the RYGB group including five internal hernia and five severe abdominal pain cases of which two required diagnostic laparoscopy.

Interpretation: SADI-S showed superior weight loss compared with RYGB at 2 years, with a similar safety profile.

Funding: French Ministry of Health (Direction Générale de l'offre de Soin - DGOS).

背景：自2007年以来，单一吻合十二指肠回肠旁路与套筒胃切除术（SADI-S）被提出作为Roux-en-Y胃旁路（RYGB）治疗肥胖的替代方案。我们进行了一项多中心随机试验，假设SADI-S在2年随访时可能比RYGB更有效。方法：这项多中心、开放标签、单独随机的优势试验在法国进行；患者从22家减肥机构招募，其中大多数是公立学术医院。主要纳入标准是BMI≥40 kg/m2或≥35 kg/m2伴有肥胖相关合并症（2型糖尿病、高血压、血脂异常、睡眠呼吸暂停或骨关节病）的患者，以及作为主要手术或袖式胃切除术后SADI-S或RYGB胃旁路手术的候选患者。主要排除因素包括既往减肥手术（袖胃切除术除外）、炎症性肠病、1型糖尿病和未经治疗的幽门螺杆菌感染。参与者被随机分配（1:1）到SADI-S或RYGB组，按中心、套筒胃切除术失败和2型糖尿病的存在进行分层。主要终点是2年体重减重百分比（%EWL）（%EWL=[（2年体重-初始体重）/（初始体重-理想体重）]× 100）。该研究已在ClinicalTrials.gov注册，编号NCT03610256，并已完成。结果：在2018年11月8日至2021年9月29日期间，共有381名患者被随机分配（意向治疗人群）并纳入主要分析（SADI-S: 190, RYGB: 191）。平均年龄44.4岁（SD 10.64），平均BMI为46.2 kg/m2(6.40)，女性265例（70%），79例（21%）为原发性袖式胃切除术。370名参与者中有43人（12%）失去随访。2年时，SADI-S组的平均EWL %明显高于RYGB组（- 76.0% [SD 26.7] vs - 68.1%[28.7]），证实了SADI-S的优越性（平均差异为- 6.72% [95% CI - 12.64 ~ - 0.80], p= 0.026）。381名受试者中有78名（20%）缺少主要结局，其中SADI-S组78名受试者中有46名（59%）缺少主要结局，RYGB组78名受试者中有32名（41%）缺少主要结局，p= 0.09。包括所有手术患者在内的安全人群中，SADI-S组与手术技术相关的严重不良事件数量为40例，包括3例吻合口渗漏和8例严重腹泻，而RYGB组为35例，包括5例内疝和5例严重腹痛，其中2例需要诊断性腹腔镜检查。解释：与RYGB相比，SADI-S在2年后表现出更好的减肥效果，并且具有相似的安全性。资助：法国卫生部（ssoin - DGOS - ssoin - DGOS方向）。

{"title":"Efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy versus Roux-en-Y gastric bypass in France (SADISLEEVE): results of a randomised, open-label, superiority trial at 2 years of follow-up.","authors":"Maud Robert, Tigran Poghosyan, Nicolas Romain-Scelle, Sebastien Czernichow, Dominique Delaunay, Adrien Sterkers, Litavan Khamphommala, Andrea Lazzati, Claire Blanchard, Robert Caiazzo, François Pattou, Emmanuel Disse","doi":"10.1016/S0140-6736(25)01070-0","DOIUrl":"https://doi.org/10.1016/S0140-6736(25)01070-0","url":null,"abstract":"Background: Since 2007, single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) has been proposed as an alternative to Roux-en-Y gastric bypass (RYGB) in the treatment of obesity. We conducted a multicentre randomised trial, with the hypothesis that SADI-S could be more effective than RYGB at 2-year follow-up.Methods: This multicentre, open-label, individually randomised superiority trial was conducted in France; patients were recruited from 22 bariatric institutions, mostly public academic hospitals. Key inclusion criteria were patients with a BMI ≥40 kg/m2 or ≥35 kg/m2 with obesity-related comorbidities (type 2 diabetes, hypertension, dyslipidaemia, sleep apnoea, or osteoarthrosis), and a candidate for SADI-S or RYGB gastric bypass as a primary surgery or after a sleeve gastrectomy. Main key exclusions included previous bariatric surgery (other than sleeve gastrectomy), inflammatory bowel disease, type 1 diabetes, and untreated Helicobacter pylori infection. Participants were randomly assigned (1:1) to SADI-S or RYGB, stratified by centre, failure of sleeve gastrectomy, and presence of type 2 diabetes. The primary endpoint was percentage excess weight loss (%EWL) at 2 years (%EWL=[(weight at 2 years - initial weight)/(initial weight - ideal weight)] × 100). The study is registered with ClinicalTrials.gov, NCT03610256 and is completed.Findings: Between Nov 8, 2018, and Sept 29, 2021, a total of 381 patients were randomly assigned (intention-to-treat population) and included in the primary analysis (SADI-S: 190, RYGB: 191). Mean age was 44·4 years (SD 10·64), mean BMI was 46·2 kg/m2 (6·40), 265 (70%) were female, and 79 (21%) had a primary sleeve gastrectomy. 43 (12%) of 370 participants were lost to follow-up. At 2 years, the mean %EWL was statistically significantly higher in the SADI-S group compared with the RYGB group (-76·0% [SD 26·7] vs -68·1% [28·7], confirming the superiority of SADI-S (mean difference -6·72% [95% CI -12·64 to -0·80], p=0·026). The primary outcome was missing for 78 (20%) of 381 participants, with 46 (59%) of 78 participants in the SADI-S group and 32 (41%) of 78 in the RYGB group, p=0·09. The number of serious adverse events related to the surgical technique in the safety population, including all operated patients, was 40 in the SADI-S group including three anastomotic leaks and eight severe diarrhoea compared with 35 in the RYGB group including five internal hernia and five severe abdominal pain cases of which two required diagnostic laparoscopy.Interpretation: SADI-S showed superior weight loss compared with RYGB at 2 years, with a similar safety profile.Funding: French Ministry of Health (Direction Générale de l'offre de Soin - DGOS).","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":"406 10505","pages":"846-859"},"PeriodicalIF":88.5,"publicationDate":"2025-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144959457","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}

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Mexico's bold new law on adequate and sustainable nutrition. 墨西哥关于充足和可持续营养的大胆新法律。