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Efficacy of anakinra in reducing progression to organ dysfunction in patients with pneumonia (INSPIRE): a randomised, double-blind, placebo-controlled, phase IIa trial anakinra减少肺炎患者器官功能障碍进展的疗效(INSPIRE):一项随机、双盲、安慰剂对照的IIa期试验
IF 13 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-29 DOI: 10.1016/j.lanepe.2025.101573
Georgios Tavoulareas , Olga Kontakou-Zoniou , Nikolaos Antonakos , Elisavet Tasouli , George Adamis , Nikolaos Kakavoulis , Evangelos Michelakis , Ilias Skopelitis , Konstantina Dakou , Christos Psarrakis , Panagiotis Koufargyris , Myrto Astriti , Styliani Sympardi , Evangelos J. Giamarellos-Bourboulis

Background

Early recognition of risk of death in pneumonia and start of precision immunotherapy to improve outcomes is an unmet need. We hypothesized that a precision strategy approach combining early recognition of interleukin (IL)-1 activation coupled with Anakinra treatment may improve pneumonia outcome.

Methods

INSPIRE is a prospective, double-blind randomized placebo-controlled trial which recruited hospitalized adults with community-acquired or hospital-acquired pneumonia, with qSOFA (quick sequential organ failure assessment) equal to 1 and plasma presepsin (soluble CD14) more than 350 pg/ml. Patients were 1:1 randomised to standard-of-care medication plus either subcutaneous placebo or subcutaneous Anakinra 100 mg once daily for 10 days. The primary endpoint was progression into organ dysfunction defined as meeting at least one of the following two conditions; (i) at least 2-point increase of the baseline SOFA score by day 7 and/or (ii) death by day 90. This was analyzed in the intention-to-treat (ITT) population. This trial is registered with the EU Clinical Trials Register (2022-002390-28) and ClinicalTrials.gov (NCT05785442).

Findings

Patients were enrolled between March 2023 and June 2024; 30 patients in the placebo arm and 30 patients in the Anakinra arm were the ITT population. The primary endpoint was met in 50·0% (15 patients) of placebo-treated and in 20·0% (6 patients) of Anakinra-treated patients (difference 30·0% [5·9 to 49%]; p: 0·011). 90-day mortality was 43·3% (13 patients) and 20·0% (6 patients) (difference 23·3% [0 to 43·7%]; p: 0·029). The overall incidence of serious treatment-emergent adverse events (TEAEs) in the placebo group was 50% and in the Anakinra group 33·3%. None of the serious TEAEs was judged to be related to treatment assignment. Production of TNFα and ΙFNγ by blood mononuclear cells was decreased.

Interpretation

Presepsin-guided Anakinra treatment prevents progression of pneumonia to organ dysfunction and death. The mechanism of benefit is associated with attenuation of cytokine production.

Funding

Hellenic Institute for the Study of Sepsis; PHC Europe BV; Swedish Orphan Biovitrum AB.
背景:认识到肺炎的死亡风险并开始精确免疫治疗以改善预后是一个尚未满足的需求。我们假设一种精确的策略方法结合早期识别白细胞介素(IL)-1激活加上Anakinra治疗可能改善肺炎的预后。方法sinspire是一项前瞻性、双盲随机安慰剂对照试验,招募qSOFA(快速顺序器官衰竭评估)等于1、血浆前压素(可溶性CD14)大于350pg /ml的社区获得性或医院获得性肺炎住院成人患者。患者按1:1随机分配至标准护理药物加皮下安慰剂或皮下阿那金100 mg,每天一次,持续10天。主要终点是进展为器官功能障碍,定义为满足以下两个条件中的至少一个;(i)到第7天基线SOFA评分至少增加2个点和/或(ii)到第90天死亡。这是在意向治疗(ITT)人群中分析的。该试验已在EU临床试验注册(2022-002390-28)和ClinicalTrials.gov (NCT05785442)注册。患者在2023年3月至2024年6月期间入组;安慰剂组的30名患者和Anakinra组的30名患者是ITT人群。安慰剂治疗组的主要终点达到50.0%(15例),anakinra治疗组的主要终点达到20.0%(6例)(差异30.0% [5.9 ~ 49%];p: 0.011)。90天死亡率分别为43.3%(13例)和20.0%(6例)(差异为23.3% [0 ~ 43.7%];p: 0.029)。安慰剂组的严重治疗不良事件(teae)总发生率为50%,阿那金组为33.3%。没有一个严重的teae被认为与治疗分配有关。血单个核细胞产生TNFα和ΙFNγ减少。presepin引导的Anakinra治疗可预防肺炎进展到器官功能障碍和死亡。其作用机制与抑制细胞因子的产生有关。希腊败血症研究所;PHC Europe BV;瑞典孤儿Biovitrum AB。
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引用次数: 0
The role of welfare regimes on socioeconomic inequalities in edentulism: a cross-national analysis of 40 countries 福利制度对蛀牙现象中社会经济不平等的作用:对40个国家的跨国分析
IF 13 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-29 DOI: 10.1016/j.lanepe.2025.101578
Roger Keller Celeste , Carol Guarnizo-Herreño , Johan Fritzell , Francine S. Costa , Olalekan Ayo-Yusuf , Aluisio J. Barros , Huihua Li , Ninuk Hariyani , Donna M. Hackley , Silvana Blanco , Jorge A. Gamonal , Gerardo Maupome , Richard G. Watt , Marco Aurelio Peres

Background

We aim to evaluate the association between welfare regimes and edentulism (total tooth loss) and to investigate whether welfare regimes modify the magnitude of socioeconomic inequalities in edentulism.

Methods

The Lancet Commission on Oral Health gathered and analysed nationally representative available data from 40 high, middle- and low-income countries, collected between 2007 and 2018. The study included 117,397 individuals 20 years or older. The outcome was edentulism, defined as the absence of all natural teeth. We categorised countries into seven welfare regimes, which served as both the primary exposure and an effect modifier. Individual-level variables included sex, age and a composite measure of socioeconomic position: “wealth” measured in quintiles. Inverse probability of treatment weight and multilevel logistic regression were employed to estimate the odds of being edentulous, and cross–level interaction terms between wealth and country factors.

Findings

Individuals at the lowest wealth quintile had the highest prevalence of edentulism in all regimes. The highest age-sex standardised prevalence was found in Eastern European countries (8.4%, 95% Confidence Interval: 7.6–9.3), followed by Corporative (8.1%, 95% CI: 7.0–9.3), while the lowest was among the Insecurity regime (0.8%, 95% CI: 0.4–1.5), followed by the Scandinavian regime (4.7%, 95% CI: 3.5–6.1). Liberal countries presented the highest magnitude of absolute and relative inequalities, where the lowest quintile had OR = 20.6 (95% CI: 15.3–27.8) times higher likelihood of being edentulous and 17.3 percentage points (pp) higher prevalence. Low-income countries in the Insecurity regime presented the lowest level of inequality. Among high- and upper-middle income countries, the Scandinavian regime had the lowest absolute inequalities (5.5 pp difference between highest and lowest quintiles). The Informal Security regime had the lowest relative differences between the highest and lowest quintiles (OR = 2.20, 95% CI: 1.06–4.59).

Interpretation

Our findings indicate that some welfare regime policies may enhance oral health while decreasing socioeconomic inequalities. Higher prevalence and inequalities among industrialised countries may reflect higher levels of oral health hazards.

Funding

This was partially supported by a National Institute for Health and Care Research (UK) grant number 132731.
我们的目的是评估福利制度和全牙缺失之间的关系,并调查福利制度是否改变了全牙缺失中社会经济不平等的程度。《柳叶刀》口腔健康委员会收集并分析了2007年至2018年期间从40个高、中、低收入国家收集的具有全国代表性的现有数据。这项研究包括117,397名20岁或以上的人。结果是无牙症,定义为没有所有天然牙齿。我们将各国分为七种福利制度,这些制度既是主要的暴露因素,也是影响调节因素。个人层面的变量包括性别、年龄和社会经济地位的综合衡量标准:以五分位数衡量的“财富”。采用治疗权重的逆概率和多水平逻辑回归来估计无牙的几率,以及财富和国家因素之间的跨水平相互作用项。研究发现,在所有国家中,财富最低的五分之一的人患蛀牙症的比例最高。年龄-性别标准化患病率最高的是东欧国家(8.4%,95%可信区间:7.6-9.3),其次是联合国家(8.1%,95%可信区间:7.0-9.3),最低的是不安全感国家(0.8%,95%可信区间:0.4-1.5),其次是斯堪的纳维亚国家(4.7%,95%可信区间:3.5-6.1)。自由国家的绝对不平等和相对不平等程度最高,其中最低五分之一的无牙可能性高出20.6倍(95% CI: 15.3-27.8),患病率高出17.3个百分点(pp)。不安全制度下的低收入国家的不平等程度最低。在高收入和中高收入国家中,斯堪的纳维亚政权的绝对不平等程度最低(最高和最低五分之一之间的差距为5.5个百分点)。非正式安全制度在最高和最低五分位数之间的相对差异最小(OR = 2.20, 95% CI: 1.06-4.59)。我们的研究结果表明,一些福利制度政策可以在减少社会经济不平等的同时促进口腔健康。工业化国家中较高的患病率和不平等现象可能反映出较高的口腔健康危害程度。该研究部分由英国国家健康与护理研究所资助,资助号为132731。
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引用次数: 0
Time to coronary angiography and revascularization in 575,247 patients with STEMI from 2012 to 2023: a retrospective population-based cohort study 2012年至2023年575247例STEMI患者冠脉造影和血运重建术时间:一项基于人群的回顾性队列研究
IF 13 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-29 DOI: 10.1016/j.lanepe.2025.101576
Paulina E. Stürzebecher , Ulrich Laufs , Philip Baum , Johannes Diers , Armin Wiegering , Konstantin Uttinger

Background

Rapid primary percutaneous coronary intervention (PPCI) in patients with ST-elevation myocardial infarction (STEMI) reduces in-hospital and long-term mortality. This study analyzes time intervals to PPCI in STEMI, risk factors for delay of PPCI, and in-hospital mortality from 2012 to 2023.

Methods

This is a retrospective population-based analysis of hospital billing data of adult STEMI patients receiving PPCI in Germany. The time for transport to hospital (TTH) was estimated using geographic routing. The in-hospital time to angiography (IHTA) was calculated using time coding of PPCI in patient records.

Findings

A total of 575,247 patients were included. The median age was 64 years, 28.5% (164,016) were female. The population with IHTA ≤60 min increased from 44.5% (22,240/49,965) in 2012 to 57.7% (24,434/42,356) in 2023 with improved TTH + IHTA ≤120 min (56.6%, 28,280/49,965, in 2012–70.2%, 29,734/42,356, in 2023). IHTA improved from median 73.1 min (IQR 25.2–186.6) in 2012 to 46.4 min (IQR 17.5–111.6) in 2023 with a stable TTH (11.4–11.9 min). Risk factors for an IHTA >60 min included age, female sex, comorbidity, presentation out of regular hours, and low-volume hospitals. In-hospital mortality increased (8.8%, 4406/49,965, in 2012, 10.4%, 4822/46,203, in 2021, 10.1%, 4272/42,356, in 2023), paralleling a rise in patient age and comorbidity. Risk factors for in-hospital mortality included female sex, increased age, comorbidity, high-volume hospitals, intervention of multiple coronary arteries, weekend admission, and presentation out of regular hours. IHTA <40 min (90–120 min as reference) and TTH + IHTA <80 min (≥120 min as reference) reduced the risk of death.

Interpretation

Combining hospital billing records with geographic routing enables benchmarking of both pre- and in-hospital delays in STEMI care. In hospital delay decreased between 2012 and 2023. Important areas for improving time delays and STEMI-related mortality include the timeliness of care outside of regular hours and a focus on women, older patients, as well as individuals with comorbidities.

Funding

There was no funding for this project or this publication.
st段抬高型心肌梗死(STEMI)患者快速经皮冠状动脉介入治疗(PPCI)可降低住院和长期死亡率。本研究分析了2012 - 2023年STEMI患者PPCI的时间间隔、PPCI延迟的危险因素和住院死亡率。方法对德国接受PPCI治疗的STEMI成人患者的医院账单数据进行回顾性人群分析。使用地理路径估计运送到医院的时间(TTH)。利用病历中PPCI的时间编码计算住院血管造影时间(IHTA)。结果:共纳入575247例患者。中位年龄64岁,28.5%(164,016)为女性。IHTA≤60 min的人群从2012年的44.5%(22240 / 49965)增加到2023年的57.7%(24434 / 42356),改善TTH + IHTA≤120 min的人群2012年为56.6%(28280 / 49965),2023年为70.2%(29734 / 42356)。IHTA从2012年的中位73.1 min (IQR 25.2-186.6)改善到2023年的46.4 min (IQR 17.5-111.6), TTH稳定(11.4-11.9 min)。60分钟IHTA的危险因素包括年龄、女性、合并症、非正常就诊时间和小容量医院。住院死亡率增加(2012年为8.8%,4406/49,965;2021年为10.4%,4822/46,203;2023年为10.1%,4272/42,356),同时患者年龄和合并症增加。住院死亡率的危险因素包括女性、年龄增长、合并症、大容量医院、多冠状动脉干预、周末入院和非正常就诊。IHTA <40 min (90 ~ 120 min为参照)和TTH + IHTA <;80 min(≥120 min为参照)降低死亡风险。将医院账单记录与地理路由相结合,可以对STEMI护理的住院前和住院延误进行基准测试。2012年至2023年间,住院延误有所减少。改善时间延误和stemi相关死亡率的重要领域包括在正常时间之外及时提供护理,并关注妇女、老年患者以及患有合并症的个人。本项目或本出版物没有资金支持。
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引用次数: 0
Parental wealth and mental disorders in Norway (2006–2023): a nationwide registry-based study of 1.4 million young people 挪威的父母财富和精神障碍(2006-2023):一项针对140万年轻人的全国性登记研究
IF 13 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-29 DOI: 10.1016/j.lanepe.2025.101567
Joakim Coleman Ebeltoft , Eivind Ystrøm , Ziada Ayorech , Espen Moen Eilertsen

Background

Young people from families with low socioeconomic position have higher rates of mental disorders. However, wealth is underexamined despite large wealth inequity worldwide. Here, we aim to investigate the relationship between early life parental wealth and mental disorders in young Norwegians.

Methods

We conducted a population study of associations between early-life parental wealth and 17 diagnostic categories of mental disorders in 1.4 M children (7–12), adolescents (13–18), and young adults (19–24) observed 2006–2023. Ranked parental socioeconomic indicators at age 0–6 (wealth, income, occupation, and education) and mental disorder diagnoses (ICD-10 and ICPC-2) were obtained from Norwegian Tax, Employment, Education, and Control and Payment of Health Reimbursements registries. Estimates were derived from mean prevalences, generalised estimating equations, and sibling comparison designs.

Findings

Parental wealth represents a gradient in young people's mental disorders across age, sex, diagnostic categories, and cohorts. The lowest wealth quintile demonstrated 87% [95% CI = 78–96%] higher 1-year prevalence than the highest quintile. In multivariable analyses, parental wealth was the strongest predictor of mental disorders relative risk in adolescents (1.83 [1.76–1.9]) and young adults (1.92 [1.8–2.04]), while wealth (1.53 [1.46–1.6]) and education (1.52 [1.45–1.6]) were the strongest predictors in children. Parental wealth has a significant within-family association with mental disorders (relative risks: children 1.57 [1.44–1.71], adolescents 1.34 [1.26–1.42], young adults 1.42 [1.31–1.54]).

Interpretation

Our study serves as a point of reference for understanding the relationship between parental wealth and mental health. Our findings establish early life parental wealth as a fundamental social gradient in young people's mental disorders.

Funding

European Research Council consolidator grant (#101045526).
来自低社会经济地位家庭的年轻人患精神疾病的比例更高。然而,尽管世界范围内存在巨大的财富不平等,但财富却没有得到充分的审视。在这里,我们的目的是调查早期生活中父母的财富和年轻挪威人精神障碍之间的关系。方法对2006-2023年的140万名儿童(7-12岁)、青少年(13-18岁)和年轻人(19-24岁)进行了早期父母财富与17种精神障碍诊断类别之间关系的人群研究。从挪威税收、就业、教育、控制和医疗报销支付登记处获得0-6岁父母社会经济指标排名(财富、收入、职业和教育)和精神障碍诊断(ICD-10和ICPC-2)。估计来自平均患病率、广义估计方程和兄弟姐妹比较设计。研究发现,父母的财富在不同年龄、性别、诊断类别和人群中表现出年轻人精神障碍的梯度。最低财富五分位数的1年患病率比最高财富五分位数高87% [95% CI = 78-96%]。在多变量分析中,父母财富是青少年(1.83[1.76-1.9])和年轻人(1.92[1.8-2.04])精神障碍相对风险的最强预测因子,而财富(1.53[1.46-1.6])和教育(1.52[1.45-1.6])是儿童精神障碍相对风险的最强预测因子。父母财富与精神障碍在家庭内部存在显著关联(相对风险:儿童1.57[1.44-1.71],青少年1.34[1.26-1.42],年轻人1.42[1.31-1.54])。本研究为理解父母财富与心理健康之间的关系提供了参考。我们的研究结果表明,早年父母的财富是年轻人精神障碍的一个基本社会梯度。资助欧洲研究委员会整合资助(#101045526)。
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引用次数: 0
Doubling the diagnostic rate of at-risk metabolic dysfunction-associated steatohepatitis—leave no one behind: author's reply 将高危代谢功能障碍相关脂肪性肝炎的诊断率提高一倍——不让任何人掉队:作者回复
IF 13 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-26 DOI: 10.1016/j.lanepe.2025.101575
Jeffrey V. Lazarus , William Alazawi , Christopher D. Byrne , Cyrielle Caussy , Paul N. Brennan
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引用次数: 0
Evaluating the effect of probiotics on severe necrotising enterocolitis in preterm infants born before 32 weeks gestation in England and Wales: a propensity-matched population study 评估益生菌对英格兰和威尔士妊娠32周前出生的早产儿严重坏死性小肠结肠炎的影响:一项倾向匹配的人群研究
IF 13 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-22 DOI: 10.1016/j.lanepe.2025.101571
Alice Aveline , Lisa Szatkowski , Janet Berrington , Kate Costeloe , Shalini Ojha , Paul Fleming , Cheryl Battersby

Background

Necrotising enterocolitis (NEC) remains an important cause of morbidity and mortality in preterm infants. This study aimed to examine whether probiotics reduce the risk of severe NEC and other key neonatal morbidities including late onset sepsis and mortality.

Methods

Retrospective study using the United Kingdom National Neonatal Research Database. Infants <32 weeks gestation in England and Wales (01/01/2016–31/12/2022) were included if alive on day four, without major congenital anomaly. A propensity score matched approach was applied matching for gestational age cohorts, birth year epochs and 17 further items. Comparators were infants who were exposed or not to probiotics within 14 days. Primary outcome was severe NEC (confirmed at laparotomy or postmortem or listed primary cause of death). Parent focus groups and former NICU patients supported this study but did not contribute to design or writing.

Findings

48,048 infants (45.2% (21,695/48,048) female), median gestational age 29.4 weeks (IQR 27.4–30.9) were included; 25.3% (12,161/48,048) were exposed to at least one of five available probiotics. 3.6% (1728/48,048) had severe NEC. Of 16,586 infants (8293 exposed and 8293 unexposed) in the propensity-matched analysis, incidence and odds ratios (OR) (95% CI) for exposed versus unexposed for severe NEC was 3.3% versus 4.2%, OR 0.80 (0.72–0.89); other definitions of NEC yielded similar results. Incidence for late onset sepsis (10.8% versus 11.5%, OR 0.94 (0.90–0.97)) and survival to discharge (96.6% versus 94.2%, OR 1.76 (1.65–1.88)). In infants <28 weeks gestation, severe NEC (8.7% versus 9.8%, OR 0.88 (0.82–0.93) and for ≥28 weeks (1.0% versus 1.7%, OR 0.59 (0.47–0.73).

Interpretation

Probiotics were associated with a reduction in severe NEC including in those <28 weeks gestation. We currently recommend neonatal units not already using probiotics, to consider the introduction of products meeting appropriate recommendations, in the context of their local morbidity rates.

Funding

NIHR Advanced Fellowship (CB reference: NIHR300617), Imperial College PhD studentship (AA), NIHR RfPB grant (NIHR203590, SO), Imperial NIHR Biomedical Research Centre.
背景:坏死性小肠结肠炎(NEC)仍然是早产儿发病和死亡的重要原因。本研究旨在研究益生菌是否能降低严重NEC和其他关键新生儿发病率(包括晚发型败血症和死亡率)的风险。方法使用英国国家新生儿研究数据库进行回顾性研究。在英格兰和威尔士(2016年1月1日- 2022年12月31日)怀孕32周的婴儿,如果在第4天存活,没有重大先天性异常,则包括在内。采用倾向评分匹配方法对胎龄队列、出生年际和其他17个项目进行匹配。比较对象是14天内接触或不接触益生菌的婴儿。主要结局是严重NEC(在剖腹手术或尸检时证实或列出的主要死因)。家长焦点小组和前NICU患者支持本研究,但没有参与设计或写作。结果:纳入48,048例婴儿(45.2%(21,695/48,048)为女性),中位胎龄29.4周(IQR 27.4-30.9);25.3%(12,161/48,048)暴露于五种可用益生菌中的至少一种。3.6%(1728/48,048)为重度NEC。在倾向匹配分析中,16586名婴儿(8293名暴露和8293名未暴露)中,暴露与未暴露的严重NEC的发病率和比值比(OR) (95% CI)为3.3%对4.2%,OR为0.80 (0.72-0.89);NEC的其他定义也得出了类似的结果。迟发性脓毒症的发生率(10.8%对11.5%,OR 0.94(0.90-0.97))和出院生存率(96.6%对94.2%,OR 1.76(1.65-1.88))。在妊娠28周的婴儿中,严重NEC(8.7%对9.8%,OR 0.88(0.82-0.93))和≥28周的婴儿中(1.0%对1.7%,OR 0.59(0.47-0.73))。解释益生菌与严重NEC的减少有关,包括在妊娠28周。我们目前建议尚未使用益生菌的新生儿单位考虑在当地发病率的情况下引入符合适当建议的产品。NIHR高级奖学金(CB参考号:NIHR300617),帝国理工学院博士奖学金(AA), NIHR RfPB资助(NIHR203590, SO),帝国NIHR生物医学研究中心。
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引用次数: 0
Anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction using hamstring autograft versus anterior cruciate ligament reconstruction using bone–patellar tendon–bone autograft: a randomised controlled trial with 5-year follow-up 前交叉韧带重建联合前外侧韧带重建采用腘绳肌腱自体移植物与前交叉韧带重建采用骨-髌腱-骨自体移植物:一项5年随访的随机对照试验
IF 13 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-20 DOI: 10.1016/j.lanepe.2025.101561
Bertrand Sonnery-Cottet , Alessandro Carrozzo , Hervé Poilvache , Jean-Marie Fayard , Benjamin Freychet , Mathieu Thaunat , Thais Dutra Vieira , Adnan Saithna

Background

Anterior Cruciate Ligament (ACL) rupture is common knee injury. Although ACL reconstruction (ACLR) is standard, graft failure rates remain high in young active patients. This study investigated whether combining ACLR with anterolateral ligament (ALL) reconstruction (ALLR) reduces grafts failure compared with ACLR.

Methods

In this prospective, single-centre, randomised controlled trial conducted at the Santy Orthopedic Center in Lyon, France, patients aged 18–35 years with symptomatic ACL rupture were randomly allocated (1:1) to ACL + ALL reconstruction using hamstring tendon autograft (ACLR + ALLR) or ACLR with bone-patellar tendon-bone autograft (ACLR). Randomisation was performed with a block size of four using telematic software by an independent study coordinator, with concealed allocation. Surgeons were informed of the assigned procedure on the morning of surgery. Outcome assessors were not blinded. The primary outcome was graft failure at 5 years, assessed clinically and by magnetic resonance imaging (MRI) by an independent sports medicine physicians not involved in the index surgery. Efficacy analyses were performed on the Full Analysis Set in accordance with the intention-to-treat principle, while safety analyses were conducted on the Safety Set. Trial registration: ClinicalTrials.gov, ID NCT03740022. The trial has been completed.

Findings

Between November 11, 2016, and January 20, 2020, 593 patients were randomized (297 assigned to ACLR + ALLR and 296 to ACLR). The mean age was 25.0 years (SD 4.5); 447 (75%) participants were male and 146 (25%) female. Of these 593 patients, 556 (94%) completed a mean 5-year follow-up. Graft failure occurred in 12/283 (4.2%) with ACLR + ALLR versus 28/273 (10.3%) with ACLR (p = 0.006; adjusted odds ratio 2.54 [95% CI 1.27; 5.36]—p = 0.008). The number needed to treat was 17 overall, and 9 in patients younger than 25 years.

Interpretation

In our study of young, active adults with ACL rupture, who are considered high-risk for graft failure, combining ACL reconstruction with anterolateral ligament reconstruction (ACLR + ALLR) significantly decreased graft failure compared with ACLR. These results suggest that ACLR + ALLR might be beneficial for young or highly active individuals and provide a basis for future research to refine patient selection, evaluate long-term outcomes beyond five years, and explore benefits in other subgroups of patients with ACL injuries.

Funding

GCS Ramsay Santé pour l'Enseignement et la Recherche funds the scientific activity at the Santy center.
前交叉韧带(ACL)断裂是常见的膝关节损伤。虽然前交叉韧带重建(ACLR)是标准的,但在年轻的活跃患者中移植物失败率仍然很高。本研究探讨与ACLR相比,ACLR联合前外侧韧带(ALL)重建(ALLR)是否能减少移植物衰竭。方法在法国里昂的Santy骨科中心进行的这项前瞻性、单中心、随机对照试验中,年龄在18-35岁的有症状的ACL断裂患者被随机分配(1:1)到ACL + ALL重建使用腘绳肌腱自体移植物(ACLR + ALLR)或ACLR结合骨-髌骨肌腱-骨自体移植物(ACLR)。随机分组由独立研究协调员使用远程信息处理软件进行,分组大小为4个,并进行隐蔽分配。外科医生在手术当天早上被告知指定的手术程序。结果评估者没有采用盲法。主要结果是5年时移植物失败,由独立的运动医学医生通过临床和磁共振成像(MRI)评估,该医生没有参与指数手术。根据意向治疗原则对全分析集进行疗效分析,对安全集进行安全性分析。试验注册:ClinicalTrials.gov,编号NCT03740022。审判已经结束。在2016年11月11日至2020年1月20日期间,593例患者被随机分配(297例分配到ACLR + ALLR, 296例分配到ACLR)。平均年龄25.0岁(SD 4.5);447名(75%)参与者为男性,146名(25%)参与者为女性。在这593例患者中,556例(94%)完成了平均5年的随访。ACLR + ALLR组的移植失败发生率为12/283(4.2%),而ACLR组的移植失败发生率为28/273 (10.3%)(p = 0.006;校正优势比2.54 [95% CI 1.27; 5.36] -p = 0.008)。需要治疗的总人数为17人,25岁以下的患者为9人。在我们的研究中,年轻、活跃的成年ACL破裂患者被认为是移植物失败的高危人群,与ACLR相比,ACL重建联合前外侧韧带重建(ACLR + ALLR)可显著减少移植物失败。这些结果表明,ACLR + ALLR可能对年轻或高度活跃的个体有益,并为未来的研究提供基础,以完善患者选择,评估5年以上的长期结果,并探索其他亚组ACL损伤患者的益处。gcs Ramsay sant pour l’enseignement et la Recherche为圣中心的科学活动提供资金。
{"title":"Anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction using hamstring autograft versus anterior cruciate ligament reconstruction using bone–patellar tendon–bone autograft: a randomised controlled trial with 5-year follow-up","authors":"Bertrand Sonnery-Cottet ,&nbsp;Alessandro Carrozzo ,&nbsp;Hervé Poilvache ,&nbsp;Jean-Marie Fayard ,&nbsp;Benjamin Freychet ,&nbsp;Mathieu Thaunat ,&nbsp;Thais Dutra Vieira ,&nbsp;Adnan Saithna","doi":"10.1016/j.lanepe.2025.101561","DOIUrl":"10.1016/j.lanepe.2025.101561","url":null,"abstract":"<div><h3>Background</h3><div>Anterior Cruciate Ligament (ACL) rupture is common knee injury. Although ACL reconstruction (ACLR) is standard, graft failure rates remain high in young active patients. This study investigated whether combining ACLR with anterolateral ligament (ALL) reconstruction (ALLR) reduces grafts failure compared with ACLR.</div></div><div><h3>Methods</h3><div>In this prospective, single-centre, randomised controlled trial conducted at the Santy Orthopedic Center in Lyon, France, patients aged 18–35 years with symptomatic ACL rupture were randomly allocated (1:1) to ACL + ALL reconstruction using hamstring tendon autograft (ACLR + ALLR) or ACLR with bone-patellar tendon-bone autograft (ACLR). Randomisation was performed with a block size of four using telematic software by an independent study coordinator, with concealed allocation. Surgeons were informed of the assigned procedure on the morning of surgery. Outcome assessors were not blinded. The primary outcome was graft failure at 5 years, assessed clinically and by magnetic resonance imaging (MRI) by an independent sports medicine physicians not involved in the index surgery. Efficacy analyses were performed on the Full Analysis Set in accordance with the intention-to-treat principle, while safety analyses were conducted on the Safety Set. Trial registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, ID <span><span>NCT03740022</span><svg><path></path></svg></span>. The trial has been completed.</div></div><div><h3>Findings</h3><div>Between November 11, 2016, and January 20, 2020, 593 patients were randomized (297 assigned to ACLR + ALLR and 296 to ACLR). The mean age was 25.0 years (SD 4.5); 447 (75%) participants were male and 146 (25%) female. Of these 593 patients, 556 (94%) completed a mean 5-year follow-up. Graft failure occurred in 12/283 (4.2%) with ACLR + ALLR versus 28/273 (10.3%) with ACLR (p = 0.006; adjusted odds ratio 2.54 [95% CI 1.27; 5.36]—p = 0.008). The number needed to treat was 17 overall, and 9 in patients younger than 25 years.</div></div><div><h3>Interpretation</h3><div>In our study of young, active adults with ACL rupture, who are considered high-risk for graft failure, combining ACL reconstruction with anterolateral ligament reconstruction (ACLR + ALLR) significantly decreased graft failure compared with ACLR. These results suggest that ACLR + ALLR might be beneficial for young or highly active individuals and provide a basis for future research to refine patient selection, evaluate long-term outcomes beyond five years, and explore benefits in other subgroups of patients with ACL injuries.</div></div><div><h3>Funding</h3><div><span>GCS Ramsay Santé pour l'Enseignement et la Recherche</span> funds the scientific activity at the Santy center.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"62 ","pages":"Article 101561"},"PeriodicalIF":13.0,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145841222","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}
引用次数: 0
Doubling the diagnostic rate of at-risk metabolic dysfunction-associated steatohepatitis—leave no one behind 将高危代谢功能障碍相关脂肪性肝炎的诊断率提高一倍——不让任何人掉队
IF 13 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-19 DOI: 10.1016/j.lanepe.2025.101572
Elamin Abdelgadir , Fatheya Alawadi , Fauzia Rashid , Alaaeldin Bashir , Jörn M. Schattenberg
{"title":"Doubling the diagnostic rate of at-risk metabolic dysfunction-associated steatohepatitis—leave no one behind","authors":"Elamin Abdelgadir ,&nbsp;Fatheya Alawadi ,&nbsp;Fauzia Rashid ,&nbsp;Alaaeldin Bashir ,&nbsp;Jörn M. Schattenberg","doi":"10.1016/j.lanepe.2025.101572","DOIUrl":"10.1016/j.lanepe.2025.101572","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"60 ","pages":"Article 101572"},"PeriodicalIF":13.0,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145790204","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}
引用次数: 0
Socioeconomic disparities in long-term mortality after infective endocarditis in Denmark: a nationwide cohort study 丹麦感染性心内膜炎后长期死亡率的社会经济差异:一项全国性队列研究
IF 13 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-19 DOI: 10.1016/j.lanepe.2025.101568
Søren K. Martiny , Morten Schmidt , Jonas A. Povlsen , Kirstine K. Søgaard , Hans E. Bøtker , Henrik T. Sørensen

Background

Socioeconomic position (SEP) influences several determinants of infective endocarditis (IE) progression. Whether IE mortality differs by SEP remains unclear. We examined 5-year mortality after IE by individual-level SEP.

Methods

Using nationwide Danish registries, we identified patients with first-time IE (2010–2022). SEP was assessed by educational and affluence level, categorised as low, medium, and high. The Kaplan–Meier estimator provided 30-day, 1-, 3-, and 5-year mortality risks, risk differences, and risk ratios. Time-varying hazard ratios were derived from flexible parametric models. We estimated attendance at outpatient and dental follow-up visits (indicating adherence to follow-up) using the Aalen-Johansen estimator and modelled hospitalisation rate during follow-up (indicating comorbid disease burden) using a joint frailty model, treating death as a competing event in all models.

Findings

The 5-year mortality by educational level was 63.1% (95% CI: 60.8%–65.2%) for low, 53.1% (95% CI: 51.3%–54.9%) for medium, and 45.8% (95% CI: 42.5%–48.8%) for high education. The excess mortality was particularly pronounced within the first 2 years. Within one year after discharge, 65.2% (95% CI: 62.9%–67.4%) of low, 73.6% (95% CI: 72.0%–75.2%) of medium, and 74.5% (95% CI: 71.8%–77.2%) of high-education patients had an outpatient contact. The corresponding five year dental visit proportions were 44.0% (95% CI: 41.6%–46.5%), 64.0% (95% CI: 62.2%–65.9%), and 74.0% (95% CI: 71.2%–76.9%), respectively. The hazard ratio for hospitalisations was 1.35 (95% CI: 1.25–1.49) when comparing low vs. high education and 1.19 (95% CI: 1.10–1.27) for low vs. medium. Estimates and time-dependent patterns were similar for affluence level.

Interpretation

Patients with low SEP had higher IE mortality, particularly within the first 2 years. Reduced adherence to follow-up care and comorbid diseases may contribute to this. Determining how the excess mortality is directly linked to the IE episode warrants further investigation.

Funding

Independent Research Fund Denmark (grant no. 3101-00102B) and Center for Population Medicine, Department of Clinical Epidemiology, Aarhus University.
社会经济地位(SEP)影响感染性心内膜炎(IE)进展的几个决定因素。是否因SEP而导致IE死亡率不同尚不清楚。我们通过个体水平sep检查IE后的5年死亡率。方法使用丹麦全国登记,我们确定了首次IE患者(2010-2022)。SEP根据教育程度和富裕程度进行评估,分为低、中、高三个等级。Kaplan-Meier估计提供了30天、1年、3年和5年的死亡率风险、风险差异和风险比。时变风险比由柔性参数模型导出。我们使用aallen - johansen估计器估计门诊和牙科随访的出席率(表明随访的依从性),并使用关节虚弱模型模拟随访期间的住院率(表明共病疾病负担),在所有模型中都将死亡视为竞争事件。低学历患者5年死亡率为63.1% (95% CI: 60.8% ~ 65.2%),中等学历患者为53.1% (95% CI: 51.3% ~ 54.9%),高学历患者为45.8% (95% CI: 42.5% ~ 48.8%)。死亡率的增加在头两年尤为明显。出院后1年内,65.2% (95% CI: 62.9% ~ 67.4%)的低学历患者、73.6% (95% CI: 72.0% ~ 75.2%)的中等学历患者和74.5% (95% CI: 71.8% ~ 77.2%)的高学历患者有门诊接触。相应的5年牙科就诊比例分别为44.0% (95% CI: 41.6%-46.5%)、64.0% (95% CI: 62.2%-65.9%)和74.0% (95% CI: 71.2%-76.9%)。当比较低教育与高等教育时,住院的风险比为1.35 (95% CI: 1.25-1.49),低教育与中等教育的风险比为1.19 (95% CI: 1.10-1.27)。富裕水平的估计和时间依赖模式相似。低SEP患者有较高的IE死亡率,特别是在头2年内。对后续护理的依从性降低和合并症可能是造成这种情况的原因。确定高死亡率如何与IE事件直接相关,需要进一步调查。资助丹麦独立研究基金(批准号:3101-00102B)和奥胡斯大学临床流行病学学系人口医学中心。
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引用次数: 0
Blood culture practices and microbiological capacity for sepsis diagnostics in Europe (2021–2022): a cross-sectional analysis of the European Sepsis Care Survey 欧洲败血症诊断的血培养实践和微生物能力(2021-2022):欧洲败血症护理调查的横断面分析
IF 13 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-12-18 DOI: 10.1016/j.lanepe.2025.101570
Christian S. Scheer , Evangelos J. Giamarellos-Bourboulis , Djillali Annane , Antonio Artigas , Abdullah Tarik Aslan , Gabriella Bottari , Hjalmar R. Bouma , Vladimir Černý , Renata Curić Radivojević , Ken Dewitte , Daniela Filipescu , Matthias Gründling , Johanna Hästbacka , Said Laribi , Annmarie Lassen , Konstantin Lebedinskii , Adam Linder , Jan Máca , Manu L.N.G. Malbrain , Gianpaola Monti , Zuzanna Górska

Background

Blood cultures (BCs) are key diagnostic elements for sepsis patients. Accurate preanalytical procedures are substantial, and results should be available as soon as possible to guide adequate antimicrobial treatment. This study aimed to evaluate BC collection practices and diagnostic capacity across European hospitals.

Methods

This cross-sectional survey investigated BC diagnostics in acute care hospitals across 37 European countries in the years 2021 and 2022. Analyses included BC guidelines, collection sites, number of BC sets in emergency departments (EDs), wards, and intensive care units (ICUs). We also examined transfer after collection, the use of on-site vs. external laboratories, opening hours, rapid testing capacity, and turn-around times of BCs processed in microbiology laboratories with different infrastructures.

Findings

Responses were collected from 907 hospitals in Europe. BC guidelines were available in 84·4% (741/878) of the hospitals. BCs were preferably collected by multiple-site sampling in EDs (62·7%, 461/735), in wards (64·0%, 513/802) and ICUs (68·5%, 518/756). One BC set was preferred in EDs in 38·4% (270/704), in wards in 40·5% (314/775), and ICUs in 34·9% (261/748). Two BC sets were preferred in EDs in 31·0% (218/704), in wards in 28·1% (218/775), and ICUs in 39·2% (293/748). 48·0% (402/838) of hospitals used on-site and 52·0% (436/838) external microbiology laboratories. Around-the-clock microbiological services were available in 10⋅0% (91/907), and rapid pathogen identification in 43·7% (396/907) of hospitals. Infrastructure with around-the-clock microbiological service and rapid testing was available in 7·4% (62/840) of hospitals, and probability of a final microbiological result within two days was highest in these hospitals compared to hospitals with limited microbiology service (for BC collected on wards: 19·6% vs. 52·7%, Odds Ratio 4·59 [95% CI 2·50–7·79], p < 0·0001).

Interpretation

Despite the availability of BC guidelines in many hospitals, current recommendations for BC collection were often neglected. Rapid testing capacity was limited in most microbiological laboratories, and around-the-clock service for BCs was very rare. As delay in results may have a detrimental impact on patient outcomes, strategies to improve these processes are urgently needed.

Funding

The European Sepsis Alliance and a grant by Becton and Dickinson.
血培养(BCs)是脓毒症患者的关键诊断要素。准确的分析前程序是重要的,结果应尽快提供,以指导适当的抗菌治疗。本研究旨在评估欧洲各医院的BC采集实践和诊断能力。方法本横断面调查调查了欧洲37个国家在2021年和2022年急性护理医院的BC诊断。分析包括BC指南、收集地点、急诊科(ed)、病房和重症监护病房(icu)的BC集数。我们还检查了收集后的转移、现场实验室与外部实验室的使用、开放时间、快速检测能力以及在不同基础设施的微生物实验室处理的bc的周转时间。调查结果收集了来自欧洲907家医院的回复。81.4%(741/878)的医院有BC指南。在急诊科(66.7%,461/735)、病房(61.4%,513/802)和icu(68.5%, 518/756)采用多点采样的方法采集bc较好。1套BC在急诊科为38.4%(270/704),病房为40.5% (314/775),icu为34.9%(261/748)。急诊科选择2套BC的比例为31.0%(218/704),病房为28.1% (218/775),icu为39.2%(293/748)。48.0%(402/838)医院使用现场微生物实验室,52.0%(436/838)医院使用外部微生物实验室。10⋅0%(91/907)的医院提供全天候微生物服务,43·7%(396/907)的医院提供快速病原体鉴定。7.4%(62/840)的医院拥有全天候微生物学服务和快速检测的基础设施,与微生物学服务有限的医院相比,这些医院在两天内获得最终微生物学结果的概率最高(在病房采集的BC: 19.6%对52.7%,优势比4.59 [95% CI 2.50 - 7.79], p < 0.0001)。尽管许多医院都有BC指南,但目前对BC收集的建议经常被忽视。大多数微生物实验室的快速检测能力有限,对bc的全天候服务非常罕见。由于结果的延迟可能对患者的预后产生不利影响,因此迫切需要改进这些过程的战略。为欧洲败血症联盟提供资金,由Becton和Dickinson资助。
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引用次数: 0
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Lancet Regional Health-Europe
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