Biomacromolecules最新文献

{"title":"Laparoscopy-assisted versus open surgery for low rectal cancer (LASRE): 3-year survival outcomes of a multicentre, randomised, controlled, non-inferiority trial","authors":"Weizhong Jiang, Jianmin Xu, Ming Cui, Huizhong Qiu, Ziqiang Wang, Liang Kang, Haijun Deng, Weiping Chen, Qingtong Zhang, Xiaohui Du, Chunkang Yang, Yincong Guo, Ming Zhong, Kai Ye, Jun You, Dongbo Xu, Xinxiang Li, Zhiguo Xiong, Kaixiong Tao, Kefeng Ding, Zhizhong Pan","doi":"10.1016/s2468-1253(24)00273-5","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00273-5","url":null,"abstract":"<h3>Background</h3>Laparoscopic surgery is increasingly used for rectal cancer, but the long-term oncological outcomes for low rectal cancer have not been fully established. We aimed to evaluate the 3-year survival outcomes of laparoscopic surgery versus open surgery in the treatment of low rectal cancer.<h3>Methods</h3>This multicentre, randomised, controlled, non-inferiority trial was conducted at 22 tertiary hospitals in China. Individuals aged 18–75 years with histologically confirmed cT1–2N0, cT3–4aN0, or cT1–4aN1–2 rectal adenocarcinoma within 5 cm from the dentate line were eligible for inclusion. Participants were randomly assigned (2:1) to undergo laparoscopic surgery or open surgery. Central randomisation was conducted using a web response system, and was stratified by clinical stage, age, sex, BMI, and American Society of Anesthesiologists classification. Investigators, patients and statisticians were not masked to group allocation. The primary outcome was 3-year disease-free survival, defined as the time from the date of surgery to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first. Non-inferiority was defined as a lower limit of one-sided 97·5% CI for group difference (laparoscopic surgery group minus open surgery group) of greater than –10%. The primary analyses were performed in the modified intention-to-treat population, which excluded patients with distant metastasis discovered during surgery and those who did not undergo surgery or underwent local resection only. The trial is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT01899547</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, and has been completed.<h3>Findings</h3>Between Nov 12, 2013, and June 6, 2018, 1070 patients were enrolled and randomly assigned to treatment. 1039 patients (685 in the laparoscopic surgery group and 354 in the open surgery group; median age 57 years, IQR 50 to 64; 620 [60%] male and 419 [40%] women) were included in the modified intention-to-treat analysis. 3-year disease-free survival was 81·4% (95% CI 78·2 to 84·1) in the laparoscopic surgery group and 79·8% (75·2 to 83·6) in the open surgery group (hazard ratio [HR] 0·92, 95% CI 0·69 to 1·23; p=0·56). The difference between groups was 1·60% (one-sided 97·5% CI –3·34 to ∞, p<0·0001 for non-inferiority). 3-year overall survival was 91·7% (95% CI 89·3 to 93·5) in the laparoscopic surgery group and 93·7% (90·6 to 95·8) in the open surgery group (HR 1·34, 95% CI 0·82 to 2·19; p=0·24). 3-year locoregional recurrence was 3·7% (95% CI 2·5 to 5·3) and 2·3% (1·1 to 4","PeriodicalId":30,"journal":{"name":"Biomacromolecules","volume":"244 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142596978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial","authors":"A James M Daveson, Richard Stubbs, Thomas M Polasek, Jorma Isola, Robert Anderson, Jason A Tye-Din, Mark Schoeman, Claudette Lionnet, Swee Lin Chen Yi Mei, Jelena Mihajlović, Martina Wirth, Evelyn Peelen, Amelie Schreieck, Hella Kohlhof, Daniel Vitt, Andreas Muehler, Franziska Buriánek","doi":"10.1016/s2468-1253(24)00248-6","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00248-6","url":null,"abstract":"<h3>Background</h3>IMU-856 is an orally available and systemically acting small molecule modulator of sirtuin 6 (SIRT6), a protein that serves as a transcriptional regulator of bowel epithelium regeneration. We aimed to evaluate the safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856 in healthy participants and in patients with coeliac disease.<h3>Methods</h3>This study reports the results from a completed first-in-human, three-part, double-blind, randomised, placebo-controlled, clinical trial of IMU-856 in healthy participants and patients with coeliac disease done in Australia and New Zealand. In part A, healthy participants were enrolled in six cohorts and randomly assigned (3:1) using a block randomisation algorithm to receive single ascending doses of IMU-856 ranging from 10 mg to 160 mg or matching placebo. Based on the results from part A, three doses were selected for part B to evaluate the safety, tolerability, and pharmacokinetics of IMU-856 once daily for 14 days using the same randomisation algorithm. Part C enrolled patients with well controlled coeliac disease. Participants were centrally randomised 1:1:1 using an interactive web response system to receive either low dose or high dose of IMU-856 or placebo once daily for 28 days that included a 15-day gluten challenge starting on day 14. The primary objective was safety and tolerability of IMU-856. Safety analyses were done on all patients who received at least one dose of the study drug. The trial is registered with the ANZCTR registry (ACTRN12620000901909).<h3>Findings</h3>Between July 27, 2020, and Oct 28, 2022, 71 healthy participants were enrolled in part A and B and assigned to either placebo (n=19) or IMU-856 (n=52). In part A and B, the IMU-856 doses were 10 mg (n=6), 20 mg (n=6), 40 mg (n=13), 80 mg (n=12), 120 mg (n=4), 160 mg (n=11). 43 patients with coeliac disease were enrolled in part C and assigned to either placebo (n=14), IMU-856 80 mg (n=14), or IMU-856 160 mg (n=15). Treatment-emergent adverse events (TEAEs) occurred in 24 (73%) of 33 participants in part A and 15 (79%) of 19 participants in part B receiving any dose of IMU-856 compared with six (50%) of 12 participants in part A and five (71%) of seven participants in part B with placebo. TEAEs were mainly mild in severity. In part C, TEAEs occured in 26 (90%) of 29 patients on any dose of IMU-856 and ten (71%) of 14 receiving placebo; the most common TEAEs with any dose of IMU-856 by preferred term were headache (13 [45%] of 29), nausea (nine [31%]), diarrhoea (eight [28%]), and abdominal distension (seven [24%]). Two serious adverse events occurred with IMU-856 treatment (one in part B [bacterial myocarditis] and one in part C [biliary colic]), both of which were unrelated to IMU-856. No dose-limiting toxicities, systematic safety laboratory changes, or deaths occurred during the study. In part C, mean decrease in villous height was –20·9 μm (SD 34·8) among patients who received IMU-856","PeriodicalId":30,"journal":{"name":"Biomacromolecules","volume":"64 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Management of portal vein thrombosis in cirrhosis – Authors' reply","authors":"Pierre-Emmanuel Rautou, Laure Elkrief","doi":"10.1016/s2468-1253(24)00353-4","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00353-4","url":null,"abstract":"No Abstract","PeriodicalId":30,"journal":{"name":"Biomacromolecules","volume":"46 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adjuvant nivolumab for gastric and gastro-oesophageal junction cancer","authors":"Fausto Petrelli, Andrea Celotti, Lorenzo Dottorini","doi":"10.1016/s2468-1253(24)00236-x","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00236-x","url":null,"abstract":"No Abstract","PeriodicalId":30,"journal":{"name":"Biomacromolecules","volume":"19 829 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bowel cancer prevention: are we missing an opportunity?","authors":"Colin Rees, Willie Hamilton","doi":"10.1016/s2468-1253(24)00314-5","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00314-5","url":null,"abstract":"No Abstract","PeriodicalId":30,"journal":{"name":"Biomacromolecules","volume":"32 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lucky: Learning to Live Again | Louise Thompson, Lucky: Learning to Live Again, Ebury Spotlight (2024), p. 304, £22·00, ISBN: 978-1529923766","authors":"Joe Moody","doi":"10.1016/s2468-1253(24)00305-4","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00305-4","url":null,"abstract":"No Abstract","PeriodicalId":30,"journal":{"name":"Biomacromolecules","volume":"1 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical outcomes of untreated adults living with chronic hepatitis B in The Gambia: an analysis of data from the prospective PROLIFICA cohort study","authors":"Gibril Ndow, Yusuke Shimakawa, Damien Leith, Sulayman Bah, Rohey Bangura, Isatou Mahmoud, Lamin Bojang, Amie Ceesay, Sainabou Drammeh, Queen Bola-Lawal, Gabriel Lambert, Perrine Hardy, Patrick Ingiliz, Yazan Haddadin, Erwan Vo-Quang, Stéphane Chevaliez, Gavin Cloherty, Sheikh Omar Bittaye, Gora Lo, Coumba Toure-Kane, Maud Lemoine","doi":"10.1016/s2468-1253(24)00226-7","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00226-7","url":null,"abstract":"<h3>Background</h3>Expanding antiviral therapy to people with chronic hepatitis B virus (HBV) infection who are ineligible to receive treatment under current international criteria has been increasingly debated. Evidence to support this approach is scarce, especially in Africa. We aimed to address this knowledge gap by analysing the clinical outcomes of people with chronic hepatitis B in The Gambia who were untreated and ineligible for antiviral therapy at diagnosis.<h3>Methods</h3>Between Dec 7, 2011, and Jan 24, 2014, we implemented the prospective PROLIFICA cohort study in The Gambia. Participants with chronic hepatitis B aged 16 years or older were recruited after large-scale, community-based HBV screening; blood bank-based HBV screening in Edward Francis Small Teaching Hospital, Banjul; and prospective follow-up of HBsAg-positive individuals via historical, population-based HBsAg serosurveys in two rural villages (Keneba and Manduar). Participants underwent HBV serology and other laboratory tests, fasting FibroScan, and abdominal ultrasound. Survival data were collected between Dec 7, 2011, and Aug 17, 2021. Between Oct 9, 2018, and Aug 17, 2021, all HBsAg-positive participants enrolled in the 2011–14 cohort were invited for a reassessment. For this analysis, we included HBsAg-positive people and excluded all participants who were eligible for treatment according to the 2012 European Association for the Study of the Liver (EASL) criteria at baseline and those who were treated irrespective of treatment eligibility. The primary outcome was all-cause mortality, assessed in all treatment-ineligible and treatment-naive participants with follow-up data. The secondary outcome, analysed in those who were reassessed, was disease progression, defined as becoming eligible for antivirals per 2017 EASL criteria; having an increase in liver fibrosis of at least one stage; or having a clinical diagnosis of hepatic decompensation or hepatocellular carcinoma.<h3>Findings</h3>943 HBsAg-positive people with chronic hepatitis B were recruited to the PROLIFICA study. Of these 943, 58 (6%) fulfilled 2012 EASL treatment eligibility criteria at baseline, 35 (4%) were ineligible for treatment but received antiviral therapy, and 44 (5%) were immediately lost to follow-up. Thus, 806 (85%) participants were analysed for the primary outcome (486 [60%] were male and 320 [40%] were female). After a median follow-up of 6·11 years (IQR 5·34–6·80), 708 (88%) participants were confirmed to be alive at last surveillance, 71 (9%) were lost to follow-up and were censored, and 27 (3%) died, giving an all-cause mortality rate of 582 per 100 000 person-years (95% CI 399–849). Of the 27 people who died, five (19%) had liver-related deaths. Of 708 participants confirmed to be alive, 544 (77%) attended follow-up and were assessed for the secondary outcome. Disease progression occurred in 36 (7%) participants: five (1%) became newly eligible for antiviral therapy per EASL 2017 criteria","PeriodicalId":30,"journal":{"name":"Biomacromolecules","volume":"243 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Launch of the PANC-PALS Consortium","authors":"Ammar A Javed, Camila Hidalgo Salinas, Christopher L Wolfgang, Marc G Besselink","doi":"10.1016/s2468-1253(24)00346-7","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00346-7","url":null,"abstract":"No Abstract","PeriodicalId":30,"journal":{"name":"Biomacromolecules","volume":"17 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dietary management of irritable bowel syndrome: considerations, challenges, and solutions","authors":"Kevin Whelan, Alexander C Ford, Helen Burton-Murray, Heidi M Staudacher","doi":"10.1016/s2468-1253(24)00238-3","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00238-3","url":null,"abstract":"Diet is a cornerstone in the management of irritable bowel syndrome (IBS). There is evidence of efficacy across the spectrum of dietary management strategies, including some supplements (eg, specific fibres), foods, and whole diets (eg, a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols [known as the low-FODMAP diet]). Whole-diet interventions, in particular those that restrict intake, can be challenging to deliver effectively and safely. Factors to consider include patient demographics, food cost and availability, and the acceptability of dietary management and its impact on food-related quality of life. There is concern regarding a potential role of restrictive whole-diet interventions in eating disorder risk. Optimal approaches to delivering dietary management in the health-care setting are unclear. The aim of this Review is to summarise the clinical evidence for the dietary management of IBS; to discuss the challenges, burdens, and risks of dietary management; and to propose how these challenges, burdens, and risks should be mitigated and minimised in clinical practice.","PeriodicalId":30,"journal":{"name":"Biomacromolecules","volume":"11 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Youth mental health in Tunisia: challenges and resources","authors":"Uta Ouali, Amina Aissa, Amine Larnaout, Zeineb Abbes, Fatma Charfi, Asma Bouden, Joseph Ventura","doi":"10.1016/s2215-0366(24)00329-8","DOIUrl":"https://doi.org/10.1016/s2215-0366(24)00329-8","url":null,"abstract":"No Abstract","PeriodicalId":30,"journal":{"name":"Biomacromolecules","volume":"8 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}