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321. Role of preoperative in-hospital delay on appendiceal perforation while awaiting appendicectomy (PERFECT): a Nordic, pragmatic, open-label, multicentre, non-inferiority, randomised controlled trial.
作者: Karoliina Jalava.;Ville Sallinen.;Hanna Lampela.;Hanna Malmi.;Ingeborg Steinholt.;Knut Magne Augestad.;Ari Leppäniemi.;Panu Mentula.
来源: Lancet. 2023年402卷10412期1552-1561页
Appendicectomy remains the standard treatment for appendicitis. No international consensus exists on the surgical urgency for acute uncomplicated appendicitis, and recommendations vary from surgery without delay to surgery within 24 h. Longer in-hospital delay has been thought to increase the risk of perforation and further morbidity. Therefore, we aimed to compare the rate of appendiceal perforation in patients undergoing appendicectomy scheduled to two different urgencies (<8 h vs <24 h).
322. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial.
作者: Zev A Wainberg.;Davide Melisi.;Teresa Macarulla.;Roberto Pazo Cid.;Sreenivasa R Chandana.;Christelle De La Fouchardière.;Andrew Dean.;Igor Kiss.;Woo Jin Lee.;Thorsten O Goetze.;Eric Van Cutsem.;A Scott Paulson.;Tanios Bekaii-Saab.;Shubham Pant.;Richard A Hubner.;Zhimin Xiao.;Huanyu Chen.;Fawzi Benzaghou.;Eileen M O'Reilly.
来源: Lancet. 2023年402卷10409期1272-1281页
Pancreatic ductal adenocarcinoma remains one of the most lethal malignancies, with few treatment options. NAPOLI 3 aimed to compare the efficacy and safety of NALIRIFOX versus nab-paclitaxel and gemcitabine as first-line therapy for metastatic pancreatic ductal adenocarcinoma (mPDAC).
323. Home-based monitoring of ovulation to time frozen embryo transfers in the Netherlands (Antarctica-2): an open-label, nationwide, randomised, non-inferiority trial.
作者: Tjitske Zaat.;Jan-Peter de Bruin.;Mariëtte Goddijn.;Marchien van Baal.;Sofie Benneheij.;Monique Brandes.;Frank Broekmans.;Astrid Cantineau.;Ben Cohlen.;Jeroen van Disseldorp.;Susanne Gielen.;Eva Groenewoud.;Arne van Heusden.;Eugenie Kaaijk.;Carolien Koks.;Corry de Koning.;Nicole Klijn.;Paul van der Linden.;Petra Manger.;Lobke Moolenaar.;Robbert van Oppenraaij.;Quirine Pieterse.;Jesper Smeenk.;Jantien Visser.;Madelon van Wely.;Femke Mol.
来源: Lancet. 2023年402卷10410期1347-1355页
The growing field of assisted reproductive techniques, including frozen-thawed embryo transfer (FET), should lead the way to the best sustainable health care without compromising pregnancy chances. Correct timing of FET is crucial to allow implantation of the thawed embryo. Nowadays, timing based on hospital-controlled monitoring of ovulation in the natural cycle of a woman is the preferred strategy because of the assumption of favourable fertility prospects. However, home-based monitoring is a simple method to prevent patient travel and any associated environmental concerns. We compared ongoing pregnancy rates after home-based monitoring versus hospital-controlled monitoring with ovulation triggering.
324. Expedited transfer to a cardiac arrest centre for non-ST-elevation out-of-hospital cardiac arrest (ARREST): a UK prospective, multicentre, parallel, randomised clinical trial.
作者: Tiffany Patterson.;Gavin D Perkins.;Alexander Perkins.;Tim Clayton.;Richard Evans.;Matthew Dodd.;Steven Robertson.;Karen Wilson.;Adam Mellett-Smith.;Rachael T Fothergill.;Paul McCrone.;Miles Dalby.;Philip MacCarthy.;Sam Firoozi.;Iqbal Malik.;Roby Rakhit.;Ajay Jain.;Jerry P Nolan.;Simon R Redwood.; .
来源: Lancet. 2023年402卷10410期1329-1337页
The International Liaison Committee on Resuscitation has called for a randomised trial of delivery to a cardiac arrest centre. We aimed to assess whether expedited delivery to a cardiac arrest centre compared with current standard of care following resuscitated cardiac arrest reduces deaths.
325. Effect of colchicine on perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery (COP-AF): an international randomised trial.
作者: David Conen.;Michael Ke Wang.;Ekaterine Popova.;Matthew T V Chan.;Giovanni Landoni.;Juan P Cata.;Cara Reimer.;Sean R McLean.;Sadeesh K Srinathan.;Juan Carlos Trujillo Reyes.;Ascension Martín Grande.;Anna Gonzalez Tallada.;Daniel I Sessler.;Edith Fleischmann.;Barbara Kabon.;Luca Voltolini.;Patrícia Cruz.;Donna E Maziak.;Laura Gutiérrez-Soriano.;William F McIntyre.;Vikas Tandon.;Elisabeth Martínez-Téllez.;Juan Jose Guerra-Londono.;Deborah DuMerton.;Randolph H L Wong.;Anna L McGuire.;Biniam Kidane.;Diego Parise Roux.;Yaron Shargall.;Jennifer R Wells.;Sandra N Ofori.;Jessica Vincent.;Lizhen Xu.;Zhuoru Li.;John W Eikelboom.;Sanjit S Jolly.;Jeff S Healey.;P J Devereaux.; .
来源: Lancet. 2023年402卷10413期1627-1635页
Higher levels of inflammatory biomarkers are associated with an increased risk of perioperative atrial fibrillation and myocardial injury after non-cardiac surgery (MINS). Colchicine is an anti-inflammatory drug that might reduce the incidence of these complications.
326. Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial.
作者: Bruce L Wilkoff.;Gerasimos Filippatos.;Christophe Leclercq.;Michael R Gold.;Ahmad S Hersi.;Kengo Kusano.;Wilfried Mullens.;G Michael Felker.;Charan Kantipudi.;Mikhael F El-Chami.;Vidal Essebag.;Bertrand Pierre.;Francois Philippon.;Francisco Perez-Gil.;Eugene S Chung.;Juan Sotomonte.;Stanley Tung.;Balbir Singh.;Babak Bozorgnia.;Satish Goel.;Hans Holger Ebert.;Niraj Varma.;Kara J Quan.;Fiorella Salerno.;Bart Gerritse.;Janelle van Wel.;Daniel E Schaber.;Dedra H Fagan.;David Birnie.; .
来源: Lancet. 2023年402卷10408期1147-1157页
Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block.
327. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial.
作者: Hope S Rugo.;Aditya Bardia.;Frederik Marmé.;Javier Cortés.;Peter Schmid.;Delphine Loirat.;Olivier Trédan.;Eva Ciruelos.;Florence Dalenc.;Patricia Gómez Pardo.;Komal L Jhaveri.;Rosemary Delaney.;Theresa Valdez.;Hao Wang.;Monica Motwani.;Oh Kyu Yoon.;Wendy Verret.;Sara M Tolaney.
来源: Lancet. 2023年402卷10411期1423-1433页
Sacituzumab govitecan demonstrated significant progression-free survival benefit over chemotherapy in the phase 3 TROPiCS-02 trial in patients with pretreated, endocrine-resistant hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ and HER2-) metastatic breast cancer with limited treatment options. Here, we report the protocol-specified final analysis of overall survival and endpoints by trophoblast cell-surface antigen 2 (Trop-2) expression and other variables.
328. Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial.
作者: Raymond Hang Wun Li.;Sue Seen Tsing Lo.;Kristina Gemzell-Danielsson.;Carol Ho Yi Fong.;Pak Chung Ho.;Ernest Hung Yu Ng.
来源: Lancet. 2023年402卷10405期851-858页
Levonorgestrel, a standard drug for emergency contraception (EC), is not effective if administered post-ovulation. A cyclo-oxygenase inhibitor could contribute synergistic effects. We investigated whether a single 40 mg oral dose of piroxicam as co-treatment with levonorgestrel improved emergency contraceptive efficacy.
329. Participation rate and yield of two home-based screening methods to detect increased albuminuria in the general population in the Netherlands (THOMAS): a prospective, randomised, open-label implementation study.
作者: Dominique van Mil.;Lyanne M Kieneker.;Birgitte Evers-Roeten.;Marc H M Thelen.;Hanne de Vries.;Marc H Hemmelder.;Annemiek Dorgelo.;Ronald W van Etten.;Hiddo J L Heerspink.;Ron T Gansevoort.
来源: Lancet. 2023年402卷10407期1052-1064页
Chronic kidney disease (CKD) has a rising global prevalence and is expected to become the fifth leading cause of death by 2030. Increased albuminuria defines the early stages of CKD and is among the strongest risk factors for progressive CKD and cardiovascular disease. The value of population screening for albuminuria to detect CKD in an early phase has yet to be studied. We aimed to evaluate the effectiveness of two home-based albuminuria population screening methods.
330. Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomised phase 3 trial.
作者: Richard Lafayette.;Jens Kristensen.;Andrew Stone.;Jürgen Floege.;Vladimir Tesař.;Hernán Trimarchi.;Hong Zhang.;Necmi Eren.;Alexander Paliege.;Heather N Reich.;Brad H Rovin.;Jonathan Barratt.; .
来源: Lancet. 2023年402卷10405期859-870页
IgA nephropathy is a chronic immune-mediated kidney disease and a major cause of kidney failure worldwide. The gut mucosal immune system is implicated in its pathogenesis, and Nefecon is a novel, oral, targeted-release formulation of budesonide designed to act at the gut mucosal level. We present findings from the 2-year, phase 3 NefIgArd trial of Nefecon in patients with IgA nephropathy.
331. Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.
作者: Simon D Kyle.;A Niroshan Siriwardena.;Colin A Espie.;Yaling Yang.;Stavros Petrou.;Emma Ogburn.;Nargis Begum.;Leonie F Maurer.;Barbara Robinson.;Caroline Gardner.;Victoria Lee.;Stephanie Armstrong.;Julie Pattinson.;Sam Mort.;Eleanor Temple.;Victoria Harris.;Ly-Mee Yu.;Peter Bower.;Paul Aveyard.
来源: Lancet. 2023年402卷10406期975-987页
Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented.
332. Nutritional supplementation to prevent tuberculosis incidence in household contacts of patients with pulmonary tuberculosis in India (RATIONS): a field-based, open-label, cluster-randomised, controlled trial.
作者: Anurag Bhargava.;Madhavi Bhargava.;Ajay Meher.;Andrea Benedetti.;Banurekha Velayutham.;G Sai Teja.;Basilea Watson.;Ganesh Barik.;Rajeev Ranjan Pathak.;Ranjit Prasad.;Rakesh Dayal.;Adarsh Kibballi Madhukeshwar.;Vineet Chadha.;Madhukar Pai.;Rajendra Joshi.;Dick Menzies.;Soumya Swaminathan.
来源: Lancet. 2023年402卷10402期627-640页
In India, tuberculosis and undernutrition are syndemics with a high burden of tuberculosis coexisting with a high burden of undernutrition in patients and in the population. The aim of this study was to determine the effect of nutritional supplementation on tuberculosis incidence in household contacts of adults with microbiologically confirmed pulmonary tuberculosis.
333. Adjuvant everolimus after surgery for renal cell carcinoma (EVEREST): a double-blind, placebo-controlled, randomised, phase 3 trial.
作者: Christopher W Ryan.;Catherine M Tangen.;Elisabeth I Heath.;Mark N Stein.;Maxwell V Meng.;Ajjai S Alva.;Sumanta K Pal.;Igor Puzanov.;Joseph I Clark.;Toni K Choueiri.;Neeraj Agarwal.;Robert G Uzzo.;Naomi B Haas.;Timothy W Synold.;Melissa Plets.;Ulka N Vaishampayan.;Brian M Shuch.;Ian M Thompson.;Primo N Lara.
来源: Lancet. 2023年402卷10407期1043-1051页
Patients undergoing resection of renal cell carcinoma are at risk of disease relapse. We evaluated the effectiveness of the mammalian target of rapamycin inhibitor everolimus administered after surgery.
334. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Patricia Pozo-Rosich.;Jessica Ailani.;Messoud Ashina.;Peter J Goadsby.;Richard B Lipton.;Uwe Reuter.;Hua Guo.;Brittany Schwefel.;Kaifeng Lu.;Ramesh Boinpally.;Rosa Miceli.;Rosa De Abreu Ferreira.;Emily McCusker.;Sung Yun Yu.;Lawrence Severt.;Michelle Finnegan.;Joel M Trugman.
来源: Lancet. 2023年402卷10404期775-785页
In this study, we aimed to evaluate the efficacy, safety, and tolerability of atogepant for the preventive treatment of chronic migraine.
335. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study.
作者: Shukui Qin.;Stephen L Chan.;Shanzhi Gu.;Yuxian Bai.;Zhenggang Ren.;Xiaoyan Lin.;Zhendong Chen.;Weidong Jia.;Yongdong Jin.;Yabing Guo.;Xiaohua Hu.;Zhiqiang Meng.;Jun Liang.;Ying Cheng.;Jianping Xiong.;Hong Ren.;Fang Yang.;Wei Li.;Yajin Chen.;Yong Zeng.;Alexander Sultanbaev.;Monika Pazgan-Simon.;Margaryta Pisetska.;Davide Melisi.;Dmitriy Ponomarenko.;Yurii Osypchuk.;Ivan Sinielnikov.;Tsai-Sheng Yang.;Xiao Liang.;Chunxia Chen.;Linna Wang.;Ann-Lii Cheng.;Ahmed Kaseb.;Arndt Vogel.; .
来源: Lancet. 2023年402卷10408期1133-1146页
Immunotherapy with immune checkpoint inhibitors combined with an anti-angiogenic tyrosine-kinase inhibitor (TKI) has been shown to improve overall survival versus anti-angiogenic therapy alone in advanced solid tumours, but not in hepatocellular carcinoma. Therefore, a clinical study was conducted to compare the efficacy and safety of the anti-PD-1 antibody camrelizumab plus the VEGFR2-targeted TKI rivoceranib (also known as apatinib) versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma.
336. Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial.
作者: Frank R Lin.;James R Pike.;Marilyn S Albert.;Michelle Arnold.;Sheila Burgard.;Theresa Chisolm.;David Couper.;Jennifer A Deal.;Adele M Goman.;Nancy W Glynn.;Theresa Gmelin.;Lisa Gravens-Mueller.;Kathleen M Hayden.;Alison R Huang.;David Knopman.;Christine M Mitchell.;Thomas Mosley.;James S Pankow.;Nicholas S Reed.;Victoria Sanchez.;Jennifer A Schrack.;B Gwen Windham.;Josef Coresh.; .
来源: Lancet. 2023年402卷10404期786-797页
Hearing loss is associated with increased cognitive decline and incident dementia in older adults. We aimed to investigate whether a hearing intervention could reduce cognitive decline in cognitively healthy older adults with hearing loss.
337. Stereotactic ablative radiotherapy with or without immunotherapy for early-stage or isolated lung parenchymal recurrent node-negative non-small-cell lung cancer: an open-label, randomised, phase 2 trial.
作者: Joe Y Chang.;Steven H Lin.;Wenli Dong.;Zhongxing Liao.;Saumil J Gandhi.;Carl M Gay.;Jianjun Zhang.;Stephen G Chun.;Yasir Y Elamin.;Frank V Fossella.;George Blumenschein.;Tina Cascone.;Xiuning Le.;Jenny V Pozadzides.;Anne Tsao.;Vivek Verma.;James W Welsh.;Aileen B Chen.;Mehmet Altan.;Reza J Mehran.;Ara A Vaporciyan.;Stephen G Swisher.;Peter A Balter.;Junya Fujimoto.;Ignacio I Wistuba.;Lei Feng.;J Jack Lee.;John V Heymach.
来源: Lancet. 2023年402卷10405期871-881页
Stereotactic ablative radiotherapy (SABR) is the standard treatment for medically inoperable early-stage non-small-cell lung cancer (NSCLC), but regional or distant relapses, or both, are common. Immunotherapy reduces recurrence and improves survival in people with stage III NSCLC after chemoradiotherapy, but its utility in stage I and II cases is unclear. We therefore conducted a randomised phase 2 trial of SABR alone compared with SABR with immunotherapy (I-SABR) for people with early-stage NSCLC.
338. Adjuvant immunotherapy with nivolumab versus observation in completely resected Merkel cell carcinoma (ADMEC-O): disease-free survival results from a randomised, open-label, phase 2 trial.
作者: Jürgen C Becker.;Selma Ugurel.;Ulrike Leiter.;Friedegund Meier.;Ralf Gutzmer.;Sebastian Haferkamp.;Lisa Zimmer.;Elisabeth Livingstone.;Thomas K Eigentler.;Axel Hauschild.;Felix Kiecker.;Jessica C Hassel.;Peter Mohr.;Michael Fluck.;Ioannis Thomas.;Marlene Garzarolli.;Imke Grimmelmann.;Konstantin Drexler.;Alexandra N Spillner.;Sebastian Eckhardt.;Dirk Schadendorf.; .
来源: Lancet. 2023年402卷10404期798-808页
Merkel cell carcinoma (MCC) is an immunogenic but aggressive skin cancer. Even after complete resection and radiation, relapse rates are high. PD-1 and PD-L1 checkpoint inhibitors showed clinical benefit in advanced MCC. We aimed to assess efficacy and safety of adjuvant immune checkpoint inhibition in completely resected MCC (ie, a setting without an established systemic standard-of-care treatment).
339. Baricitinib in juvenile idiopathic arthritis: an international, phase 3, randomised, double-blind, placebo-controlled, withdrawal, efficacy, and safety trial.
作者: Athimalaipet V Ramanan.;Pierre Quartier.;Nami Okamoto.;Ivan Foeldvari.;Alberto Spindler.;Šárka Fingerhutová.;Jordi Antón.;Zhongkai Wang.;Gabriella Meszaros.;Joana Araújo.;Ran Liao.;Stuart Keller.;Hermine I Brunner.;Nicolino Ruperto.; .; .
来源: Lancet. 2023年402卷10401期555-570页
Juvenile idiopathic arthritis can be refractory to some or all treatment regimens, therefore new medications are needed to treat this population. This trial assessed the efficacy and safety of baricitinib, an oral Janus kinase 1/2-selective inhibitor, versus placebo in patients with juvenile idiopathic arthritis.
340. First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study.
作者: Siow Ming Lee.;Christian Schulz.;Kumar Prabhash.;Dariusz Kowalski.;Aleksandra Szczesna.;Baohui Han.;Achim Rittmeyer.;Toby Talbot.;David Vicente.;Raffaele Califano.;Diego Cortinovis.;Anh Tuan Le.;Dingzhi Huang.;Geoffrey Liu.;Federico Cappuzzo.;Jessica Reyes Contreras.;Martin Reck.;Ramon Palmero.;Milena Perez Mak.;Youyou Hu.;Stefanie Morris.;Elen Höglander.;Mary Connors.;Alice M Biggane.;Hans Kristian Vollan.;Solange Peters.
来源: Lancet. 2023年402卷10400期451-463页
Despite immunotherapy advancements for patients with advanced or metastatic non-small-cell lung cancer (NSCLC), pivotal first-line trials were limited to patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 and a median age of 65 years or younger. We aimed to compare the efficacy and safety of first-line atezolizumab monotherapy with single-agent chemotherapy in patients ineligible for platinum-based chemotherapy.
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