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421. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial.
作者: Alexandre Mebazaa.;Beth Davison.;Ovidiu Chioncel.;Alain Cohen-Solal.;Rafael Diaz.;Gerasimos Filippatos.;Marco Metra.;Piotr Ponikowski.;Karen Sliwa.;Adriaan A Voors.;Christopher Edwards.;Maria Novosadova.;Koji Takagi.;Albertino Damasceno.;Hadiza Saidu.;Etienne Gayat.;Peter S Pang.;Jelena Celutkiene.;Gad Cotter.
来源: Lancet. 2022年400卷10367期1938-1952页
There is a paucity of evidence for dose and pace of up-titration of guideline-directed medical therapies after admission to hospital for acute heart failure.
422. LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial.
作者: Shweta Urva.;Tamer Coskun.;Mei Teng Loh.;Yu Du.;Melissa K Thomas.;Sirel Gurbuz.;Axel Haupt.;Charles T Benson.;Martha Hernandez-Illas.;David A D'Alessio.;Zvonko Milicevic.
来源: Lancet. 2022年400卷10366期1869-1881页
Treating hyperglycaemia and obesity in individuals with type 2 diabetes using multi-receptor agonists can improve short-term and long-term outcomes. LY3437943 is a single peptide with agonist activity for glucagon, glucose-dependent insulinotropic polypeptide (GIP), and glucagon-like peptide 1 (GLP-1) receptors that is currently in development for the treatment of type 2 diabetes and for the treatment of obesity and associated comorbidities. We investigated the safety, pharmacokinetics, and pharmacodynamics of multiple weekly doses of LY3437943 in people with type 2 diabetes in a 12-week study.
423. Intermediate-dose versus low-dose low-molecular-weight heparin in pregnant and post-partum women with a history of venous thromboembolism (Highlow study): an open-label, multicentre, randomised, controlled trial.
作者: Ingrid M Bistervels.;Andrea Buchmüller.;Hanke M G Wiegers.;Fionnuala Ní Áinle.;Bernard Tardy.;Jennifer Donnelly.;Peter Verhamme.;Anne F Jacobsen.;Anette T Hansen.;Marc A Rodger.;Maria T DeSancho.;Roman G Shmakov.;Nick van Es.;Martin H Prins.;Céline Chauleur.;Saskia Middeldorp.; .; .
来源: Lancet. 2022年400卷10365期1777-1787页
Pregnancy-related venous thromboembolism is a leading cause of maternal morbidity and mortality, and thromboprophylaxis is indicated in pregnant and post-partum women with a history of venous thromboembolism. The optimal dose of low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy and the post-partum period is uncertain.
424. Bivalirudin plus a high-dose infusion versus heparin monotherapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomised trial.
作者: Yi Li.;Zhenyang Liang.;Lei Qin.;Mian Wang.;Xianzhao Wang.;Huanyi Zhang.;Yin Liu.;Yan Li.;Zhisheng Jia.;Limin Liu.;Hongyan Zhang.;Jun Luo.;Songwu Dong.;Jincheng Guo.;Hengqing Zhu.;Shengli Li.;Haijun Zheng.;Lijun Liu.;Yanqing Wu.;Yiming Zhong.;Miaohan Qiu.;Yaling Han.;Gregg W Stone.
来源: Lancet. 2022年400卷10366期1847-1857页
Previous randomised trials of bivalirudin versus heparin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) have reported conflicting results, in part because of treatment with different pharmacological regimens. We designed a large-scale trial examining bivalirudin with a post-PCI high-dose infusion compared with heparin alone, the regimens that previous studies have shown to have the best balance of safety and efficacy.
425. Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial.
作者: Paul R Kalra.;John G F Cleland.;Mark C Petrie.;Elizabeth A Thomson.;Philip A Kalra.;Iain B Squire.;Fozia Z Ahmed.;Abdallah Al-Mohammad.;Peter J Cowburn.;Paul W X Foley.;Fraser J Graham.;Alan G Japp.;Rebecca E Lane.;Ninian N Lang.;Andrew J Ludman.;Iain C Macdougall.;Pierpaolo Pellicori.;Robin Ray.;Michele Robertson.;Alison Seed.;Ian Ford.; .
来源: Lancet. 2022年400卷10369期2199-2209页
For patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric carboxymaltose administration improves quality of life and exercise capacity in the short-term and reduces hospital admissions for heart failure up to 1 year. We aimed to evaluate the longer-term effects of intravenous ferric derisomaltose on cardiovascular events in patients with heart failure.
426. Personalised cooler dialysate for patients receiving maintenance haemodialysis (MyTEMP): a pragmatic, cluster-randomised trial.
Haemodialysis centres have conventionally provided maintenance haemodialysis using a standard dialysate temperature (eg, 36·5°C) for all patients. Many centres now use cooler dialysate (eg, 36·0°C or lower) for potential cardiovascular benefits. We aimed to assess whether personalised cooler dialysate, implemented as centre-wide policy, reduced the risk of cardiovascular-related death or hospital admission compared with standard temperature dialysate.
427. Intensive blood pressure control after endovascular thrombectomy for acute ischaemic stroke (ENCHANTED2/MT): a multicentre, open-label, blinded-endpoint, randomised controlled trial.
作者: Pengfei Yang.;Lili Song.;Yongwei Zhang.;Xiaoxi Zhang.;Xiaoying Chen.;Yunke Li.;Lingli Sun.;Yingfeng Wan.;Laurent Billot.;Qiang Li.;Xinwen Ren.;Hongjian Shen.;Lei Zhang.;Zifu Li.;Pengfei Xing.;Yongxin Zhang.;Ping Zhang.;Weilong Hua.;Fang Shen.;Yihan Zhou.;Bing Tian.;Wenhuo Chen.;Hongxing Han.;Liyong Zhang.;Chenghua Xu.;Tong Li.;Ya Peng.;Xincan Yue.;Shengli Chen.;Changming Wen.;Shu Wan.;Congguo Yin.;Ming Wei.;Hansheng Shu.;Guangxian Nan.;Sheng Liu.;Wenhua Liu.;Yiling Cai.;Yi Sui.;Maohua Chen.;Yu Zhou.;Qiao Zuo.;Dongwei Dai.;Rui Zhao.;Qiang Li.;Qinghai Huang.;Yi Xu.;Benqiang Deng.;Tao Wu.;Jianping Lu.;Xia Wang.;Mark W Parsons.;Ken Butcher.;Bruce Campbell.;Thompson G Robinson.;Mayank Goyal.;Diederik Dippel.;Yvo Roos.;Charles Majoie.;Longde Wang.;Yongjun Wang.;Jianmin Liu.;Craig S Anderson.; .
来源: Lancet. 2022年400卷10363期1585-1596页
The optimum systolic blood pressure after endovascular thrombectomy for acute ischaemic stroke is uncertain. We aimed to compare the safety and efficacy of blood pressure lowering treatment according to more intensive versus less intensive treatment targets in patients with elevated blood pressure after reperfusion with endovascular treatment.
428. Helicobacter pylori eradication for primary prevention of peptic ulcer bleeding in older patients prescribed aspirin in primary care (HEAT): a randomised, double-blind, placebo-controlled trial.
作者: Chris Hawkey.;Anthony Avery.;Carol A C Coupland.;Colin Crooks.;Jennifer Dumbleton.;F D Richard Hobbs.;Denise Kendrick.;Michael Moore.;Clive Morris.;Gregory Rubin.;Murray Smith.;Diane Stevenson.; .
来源: Lancet. 2022年400卷10363期1597-1606页
Peptic ulcers in patients receiving aspirin are associated with Helicobacter pylori infection. We aimed to investigate whether H pylori eradication would protect against aspirin-associated ulcer bleeding.
429. Routine sterile glove and instrument change at the time of abdominal wound closure to prevent surgical site infection (ChEETAh): a pragmatic, cluster-randomised trial in seven low-income and middle-income countries.
Surgical site infection (SSI) remains the most common complication of surgery around the world. WHO does not make recommendations for changing gloves and instruments before wound closure owing to a lack of evidence. This study aimed to test whether a routine change of gloves and instruments before wound closure reduced abdominal SSI.
430. Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial.
作者: Victoria Hodgetts Morton.;Philip Toozs-Hobson.;Catherine A Moakes.;Lee Middleton.;Jane Daniels.;Nigel A B Simpson.;Andrew Shennan.;Fidan Israfil-Bayli.;Andrew K Ewer.;Jim Gray.;Mark Slack.;Jane E Norman.;Christoph Lees.;Konstantinos Tryposkiadis.;Max Hughes.;Peter Brocklehurst.;R Katie Morris.
来源: Lancet. 2022年400卷10361期1426-1436页
Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage.
431. Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial.
Chlorhexidine skin antisepsis is frequently recommended for most surgical procedures; however, it is unclear if these recommendations should apply to surgery involving traumatic contaminated wounds where povidone-iodine has previously been preferred. We aimed to compare the effect of aqueous 10% povidone-iodine versus aqueous 4% chlorhexidine gluconate on the risk of surgical site infection in patients who required surgery for an open fracture.
432. Comparing dedicated and designated approaches to integrating task-shared psychological interventions into chronic disease care in South Africa: a three-arm, cluster randomised, multicentre, open-label trial.
作者: Bronwyn Myers.;Carl J Lombard.;Crick Lund.;John A Joska.;Naomi Levitt.;Tracey Naledi.;Petal Petersen Williams.;Claire van der Westhuizen.;Pim Cuijpers.;Dan J Stein.;Katherine R Sorsdahl.
来源: Lancet. 2022年400卷10360期1321-1333页
Community health workers (CHWs) are increasingly providing task-shared psychological interventions for depression and alcohol use in primary health care in low-income and middle-income countries. We aimed to compare the effectiveness of CHWs dedicated to deliver care with CHWs designated to deliver care over and above their existing responsibilities and with treatment as usual for patients with a chronic physical disease.
433. Cardiovascular outcomes in adults with hypertension with evening versus morning dosing of usual antihypertensives in the UK (TIME study): a prospective, randomised, open-label, blinded-endpoint clinical trial.
作者: Isla S Mackenzie.;Amy Rogers.;Neil R Poulter.;Bryan Williams.;Morris J Brown.;David J Webb.;Ian Ford.;David A Rorie.;Greg Guthrie.;J W Kerr Grieve.;Filippo Pigazzani.;Peter M Rothwell.;Robin Young.;Alex McConnachie.;Allan D Struthers.;Chim C Lang.;Thomas M MacDonald.; .
来源: Lancet. 2022年400卷10361期1417-1425页
Studies have suggested that evening dosing with antihypertensive therapy might have better outcomes than morning dosing. The Treatment in Morning versus Evening (TIME) study aimed to investigate whether evening dosing of usual antihypertensive medication improves major cardiovascular outcomes compared with morning dosing in patients with hypertension.
434. Allopurinol versus usual care in UK patients with ischaemic heart disease (ALL-HEART): a multicentre, prospective, randomised, open-label, blinded-endpoint trial.
作者: Isla S Mackenzie.;Christopher J Hawkey.;Ian Ford.;Nicola Greenlaw.;Filippo Pigazzani.;Amy Rogers.;Allan D Struthers.;Alan G Begg.;Li Wei.;Anthony J Avery.;Jaspal S Taggar.;Andrew Walker.;Suzanne L Duce.;Rebecca J Barr.;Jennifer S Dumbleton.;Evelien D Rooke.;Jonathan N Townend.;Lewis D Ritchie.;Thomas M MacDonald.; .
来源: Lancet. 2022年400卷10359期1195-1205页
Allopurinol is a urate-lowering therapy used to treat patients with gout. Previous studies have shown that allopurinol has positive effects on several cardiovascular parameters. The ALL-HEART study aimed to determine whether allopurinol therapy improves major cardiovascular outcomes in patients with ischaemic heart disease.
435. Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial.
作者: Deepak L Bhatt.;Muthiah Vaduganathan.;David E Kandzari.;Martin B Leon.;Krishna Rocha-Singh.;Raymond R Townsend.;Barry T Katzen.;Suzanne Oparil.;Sandeep Brar.;Vanessa DeBruin.;Martin Fahy.;George L Bakris.; .
来源: Lancet. 2022年400卷10361期1405-1416页
The SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial showed the safety but not efficacy of the Symplicity system (Medtronic, Santa Rosa, CA, USA) at 6 months follow-up in patients with treatment-resistant hypertension. This final report presents the 36-month follow-up results.
436. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Amy S Paller.;Eric L Simpson.;Elaine C Siegfried.;Michael J Cork.;Andreas Wollenberg.;Peter D Arkwright.;Weily Soong.;Mercedes E Gonzalez.;Lynda C Schneider.;Robert Sidbury.;Benjamin Lockshin.;Steven Meltzer.;Zhixiao Wang.;Leda P Mannent.;Nikhil Amin.;Yiping Sun.;Elizabeth Laws.;Bolanle Akinlade.;Myles Dillon.;Matthew P Kosloski.;Mohamed A Kamal.;Ariane Dubost-Brama.;Naimish Patel.;David M Weinreich.;George D Yancopoulos.;John T O'Malley.;Ashish Bansal.; .
来源: Lancet. 2022年400卷10356期908-919页
Current systemic treatments for children younger than 6 years with moderate-to-severe atopic dermatitis that is uncontrolled with topical therapies might have suboptimal efficacy and safety. Dupilumab is approved for older children and adults with atopic dermatitis and for other type 2 inflammatory conditions. We aimed to evaluate efficacy and safety of dupilumab with concomitant low-potency topical corticosteroids in children aged 6 months to younger than 6 years with moderate-to-severe atopic dermatitis.
437. Linzagolix with and without hormonal add-back therapy for the treatment of symptomatic uterine fibroids: two randomised, placebo-controlled, phase 3 trials.
作者: Jacques Donnez.;Hugh S Taylor.;Elizabeth A Stewart.;Linda Bradley.;Erica Marsh.;David Archer.;Ayman Al-Hendy.;Felice Petraglia.;Nelson Watts.;Jean-Pierre Gotteland.;Elke Bestel.;Paul Terrill.;Ernest Loumaye.;Andrew Humberstone.;Elizabeth Garner.
来源: Lancet. 2022年400卷10356期896-907页
Uterine fibroids are common non-cancerous neoplasm that cause heavy menstrual bleeding and other signs. Linzagolix is an oral gonadotropin-releasing hormone receptor antagonist taken once per day that dose-dependently suppresses gonadal steroids and might reduce uterine-fibroid-associated signs. Two phase 3 trials were conducted to confirm the efficacy and safety of linzagolix at full-suppression (200 mg) and partial-suppression (100 mg) doses with or without hormonal add-back therapy (1 mg oestradiol and 0·5 mg norethisterone acetate) compared with placebo for the treatment of symptomatic uterine fibroids.
438. Combined nivolumab and ipilimumab with or without stereotactic body radiation therapy for advanced Merkel cell carcinoma: a randomised, open label, phase 2 trial.
作者: Sungjune Kim.;Evan Wuthrick.;Dukagjin Blakaj.;Zeynep Eroglu.;Claire Verschraegen.;Ram Thapa.;Matthew Mills.;Khaled Dibs.;Casey Liveringhouse.;Jeffery Russell.;Jimmy J Caudell.;Ahmad Tarhini.;Joseph Markowitz.;Kari Kendra.;Richard Wu.;Dung-Tsa Chen.;Anders Berglund.;Lauren Michael.;Mia Aoki.;Min-Hsuan Wang.;Imene Hamaidi.;Pingyan Cheng.;Janis de la Iglesia.;Robbert J Slebos.;Christine H Chung.;Todd C Knepper.;Carlos M Moran-Segura.;Jonathan V Nguyen.;Bradford A Perez.;Trevor Rose.;Louis Harrison.;Jane L Messina.;Vernon K Sondak.;Kenneth Y Tsai.;Nikhil I Khushalani.;Andrew S Brohl.
来源: Lancet. 2022年400卷10357期1008-1019页
Merkel cell carcinoma is among the most aggressive and lethal of primary skin cancers, with a high rate of distant metastasis. Anti-programmed death receptor 1 (anti-PD-1) and programmed death ligand 1 (PD-L1) monotherapy is currently standard of care for unresectable, recurrent, or metastatic Merkel cell carcinoma. We assessed treatment with combined nivolumab plus ipilimumab, with or without stereotactic body radiotherapy (SBRT) in patients with advanced Merkel cell carcinoma as a first-line therapy or following previous treatment with anti-PD-1 and PD-L1 monotherapy.
439. Adjuvant nivolumab plus ipilimumab or nivolumab alone versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): final results of a randomised, double-blind, phase 2 trial.
作者: Elisabeth Livingstone.;Lisa Zimmer.;Jessica C Hassel.;Michael Fluck.;Thomas K Eigentler.;Carmen Loquai.;Sebastian Haferkamp.;Ralf Gutzmer.;Friedegund Meier.;Peter Mohr.;Axel Hauschild.;Bastian Schilling.;Christian Menzer.;Felix Kiecker.;Edgar Dippel.;Alexander Roesch.;Mirjana Ziemer.;Beate Conrad.;Silvia Körner.;Christine Windemuth-Kieselbach.;Leonora Schwarz.;Claus Garbe.;Jürgen C Becker.;Dirk Schadendorf.; .
来源: Lancet. 2022年400卷10358期1117-1129页
The IMMUNED trial previously showed significant improvements in recurrence-free survival for adjuvant nivolumab plus ipilimumab as well as for adjuvant nivolumab alone in patients with stage IV melanoma with no evidence of disease after resection or radiotherapy. Here, we report the final analysis, including overall survival data.
440. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial.
作者: Sumanta Kumar Pal.;Robert Uzzo.;Jose Antonio Karam.;Viraj A Master.;Frede Donskov.;Cristina Suarez.;Laurence Albiges.;Brian Rini.;Yoshihiko Tomita.;Ariel Galapo Kann.;Giuseppe Procopio.;Francesco Massari.;Matthew Zibelman.;Igor Antonyan.;Mahrukh Huseni.;Debasmita Basu.;Bo Ci.;William Leung.;Omara Khan.;Sarita Dubey.;Axel Bex.
来源: Lancet. 2022年400卷10358期1103-1116页
The standard of care for locoregional renal cell carcinoma is surgery, but many patients experience recurrence. The objective of the current study was to determine if adjuvant atezolizumab (vs placebo) delayed recurrence in patients with an increased risk of recurrence after resection.
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