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1. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial.
作者: Brian G M Durie.;Antje Hoering.;Muneer H Abidi.;S Vincent Rajkumar.;Joshua Epstein.;Stephen P Kahanic.;Mohan Thakuri.;Frederic Reu.;Christopher M Reynolds.;Rachael Sexton.;Robert Z Orlowski.;Bart Barlogie.;Angela Dispenzieri.
来源: Lancet. 2017年389卷10068期519-527页
Lenalidomide plus dexamethasone is a reference treatment for patients with newly diagnosed myeloma. The combination of the proteasome inhibitor bortezomib with lenalidomide and dexamethasone has shown significant efficacy in the setting of newly diagnosed myeloma. We aimed to study whether the addition of bortezomib to lenalidomide and dexamethasone would improve progression-free survival and provide better response rates in patients with previously untreated multiple myeloma who were not planned for immediate autologous stem-cell transplant.
2. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!).
作者: Ana Maria Henao-Restrepo.;Anton Camacho.;Ira M Longini.;Conall H Watson.;W John Edmunds.;Matthias Egger.;Miles W Carroll.;Natalie E Dean.;Ibrahima Diatta.;Moussa Doumbia.;Bertrand Draguez.;Sophie Duraffour.;Godwin Enwere.;Rebecca Grais.;Stephan Gunther.;Pierre-Stéphane Gsell.;Stefanie Hossmann.;Sara Viksmoen Watle.;Mandy Kader Kondé.;Sakoba Kéïta.;Souleymane Kone.;Eewa Kuisma.;Myron M Levine.;Sema Mandal.;Thomas Mauget.;Gunnstein Norheim.;Ximena Riveros.;Aboubacar Soumah.;Sven Trelle.;Andrea S Vicari.;John-Arne Røttingen.;Marie-Paule Kieny.
来源: Lancet. 2017年389卷10068期505-518页
rVSV-ZEBOV is a recombinant, replication competent vesicular stomatitis virus-based candidate vaccine expressing a surface glycoprotein of Zaire Ebolavirus. We tested the effect of rVSV-ZEBOV in preventing Ebola virus disease in contacts and contacts of contacts of recently confirmed cases in Guinea, west Africa.
3. Safety and immunogenicity of a recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in Sierra Leone: a single-centre, randomised, double-blind, placebo-controlled, phase 2 trial.
作者: Feng-Cai Zhu.;Alie H Wurie.;Li-Hua Hou.;Qi Liang.;Yu-Hua Li.;James B W Russell.;Shi-Po Wu.;Jing-Xin Li.;Yue-Mei Hu.;Qiang Guo.;Wen-Bo Xu.;Abdul R Wurie.;Wen-Juan Wang.;Zhe Zhang.;Wen-Jiao Yin.;Manal Ghazzawi.;Xu Zhang.;Lei Duan.;Jun-Zhi Wang.;Wei Chen.
来源: Lancet. 2017年389卷10069期621-628页
A recombinant adenovirus type-5 vector-based vaccine expressing the glycoprotein of Ebola Zaire Makona variant showed good safety and immunogenicity in a phase 1 trial of healthy Chinese adults. We aimed to assess the safety and immunogenicity of this vaccine in healthy adults in Sierra Leone and to determine the optimal dose.
4. An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Richard B Warren.;Ulrich Mrowietz.;Ralph von Kiedrowski.;Johannes Niesmann.;Dagmar Wilsmann-Theis.;Kamran Ghoreschi.;Ina Zschocke.;Thomas M Falk.;Norbert Blödorn-Schlicht.;Kristian Reich.
来源: Lancet. 2017年389卷10068期528-537页
Methotrexate is one of the most commonly used systemic drugs for the treatment of moderate to severe psoriasis; however, high-quality evidence for its use is sparse and limited to use of oral dosing. We aimed to assess the effect of an intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis.
5. Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial.
作者: Suzanne Hagen.;Cathryn Glazener.;Doreen McClurg.;Christine Macarthur.;Andrew Elders.;Peter Herbison.;Don Wilson.;Philip Toozs-Hobson.;Christine Hemming.;Jean Hay-Smith.;Marissa Collins.;Sylvia Dickson.;Janet Logan.
来源: Lancet. 2017年389卷10067期393-402页
Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment.
6. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT).
作者: Cathryn Ma Glazener.;Suzanne Breeman.;Andrew Elders.;Christine Hemming.;Kevin G Cooper.;Robert M Freeman.;Anthony Rb Smith.;Fiona Reid.;Suzanne Hagen.;Isobel Montgomery.;Mary Kilonzo.;Dwayne Boyers.;Alison McDonald.;Gladys McPherson.;Graeme MacLennan.;John Norrie.; .
来源: Lancet. 2017年389卷10067期381-392页
The use of transvaginal mesh and biological graft material in prolapse surgery is controversial and has led to a number of enquiries into their safety and efficacy. Existing trials of these augmentations are individually too small to be conclusive. We aimed to compare the outcomes of prolapse repair involving either synthetic mesh inlays or biological grafts against standard repair in women.
7. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial.
作者: Firas H El-Khatib.;Courtney Balliro.;Mallory A Hillard.;Kendra L Magyar.;Laya Ekhlaspour.;Manasi Sinha.;Debbie Mondesir.;Aryan Esmaeili.;Celia Hartigan.;Michael J Thompson.;Samir Malkani.;J Paul Lock.;David M Harlan.;Paula Clinton.;Eliana Frank.;Darrell M Wilson.;Daniel DeSalvo.;Lisa Norlander.;Trang Ly.;Bruce A Buckingham.;Jamie Diner.;Milana Dezube.;Laura A Young.;April Goley.;M Sue Kirkman.;John B Buse.;Hui Zheng.;Rajendranath R Selagamsetty.;Edward R Damiano.;Steven J Russell.
来源: Lancet. 2017年389卷10067期369-380页
The safety and effectiveness of a continuous, day-and-night automated glycaemic control system using insulin and glucagon has not been shown in a free-living, home-use setting. We aimed to assess whether bihormonal bionic pancreas initialised only with body mass can safely reduce mean glycaemia and hypoglycaemia in adults with type 1 diabetes who were living at home and participating in their normal daily routines without restrictions on diet or physical activity.
8. Counselling for Alcohol Problems (CAP), a lay counsellor-delivered brief psychological treatment for harmful drinking in men, in primary care in India: a randomised controlled trial.
作者: Abhijit Nadkarni.;Benedict Weobong.;Helen A Weiss.;Jim McCambridge.;Bhargav Bhat.;Basavaraj Katti.;Pratima Murthy.;Michael King.;David McDaid.;A-La Park.;G Terence Wilson.;Betty Kirkwood.;Christopher G Fairburn.;Richard Velleman.;Vikram Patel.
来源: Lancet. 2017年389卷10065期186-195页
Although structured psychological treatments are recommended as first-line interventions for harmful drinking, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of Counselling for Alcohol Problems (CAP), a brief psychological treatment delivered by lay counsellors to patients with harmful drinking attending routine primary health-care settings.
9. The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial.
作者: Vikram Patel.;Benedict Weobong.;Helen A Weiss.;Arpita Anand.;Bhargav Bhat.;Basavraj Katti.;Sona Dimidjian.;Ricardo Araya.;Steve D Hollon.;Michael King.;Lakshmi Vijayakumar.;A-La Park.;David McDaid.;Terry Wilson.;Richard Velleman.;Betty R Kirkwood.;Christopher G Fairburn.
来源: Lancet. 2017年389卷10065期176-185页
Although structured psychological treatments are recommended as first-line interventions for depression, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of a brief psychological treatment (Healthy Activity Program [HAP]) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care settings.
10. Clinical remission in patients with moderate-to-severe Crohn's disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial.
作者: Séverine Vermeire.;Stefan Schreiber.;Robert Petryka.;Tanja Kuehbacher.;Xavier Hebuterne.;Xavier Roblin.;Maria Klopocka.;Adrian Goldis.;Maria Wisniewska-Jarosinska.;Andrey Baranovsky.;Robert Sike.;Kremena Stoyanova.;Chantal Tasset.;Annegret Van der Aa.;Pille Harrison.
来源: Lancet. 2017年389卷10066期266-275页
Filgotinib (GLPG0634, GS-6034) is a once-daily, orally administered, Janus kinase 1 (JAK1)-selective inhibitor. The FITZROY study examined the efficacy and safety of filgotinib for the treatment of moderate-to-severe Crohn's disease.
11. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial.
作者: Achim Rittmeyer.;Fabrice Barlesi.;Daniel Waterkamp.;Keunchil Park.;Fortunato Ciardiello.;Joachim von Pawel.;Shirish M Gadgeel.;Toyoaki Hida.;Dariusz M Kowalski.;Manuel Cobo Dols.;Diego L Cortinovis.;Joseph Leach.;Jonathan Polikoff.;Carlos Barrios.;Fairooz Kabbinavar.;Osvaldo Arén Frontera.;Filippo De Marinis.;Hande Turna.;Jong-Seok Lee.;Marcus Ballinger.;Marcin Kowanetz.;Pei He.;Daniel S Chen.;Alan Sandler.;David R Gandara.; .
来源: Lancet. 2017年389卷10066期255-265页
Atezolizumab is a humanised antiprogrammed death-ligand 1 (PD-L1) monoclonal antibody that inhibits PD-L1 and programmed death-1 (PD-1) and PD-L1 and B7-1 interactions, reinvigorating anticancer immunity. We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer.
12. A cleaner burning biomass-fuelled cookstove intervention to prevent pneumonia in children under 5 years old in rural Malawi (the Cooking and Pneumonia Study): a cluster randomised controlled trial.
作者: Kevin Mortimer.;Chifundo B Ndamala.;Andrew W Naunje.;Jullita Malava.;Cynthia Katundu.;William Weston.;Deborah Havens.;Daniel Pope.;Nigel G Bruce.;Moffat Nyirenda.;Duolao Wang.;Amelia Crampin.;Jonathan Grigg.;John Balmes.;Stephen B Gordon.
来源: Lancet. 2017年389卷10065期167-175页
WHO estimates exposure to air pollution from cooking with solid fuels is associated with over 4 million premature deaths worldwide every year including half a million children under the age of 5 years from pneumonia. We hypothesised that replacing open fires with cleaner burning biomass-fuelled cookstoves would reduce pneumonia incidence in young children.
13. Two-step egg introduction for prevention of egg allergy in high-risk infants with eczema (PETIT): a randomised, double-blind, placebo-controlled trial.
作者: Osamu Natsume.;Shigenori Kabashima.;Junko Nakazato.;Kiwako Yamamoto-Hanada.;Masami Narita.;Mai Kondo.;Mayako Saito.;Ai Kishino.;Tetsuya Takimoto.;Eisuke Inoue.;Julian Tang.;Hiroshi Kido.;Gary W K Wong.;Kenji Matsumoto.;Hirohisa Saito.;Yukihiro Ohya.; .
来源: Lancet. 2017年389卷10066期276-286页
Evidence is accumulating that early consumption is more beneficial than is delayed introduction as a strategy for primary prevention of food allergy. However, allergic reactions caused by early introduction of such solid foods have been a problematic issue. We investigated whether or not early stepwise introduction of eggs to infants with eczema combined with optimal eczema treatment would prevent egg allergy at 1 year of age.
14. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Jordi Bruix.;Shukui Qin.;Philippe Merle.;Alessandro Granito.;Yi-Hsiang Huang.;György Bodoky.;Marc Pracht.;Osamu Yokosuka.;Olivier Rosmorduc.;Valeriy Breder.;René Gerolami.;Gianluca Masi.;Paul J Ross.;Tianqiang Song.;Jean-Pierre Bronowicki.;Isabelle Ollivier-Hourmand.;Masatoshi Kudo.;Ann-Lii Cheng.;Josep M Llovet.;Richard S Finn.;Marie-Aude LeBerre.;Annette Baumhauer.;Gerold Meinhardt.;Guohong Han.; .
来源: Lancet. 2017年389卷10064期56-66页
There are no systemic treatments for patients with hepatocellular carcinoma (HCC) whose disease progresses during sorafenib treatment. We aimed to assess the efficacy and safety of regorafenib in patients with HCC who have progressed during sorafenib treatment.
15. Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): a phase 2, pharmacokinetic, randomised, placebo-controlled trial.
作者: John R Teerlink.;G Michael Felker.;John J V McMurray.;Scott D Solomon.;Kirkwood F Adams.;John G F Cleland.;Justin A Ezekowitz.;Assen Goudev.;Peter Macdonald.;Marco Metra.;Veselin Mitrovic.;Piotr Ponikowski.;Pranas Serpytis.;Jindrich Spinar.;János Tomcsányi.;Hans J Vandekerckhove.;Adriaan A Voors.;Maria Laura Monsalvo.;James Johnston.;Fady I Malik.;Narimon Honarpour.; .
来源: Lancet. 2016年388卷10062期2895-2903页
Impaired contractility is a feature of heart failure with reduced ejection fraction. We assessed the pharmacokinetics and effects on cardiac function and structure of the cardiac myosin activator, omecamtiv mecarbil.
16. Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study.
作者: Helen K Reddel.;William W Busse.;Søren Pedersen.;Wan C Tan.;Yu-Zhi Chen.;Carin Jorup.;Dan Lythgoe.;Paul M O'Byrne.
来源: Lancet. 2017年389卷10065期157-166页
Low-dose inhaled corticosteroids (ICS) are highly effective for reducing asthma exacerbations and mortality. Conventionally, ICS treatment is recommended for patients with symptoms on more than 2 days per week, but this criterion has scant evidence. We aimed to assess the validity of the previous symptom-based cutoff for starting ICS by establishing whether there was a differential response to budesonide versus placebo for severe asthma exacerbations, lung function, and asthma symptom control across subgroups identified by baseline asthma symptom frequency.
17. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial.
作者: John F R Robertson.;Igor M Bondarenko.;Ekaterina Trishkina.;Mikhail Dvorkin.;Lawrence Panasci.;Alexey Manikhas.;Yaroslav Shparyk.;Servando Cardona-Huerta.;Kwok-Leung Cheung.;Manuel Jesus Philco-Salas.;Manuel Ruiz-Borrego.;Zhimin Shao.;Shinzaburo Noguchi.;Jacqui Rowbottom.;Mary Stuart.;Lynda M Grinsted.;Mehdi Fazal.;Matthew J Ellis.
来源: Lancet. 2016年388卷10063期2997-3005页
Aromatase inhibitors are a standard of care for hormone receptor-positive locally advanced or metastatic breast cancer. We investigated whether the selective oestrogen receptor degrader fulvestrant could improve progression-free survival compared with anastrozole in postmenopausal patients who had not received previous endocrine therapy.
18. Rabbit-ATG or basiliximab induction for rapid steroid withdrawal after renal transplantation (Harmony): an open-label, multicentre, randomised controlled trial.
作者: Oliver Thomusch.;Michael Wiesener.;Mirian Opgenoorth.;Andreas Pascher.;Rainer Peter Woitas.;Oliver Witzke.;Bernd Jaenigen.;Markus Rentsch.;Heiner Wolters.;Thomas Rath.;Tülay Cingöz.;Urs Benck.;Bernhard Banas.;Christian Hugo.
来源: Lancet. 2016年388卷10063期3006-3016页
Standard practice for immunosuppressive therapy after renal transplantation is quadruple therapy using antibody induction, low-dose tacrolimus, mycophenolate mofetil, and corticosteroids. Long-term steroid intake significantly increases cardiovascular risk factors with negative effects on the outcome, especially post-transplantation diabetes associated with morbidity and mortality. In this trial, we examined the efficacy and safety parameters of rapid steroid withdrawal after induction therapy with either rabbit antithymocyte globulin (rabbit ATG) or basiliximab in immunologically low-risk patients during the first year after kidney transplantation.
19. Intratympanic methylprednisolone versus gentamicin in patients with unilateral Ménière's disease: a randomised, double-blind, comparative effectiveness trial.
作者: Mitesh Patel.;Kiran Agarwal.;Qadeer Arshad.;Mohamed Hariri.;Peter Rea.;Barry M Seemungal.;John F Golding.;Jonny P Harcourt.;Adolfo M Bronstein.
来源: Lancet. 2016年388卷10061期2753-2762页
Ménière's disease is characterised by severe vertigo attacks and hearing loss. Intratympanic gentamicin, the standard treatment for refractory Ménière's disease, reduces vertigo, but damages vestibular function and can worsen hearing. We aimed to assess whether intratympanic administration of the corticosteroid methylprednisolone reduces vertigo compared with gentamicin.
20. Efficacy and safety of tau-aggregation inhibitor therapy in patients with mild or moderate Alzheimer's disease: a randomised, controlled, double-blind, parallel-arm, phase 3 trial.
作者: Serge Gauthier.;Howard H Feldman.;Lon S Schneider.;Gordon K Wilcock.;Giovanni B Frisoni.;Jiri H Hardlund.;Hans J Moebius.;Peter Bentham.;Karin A Kook.;Damon J Wischik.;Bjoern O Schelter.;Charles S Davis.;Roger T Staff.;Luc Bracoud.;Kohkan Shamsi.;John M D Storey.;Charles R Harrington.;Claude M Wischik.
来源: Lancet. 2016年388卷10062期2873-2884页
Leuco-methylthioninium bis(hydromethanesulfonate; LMTM), a stable reduced form of the methylthioninium moiety, acts as a selective inhibitor of tau protein aggregation both in vitro and in transgenic mouse models. Methylthioninium chloride has previously shown potential efficacy as monotherapy in patients with Alzheimer's disease. We aimed to determine whether LMTM was safe and effective in modifying disease progression in patients with mild to moderate Alzheimer's disease.
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