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1701. Granulocyte-macrophage colony stimulating factor administered as prophylaxis for reduction of sepsis in extremely preterm, small for gestational age neonates (the PROGRAMS trial): a single-blind, multicentre, randomised controlled trial.
Systemic sepsis is a major cause of death in preterm neonates. There are compelling theoretical reasons why treatment with haemopoietic colony-stimulating factors might reduce sepsis and improve outcomes, and as a consequence these agents have entered into use in neonatal medicine without adequate evidence. We assessed whether granulocyte-macrophage colony stimulating factor (GM-CSF) administered as prophylaxis to preterm neonates at high risk of neutropenia would reduce sepsis, mortality, and morbidity.
1702. Effect and cost-effectiveness of step-up versus step-down treatment with antacids, H2-receptor antagonists, and proton pump inhibitors in patients with new onset dyspepsia (DIAMOND study): a primary-care-based randomised controlled trial.
作者: Corine J van Marrewijk.;Suhreta Mujakovic.;Gerdine A J Fransen.;Mattijs E Numans.;Niek J de Wit.;Jean W M Muris.;Martijn G H van Oijen.;Jan B M J Jansen.;Diederik E Grobbee.;J André Knottnerus.;Robert J F Laheij.
来源: Lancet. 2009年373卷9659期215-25页
Substantial physician workload and high costs are associated with the treatment of dyspepsia in primary health care. Despite the availability of consensus statements and guidelines, the most cost-effective empirical strategy for initial management of the condition remains to be determined. We compared step-up and step-down treatment strategies for initial management of patients with new onset dyspepsia in primary care.
1703. Multiple courses of antenatal corticosteroids for preterm birth (MACS): a randomised controlled trial.
作者: Kellie E Murphy.;Mary E Hannah.;Andrew R Willan.;Sheila A Hewson.;Arne Ohlsson.;Edmond N Kelly.;Stephen G Matthews.;Saroj Saigal.;Elizabeth Asztalos.;Susan Ross.;Marie-France Delisle.;Kofi Amankwah.;Patricia Guselle.;Amiram Gafni.;Shoo K Lee.;B Anthony Armson.; .
来源: Lancet. 2008年372卷9656期2143-51页
One course of antenatal corticosteroids reduces the risk of respiratory distress syndrome and neonatal death. Weekly doses given to women who remain undelivered after a single course may have benefits (less respiratory morbidity) or cause harm (reduced growth in utero). We aimed to find out whether multiple courses of antenatal corticosteroids would reduce neonatal morbidity and mortality without adversely affecting fetal growth.
1704. Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial.
作者: Anders Widmark.;Olbjørn Klepp.;Arne Solberg.;Jan-Erik Damber.;Anders Angelsen.;Per Fransson.;Jo-Asmund Lund.;Ilker Tasdemir.;Morten Hoyer.;Fredrik Wiklund.;Sophie D Fosså.; .; .
来源: Lancet. 2009年373卷9660期301-8页
Several studies have shown the efficacy of endocrine therapy in combination with radiotherapy in high-risk prostate cancer. To assess the effect of radiotherapy, we did an open phase III study comparing endocrine therapy with and without local radiotherapy, followed by castration on progression.
1705. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study.
Hysterectomy and bilateral salpingo-oophorectomy (BSO) is the standard surgery for stage I endometrial cancer. Systematic pelvic lymphadenectomy has been used to establish whether there is extra-uterine disease and as a therapeutic procedure; however, randomised trials need to be done to assess therapeutic efficacy. The ASTEC surgical trial investigated whether pelvic lymphadenectomy could improve survival of women with endometrial cancer.
1706. Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial.
作者: M F Gomes.;M A Faiz.;J O Gyapong.;M Warsame.;T Agbenyega.;A Babiker.;F Baiden.;E B Yunus.;F Binka.;C Clerk.;P Folb.;R Hassan.;M A Hossain.;O Kimbute.;A Kitua.;S Krishna.;C Makasi.;N Mensah.;Z Mrango.;P Olliaro.;R Peto.;T J Peto.;M R Rahman.;I Ribeiro.;R Samad.;N J White.; .
来源: Lancet. 2009年373卷9663期557-66页
Most malaria deaths occur in rural areas. Rapid progression from illness to death can be interrupted by prompt, effective medication. Antimalarial treatment cannot rescue terminally ill patients but could be effective if given earlier. If patients who cannot be treated orally are several hours from facilities for injections, rectal artesunate can be given before referral and acts rapidly on parasites. We investigated whether this intervention reduced mortality and permanent disability.
1707. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial.
作者: Stephanie Skoler-Karpoff.;Gita Ramjee.;Khatija Ahmed.;Lydia Altini.;Marlena Gehret Plagianos.;Barbara Friedland.;Sumen Govender.;Alana De Kock.;Nazira Cassim.;Thesla Palanee.;Gregory Dozier.;Robin Maguire.;Pekka Lahteenmaki.
来源: Lancet. 2008年372卷9654期1977-87页
Female-initiated HIV-prevention options, such as microbicides, are urgently needed. We assessed Carraguard, a carrageenan-based compound developed by the Population Council, for its efficacy and long-term safety in prevention of HIV infection in women.
1708. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials.
作者: Shantha Mw Rajaratnam.;Mihael H Polymeropoulos.;Dennis M Fisher.;Thomas Roth.;Christin Scott.;Gunther Birznieks.;Elizabeth B Klerman.
来源: Lancet. 2009年373卷9662期482-91页
Circadian rhythm sleep disorders are common causes of insomnia for millions of individuals. We did a phase II study to establish efficacy and physiological mechanism, and a phase III study to confirm efficacy of the melatonin agonist tasimelteon (VEC-162) for treatment of transient insomnia associated with shifted sleep and wake time.
1709. General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial.
作者: .;S C Lewis.;C P Warlow.;A R Bodenham.;B Colam.;P M Rothwell.;D Torgerson.;D Dellagrammaticas.;M Horrocks.;C Liapis.;A P Banning.;M Gough.;M J Gough.
来源: Lancet. 2008年372卷9656期2132-42页
The effect of carotid endarterectomy in lowering the risk of stroke ipsilateral to severe atherosclerotic carotid-artery stenosis is offset by complications during or soon after surgery. We compared surgery under general anaesthesia with that under local anaesthesia because prediction and avoidance of perioperative strokes might be easier under local anaesthesia than under general anaesthesia.
1710. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial.
作者: Tony W Ho.;Michel D Ferrari.;David W Dodick.;Vince Galet.;James Kost.;Xiaoyin Fan.;Heather Leibensperger.;Samar Froman.;Christopher Assaid.;Christopher Lines.;Hille Koppen.;Paul K Winner.
来源: Lancet. 2008年372卷9656期2115-23页
Calcitonin gene-related peptide (CGRP) probably has a role in migraine pathophysiology, and antagonism of its receptors might provide treatment without the vasoconstrictor effects of triptans. We aimed to assess the clinical profile of MK-0974 (telcagepant), an orally bioavailable antagonist of CGRP receptor.
1711. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial.
作者: Edward S Kim.;Vera Hirsh.;Tony Mok.;Mark A Socinski.;Radj Gervais.;Yi-Long Wu.;Long-Yun Li.;Claire L Watkins.;Mark V Sellers.;Elizabeth S Lowe.;Yan Sun.;Mei-Lin Liao.;Kell Osterlind.;Martin Reck.;Alison A Armour.;Frances A Shepherd.;Scott M Lippman.;Jean-Yves Douillard.
来源: Lancet. 2008年372卷9652期1809-18页
Two phase II trials in patients with previously-treated advanced non-small-cell lung cancer suggested that gefitinib was efficacious and less toxic than was chemotherapy. We compared gefitinib with docetaxel in patients with locally advanced or metastatic non-small-cell lung cancer who had been pretreated with platinum-based chemotherapy.
1712. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial.
作者: Susan P Buchbinder.;Devan V Mehrotra.;Ann Duerr.;Daniel W Fitzgerald.;Robin Mogg.;David Li.;Peter B Gilbert.;Javier R Lama.;Michael Marmor.;Carlos Del Rio.;M Juliana McElrath.;Danilo R Casimiro.;Keith M Gottesdiener.;Jeffrey A Chodakewitz.;Lawrence Corey.;Michael N Robertson.; .
来源: Lancet. 2008年372卷9653期1881-1893页
Observational data and non-human primate challenge studies suggest that cell-mediated immune responses might provide control of HIV replication. The Step Study directly assessed the efficacy of a cell-mediated immunity vaccine to protect against HIV-1 infection or change in early plasma HIV-1 levels.
1713. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study.
作者: Ludwig Kappos.;Ralf Gold.;David H Miller.;David G Macmanus.;Eva Havrdova.;Volker Limmroth.;Chris H Polman.;Klaus Schmierer.;Tarek A Yousry.;Minhua Yang.;Mefkûre Eraksoy.;Eva Meluzinova.;Ivan Rektor.;Katherine T Dawson.;Alfred W Sandrock.;Gilmore N O'Neill.; .
来源: Lancet. 2008年372卷9648期1463-72页
Oral fumarate (BG00012) might have dual anti-inflammatory and neuroprotective effects. Our aim was to assess the efficacy and safety of BG00012 in patients with relapsing-remitting multiple sclerosis.
1714. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial.
作者: Arne Astrup.;Sten Madsbad.;Leif Breum.;Thomas J Jensen.;Jens Peter Kroustrup.;Thomas Meinert Larsen.
来源: Lancet. 2008年372卷9653期1906-1913页
Weight-loss drugs produce an additional mean weight loss of only 3-5 kg above that of diet and placebo over 6 months, and more effective pharmacotherapy of obesity is needed. We assessed the efficacy and safety of tesofensine-an inhibitor of the presynaptic uptake of noradrenaline, dopamine, and serotonin-in patients with obesity.
1715. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial.
作者: Salim Abdulla.;Issaka Sagara.;Steffen Borrmann.;Umberto D'Alessandro.;Raquel González.;Mary Hamel.;Bernhards Ogutu.;Andreas Mårtensson.;John Lyimo.;Hamma Maiga.;Philip Sasi.;Alain Nahum.;Quique Bassat.;Elizabeth Juma.;Lucas Otieno.;Anders Björkman.;Hans Peter Beck.;Kim Andriano.;Marc Cousin.;Gilbert Lefèvre.;David Ubben.;Zulfikarali Premji.
来源: Lancet. 2008年372卷9652期1819-27页
Combination treatments, preferably containing an artemisinin derivative, are recommended to improve efficacy and prevent Plasmodium falciparum drug resistance. Our aim was to show non-inferiority of a new dispersible formulation of artemether-lumefantrine to the conventional crushed tablet in the treatment of young children with uncomplicated malaria.
1716. Effect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial.
作者: Vishwajeet Kumar.;Saroj Mohanty.;Aarti Kumar.;Rajendra P Misra.;Mathuram Santosham.;Shally Awasthi.;Abdullah H Baqui.;Pramod Singh.;Vivek Singh.;Ramesh C Ahuja.;Jai Vir Singh.;Gyanendra Kumar Malik.;Saifuddin Ahmed.;Robert E Black.;Mahendra Bhandari.;Gary L Darmstadt.; .
来源: Lancet. 2008年372卷9644期1151-62页
In rural India, most births take place in the home, where high-risk care practices are common. We developed an intervention of behaviour change management, with a focus on prevention of hypothermia, aimed at modifying practices and reducing neonatal mortality.
1717. Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial.
作者: John A Baron.;Robert S Sandler.;Robert S Bresalier.;Angel Lanas.;Dion G Morton.;Robert Riddell.;Erik R Iverson.;David L Demets.
来源: Lancet. 2008年372卷9651期1756-64页
Selective inhibition of cyclo-oxygenase-2 has been associated with an increased risk of cardiovascular events in several clinical trials. The Adenomatous Polyp Prevention on Vioxx (APPROVe) study assessed the effect of 3-year treatment with a cyclo-oxygenase-2 inhibitor, rofecoxib (25 mg), on recurrence of neoplastic polyps of the large bowel. We report the cardiovascular outcomes of a long-term follow-up of participants in the trial.
1718. Effect of candesartan on progression and regression of retinopathy in type 2 diabetes (DIRECT-Protect 2): a randomised placebo-controlled trial.
作者: Anne Katrin Sjølie.;Ronald Klein.;Massimo Porta.;Trevor Orchard.;John Fuller.;Hans Henrik Parving.;Rudy Bilous.;Nish Chaturvedi.; .
来源: Lancet. 2008年372卷9647期1385-93页
Diabetic retinopathy remains a leading cause of visual loss in people of working age. We examined whether candesartan treatment could slow the progression and, secondly, induce regression of retinopathy in people with type 2 diabetes.
1719. Effect of candesartan on prevention (DIRECT-Prevent 1) and progression (DIRECT-Protect 1) of retinopathy in type 1 diabetes: randomised, placebo-controlled trials.
作者: Nish Chaturvedi.;Massimo Porta.;Ronald Klein.;Trevor Orchard.;John Fuller.;Hans Henrik Parving.;Rudy Bilous.;Anne Katrin Sjølie.; .
来源: Lancet. 2008年372卷9647期1394-402页
Results of previous studies suggest that renin-angiotensin system blockers might reduce the burden of diabetic retinopathy. We therefore designed the DIabetic REtinopathy Candesartan Trials (DIRECT) Programme to assess whether candesartan could reduce the incidence and progression of retinopathy in type 1 diabetes.
1720. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial.
作者: Alan Garber.;Robert Henry.;Robert Ratner.;Pedro A Garcia-Hernandez.;Hiromi Rodriguez-Pattzi.;Israel Olvera-Alvarez.;Paula M Hale.;Milan Zdravkovic.;Bruce Bode.; .
来源: Lancet. 2009年373卷9662期473-81页
New treatments for type 2 diabetes mellitus are needed to retain insulin-glucose coupling and lower the risk of weight gain and hypoglycaemia. We aimed to investigate the safety and efficacy of liraglutide as monotherapy for this disorder.
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