共查询到10条相似文献,搜索用时 125 毫秒
1.
Corticosteroids for the prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial 总被引:13,自引:1,他引:12
Halonen J Halonen P Järvinen O Taskinen P Auvinen T Tarkka M Hippeläinen M Juvonen T Hartikainen J Hakala T 《JAMA》2007,297(14):1562-1567
Context Atrial fibrillation (AF) is the most common arrhythmia to occur after cardiac surgery. An exaggerated inflammatory response has been proposed to be one etiological factor. Objective To test whether intravenous corticosteroid administration after cardiac surgery prevents AF after cardiac surgery. Design, Setting, and Patients A double-blind, randomized multicenter trial (study enrollment August 2005–June 2006) in 3 university hospitals in Finland of 241 consecutive patients without prior AF or flutter and scheduled to undergo first on-pump coronary artery bypass graft (CABG) surgery, aortic valve replacement, or combined CABG surgery and aortic valve replacement. Intervention Patients were randomized to receive either 100-mg hydrocortisone or matching placebo as follows: the first dose in the evening of the operative day, then 1 dose every 8 hours during the next 3 days. In addition, all patients received oral metoprolol (50-150 mg/d) titrated to heart rate. Main Outcome Measure Occurrence of AF during the first 84 hours after cardiac surgery. Results The incidence of postoperative AF was significantly lower in the hydrocortisone group (36/120 [30%]) than in the placebo group (58/121 [48%]; adjusted hazard ratio, 0.54; 95% confidence interval, 0.35-0.83; P = .004; number needed to treat, 5.6). Compared with placebo, patients receiving hydrocortisone did not have higher rates of superficial or deep wound infections, or other major complications. Conclusion Intravenous hydrocortisone reduced the incidence of AF after cardiac surgery. Trial Registration clinicaltrials.gov Identifier: NCT00442494 相似文献
2.
Brouwer IA Zock PL Camm AJ Böcker D Hauer RN Wever EF Dullemeijer C Ronden JE Katan MB Lubinski A Buschler H Schouten EG;SOFA Study Group 《JAMA》2006,295(22):2613-2619
Context Very-long-chain n-3 polyunsaturated fatty acids (omega-3 PUFAs) from fish are thought to reduce risk of sudden death, possibly by reducing susceptibility to cardiac arrhythmia. Objective To study the effect of supplemental fish oil vs placebo on ventricular tachyarrhythmia or death. Design, Setting, and Patients The Study on Omega-3 Fatty acids and ventricular Arrhythmia (SOFA) was a randomized, parallel, placebo-controlled, double-blind trial conducted at 26 cardiology clinics across Europe. A total of 546 patients with implantable cardioverter-defibrillators (ICDs) and prior documented malignant ventricular tachycardia (VT) or ventricular fibrillation (VF) were enrolled between October 2001 and August 2004. Patients were randomly assigned to receive 2 g/d of fish oil (n = 273) or placebo (n = 273) for a median period of 356 days (range, 14-379 days). Main Outcome Measure Appropriate ICD intervention for VT or VF, or all-cause death. Results The primary end point occurred in 81 (30%) patients taking fish oil vs 90 (33%) patients taking placebo (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.64-1.16; P = .33). In prespecified subgroup analyses, the HR was 0.91 (95% CI, 0.66-1.26) for fish oil vs placebo in the 411 patients who had experienced VT in the year before the study, and 0.76 (95% CI, 0.52-1.11) for 332 patients with prior myocardial infarctions. Conclusion Our findings do not indicate evidence of a strong protective effect of intake of omega-3 PUFAs from fish oil against ventricular arrhythmia in patients with ICDs. Trial Registration clinicaltrials.gov Identifier: NCT00110838 相似文献
3.
Effects of tezosentan on symptoms and clinical outcomes in patients with acute heart failure: the VERITAS randomized controlled trials 总被引:5,自引:0,他引:5
McMurray JJ Teerlink JR Cotter G Bourge RC Cleland JG Jondeau G Krum H Metra M O'Connor CM Parker JD Torre-Amione G van Veldhuisen DJ Lewsey J Frey A Rainisio M Kobrin I;VERITAS Investigators 《JAMA》2007,298(17):2009-2019
Context Plasma concentrations of the vasoconstrictor peptide endothelin-1 are increased in patients with heart failure, and higher concentrations are associated with worse outcomes. Tezosentan is an intravenous short-acting endothelin receptor antagonist that has favorable hemodynamic actions in heart failure. Objective To determine if tezosentan improves outcomes in patients with acute heart failure. Design, Setting, and Participants The Value of Endothelin Receptor Inhibition With Tezosentan in Acute Heart Failure Studies, 2 independent, identical, and concurrent randomized, double-blind, placebo-controlled, parallel-group trials conducted from April 2003 through January 2005 at sites in Australia, Europe, Israel, and North America. Patients admitted within the previous 24 hours with persisting dyspnea and a respiratory rate of 24/min or greater were eligible provided they fulfilled 2 of 4 criteria: (1) elevated plasma concentrations of B-type or N-terminal pro–B-type natriuretic peptide, (2) clinical pulmonary edema, (3) radiologic pulmonary congestion or edema, or (4) left ventricular systolic dysfunction. Intervention Infusion of tezosentan (5 mg/h for 30 minutes, followed by 1 mg/h for 24 to 72 hours [n = 730]) or placebo (n = 718). Main Outcome Measures The coprimary end points were change in dyspnea (measured at 3, 6, and 24 hours using a visual analog scale from 0-100) over 24 hours (as area under the curve) in the individual trials and incidence of death or worsening heart failure at 7 days in both trials combined. Results Of the 1435 patients who received treatment as assigned, 855 (60%) were men; mean age was 70 years. Mean left ventricular ejection fraction (measured in 779 patients [54%]) was 29% (SD, 11%). Baseline dyspnea scores were similar in the 2 treatment groups. Tezosentan did not improve dyspnea more than placebo in either trial, with a mean treatment difference of –12 (95% confidence interval [CI], –105 to 81) mm · h (P = .80) in the first trial and –25 (95% CI, –119 to 69) mm · h (P = .60) in the second. The incidence of death or worsening heart failure at 7 days in the combined trials was 26% in each treatment group (odds ratio, 0.99; 95% confidence interval, 0.82-1.21; P = .95). Conclusion The endothelin receptor antagonist tezosentan did not improve symptoms or clinical outcomes in patients with acute heart failure. Trial Registration clinicaltrials.gov Identifiers: NCT00525707 (VERITAS-1) and NCT00524433 (VERITAS-2). 相似文献
4.
Brandes JL Kudrow D Stark SR O'Carroll CP Adelman JU O'Donnell FJ Alexander WJ Spruill SE Barrett PS Lener SE 《JAMA》2007,297(13):1443-1454
Context Multiple pathogenic mechanisms may be involved in generating the migraine symptom complex, and multimechanism-targeted therapy may confer advantages over monotherapy. Objective To evaluate the efficacy and safety of a fixed-dose tablet containing sumatriptan succinate and naproxen sodium relative to efficacy and safety of each monotherapy and placebo for the acute treatment of migraine. Design, Setting, and Participants Two replicate, randomized, double-blind, single-attack, parallel-group studies conducted among 1461 (study 1) and 1495 (study 2) patients at 118 US clinical centers who were diagnosed as having migraine and received study treatment for a moderate or severe migraine attack. Interventions Patients were randomized in a 1:1:1:1 ratio to receive a single tablet containing sumatriptan, 85 mg, and naproxen sodium, 500 mg; sumatriptan, 85 mg (monotherapy); naproxen sodium, 500 mg (monotherapy); or placebo, to be used after onset of a migraine with moderate to severe pain. Main Outcome Measures Primary outcome measures included the percentages of patients with headache relief 2 hours after dosing, absence of photophobia, absence of phonophobia, and absence of nausea for the comparison between sumatriptannaproxen sodium and placebo, and the percentages of patients with sustained pain-free response for the comparison between sumatriptannaproxen sodium and each monotherapy. Results Sumatriptannaproxen sodium was more effective than placebo for headache relief at 2 hours after dosing (study 1, 65% vs 28%; P<.001 and study 2, 57% vs 29%; P<.001), absence of photophobia at 2 hours (58% vs 26%; P<.001 and 50% vs 32%; P<.001), and absence of phonophobia at 2 hours (61% vs 38%; P<.001 and 56% vs 34%; P<.001). The absence of nausea 2 hours after dosing was higher with sumatriptannaproxen sodium than placebo in study 1 (71% vs 65%; P = .007), but in study 2 rates of absence of nausea did not differ between sumatriptannaproxen sodium and placebo (65% vs 64%; P = .71). For 2- to 24-hour sustained pain-free response, sumatriptannaproxen sodium was superior at P<.01 (25% and 23% in studies 1 and 2, respectively) to sumatriptan monotherapy (16% and 14% in studies 1 and 2), naproxen sodium monotherapy (10% and 10% in studies 1 and 2), and placebo (8% and 7% in studies 1 and 2). The incidence of adverse events was similar between sumatriptannaproxen sodium and sumatriptan monotherapy. Conclusion Sumatriptan, 85 mg, plus naproxen sodium, 500 mg, as a single tablet for acute treatment of migraine resulted in more favorable clinical benefits compared with either monotherapy, with an acceptable and well-tolerated adverse effect profile. Trial Registration clinicaltrials.gov Identifiers: NCT00434083 (study 1); NCT00433732 (study 2) 相似文献
5.
Fluoxetine after weight restoration in anorexia nervosa: a randomized controlled trial 总被引:5,自引:0,他引:5
Walsh BT Kaplan AS Attia E Olmsted M Parides M Carter JC Pike KM Devlin MJ Woodside B Roberto CA Rockert W 《JAMA》2006,295(22):2605-2612
Context Antidepressant medication is frequently prescribed for patients with anorexia nervosa. Objective To determine whether fluoxetine can promote recovery and prolong time-to-relapse among patients with anorexia nervosa following weight restoration. Design, Setting, and Participants Randomized, double-blind, placebo-controlled trial. From January 2000 until May 2005, 93 patients with anorexia nervosa received intensive inpatient or day-program treatment at the New York State Psychiatric Institute or Toronto General Hospital. Participants regained weight to a minimum body mass index (calculated as weight in kilograms divided by the square of height in meters) of 19.0 and were then eligible to participate in the randomized phase of the trial. Interventions Participants were randomly assigned to receive fluoxetine or placebo and were treated for up to 1 year as outpatients in double-blind fashion. All patients also received individual cognitive behavioral therapy. Main Outcome Measures The primary outcome measures were time-to-relapse and the proportion of patients successfully completing 1 year of treatment. Results Forty-nine patients were assigned to fluoxetine and 44 to placebo. Similar percentages of patients assigned to fluoxetine and to placebo maintained a body mass index of at least 18.5 and remained in the study for 52 weeks (fluoxetine, 26.5%; placebo, 31.5%; P = .57). In a Cox proportional hazards analysis, with prerandomization body mass index, site, and diagnostic subtype as covariates, there was no significant difference between fluoxetine and placebo in time-to-relapse (hazard ratio, 1.12; 95% CI, 0.65-2.01; P = .64). Conclusions This study failed to demonstrate any benefit from fluoxetine in the treatment of patients with anorexia nervosa following weight restoration. Future efforts should focus on developing new models to understand the persistence of this illness and on exploring new psychological and pharmacological treatment approaches. Trial Registration clinicaltrials.gov Identifier: NCT00288574 相似文献
6.
Effectiveness of a strategy to improve adherence to tuberculosis treatment in a resource-poor setting: a cluster randomized controlled trial 总被引:4,自引:0,他引:4
Context Poor adherence to treatment remains a major obstacle to efficient tuberculosis (TB) control in developing countries. Innovative strategies to improve access and adherence to treatment are needed. Objectives To assess the effectiveness of a contextualized intervention strategy aimed at improving patients' adherence to treatment and to evaluate its impact on TB control in a resource-poor country in Africa with prevalent TB infection. Design, Setting, and Patients A cluster randomized controlled trial, conducted between June 2003 and January 2005, at 16 government district health centers in Senegal. Patients older than 15 years with newly diagnosed sputum smearpositive pulmonary TB were randomly assigned to the intervention or control group. Intervention The intervention strategy included reinforced counseling through improved communication between health personnel and patients, decentralization of treatment, choice of directly observed therapy (DOT) supporter by the patient, and reinforcement of supervision activities. In the control group, the usual TB control program procedures remained unchanged. Main Outcome Measure Proportion of patients successfully completing the 8-month course of treatment and the proportion of patients defaulting from treatment. Results A total of 1522 patients were recruited into the study. Treatment was successful for 682 (88%) of 778 patients recruited in the intervention group, and for 563 (76%) of 744 patients recruited in the control group (adjusted risk ratio [RR], 1.18; 95% confidence interval [CI], 1.03-1.34). The proportion of patients defaulting was reduced in the intervention group to 5.5% (n = 43) compared with 16.8% (n = 125) in the control group (adjusted RR, 0.43; 95% CI, 0.21-0.89). Conclusion The intervention package based on improved patients counseling and communication, decentralization of treatment, patient choice of DOT supporter, and reinforcement of supervision activities led to improvement in patient outcomes compared with the usual TB control procedures. This approach may be generalized in the context of TB control programs in resource-poor countries. Trial Registration clinicaltrials.gov Identifier: NCT00412009 相似文献
7.
Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial 总被引:17,自引:0,他引:17
Mebazaa A Nieminen MS Packer M Cohen-Solal A Kleber FX Pocock SJ Thakkar R Padley RJ Põder P Kivikko M;SURVIVE Investigators 《JAMA》2007,297(17):1883-1891
Context Because acute decompensated heart failure causes substantial morbidity and mortality, there is a need for agents that at least improve hemodynamics and relieve symptoms without adversely affecting survival. Objective To assess the effect of a short-term intravenous infusion of levosimendan or dobutamine on long-term survival. Design, Setting, and Patients The Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support (SURVIVE) study was a randomized, double-blind trial comparing the efficacy and safety of intravenous levosimendan or dobutamine in 1327 patients hospitalized with acute decompensated heart failure who required inotropic support. The trial was conducted at 75 centers in 9 countries and patients were randomized between March 2003 and December 2004. Interventions Intravenous levosimendan (n = 664) or intravenous dobutamine (n = 663). Main Outcome Measure All-cause mortality at 180 days. Results All-cause mortality at 180 days occurred in 173 (26%) patients in the levosimendan group and 185 (28%) patients in the dobutamine group (hazard ratio, 0.91; 95% confidence interval, 0.74-1.13; P = .40). The levosimendan group had greater decreases in B-type natriuretic peptide level at 24 hours that persisted through 5 days compared with the dobutamine group (P<.001 for all time points). There were no statistical differences between treatment groups for the other secondary end points (all-cause mortality at 31 days, number of days alive and out of the hospital, patient global assessment, patient assessment of dyspnea at 24 hours, and cardiovascular mortality at 180 days). There was a higher incidence of cardiac failure in the dobutamine group. There were higher incidences of atrial fibrillation, hypokalemia, and headache in the levosimendan group. Conclusion Despite an initial reduction in plasma B-type natriuretic peptide level in patients in the levosimendan group compared with patients in the dobutamine group, levosimendan did not significantly reduce all-cause mortality at 180 days or affect any secondary clinical outcomes. Trial Registration clinicaltrials.gov Identifier: NCT00348504 相似文献
8.
Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism 总被引:4,自引:0,他引:4
Kearon C Ginsberg JS Julian JA Douketis J Solymoss S Ockelford P Jackson S Turpie AG MacKinnon B Hirsh J Gent M;Fixed-Dose Heparin 《JAMA》2006,296(8):935-942
Context When unfractionated heparin is used to treat acute venous thromboembolism, it is usually administered by intravenous infusion with coagulation monitoring, which requires hospitalization. However, subcutaneous administration of fixed-dose, weight-adjusted, unfractionated heparin may be suitable for inpatient and outpatient treatment of venous thromboembolism. Objective To determine if fixed-dose, weight-adjusted, subcutaneous unfractionated heparin is as effective and safe as low-molecular-weight heparin for treatment of venous thromboembolism. Design, Setting, and Patients Randomized, open-label, adjudicator-blinded, noninferiority trial of 708 patients aged 18 years or older with acute venous thromboembolism from 6 university-affiliated clinical centers in Canada and New Zealand conducted from September 1998 through February 2004. Of the randomized patients, 11 were subsequently excluded from the analysis of efficacy and 8 from the analysis of safety. Interventions Unfractionated heparin was administered subcutaneously as an initial dose of 333 U/kg, followed by a fixed dose of 250 U/kg every 12 hours (n = 345). Low-molecular-weight heparin (dalteparin or enoxaparin) was administered subcutaneously at a dose of 100 IU/kg every 12 hours (n = 352). Both treatments could be administered out of hospital and both were overlapped with 3 months of warfarin therapy. Main Outcome Measures Recurrent venous thromboembolism within 3 months and major bleeding within 10 days of randomization. Results Recurrent venous thromboembolism occurred in 13 patients in the unfractionated heparin group (3.8%) compared with 12 patients in the low-molecular-weight heparin group (3.4%; absolute difference, 0.4%; 95% confidence interval, 2.6% to 3.3%). Major bleeding during the first 10 days of treatment occurred in 4 patients in the unfractionated heparin group (1.1%) compared with 5 patients in the low-molecular-weight heparin group (1.4%; absolute difference, 0.3%; 95% confidence interval, 2.3% to 1.7%). Treatment was administered entirely out of hospital in 72% of the unfractionated heparin group and 68% of the low-molecular-weight heparin group. Conclusion Fixed-dose subcutaneous unfractionated heparin is as effective and safe as low-molecular-weight heparin in patients with acute venous thromboembolism and is suitable for outpatient treatment. Trial Registration clinicaltrials.gov Identifier: NCT00182403 相似文献
9.
APEX AMI Investigators Armstrong PW Granger CB Adams PX Hamm C Holmes D O'Neill WW Todaro TG Vahanian A Van de Werf F 《JAMA》2007,297(1):43-51
Context Reperfusion with percutaneous transluminal coronary intervention (PCI) is effective at improving outcomes in patients with acute ST-elevation myocardial infarction (STEMI). However, in patients without prompt reestablishment of brisk coronary flow and tissue perfusion, mortality remains high, providing an opportunity for novel treatments, including anti-inflammatory agents. Objective To evaluate the effectiveness of pexelizumab, a humanized monoclonal antibody that binds the C5 component of complement, as an adjunct to PCI in improving 30-day mortality from STEMI. Design, Setting, and Patients This trial was a prospective, multicenter, double-blind, placebo-controlled, phase 3 study of the intravenous administration of pexelizumab in conjunction with primary PCI in STEMI with prespecified high-risk electrocardiographic findings. The trial was intended to enroll 8500 patients, but in conjunction with the US Food and Drug Administration enrollment was modified to 5745 patients presenting from 296 hospitals in 17 countries from July 13, 2004, to May 11, 2006. Interventions Two thousand eight hundred eighty-five patients were randomly assigned to receive placebo and 2860 to receive pexelizumab given as a 2-mg/kg intravenous bolus prior to PCI followed by 0.05-mg/kg per hour infusion over the subsequent 24 hours. Patients were randomized within 6 hours of symptom onset. Main Outcome Measures The primary end point was all-cause mortality through day 30. Secondary end points were death through day 90 and the composite of death, cardiogenic shock, or congestive heart failure through days 30 and 90. Results No difference in mortality through day 30 was observed between the pexelizumab and placebo treatment groups, with 116 patients (4.06%) and 113 patients (3.92%) who died in the respective groups (hazard ratio [HR], 1.04; 95% confidence interval [CI], 0.80-1.35; log-rank P = .78). The composite end points of death, shock, or heart failure were also similar with 257 patients (8.99%) receiving pexelizumab and 265 patients (9.19%) receiving placebo at 30 days (HR, 0.98; 95% CI, 0.83-1.16; P = .81) and 293 patients (10.24%) receiving pexelizumab and 293 patients (10.16%) receiving placebo at 90 days (HR, 1.01; 95% CI, 0.86-1.19; P = .91). Conclusion In this large clinical trial of patients treated with primary PCI for STEMI, mortality was low and unaffected by administration of pexelizumab. Trial Registration clinicaltrials.gov Identifier: NCT00091637 相似文献
10.
Sivertsen B Omvik S Pallesen S Bjorvatn B Havik OE Kvale G Nielsen GH Nordhus IH 《JAMA》2006,295(24):2851-2858
Context Insomnia is a common condition in older adults and is associated with a number of adverse medical, social, and psychological consequences. Previous research has suggested beneficial outcomes of both psychological and pharmacological treatments, but blinded placebo-controlled trials comparing the effects of these treatments are lacking. Objective To examine short- and long-term clinical efficacy of cognitive behavioral therapy (CBT) and pharmacological treatment in older adults experiencing chronic primary insomnia. Design, Setting, and Participants A randomized, double-blinded, placebo-controlled trial of 46 adults (mean age, 60.8 y; 22 women) with chronic primary insomnia conducted between January 2004 and December 2005 in a single Norwegian university-based outpatient clinic for adults and elderly patients. Intervention CBT (sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relaxation; n = 18), sleep medication (7.5-mg zopiclone each night; n = 16), or placebo medication (n = 12). All treatment duration was 6 weeks, and the 2 active treatments were followed up at 6 months. Main Outcome Measures Ambulant clinical polysomnographic data and sleep diaries were used to determine total wake time, total sleep time, sleep efficiency, and slow-wave sleep (only assessed using polysomnography) on all 3 assessment points. Results CBT resulted in improved short- and long-term outcomes compared with zopiclone on 3 out of 4 outcome measures. For most outcomes, zopiclone did not differ from placebo. Participants receiving CBT improved their sleep efficiency from 81.4% at pretreatment to 90.1% at 6-month follow-up compared with a decrease from 82.3% to 81.9% in the zopiclone group. Participants in the CBT group spent much more time in slow-wave sleep (stages 3 and 4) compared with those in other groups, and spent less time awake during the night. Total sleep time was similar in all 3 groups; at 6 months, patients receiving CBT had better sleep efficiency using polysomnography than those taking zopiclone. Conclusion These results suggest that interventions based on CBT are superior to zopiclone treatment both in short- and long-term management of insomnia in older adults. Trial Registration clinicaltrials.gov Identifier: NCT00295386 相似文献