Lancet
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
GISSI-2: a factorial randomised trial of alteplase versus streptokinase and heparin versus no heparin among 12,490 patients with acute myocardial infarction. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico.
A multicentre, randomised, open trial with a 2 x 2 factorial design was conducted to compare the benefits and risks of two thrombolytic agents, streptokinase (SK, 1.5 MU infused intravenously over 30-60 min) and alteplase (tPA, 100 mg infused intravenously over 3 h) in patients with acute myocardial infarction admitted to coronary care units within 6 h from onset of symptoms. The patients were also randomised to receive heparin (12,500 U subcutaneously twice daily until discharge from hospital, starting 12 h after beginning the tPA or SK infusion) or usual therapy. All patients without specific contraindications were given atenolol (5-10 mg iv) and aspirin (300-325 mg a day). ⋯ The incidence of major bleeds was significantly higher in SK and heparin treated patients (respectively, tPA 0.5%, SK 1.0%, RR 0.57, 95% Cl 0.38-0.85; hep 1.0%, no hep 0.6%, RR 1.64, 95% Cl 1.09-2.45), whereas the overall incidence of stroke was similar in all groups. SK and tPA appear equally effective and safe for use in routine conditions of care, in all infarct patients who have no contraindications, with or without post-thrombolytic heparin treatment. The 8.8% hospital mortality of the study population (compared with approximately 13% in the control cohort of the GISSI-1 trial) indicates the beneficial impact of the proven acute treatments for AMI.
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Randomized Controlled Trial Comparative Study Clinical Trial
Safety and efficacy of xenon in routine use as an inhalational anaesthetic.
40 patients (24 male, 16 female, aged 21-59 years) of American Society of Anesthesiologists class I or II who were undergoing routine surgery took part in a randomised, double-blind comparison of the anaesthetic efficacy and potency of xenon and nitrous oxide and their effects on the circulatory and respiratory systems. During anaesthesia, for each rise in blood pressure of more than 20% of the preanaesthetic (baseline) value, the patient received 0.1 mg fentanyl. The total amount of fentanyl required per patient was used as an index of the anaesthetic potency of the study gases. ⋯ Changes in blood pressure were significantly greater throughout the study in the nitrous oxide than in the xenon group. Thorax-lung compliance fell during the study period in the nitrous oxide group but not in the xenon group. Thus, xenon is a potent and effective anaesthetic which can be safely used under routine conditions.