ABSTRACT
BACKGROUND: The standard initial treatment of hemodynamically stable patients with pulmonary embolism is intravenous unfractionated heparin, requiring laboratory monitoring and hospitalization. METHODS: We conducted a randomized, open-label trial involving 2213 patients with acute symptomatic pulmonary embolism to compare the efficacy and safety of the synthetic antithrombotic agent fondaparinux with those of unfractionated heparin and to document noninferiority in terms of efficacy. Patients received either fondaparinux (5.0, 7.5, or 10.0 mg in patients weighing less than 50, 50 to 100, or more than 100 kg, respectively) subcutaneously once daily or a continuous intravenous infusion of unfractionated heparin (ratio of the activated partial-thromboplastin time to a control value, 1.5 to 2.5), both given for at least five days and until the use of vitamin K antagonists resulted in an international normalized ratio above 2.0. The primary efficacy outcome was the three-month incidence of the composite end point of symptomatic, recurrent pulmonary embolism (nonfatal or fatal) and new or recurrent deep-vein thrombosis. RESULTS: Forty-two of the 1103 patients randomly assigned to receive fondaparinux (3.8 percent) had recurrent thromboembolic events, as compared with 56 of the 1110 patients randomly assigned to receive unfractionated heparin (5.0 percent), for an absolute difference of -1.2 percent in favor of fondaparinux (95 percent confidence interval, -3.0 to 0.5). Major bleeding occurred in 1.3 percent of the patients treated with fondaparinux and 1.1 percent of those treated with unfractionated heparin. Mortality rates at three months were similar in the two groups. Of the patients in the fondaparinux group, 14.5 percent received the drug in part on an outpatient basis. CONCLUSIONS: Once-daily, subcutaneous administration of fondaparinux without monitoring is at least as effective and is as safe as adjusted-dose, intravenous administration of unfractionated heparin in the initial treatment of hemodynamically stable patients with pulmonary embolism.
Subject(s)
Fibrinolytic Agents/therapeutic use , Heparin/therapeutic use , Polysaccharides/therapeutic use , Pulmonary Embolism/drug therapy , Aged , Drug Administration Schedule , Factor Xa Inhibitors , Female , Fibrinolytic Agents/adverse effects , Fondaparinux , Hemorrhage/chemically induced , Heparin/adverse effects , Humans , Infusions, Intravenous , Injections, Subcutaneous , Male , Middle Aged , Polysaccharides/adverse effects , Pulmonary Embolism/mortality , Pulmonary Embolism/prevention & control , Secondary Prevention , Single-Blind MethodABSTRACT
PURPOSE: We compare the bacteriological and clinical efficacy of rufloxacin and ciprofloxacin in patients with acute uncomplicated pyelonephritis. MATERIALS AND METHODS: A total of 110 outpatients was enrolled in a randomized, double-blind multicenter study and treated for 10 days with 200 mg. rufloxacin daily (after a loading dose of 400 mg. on day 1) or 500 mg. ciprofloxacin twice daily. Bacteriological and clinical efficacy was based on the accumulated outcomes assessed at the end of treatment, and at 2 and 4 to 6 weeks. RESULTS: The bacteriological and clinical success rates of rufloxacin and ciprofloxacin were comparable: 55.6% versus 58.8% and 74% versus 71%, respectively (95% confidence interval -28% to +22% and -20% to +25%, respectively). Both study medications were well tolerated. CONCLUSIONS: Rufloxacin once daily is a good alternative in the outpatient treatment of acute uncomplicated pyelonephritis.
Subject(s)
Anti-Infective Agents/therapeutic use , Ciprofloxacin/therapeutic use , Fluoroquinolones , Pyelonephritis/drug therapy , Quinolones/therapeutic use , Acute Disease , Adolescent , Adult , Aged , Aged, 80 and over , Ambulatory Care , Anti-Infective Agents/administration & dosage , Anti-Infective Agents/adverse effects , Ciprofloxacin/administration & dosage , Ciprofloxacin/adverse effects , Double-Blind Method , Drug Administration Schedule , Escherichia coli Infections/drug therapy , Female , Follow-Up Studies , Humans , Male , Middle Aged , Pyelonephritis/microbiology , Quinolones/administration & dosage , Quinolones/adverse effects , Treatment OutcomeABSTRACT
Propolis is a natural product of bees which exhibits an antimicrobial effect. In the study the existence of a bactericidal effect against several strains isolated from patients with infections in their upper respiratory tracts is demonstrated. In light of the use of propolis as a therapeutic agent in natural medicine for common colds and inflammatory processes this effect is discussed.
