Clinical therapeutics
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Clinical therapeutics · Dec 2010
Randomized Controlled TrialA phase III, randomized, open-label study to assess the tolerability and immunogenicity of an H5N1 influenza vaccine administered to healthy adults with a 1-, 2-, 3-, or 6-week interval between first and second doses.
Preparedness for an H5N1 influenza pre-pandemic requires effective and well-tolerated emergency vaccination strategies that provide both pandemic strain-specific and heterologous protection. ⋯ Two 7.5-μg doses of MF59-adjuvanted H5N1 influenza vaccine given 2, 3, or 6 weeks apart afforded H5N1-specific immunity and met the CHMP licensure criterion for seroprotection in these healthy volunteers. Clinically relevant levels of heterologous immunity were observed when the 2 doses of vaccine were administered either 2 or 3 weeks apart; however, the licensure criterion for seroprotection was not met in this case.
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Clinical therapeutics · Dec 2010
Randomized Controlled Trial Multicenter StudyA randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery.
Intravenous acetaminophen has been approved in Europe and elsewhere for the treatment of acute pain and fever, and was recently approved by the US Food and Drug Administration (FDA) for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. ⋯ Both regimens of intravenous acetaminophen (1000 mg q6h and 650 mg q4h) were associated with statistically significant analgesic efficacy compared with placebo and were well tolerated in these adults after abdominal laparoscopic surgery. ClinicalTrials.gov identifier: NCT00564486.
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Clinical therapeutics · Dec 2010
ReviewContemporary pharmacologic treatments for spasticity of the upper limb after stroke: a systematic review.
Muscle spasticity after stroke may be painful and severe and may restrict the patient's ability to perform routine daily tasks, particularly when the affected muscles are in the upper limbs. Treatments targeted at reducing this spasticity have evolved over time. ⋯ The 54 studies included in this systematic review of treatments for upper limb spasticity after stroke measured multiple outcomes using a variety of instruments. Fifty-one studies focused on treatment with a BTX formulation. BTX appeared to be an effective and well-tolerated focal treatment for reducing tonicity in patients with upper limb spasticity after stroke, supporting current guideline recommendations.
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Clinical therapeutics · Dec 2010
Randomized Controlled TrialEfficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children.
Many pediatricians recommend, and many parents administer, alternating or combined doses of ibuprofen and acetaminophen for fever. Limited data support this practice with standard US doses. ⋯ During a single 6-hour observation period for these participating children, combined and alternating doses of ibuprofen and acetaminophen provided greater antipyresis than ibuprofen alone at 4 to 6 hours. ClinicalTrials.gov identifier: NCT00267293.
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Clinical therapeutics · Dec 2010
Comparative StudyModeling the cost-effectiveness of prothrombin complex concentrate compared with fresh frozen plasma in emergency warfarin reversal in the United kingdom.
Warfarin is the most commonly used oral anticoagulant in the United Kingdom. Indications for its long-term use include recurrent venous thrombosis, prosthetic heart valves, stroke prevention in atrial fibrillation, valvular heart disease, and prosthetic heart valve replacement. ⋯ PCC appeared to be a more cost-effective treatment than FFP for the emergency reversal of warfarin, from the perspective of the UK National Health Service, in this model analysis.