The Laryngoscope
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Randomized Controlled Trial Clinical Trial
Safety and biological efficacy of an adeno-associated virus vector-cystic fibrosis transmembrane regulator (AAV-CFTR) in the cystic fibrosis maxillary sinus.
The host immune response and low vector efficiency have been key impediments to effective cystic fibrosis transmembrane regulator (CFTR) gene transfer for cystic fibrosis (CF). An adeno-associated virus vector (AAV-CFTR) was used in a phase I dose-escalation study to transfer CFTR cDNA into respiratory epithelial cells of the maxillary sinus of 10 CF patients. ⋯ AAV-CFTR administration to the maxillary sinus results in successful, dose-dependent gene transfer to the maxillary sinus and alterations in sinus TEPD suggestive of a functional effect, with little or no cytopathic or host immune response. Further study is warranted for AAV vectors as they may prove useful for CFTR gene transfer and other in vivo gene transfer therapies. A prospective, randomized, double-blind, placebo-controlled, within-subjects, phase II clinical trial of the effect AAV-CFTR on clinical recurrence of sinusitis will determine the clinical efficacy of AAV gene therapy for CF.
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Comparative Study Clinical Trial
Plasma adrenaline concentrations during functional endoscopic sinus surgery.
Vasoconstrictors (i.e., epinephrine) are routinely applied before functional endoscopic sinus surgery (FESS) but may have significant cardiac side effects. The controversy concerning clinical application of adrenaline is discussed. ⋯ Although systemic absorption of locally injected vasoconstrictors occurs, adrenaline-related side effects during FESS are extremely rare when the patient is monitored exactly.