A preliminary report on the effects of paclitaxel-impregnated stents on sheep nasal mucosa.
BACKGROUND
Traditional frontal sinus stents serve only as mechanical devices. It has been proposed that stents also may serve as drug-delivery systems for the topical application of drugs that minimize postoperative scarring. Paclitaxel (Taxol), which has recognized antiscarring effects, may be incorporated via a polymeric formulation into standard rubber stents. The impact of topically applied paclitaxel on the morphology of the nasal mucosa is unknown.


METHODS
An adult sheep model was used for this study. A modified rubber T-tube stent (incorporating paclitaxel at varying dosages) was secured to each side of the septum in four animals (eight sides). An unmodified T-tube was placed on each side of one animal, a T-tube with the drug carrier (but no paclitaxel) was placed on each side of the second animal, and T-tubes with varying paclitaxel were placed on each side of the final two animals. After 4 weeks, animals were killed and the nasal mucosa was harvested. The nasal mucosa was sectioned and stained with hematoxylin and eosin. A pathologist then assessed the nasal mucosa for vascular congestion, glandular atrophy, chronic inflammation, mucosal metaplasia, and mucosal ulceration.


RESULTS
No consistent histopathological differences were noted in the specimens. All specimens showed varying degrees of vascular congestion, glandular atrophy, chronic inflammation, and mucosal metaplasia; the paclitaxel-impregnated stents were not consistently associated with more severe mucosal injury. Finally, mucosal ulceration was noted to be very rare in all specimens.


CONCLUSIONS
This preliminary report describes the impact of paclitaxel-impregnated stents on sheep nasal mucosa, which tolerated these stents very well. Because paclitaxel minimizes scarring reactions at very low concentrations, paclitaxel-impregnated stents may prove useful in clinical situations in which frontal sinus stenting is deemed necessary. Additional investigations with animal models, as well as clinical trials, may be warranted.
Herrmann
Brian W
BW
Department of Otolaryngology, Washington University, School of Medicine, St. Louis, Missouri 63110-1077, USA.
Citardi
Martin J
MJ
Vogler
George
G
Gardner
Laura
L
Smith
Greg
G
Javer
Amin R
AR
Burt
Helen M
HM
Jackson
John
J
Kuhn
Frederick A
FA
D000818:Animals; D001707:Biopsy, Needle; D020099:Coated Materials, Biocompatible; D004195:Disease Models, Animal; D005260:Female; D007150:Immunohistochemistry; D008297:Male; D009297:Nasal Mucosa / Q000187:drug effects* / Q000473:pathology*; D017239:Paclitaxel / Q000009:adverse effects / Q000494:pharmacology*; D010865:Pilot Projects; D011897:Random Allocation; D012307:Risk Factors; D012680:Sensitivity and Specificity; D034561:Sheep, Domestic; D015607:Stents
D020099:Coated Materials, Biocompatible; D017239:Paclitaxel