under the inferior turbinate on the lateral wall of the nose, to
provide anesthesia up to the level of its posterior attachment. A
Karl Storz canula with a distal lip was directed under the inferior
turbinate with endoscopic guidance and rotated to get to the
posterosuperior area of the inferior meatus because penetration
is easier at that level. The endoscope was removed, and a trocar
or a specially designed trephine was used to penetrate the max-
illary antrum. Once the canula was in place with the aid of
endoscopy and tissue resection if needed, the MAST was pushed
through, into the cavity, and the canula removed. In effect, this
technique is a sinus lavage procedure in which the tube is left in
place.
the maxillary sinus mucosa to environmental air, may
serve to increase mucosal inflammation and the need for
surgical revision.
Intubation and irrigation of the maxillary cavity have
been used for some time,18 and instillation of saline solu-
tion has been associated with increased levels of immuno-
globulin A (IgA), immunoglobulin G (IgG), complement
fractions 3 and 4 (C3 and C4), and a reduction in proteo-
lytic activity.19 In light of this, we proposed that intuba-
tion and instillation of topical corticosteroids directly into
the maxillary sinus might be more beneficial because it
allows for steroids to access the inflamed site. Indeed, we
demonstrate in the current study that instillation of top-
ical budesonide into the maxillary sinus of patients with
persistent CRS was successful in reducing both the sinus
inflammation and the clinical symptoms. Furthermore,
some of these patients were symptom free for up to 12
months after treatment with significant reduction in med-
ication needs for sinus and pulmonary disease. As such,
our results indicate that this route of administration holds
real potential as a method of treating patients with per-
sistent CRS.
Study Design and Tissue Collection
The maxillary sinus was intubated, and the patient received
a 3-week course of steroid or placebo treatment in which 256 g
topical budesonide (five sprays of Rhinocort [Astra-Zeneca Can-
ada, Inc., Mississauga, Ontario, Canada], 100 g/spray) in a 3-mL
syringe injected through a 19-gauge needle) or matched placebo
was instilled directly into the maxillary sinus using the MAST.
Follow-up visits were scheduled at 2 and 3 weeks. Biopsy speci-
mens were obtained from the most affected maxillary sinus at the
time of intubation and after the 3-week treatment period. The
Karl Storz flexible optical biopsy and grasping forceps with a
2.7-mm oblique telescope was used to gain access to the maxillary
sinus cavity either through the opened middle meatus or through
the canula passing under the inferior meatus into the sinus
cavity. Each tissue sample was bisected with a No. 11 blade and
processed for in situ hybridization or immunocytochemical study.
Patients with pollen sensitivity underwent intubation at a time
outside the respective pollen season.
PATIENTS AND METHODS
Patients
The current study was undertaken after approval by the
Ethics Committee of Notre Dame Hospital (Montreal, Quebec,
Canada). Patients were enrolled and followed for 1 year between
November 1995 and April 1998. Written, informed consent was
obtained in 29 nonsmoking patients with CRS, which was defined
as a clinical syndrome of rhinorrhea, congestion, and facial
pressure-pain lasting for more than 6 months and resistant to
medical therapy, including antibiotics, topical steroids, or oral
prednisone. In all patients, persistent CRS was confirmed by
nasosinusal endoscopy examination that showed diffuse bilateral
thickening or erythema in both the ethmoid and maxillary si-
nuses with obvious signs of inflammation (Fig. 1). The presence of
atopy was determined clinically by positive reaction on skin test
(wheal Ն3 mm) to house dust mite, as well as a panel of 11 other
common aeroallergens. Peripheral eosinophil counts with com-
plete blood cell counts were performed in all patients, and the
presence of specific IgE was determined by RAST testing in
patients with negative or small skin reactions. Nasal steroids
were withheld for 14 days and systemic steroids were witheld for
2 months withheld before the study. Patients with nasal polyposis
or immunodeficiency and individuals who required further sinus
surgery were excluded from the study.
Assessment of Clinical Response
Categorization of the patients into responders and nonre-
sponders to maxillary sinus irrigation and steroid administration
was performed using a total score based on questionnaires and
endoscopic evaluation. Patients were assessed before as well as 3
weeks and 6 to 12 months after intubation. The questionnaire
assessed all of the patient’s symptoms without focusing on the
side that was treated. The questionnaire focused on three major
symptoms: facial pressure or pain, nasal congestion, and obstruc-
tion and rhinorrhea, as assessed by the patient using an ordinal
scaled visual analogue score of 0 to 10 (0 ϭ no symptoms and 10
ϭ severe symptoms). At the 3-week visit videoendoscopy was
performed, providing an objective evaluation of the nasal, eth-
moidal, and maxillary sinus cavity. The endoscopic appearances
were quantified on a three-point basis for the presence of dis-
charge (0 ϭ none, 1 ϭ clear and thin, and 2 ϭ thick and purulent)
and mucosal status (0 ϭ normoplasia, 1 ϭ light hyperplasia with
no erythema, and 2 ϭ hyperplasia or obvious erythema). A total
score was calculated for each visual analogue scale and the en-
doscopic assessment. The patients were considered to have re-
sponded to intubation when they reported a digital analogue
score of less than 2.5 for all the symptom scores or an average
decrease of at least 50% from the initial score and when the
endoscopic score was 0 or 1 at 3 weeks after the intubation. The
follow-up period consisted of a visit at 3 to 6 months and at 1 year.
Intubation of Maxillary Sinus
Only one of the maxillary sinuses was intubated. The most
affected maxillary sinus identified during endoscopy was selected
for intubation. The maxillary antrum sinusotomy tube (MAST)
(Fig. 2) is a flexible tube that is used to provide access to the
maxillary sinus cavity and has an anchoring member at its distal
end. The curve of this distal end and the flanges conform to the
lateral wall of the nose and keep the flexible tube under the
inferior turbinate, leaving the airway passage free of obstruction.
When the proximal end is cut at the level of the nostril, it does not
show outside the nose, yet is still accessible to the patient for
self-irrigation (Fig. 3). Every MAST was installed with the pa-
tient under local anesthesia using 4% topical lidocaine and
adrenalin for 10 minutes before injecting 1 to 2 mL of 1% lido-
caine (1:100,000) at the anterior part of the inferior turbinate and
Immunocytochemistry
The cellular infiltrate was quantitated by performing alka-
line phosphatase–antialkaline phosphatase immunocytochemis-
try on sections of biopsy tissue obtained from the maxillary sinus,
as previously described.20 Mouse anti-human monoclonal anti-
body directed against CD4 and major basic protein (MBP) (kind
gift from Redwan Moqbel, PhD, University of Alberta, Edmonton,
Alberta, Canada) to detect T cells and eosinophils, respectively.
Laryngoscope 112: May 2002
Lavigne et al.: Budesonide for Chronic Rhinosinusitis
859