166 / 236
Varvyanskaya and Lopatin
TABLE 1.
Baseline characteristics of the 3 treatment arms
Parameters
Group 1
(antibiotics 24 weeks)
Group 2
(antibiotics 12 weeks)
Group 3
(control no antibiotic)
All study
patients
Mean age (years)
42.3
49.7
54.9
48.7
Gender distribution (male/female)
14/8
9/13
13/9
36/30
Atopy confirmed by skin prick tests (patients)
6
7
6
19 (28.7%)
Concomitant asthma (patients)
13
12
10
35 (53%)
Revision surgery (patients)
17
18
17
52 (79%)
Mean number of previous sinus surgeries
3.0
±
1.4
3.7
±
1.8
2.8
±
1.6
3.2
Mean interval between last surgery and
enrollment into the study (months)
19.2
±
8.7
17.0
±
8.2
21.8
±
6.2
19.4
SNOT-20 (points)
2.20
±
0.54
2.64
±
0.49
2.44
±
0.18
2.42
VAS (points)
8.2
±
0.71
8.7
±
0.87
7.7
±
0.91
8.1
Sniffing Sticks test (points)
2.4
±
0.92
0.9
±
0.80
2.2
±
1.28
1.86
Saccharin transit time (minutes)
15.6
±
4.1
20.4
±
6.4
22.8
±
3.7
17.9
EAS (points)
12.09
±
0.96
12.78
±
0.92
11.42
±
1.09
12.12
Total nasal resistance (Pa/cm
3
/second)
4.22
±
2.1
2.09
±
1.2
2.25
±
1.0
2.85
Total nasal cavity volume (cm
3
)
8.53
±
1.20
9.00
±
1.69
9.97
±
2.33
9.17
Lund-Mackay CT score (points)
21.68
±
1.2
21.84
±
1.66
21.2
±
1.57
21.60
ECP level in nasal secretion (ng/mL)
412.2
±
123.1
279.4
±
85.9
330.8
±
104.5
340.8
CT
=
computed tomography; EAS
=
endoscopic appearances score; ECP
=
eosinophil cationic protein; SNOT-20
=
20-item SinoNasal Outcome Test; VAS
=
visual
analogue scale.
it is the non-antimicrobial properties of the macrolides
(erythromycin, roxithromycin, clarithromycin) that con-
tribute to their anti-inflammatory effects, which includes
inhibition of both neutrophilic and eosinophilic inflamma-
tion. The macrolides are capable of modulating the immune
response, inhibiting polyp growth, destroying biofilms, and
enhancing the protective properties of the respiratory tract
mucosa.
6–9
Macrolide effectiveness in patients with CRS without NP
has been confirmed; however, their efficacy in CRSwNP
patients has not been thoroughly investigated.
4
Therefore,
our prospective randomized controlled study was designed
to evaluate the efficacy and safety of a long-term course
(3 and 6 months) of low-dose clarithromycin therapy in
patients with CRSwNP after functional endoscopic sinus
surgery (FESS).
Patients and methods
A total of 66 patients (36 men and 30 women) aged from
18 to 77 (average, 48.7) years with bilateral CRSwNP con-
firmed by endoscopy were recruited. The study period was
from January 2008 to March 2011. All 66 patients were
randomly assigned (sealed envelope system) to 1 of 3 study
groups (22 patients per group) as follows: group 1 (antibi-
otics for 24 weeks); group 2 (antibiotics for 12 weeks); and
group 3 (control, no antibiotics).
All 3 groups received topical nasal steroid spray
(mometasone furoate), 400
μ
g/day for 24 weeks after FESS.
The macrolide antibiotic used in both groups 1 and 2 was
clarithromycin 250 mg/day (Klacid; Abbott Laboratories,
Abbott Park, Illinois, USA). The majority of patients (79%)
had at least 1 previous sinus surgery without long-term
success; the mean number of previous surgeries in all 66
patients was 3.2 (Table 1).
Exclusion criteria included the following: unilateral CR-
SwNP, macrolide intolerance, use of systemic steroids,
pregnancy, lactation, and severe somatic diseases. We ex-
cluded all patients who were on systemic steroids because in
Russia, systemic steroid therapy is reserved only for severe
BA patients. It would be unethical to discontinue systemic
steroids in these BA patients; in addition, systemic steroids
could have a negative impact on reliability of our study re-
sults. The Ethics Committee of the Sechenov First Moscow
State Medical University, required that all patients in all
3 groups maintain use of topical nasal steroids after FESS
otherwise NP can rapidly reoccur.
10
After recruitment, all 66 patients underwent bilateral
FESS performed by the same surgeon (senior author
Lopatin A.). Patients in group 1 (antibiotics for 24 weeks)
and group 2 (antibiotics for 12 weeks) began long-term
therapy with clarithromycin 250 mg/day on the first post-
operative day and over 24 weeks (6 months) or 12 weeks
International Forum of Allergy & Rhinology, Vol. 4, No. 7, July 2014
144