2016 Section 5 Green Book

Varvyanskaya and Lopatin

TABLE 1. Baseline characteristics of the 3 treatment arms

Group 1 (antibiotics 24 weeks)

Group 2 (antibiotics 12 weeks)

Group 3 (control no antibiotic)

All study patients

Parameters

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 19.2 ± 8.7

3.7 ± 1.8 17.0 ± 8.2

2.8 ± 1.6 21.8 ± 6.2

3.2

Mean interval between last surgery and enrollment into the study (months)

19.4

SNOT-20 (points)

2.20 ± 0.54 8.2 ± 0.71 2.4 ± 0.92 15.6 ± 4.1 12.09 ± 0.96 4.22 ± 2.1 8.53 ± 1.20 21.68 ± 1.2 412.2 ± 123.1

2.64 ± 0.49 8.7 ± 0.87 0.9 ± 0.80 20.4 ± 6.4 12.78 ± 0.92 2.09 ± 1.2 9.00 ± 1.69 21.84 ± 1.66 279.4 ± 85.9

2.44 ± 0.18 7.7 ± 0.91 2.2 ± 1.28 22.8 ± 3.7 11.42 ± 1.09 2.25 ± 1.0 9.97 ± 2.33 21.2 ± 1.57 330.8 ± 104.5

2.42

VAS (points)

8.1

Sniffing Sticks test (points)

1.86

Saccharin transit time (minutes)

17.9

EAS (points)

12.12

Total nasal resistance (Pa/cm 3 /second)

2.85

Total nasal cavity volume (cm 3 )

9.17

Lund-Mackay CT score (points)

21.60

ECP level in nasal secretion (ng/mL)

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