2016 Section 5 Green Book

Varvyanskaya and Lopatin

Statistical analysis After consulting a medical statistician, the results obtained were entered into a computerized database and processed using the statistical software package SPSS version 17.0 for Windows. Wilcoxon signed rank tests were performed to evaluate treatment effects at various time points. Values were presented as means ± standard deviations. Changes within and between groups were considered statistically significant when p values were < 0.05. Results Eleven patients were dropped from the study for various reasons: 8 patients in group 2 (antibiotics for 12 weeks) were withdrawn. One patient developed abdominal pain after starting clarithromycin therapy; a second patient was withdrawn because of nightmares beginning 3 days af- ter starting clarithromycin treatment. One female in the same group developed an exacerbation of erosive duodeni- tis 2 months after enrollment and was withdrawn whereas 5 others were withdrawn because of noncompliance. One female patient in group 3 (control no antibiotics) was ex- cluded because of pregnancy and 2 others in this group were withdrawn because of noncompliance. Therefore, 55 patients completed the study and at the last visit all 22 patients in group 1 (antibiotics for 24 weeks) completed the study, 14 patients remained in group 2 (antibiotics for 12 weeks), and 19 patients remained in group 3 (control no antibiotics). Thirty-five patients had BA, and 27 of these 35 patients presented with AERD. Atopy was confirmed by skin prick tests in 19 of the 66 initial patients. There were no signif- icant differences between the 3 groups regarding age, sex, presence of atopy, severity of the disease, and number of previous surgeries, as well as all the other initial parame- ters that we examined. Baseline characteristics of each of the 3 treatment arms: group 1 (antibiotics for 24 weeks), group 2 (antibiotics for 12 weeks), and group 3 (control no antibiotics) are presented in Table 1. Treatment results were better for patients completing the course of long-term clarithromycin treatment in group 1 (antibiotics for 24 weeks) and group 2 (antibiotics for 12 weeks) compared to patients in group 3 (control no antibiotics). Statistically significant differences ( p < 0.05) were ob- tained for all parameters (but not at every visit) between the study medication groups 1 and 2 and group 3 (control no antibiotics) with the only exception being for VAS and AR where statistically significant evidence was not achieved. SNOT-20 The initial SNOT-20 scores were 2.20 ± 0.54 in group 1 (antibiotics for 24 weeks), 2.64 ± 0.49 in group 2 (antibi- otics for 12 weeks), and 2.44 ± 0.18 in group 3 (control no antibiotics). After the FESS, QoL improved and the sever- ity of the rhinosinusitis symptoms was relieved in all study

2 = thick, purulent discharge. The mucosal edema was scored as follows: 0 = absent; 1 = mild; 2 = severe. Crust- ing and scarring in the postoperative cavity was scored as follows: 0 = absent; 1 = mild; and 2 = severe; these findings were evaluated for the right and left nasal cavity separately. Active anterior rhinomanometry and acoustic rhinometry The active anterior rhinomanometry (AAR) and acoustic rhinometry (AR) studies were carried out with the SRE 2000 R device (Rhinometrics, Lynge, Denmark), which al- lowed performing both tests: AAR objectively assessed both nasal resistance and nasal airflow whereas AR reflected the geometry and the volume of the entire nasal cavity. Multislice computed tomography Multislice computed tomography (CT) of the nose and paranasal sinuses was performed prior to and 6 months af- ter FESS on all patients. One-half-centimeter (5 mm) slices in both the axial and coronal planes were obtained. The degree of opacification of a particular sinus (0-2) and the ostiomeatal complex (0 = intact, 2 = occluded) were cal- culated using the Lund-Mackay scoring system. 4,13 Eosinophil cationic protein Eosinophil cationic protein (ECP) contents in the nasal discharge was measured using a collection kit with data generated by the automatic chemiluminescent analyzer IMMULITE R 1000 (Siemens Healthcare Diagnostics Inc, NY, USA). To collect the mucus, a piece of sterile foam- rubber sponge measuring 20 × 20 × 5 mm was introduced into the middle meatus for 20 minutes. After removal, the sponge was placed in a 10-mL test tube and centrifuged for 3 minutes at a velocity of 4000 rpm allowing for collection of 0.2 to 1.0 mL of mucus for further analysis. The test sensitivity was 0.2 ng/mL. Microbiological testing Nasal swab for microbiological testing was collected from the middle nasal meatus prior to FESS and at all postoper- ative visits. Culture and sensitivity (resistance) testing was performed using bacteriological analyzer Walk Away-40 (Dade Behring, Marburg, Germany) and the disk diffusion method (Becton Dickinson discs with clarithromycin, USA). Results were estimated according to the CLSI (clinical and laboratory standards institute) recommendations. Skin prick tests Skin prick tests for indoor and outdoor allergens were per- formed in all patients using standard methods. Final assessment of treatment results Final assessment of treatment results was carried out us- ing the changes of EAS and Lund-Mackay CT scores at 24 weeks after FESS.

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