1. Tobramycin + hialuronic acid group Tobramycin + hialuronic acid group
TOBRAMYCIN AND HYALURONIC ACID NASAL SOLUTION: BEYOND ANTMICROBIAL EFFECT
Claut L1, Di Cicco M2, Cariani L3, Defilippi G3, Costantini D1, Colombo C1.
1 CF Center, Department of Pediatrics, Fond. IRCCS Ca’ Granda, Osp. M. Policlinico, Milan, Italy 2 ENT Department, Fond. IRCCS Ca’ Granda, Osp. M. Policlinico, Milan, Italy 3 Central lab CF Microbiology, Fond. IRCCS Ca’ Granda, Osp. M. Policlinico, Milan, Italy
Nasopharyngeal carriage of pathogens is important as potential source of bronchial colonization.
Defective clearance of mucus is present in both upper and lower respiratory tract in CF and the altered composition of airway secretion leads to increased infection and persistence of bacteria.
Hyaluronic acid was demonstrated to increase ASL and could be potentially effective in CF.
Aim
The present study aimed to compare tolerability and efficacy of tobramycin nasal solution to hyaluronic acid in CF pts carrying nasal bacteria.
Subjects and Methods
We enrolled 27 pts (22M), mean age 14,6 (range 5-27 yrs) attending our CF centre, with positive bilateral naris swab at start of the study (T0) and randomly assigned either to tobramycin + sodic hyaluronate 0.2%, group A, or placebo (sodic hyaluronate 0.2%), group B, for 14 days. Nasal swabs were evaluated 1-2 week after therapy (T1). ENT evaluation was done by rhinofiberoptic endoscopy (Olympus ENF type XP) and endoscopic score was attributed for nasal mucosa, secretion and obstruction (0-2 absent-severe alteration). Statistical differences between the two groups at T0 and T1 were determined using the Cochran-Mantel-Haenszel test.
The nasal swabs were placed into 1mL of 0.9% sodium chloride for processing. After 20 minutes, the samples were vortexed and 0.1 mL was cultured on different agar plates to detect Gram positive and Gram negative bacteria. The treatment was considered to be useful when a two-fold decrease of CFU between T0 and T1 was found.
Results
Tobramycin + Hialuronic acid
(14 pts,28 swabs)
Hialuronic acid
13(pts,26 swabs)
Unchanged Bacterial load
9 (32.1%)
15 (57.7%)
Amelioration in bacterial load
19 (67.9%)
11 (43.2%)
Tobramycin + hialuronic acid group
14 pts
Hialuronic acid
13 pts
Visit 1 (T0)
Visit 2 (T1)
Normal mucosa
(score 0)
0 (0%)
10 (71.4%)
2 (15.4%)
Hyperemia
(Score 1)
11(78.6%) 11
3 (21.4%) 3
10 (76.9%) 10
9 (69.2%) 9
Distrophic mucosa
(score 2) 6
1 (7.2%) 2
3 (21.9%) 4
Total score 17 5 16 13
1) Antibacterial activity: Reduction in bacterial count was found in 19/28 (67.9%) swabs in treatment group and 11/26 (43.2%) in the placebo group (p= 0.059)
2) Nasal mucosa changes: We observed a significant reduction in the medium endoscopic score, between T0 and T1, that is 17 to 5 in group A versus 16 to 13 in group B (p=0.0161).
Tobramycin + hialuronic acid group
14 pts
Hialuronic acid
13 pts
Visit 1 (T0)
Visit 2 (T1)
No nasal secretion
1 (7.1%)
12 (85.7%)
1 (7.7%)
2 (15.4%)
Presence of purulent nasal secretion
13 (92.9%)
2 (14.3%
12 (92.3%)
11(84.6%)
3)Purulent nasal secretion decreased in 85.7% (12/14) of group A pts as compared to 15.4% (2/13) in group B (p=0.0016).
4) NO SIDE EFFECTS WERE RECORDERED
Conclusions
Tobramycin nasal solution is safe and effective, mostly restoring trophism of nasal mucosa and reducing nasal secretion. The addition of hyaluronic acid may potentiate the effect of tobramycin by means of increased hydration and mucus clearance.
Finally antimicrobial activity is not statistically significant.