BACKGROUND: The use of short-acting beta2-agonists is associated with oral mucosa injuries that are probably provoked by decreased saliva flow and decreased concentrations of immunoglobulin (Ig)A in saliva. OBJECTIVES: To explore the effect of salmeterol, alone or combined with beclomethasone, on the health of oral mucosa, as well as its effect on saliva flow and IgA concentration in saliva. METHODS:Patients ranging in age from 6 to 15 years with moderate-persistent chronic asthma were enrolled. Patients received two 6-week treatments, one with salmeterol plus beclomethasone and the other with only salmeterol, with a 1-week washout period between treatments. Patients had oral cavity examinations and assessments of saliva flow, IgA in saliva, and total protein in saliva before the beginning and at the end of each treatment RESULTS: The results of the baseline oral examinations were normal in all patients. The postsalmetrol (PS) examinations detected 13 patients with gingivitis and the postbeclomethasone-salmeterol (PBS) examinations disclosed 10 patients with gingivitis and 1 with lower-lip ulceration. Baseline saliva flow was 16.25 +/- 7.04 mm/minute (confidence interval [CI] 95% 13.67; 18.89), PS was 13.53 +/- 5.93 mm/minute (CI 95% 11.33; 15.73), and PBS was 16.57 +/- 5.54 mm/minute (CI 95% 14.51; 18.62). No statistical differences between the different assessments were found. Mean saliva IgA at baseline was 4.99 +/- 1.96 mg/dL (CI 95% 4.26; 5.71), PS IgA was 6.53 +/- 3.02 mg/dL (CI 95% 5.41; 7.65), and PBS IgA was 4.82 +/- 1.98 mg/dL (CI 95% 4.08; 5.56). PS IgA was significantly higher than the other two determinations (P < 0.05 by Bonferroni and Tukey tests). Baseline saliva IgA-to-protein ratio was 0.72 +/- 0.24 (95% CI 0.64; 0.80), PS IgA:protein ratio was 1.02 +/- 0.38 (95% CI 0.88; 1.16), and PBS IgA:protein ratio was 0.72 +/- 0.25 (95% CI 0.62; 0.82). PS IgA:protein ratio was significantly higher than the other two determinations (P < 0.05 by Bonferroni and Tukey tests). CONCLUSIONS: In the present study it was demonstrated that salmeterol alone or in combination with beclomethasone induced injuries in the oral mucosa, but only salmeterol alone induced increases in the total and protein-adjusted IgA in saliva.
RCT Entities:
BACKGROUND: The use of short-acting beta2-agonists is associated with oral mucosa injuries that are probably provoked by decreased saliva flow and decreased concentrations of immunoglobulin (Ig)A in saliva. OBJECTIVES: To explore the effect of salmeterol, alone or combined with beclomethasone, on the health of oral mucosa, as well as its effect on saliva flow and IgA concentration in saliva. METHODS:Patients ranging in age from 6 to 15 years with moderate-persistent chronic asthma were enrolled. Patients received two 6-week treatments, one with salmeterol plus beclomethasone and the other with only salmeterol, with a 1-week washout period between treatments. Patients had oral cavity examinations and assessments of saliva flow, IgA in saliva, and total protein in saliva before the beginning and at the end of each treatment RESULTS: The results of the baseline oral examinations were normal in all patients. The postsalmetrol (PS) examinations detected 13 patients with gingivitis and the postbeclomethasone-salmeterol (PBS) examinations disclosed 10 patients with gingivitis and 1 with lower-lip ulceration. Baseline saliva flow was 16.25 +/- 7.04 mm/minute (confidence interval [CI] 95% 13.67; 18.89), PS was 13.53 +/- 5.93 mm/minute (CI 95% 11.33; 15.73), and PBS was 16.57 +/- 5.54 mm/minute (CI 95% 14.51; 18.62). No statistical differences between the different assessments were found. Mean saliva IgA at baseline was 4.99 +/- 1.96 mg/dL (CI 95% 4.26; 5.71), PS IgA was 6.53 +/- 3.02 mg/dL (CI 95% 5.41; 7.65), and PBS IgA was 4.82 +/- 1.98 mg/dL (CI 95% 4.08; 5.56). PS IgA was significantly higher than the other two determinations (P < 0.05 by Bonferroni and Tukey tests). Baseline saliva IgA-to-protein ratio was 0.72 +/- 0.24 (95% CI 0.64; 0.80), PS IgA:protein ratio was 1.02 +/- 0.38 (95% CI 0.88; 1.16), and PBS IgA:protein ratio was 0.72 +/- 0.25 (95% CI 0.62; 0.82). PS IgA:protein ratio was significantly higher than the other two determinations (P < 0.05 by Bonferroni and Tukey tests). CONCLUSIONS: In the present study it was demonstrated that salmeterol alone or in combination with beclomethasone induced injuries in the oral mucosa, but only salmeterol alone induced increases in the total and protein-adjusted IgA in saliva.