Efficacy and safety of dexamethasone ointment on recurrent aphthous ulceration.
Author(s): Liu C, Zhou Z, Liu G, Wang Q, Chen J, Wang L, Zhou Y, Dong G, Xu X, Wang Y, Guo
Y, Lin M, Wu L, Du G, Wei C, Zeng X, Wang X, Wu J, Li B, Zhou G, Zhou H.
Affiliation(s): State Key Laboratory of Oral Diseases, West China School of Stomatology, Sichuan
University, Chengdu, China.
Publication date & source: 2012, Am J Med. , 125(3):292-301
OBJECTIVE: Recurrent aphthous ulceration is the most common oral mucosal lesion
and may be associated with many systemic diseases. Topical corticosteroids are
used frequently for recurrent aphthous ulceration; however, the number of
high-quality clinical experiments available is insufficient, and no reports exist
on the blood level of corticosteroids after topical usage in the oral mucosa. The
objective was to determine the efficacy and safety of dexamethasone ointment in
the treatment of recurrent aphthous ulceration and detect serum dexamethasone
concentrations in the patients.
METHODS: A randomized, double-blinded, placebo-controlled, parallel, multicenter
clinical trial was conducted in 5 centers to compare the efficacy and safety of
dexamethasone ointment with placebo. There were 810 patients with minor recurrent
aphthous ulcerations screened for study eligibility, and 240 patients were
enrolled at 5 centers from March 1, 2009 to April 30, 2010; 120 were assigned
randomly to the treatment group and 120 to a control group. Patients were
instructed to apply the given agent to the identified ulcer 3 times a day (after
meals) for 5 days. The size, pain level, healing ratio, and average duration of
ulcers and the safety of the agents were evaluated. The serum concentration of
dexamethasone was detected using a high-performance liquid chromatography/mass
spectrometry assay.
RESULTS: The results showed that baseline characteristics were similar (P>.5). At
day 6 ± 2 after treatment, there was significant difference in the variation of
ulcer size between the treatment group (7.167 ± 6.3415 mm(2)) and the control
group (4.346 ± 7.0666 mm(2); P = .000); and in the variation of pain level
between the treatment group (5.623 ± 1.9570) and the control group (4.940 ±
2.2449; P = .001). The healing ratio was 83.33% in the treatment group and 54.70%
in the control group (P = .000). No severe adverse reactions were observed. No
serum dexamethasone was detected before or after the use of the agents (<0.502
ng/mL).
CONCLUSION: Dexamethasone ointment was efficient in the treatment of recurrent
aphthous ulceration and was safe as evaluated using clinical assessment and serum
level detection.
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