Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics · 2006
An evaluation on the efficacy and safety of amlexanox oral adhesive tablets in the treatment of recurrent minor aphthous ulceration in a Chinese cohort: a randomized, double-blind, vehicle-controlled, unparallel multicenter clinical trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Liu Jie, Zeng Xin, Chen Qianming, Cai Yang, Chen Fangchun, Wang Yan, Zhou Hongmei, Lin Mei, Shi Jing, Wang Zhi, Zhang Yuanyuan
Аннотация
OBJECTIVE: The objectives of this study were to clinically determine the topical efficacy and safety of amlexanox oral adhesive tablets in the treatment of recurrent minor aphthous ulcerations (MiRAU) in a Chinese cohort.
STUDY DESIGN: A randomized, double-blind, vehicle-controlled, unparallel multicenter clinical trial was carried out. The tablets were applied by subjects themselves 4 times a day for 5 days. Four parameters (pain scale, size change, degree of erythema and exudation, and efficacy index) were recorded both before (baseline) and during the trial (on the morning of days 4 and 6).
RESULTS: There were 104 and 108 subjects who fulfilled the trial in the amlexanox group and the vehicle-control group, respectively. Group differences for all parameters but degree of erythema and exudation of day 4 were statistically significant both for the day 4 visit and the day 6 visit (P < .05). No systemic side effects were reported.
CONCLUSIONS: Amlexanox oral adhesive tablets are effective and safe in reducing aphthous ulcer pain and lesion size, as well as erythema and exudation in this Chinese cohort.
STUDY DESIGN: A randomized, double-blind, vehicle-controlled, unparallel multicenter clinical trial was carried out. The tablets were applied by subjects themselves 4 times a day for 5 days. Four parameters (pain scale, size change, degree of erythema and exudation, and efficacy index) were recorded both before (baseline) and during the trial (on the morning of days 4 and 6).
RESULTS: There were 104 and 108 subjects who fulfilled the trial in the amlexanox group and the vehicle-control group, respectively. Group differences for all parameters but degree of erythema and exudation of day 4 were statistically significant both for the day 4 visit and the day 6 visit (P < .05). No systemic side effects were reported.
CONCLUSIONS: Amlexanox oral adhesive tablets are effective and safe in reducing aphthous ulcer pain and lesion size, as well as erythema and exudation in this Chinese cohort.