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KMID : 0377619960610050387
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Korean Jungang Medical Journal
1996 Volume.61 No. 5 p.387 ~ p.395
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Clinical Evaluation of Emedastine difumarate(Remicut^(®)) on Treatment of Perennial Allergic Rhinitis
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Abstract
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A double-blind, randomized, placebo-controlled study involving 45 patients with perennial allergic rhinitis was conducted to assess the efficacy, safety and usefulness of emedastine difumarate. Patients were randomized to receive either twice daily 4 mg Emedastine(E group, 30 patients) or matching placebo oral capsule(P group, 15 patients) with a treatment duration of two weeks. Efficacy was assessed by patients´ recording daily the severity of :.he symptoms of perennial allergic rhinitis on according to analogue scales and by physical findings. Analysis of this diary data showed significant reductions in sneezing, running nose during emedastine treatment. There was no evidence of a consistent change in physical findings following treatment with emedastine. Assessments of global therapeutic efficacy showed improvement rating of 33.3 % in the E group with and more and significant difference between the E and the P group(p<0.05).
Regarding the global safety rating, 80.0% of the E group was assessed as safe with no significant differences between the two groups and most frequent adverse event was somnolence. Emedastine oral intake was well tolerated by the patients and there was no case of stopping the test due to side effect.
The global usefulness rate was 33.3 % for the E group, significant differences being noted between the two groups(p<0.05).
Overall, the results of these study indicate that emedastine administered twice daily is a safe and efficacious treatment for the perennial allergic rhinitis.
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