Drug Use Investigation of Ebastine in Pediatric Patients with Allergic Rhinitis, Urticaria and Skin Disorder Accompanied with Itch.
|
Accession number;03A0708406
|
| Title;Drug Use Investigation of Ebastine in Pediatric Patients with Allergic Rhinitis, Urticaria and Skin Disorder Accompanied with Itch. |
| Author;
HACHIYA HIROYUKI
(Dainippon Pharm. Co., Ltd.)
TAKEMOTO YUICHI
(Dainippon Pharm. Co., Ltd.)
MASUI TAKAAKI
(Dainippon Pharm. Co., Ltd.)
YOKOTA MASAYUKI
(Meiji Seika Kaisha, Ltd.)
BABA KOTARO
(Dokkyo Univ. School of Medicine, JPN)
YAMAMOTO SHOSO
(Hiroshima Univ., JPN)
|
Journal Title;Journal of Clinical Therapeutics & Medicines
|
Journal Code:Y0906A
|
ISSN:0910-8211
|
|
VOL.19;NO.9;PAGE.1029-1046(2003)
|
| Figure&Table&Reference;FIG.1, TBL.14, REF.23 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;In compliance with Japanese regulatory requirement, Drug Use Investigation of ebastine was conducted on patients with allergic rhinitis, urticaria and skin disorders during the period from July 1996 to September 1999. We collected case reports from 7,277 patients in all during the period for surveillance. Out of all these patients, 377 patients were pediatric patients defined to be younger than 15-years old, and the number of the pediatric patients who were evaluated for safety and efficacy was 352 and 347, respectively. The pediatric patients classified by age was 4 patients 4-5 years old, 137 patients in 6-11 years old, and 211 patients in 12-14 years old. The majority of the pediatric patients was those studying in elementary or junior-high schools. The pediatric patients classified by the medical department which they visited was 227 patients in Ear/Nose/Throat (ENT) departments and 123 patients in dermatology departments, with 2 patients in other departments. Out of 352 pediatric patients evaluated for safety, 6 patients (5 patients with somnolence and 1 patient with rash) developed non-serious adverse reactions, reporting 1.7 % incidence of adverse reactions. The percentage of pediatric patients who visited ENT departments and showed efficacy of the drug was 73.8%. The efficacy on patients with seasonal rhinitis and patients with perennial rhinitis was 77.8 % and 71.5 %, respectively. The percentage of patients who visited dermatology departments and showed efficacy of the drug was 78.7%. The efficacy on patients with urticaria and those with eczema/dermatitis was 93.5% and 74.1 %, respectively. Based on the above results, it is concluded that ebastine is a drug with good efficacy and less incidence in adverse reactions for pediatric patients. (author abst.) |
|
|
|
Related Articles;
|
|
