Epinastine 경구제(품명: 아르기정 등)
■ 고시 개정 전체내용
1차적으로 투약비용이 저렴한 항히스타민제를 투여하였으나 졸림 등 부작용이 있어 2차적으로 허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
– 아 래 –
가. 알레르기비염
나.두드러기, 습진ㆍ피부염, 피부가려움, 가려움발진(痒疹), 가려움을 동반한 보통건선
■ 고시 신설 고시번호(시행일자)
고시 제2023-296호(2024.1.1.)
■ 고시 신설 사유
○’23년 급여적정성 재평가 결과에 따라, 급여기준을 변경함
■ 관련문헌 등
· Harrison’s Principles of Internal Medicine(21판/2022)
· Ocular surface disease: Cornea, Conjunctiva and Tear film(2013)
· Cornea(2022)
· Clinical Ocular Pharmacology(5판/2013)
· Kanski’s clinical ophthalmology(9판/2020)
· Ophthalmology(6판/2023)
· The Will’s eye manual(8판/2021)
· 흔히 보는 피부질환(3판/2015)
· 약물치료학 제2권/제5개정
· Japanese guidelines for adult asthma(2020)
· Japanese guidelines for allergic rhinitis(2020)
· Japanese Guidelines for Diagnosis and Treatment of Urticaria in Comparison with Other Countries(2012)
· Treatment of seasonal allergic rhinitis: An evidence-based focused 2017 guideline update(2017)
· Okubo, Kimihiro, and Minoru Gotoh. “Inhibition of the antigen provoked nasal reaction by second-generation antihistamines in patients with Japanese cedar pollinosis.” Allergology International 55.3 (2006): 261-269.
· Furue, Masutaka, Hiroshi Terao, and Tetsuya Koga. “Effects of cetirizine and epinastine on the skin response to histamine iontophoresis.” Journal of dermatological science 25.1 (2001): 59-63.
· Leroy, T., and D. Van Neste. “DERMAL OBJECTIVE PHARMACODYNAMIC PROFILE OF CETIRIZINE AND EPINASTINE: TWO CONTROLLED, RANDOMISED, DOUBLEBLIND, CROSSOVER STUDIES.” International journal of clinical practice 56.8 (2002): 568-573.
· Finegold, Ira, et al. “Efficacy and response with olopatadine versus epinastine in ocular allergic symptoms: a post hoc analysis of data from a conjunctival allergen challenge study.” Clinical therapeutics 28.10 (2006): 1630-1638.
· Borazan, Mehmet, et al. “Efficacy of olopatadine HCI 0.1%, ketotifen fumarate 0.025%, epinastine HCI 0.05%, emedastine 0.05% and fluorometholone acetate 0.1% ophthalmic solutions for seasonal allergic conjunctivitis: a placebocontrolled environmental trial.” Acta Ophthalmologica 87.5 (2009): 549-554.
· Fujishima, Hiroshi, Yuichi Ohashi, and Etsuko Takamura. “Efficacy of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival cedar pollen allergen challenge.” Annals of Allergy, Asthma & Immunology 113.4 (2014): 476-481.
· Tagawa, Yoshiaki, et al. “Evaluating the efficacy of epinastine ophthalmic solution using a conjunctivitis allergen challenge model in patients with birch pollen allergic conjunctivitis.” Allergology International 66.2 (2017): 338-343.
· Abelson, Mark B., et al. “Efficacy and tolerability of ophthalmic epinastine assessed using the conjunctival antigen challenge model in patients with a history of allergic conjunctivitis.” Clinical therapeutics 26.1 (2004): 35-47.
· Whitcup, Scott M., et al. “Efficacy and tolerability of ophthalmic epinastine: a randomized, double-masked, parallel-group, active-and vehicle-controlled environmental trial in patients with seasonal allergic conjunctivitis.” Clinical therapeutics 26.1 (2004): 29-34.
· Figus, Michele, et al. “Treatment of allergic conjunctivitis: results of a 1-month, single-masked randomized study.” European Journal of Ophthalmology 20.5 (2010): 811-818.
· Mah, Francis S., et al. “Efficacy and comfort of olopatadine 0.2% versus epinastine 0.05% ophthalmic solution for treating itching and redness induced by conjunctival allergen challenge.” Current medical research and opinion 23.6 (2007): 1445-1452.
· Lanier, Bobby Q., et al. “Clinical efficacy of olopatadine vs epinastine ophthalmic solution in the conjunctival allergen challenge model.” Current medical research and opinion 20.8 (2004): 1227-1233.
■ 변경 전 고시번호(시행일자)
고시 제2018-253호(2018.12.1.)
