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更新于：2025-01-08
Epinastine Hydrochloride
盐酸依匹斯汀
更新于：2025-01-08
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C16H16ClN3 |
InChIKeyVKXSGUIOOQPGAF-UHFFFAOYSA-N |
CAS号108929-04-0 |
关联
49
项与 盐酸依匹斯汀 相关的临床试验CTR20243732
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100 项与 盐酸依匹斯汀 相关的临床结果
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100 项与 盐酸依匹斯汀 相关的转化医学
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100 项与 盐酸依匹斯汀 相关的专利（医药）
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212
项与 盐酸依匹斯汀 相关的文献（医药）2024-11-22Cureus Journal of Medical Science
Efficacy of Epinastine Eyelid Cream in Pediatric Vernal Keratoconjunctivitis: A Case Report
Article
作者: Hashida, Noriyasu ; Mamoto, Yukinori ; Hirose, Rina ; Shiozaki, Daiki
Allergic conjunctivitis (AC) is characterized by inflammatory responses in the conjunctiva and is often complicated by atopic dermatitis and mechanical irritation. Vernal keratoconjunctivitis (VKC), a severe subtype of AC, presents unique challenges in its diagnosis and management, particularly in pediatric patients. This case report describes an eight-year-old girl with VKC who exhibited poor adherence to a prescribed regimen of 0.05% epinastine ophthalmic solution and corticosteroid eye drops, resulting in persistent symptoms. Despite initial treatment, the patient's condition included giant papillae and thickened tarsal conjunctivae that were resistant to standard therapies. Upon transitioning to 0.5% epinastine eyelid cream, the patient showed improved adherence and partial symptom resolution. However, new limbal lesions, including Horner-Trantas dots, were observed following the cessation of steroid therapy. The reintroduction of steroids led to significant improvements in conjunctival lesions and complete resolution of limbal gelatinous hyperplasia. This case underscores the potential of epinastine eyelid cream in managing VKC, particularly in patients with adherence issues, and highlights the need for careful monitoring and combination therapy in severe cases. Further studies are needed to evaluate the long-term efficacy and safety of epinastine eyelid cream. However, once-daily application of eyelid cream may serve as a viable treatment and management option for pediatric patients with VKC.
2024-11-01JAPANESE JOURNAL OF OPHTHALMOLOGY
Safety and efficacy of a novel 0.5% epinastine topical eyelid cream in allergic conjunctivitis: a phase 3 trial
Article
作者: Shoji, Jun ; Fujishima, Hiroshi
Abstract:
Purpose:
The high prevalence of allergic conjunctivitis in Japan necessitates novel, easy-to-use treatment options for prophylactic use. We evaluated the safety and efficacy of a newly-developed 0.5% epinastine topical eyelid cream to prevent the development of allergic conjunctivitis.
Study design:
This was a phase 3, single-centre, double-masked, intra-patient randomised trial in asymptomatic adults (aged 20–65 years) with seasonal allergic conjunctivitis in Japan.
Methods:
The left and right eyes of eligible patients were randomised to receive a topical application of either 0.5% epinastine cream (~ 30 mg per dose) to one eye or placebo cream to the other (on the outer skin of the upper and lower eyelids) after a conjunctival antigen challenge (CAC) test. Symptom severity was assessed up to 24 h post-treatment. Primary efficacy endpoints were mean ocular itching and conjunctival hyperaemia severity scores in each eye; safety endpoints included adverse events (AEs) and adverse drug reaction (ADRs).
Results:
In total, 30 patients (60 eyes) were included in the study. The 0.5% epinastine topical eyelid cream reduced mean ocular itching scores (difference in least squares means ± standard error, − 1.12 ± 0.214; p < 0.0001) and mean conjunctival hyperaemia scores (− 0.54 ± 0.197; p = 0.0097) 24 h after treatment versus placebo. The 0.5% epinastine topical eyelid cream was well tolerated, with no AEs or ADRs reported.
Conclusion:
With its novel route of administration, 0.5% epinastine topical eyelid cream may be considered a unique, easy-to-use, once-daily treatment option to prevent the onset of seasonal allergic conjunctivitis.
2024-08-01HOSPITAL PHARMACY
Cost-effectiveness Analysis of Second-Generation Antihistamine 1 Receptor Blockers and Japanese Kampo Shoseiryuto for Treating Perennial Allergic Rhinitis in Outpatient Settings in Japan
Article
作者: Sasaki, Ayaka ; Egawa, Kei ; Kashiwabara, Masami ; Nakagawa, Naoto
Objectives: Perennial allergic rhinitis (PAR) is common in Japan. Second-generation antihistamines (SGAs) are commonly used for its treatment; however, it remains unclear which SGA is the most cost-effective. Additionally, the pharmacoeconomics of Japanese Kampo shoseiryuto (which was traditionally prescribed to treat PAR in Japan) remains poorly understood. In this study, we aimed to investigate the effectiveness of various SGAs and shoseiryuto for the treatment of PAR in Japanese outpatients, from the healthcare payer’s perspective. Methods: The most cost- and clinically effective SGAs were determined from a list of 6 SGAs (bepotastine, 10 mg; cetirizine, 10 mg; ebastine, 10 mg; epinastine, 20 mg; loratadine, 10 mg; and olopatadine, 5 mg) together with shoseiryuto, using the overall improvement rate through a model-based analysis. The time horizon was 28 days. Costs were determined based on the Medical Fee Index in 2020. Deterministic and probabilistic sensitivity analyses were conducted to address the uncertainty of the base-case results. Results: Overall, bepotastine (10 mg) and ebastine (10 mg) were cost-effective. Shoseiryuto was less cost-effective than ebastine (10 mg) (dominated). Ebastine (10 mg) was the most cost-effective option based on deterministic and probabilistic sensitivity analyses. Conclusions: Ebastine (10 mg) was the most cost-effective treatment strategy for PAR among the agents evaluated in this study. This insight could aid in establishing an appropriate formulary for treating PAR in hospitals and communities.
100 项与 盐酸依匹斯汀 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 变应性结膜炎 | 日本 | 2013-09-20 | |
| 季节性过敏性结膜炎 | 瑞典 | 2003-03-04 | |
| 银屑病 | 中国 | 2000-06-16 | |
| 哮喘 | 日本 | 1994-04-01 | |
| 皮炎 | 日本 | 1994-04-01 | |
| 湿疹 | 日本 | 1994-04-01 | |
| 痒疹 | 日本 | 1994-04-01 | |
| 瘙痒 | 日本 | 1994-04-01 | |
| 过敏性鼻炎 | 日本 | 1994-04-01 | |
| 荨麻疹 | 日本 | 1994-04-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 季节性过敏性鼻炎 | 临床3期 | - | 2007-12-18 | |
| 特应性皮炎 | 临床3期 | - | 2001-06-01 | |
| 常年性变应性鼻炎 | 临床3期 | - | 2000-05-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 87 | Epinastine (DE-114) (Epinastine (DE-114) Ophthalmic Solution) | 鏇構鏇顧夢構遞鹹獵觸(壓製夢憲構繭淵襯鹹鑰) = 鑰鏇餘醖顧憲鏇廠觸壓 膚鹹鹽積憲膚鏇膚鑰窪 (淵製糧蓋餘糧繭鏇鑰醖, 鹹鑰蓋襯淵鹹願願憲繭 ~ 鑰獵鬱構積餘構鏇繭鹹) 更多 | - | 2014-11-05 | ||
Placebo (Placebo Ophthalmic Solution) | 鏇構鏇顧夢構遞鹹獵觸(壓製夢憲構繭淵襯鹹鑰) = 衊顧衊醖遞壓艱夢醖壓 膚鹹鹽積憲膚鏇膚鑰窪 (淵製糧蓋餘糧繭鏇鑰醖, 蓋遞廠醖醖積醖鏇構鹹 ~ 醖糧襯鏇夢願餘獵醖夢) 更多 | ||||||
临床3期 | 130 | 淵衊壓觸鏇窪膚觸鹹蓋(衊鑰繭繭襯網膚觸鬱夢) = 築選蓋鹽齋糧繭衊構觸 餘窪觸繭夢鏇齋齋醖衊 (夢構繭廠鏇蓋獵顧範壓, 憲獵艱顧膚憲齋範膚鹽 ~ 簾獵醖淵選顧築壓鏇膚) 更多 | - | 2014-09-23 | |||
临床4期 | 79 | (Elestat) | 顧淵壓願願鹽鏇衊繭鑰(獵顧壓顧鏇觸獵醖觸網) = 築簾淵齋蓋廠鬱製築範 壓壓觸遞繭憲範廠簾觸 (獵獵範築獵觸願餘積鏇, 觸繭餘顧壓願壓齋範鬱 ~ 齋鹹簾築襯壓遞鏇鑰築) 更多 | - | 2009-05-27 | ||
(Pataday) | 顧淵壓願願鹽鏇衊繭鑰(獵顧壓顧鏇觸獵醖觸網) = 範淵膚積鹹蓋襯網願襯 壓壓觸遞繭憲範廠簾觸 (獵獵範築獵觸願餘積鏇, 膚築壓觸夢鬱簾窪繭窪 ~ 壓繭願淵壓蓋範製窪鏇) 更多 | ||||||
N/A | 99 | Epinastine HCl 0.05% | 簾艱繭蓋衊積襯繭遞獵(鬱餘壓獵鏇願壓夢鹽艱) = Three (5.9%) epinastine patients and 7 (14.6%) ketotifen patients experienced adverse events. Treatment-related sleep disorder was reported for 2 ketotifen-treated patients, but was not found in epinastine-treated patients. 遞鑰遞選繭鹹觸鬱選醖 (觸積顧鏇築膚簾獵膚範 ) | - | 2004-05-01 | ||
N/A | - | - | Epinastine HCl 0.05% | 遞夢顧願製壓窪鏇繭觸(積遞衊鑰觸範襯鑰夢積) = primarily colds/URI, was the most frequent AE reported in 5.0% of epinastine subjects and 8.3% of vehicle subjects 積鏇繭簾齋繭衊簾憲糧 (範積糧觸糧構鹹廠鹹蓋 ) | 积极 | 2003-05-01 | |
Vehicle | |||||||
N/A | - | Epinastine HCl 0.05% | 遞願遞糧遞壓鬱壓憲憲(鏇壓積鏇鹹鑰鹹廠顧繭) = 膚顧觸淵獵窪簾窪廠衊 鑰鑰簾淵憲齋製壓夢鬱 (範觸鬱簾繭糧壓製襯繭 ) | 积极 | 2003-05-01 | ||
遞願遞糧遞壓鬱壓憲憲(鏇壓積鏇鹹鑰鹹廠顧繭) = 獵衊夢範鏇積願網壓鹽 鑰鑰簾淵憲齋製壓夢鬱 (範觸鬱簾繭糧壓製襯繭 ) | |||||||
N/A | 14 | 壓廠繭醖蓋窪繭獵壓鹽(顧選憲網顧網範遞醖鬱) = No adverse events nor any clinically relevant changes in visual acuity, biomicroscopy, ophthalmoscopy, vital signs, physical examination, or laboratory parameters were observed during the study 鏇衊築壓窪觸製醖繭範 (鹽醖鑰遞夢範醖簾餘製 ) | 积极 | 2003-05-01 |
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