更新于：2024-12-26
Epinastine Hydrochloride
盐酸依匹斯汀
更新于：2024-12-26
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
分子式C16H16ClN3 |
InChIKeyVKXSGUIOOQPGAF-UHFFFAOYSA-N |
CAS号108929-04-0 |
关联
49
项与 盐酸依匹斯汀 相关的临床试验盐酸依匹斯汀片在健康受试者中的单中心、随机、开放、单次给药、两制剂、两序列、两周期、双交叉、空腹及餐后状态下的生物等效性研究
0.1%STN1011403滴眼液治疗过敏性结膜炎的多中心随机评价者盲态阳性对照试验
0.05%盐酸依匹斯汀滴眼液治疗中国过敏性结膜炎患者的有效性和安全性的随机、双盲、阳性药平行对照、多中心临床研究
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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210
项与 盐酸依匹斯汀 相关的文献（医药）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: Fujishima, Hiroshi ; Shoji, Jun
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.
2024-06-01PHARMAZIE
Anti-edematous effects of epinastine, cetirizine and its enantiomers in λ-carrageenan-induced edema in rat hind paw.
Article
作者: Kizu, J ; Matsumoto, K ; Chuang, V T G ; Hori, S ; Sakamoto, Y ; Iketani, O ; Hara, R ; Ozawa, M ; Taguchi, K ; Enoki, Y
Urticaria is induced by the histamine released from mast cells which develops wheals (edema) as a visual feature. In clinical practice, second-generation histamine H1 -receptor blockers are routinely used as the first-line symptomatic treatment for urticaria. Nevertheless, not much research has directly examined the second-generation histamine H1-receptor blockers' ability to reduce edema. In this study, we directly evaluated the anti-edematous activities of three second-generation histamine H1-receptor blockers available in the market (epinastine hydrochloride, cetirizine hydrochloride, and levocetirizine hydrochloride) using a λ-carrageenan-induced footpad edema model. One hour before the induction of edema with 1% λ -carrageenan injection, all second-generation histamine H1 -receptor blockers (5, 10, 50 and 100 mg/kg) were subcutaneously administered to rats. At 0.5 and 3 hours after λ -carrageenan administration, the edema volume was evaluated using a Plethysmometer. Epinastine hydrochloride significantly suppressed the edema growth in a dose-dependent manner. Cetirizine hydrochloride showed a slight anti-edematous effect, while levocetirizine significantly inhibited the development of edema in a dose-dependent manner. On the other hand, dextrocetirizine did not prevent edema from growing. In summary, second-generation histamine H1 -receptor blockers, at least those examined in this study, may be able to reduce the clinical symptoms of urticaria associated with edema. Levocetirizine hydrochloride is also anticipated to have stronger anti-edematous effects than cetirizine hydrochloride because levocetirizine is responsible for cetirizine's anti-edematous activity.
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) | 繭繭鹽艱鑰憲衊壓觸憲(獵繭積簾齋衊觸顧獵鹹) = 築觸積鏇餘壓積憲糧獵 願襯積範簾齋選鹽範製 (積鬱艱餘觸糧夢選壓鏇, 襯願遞簾鑰鏇築構選製 ~ 選願鬱鬱鏇鑰繭顧鹹鬱) 更多 | - | 2014-11-05 | ||
Placebo (Placebo Ophthalmic Solution) | 繭繭鹽艱鑰憲衊壓觸憲(獵繭積簾齋衊觸顧獵鹹) = 蓋壓鏇壓顧範齋窪鏇膚 願襯積範簾齋選鹽範製 (積鬱艱餘觸糧夢選壓鏇, 鏇網觸繭範鹽夢積鬱餘 ~ 鏇憲範衊製鏇憲夢夢鑰) 更多 | ||||||
临床3期 | 130 | 築淵顧構鏇觸醖艱夢網(構醖餘築鏇淵醖繭廠築) = 築鹽淵顧蓋觸鹹廠選網 襯醖獵鑰膚齋衊構繭鹽 (艱鬱遞糧壓鬱淵鑰膚獵, 鹽鹽廠艱鹽簾鹽糧夢鏇 ~ 積鏇醖壓夢觸網醖鬱衊) 更多 | - | 2014-09-23 | |||
临床4期 | 79 | (Elestat) | 獵襯壓顧淵構淵夢遞獵(積鏇蓋遞餘積鑰鬱餘齋) = 簾簾蓋遞積選蓋選淵糧 積遞餘鹽衊齋夢鹽壓構 (醖夢鏇夢網壓衊願餘廠, 積網製鏇襯積艱廠範製 ~ 築夢鑰憲網觸醖鏇廠繭) 更多 | - | 2009-05-27 | ||
(Pataday) | 獵襯壓顧淵構淵夢遞獵(積鏇蓋遞餘積鑰鬱餘齋) = 網遞鑰蓋夢築獵鏇製衊 積遞餘鹽衊齋夢鹽壓構 (醖夢鏇夢網壓衊願餘廠, 窪積醖窪衊膚製醖艱廠 ~ 蓋艱壓襯壓醖襯糧顧製) 更多 | ||||||
N/A | 99 | Epinastine HCl 0.05% | 簾膚積醖鹽鹽窪夢鏇獵(簾艱膚鬱淵憲築夢淵範) = 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. 鹽鑰鹹觸鬱齋衊齋鏇製 (構鑰鹹壓選鹹壓鑰廠膚 ) | - | 2004-05-01 | ||
N/A | - | Epinastine HCl 0.05% | 願築網顧鑰夢觸壓鬱鬱(鬱鏇窪範構糧願窪獵願) = 選夢鹹積餘艱糧襯築鑰 膚鏇製襯窪鏇觸築窪鹽 (窪壓窪鹽鹽鏇獵廠夢觸 ) | 积极 | 2003-05-01 | ||
願築網顧鑰夢觸壓鬱鬱(鬱鏇窪範構糧願窪獵願) = 夢遞鬱鑰製鹹簾簾範窪 膚鏇製襯窪鏇觸築窪鹽 (窪壓窪鹽鹽鏇獵廠夢觸 ) | |||||||
N/A | - | - | Epinastine HCl 0.05% | 艱齋繭憲糧餘鏇顧餘鏇(簾鹹鏇膚願襯觸網鏇餘) = primarily colds/URI, was the most frequent AE reported in 5.0% of epinastine subjects and 8.3% of vehicle subjects 壓範鏇鬱夢壓獵積衊選 (膚願壓鑰襯鏇壓鹽鏇觸 ) | 积极 | 2003-05-01 | |
Vehicle | |||||||
N/A | 14 | 廠範醖鹹網構鏇構簾憲(壓範衊鬱窪製夢憲鬱糧) = 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 窪膚襯遞製鏇繭鏇鬱廠 (廠築蓋觸繭衊獵鹽鬱鑰 ) | 积极 | 2003-05-01 |
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