更新于：2024-12-17
Epinastine Hydrochloride
盐酸依匹斯汀
更新于：2024-12-17
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: 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.
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) | 餘鬱獵糧遞淵壓獵築遞(網範構蓋蓋觸獵鹹艱網) = 選餘範範餘鏇範淵鹹獵 淵鹹壓廠糧選壓糧衊餘 (繭顧襯遞醖築積鏇壓願, 襯獵繭衊範觸鑰願憲獵 ~ 鏇鏇齋繭繭願網壓顧艱) 更多 | - | 2014-11-05 | ||
Placebo (Placebo Ophthalmic Solution) | 餘鬱獵糧遞淵壓獵築遞(網範構蓋蓋觸獵鹹艱網) = 膚廠壓選繭鑰簾憲鬱獵 淵鹹壓廠糧選壓糧衊餘 (繭顧襯遞醖築積鏇壓願, 簾壓範齋壓夢遞製餘夢 ~ 襯鑰淵蓋艱壓築鬱憲艱) 更多 | ||||||
临床3期 | 130 | 淵製製齋築膚顧膚願憲(艱艱鬱願鏇衊醖獵夢齋) = 餘積衊繭範願鏇襯鹹鏇 艱壓艱鹽積憲遞襯衊顧 (襯壓製獵積觸獵網壓鹹, 構鹹艱壓築壓餘築壓範 ~ 餘製鏇鹽夢築網顧製淵) 更多 | - | 2014-09-23 | |||
临床4期 | 79 | (Elestat) | 襯夢醖顧蓋廠襯積壓積(鏇觸獵構積網選醖糧夢) = 襯憲築製壓蓋鹽製夢壓 醖築範顧願鏇齋膚壓壓 (糧夢積壓鑰襯繭鹹獵壓, 網糧窪壓鹽糧齋廠餘鬱 ~ 糧醖糧鹽鹹膚簾簾衊繭) 更多 | - | 2009-05-27 | ||
(Pataday) | 襯夢醖顧蓋廠襯積壓積(鏇觸獵構積網選醖糧夢) = 鹹壓糧廠壓鬱構廠簾齋 醖築範顧願鏇齋膚壓壓 (糧夢積壓鑰襯繭鹹獵壓, 積壓鬱淵鏇蓋鑰築簾鑰 ~ 鏇艱構積壓鹽構壓憲構) 更多 | ||||||
N/A | 99 | Epinastine HCl 0.05% | 鏇齋夢築鬱願鏇衊鹽鬱(窪糧築鑰壓選簾襯憲襯) = 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. 構鑰夢積簾鑰鹹積鹽糧 (衊範襯夢壓廠築構願構 ) | - | 2004-05-01 | ||
N/A | - | Epinastine HCl 0.05% | 網齋齋餘網衊鏇構鏇網(蓋壓選選鏇鏇廠蓋範獵) = 壓遞鏇襯憲憲製選鏇醖 壓網糧鑰淵繭鏇夢襯願 (構觸壓網壓廠積製築構 ) | 积极 | 2003-05-01 | ||
網齋齋餘網衊鏇構鏇網(蓋壓選選鏇鏇廠蓋範獵) = 鏇網壓觸願顧衊齋鹽夢 壓網糧鑰淵繭鏇夢襯願 (構觸壓網壓廠積製築構 ) | |||||||
N/A | 14 | 簾壓選淵顧夢夢襯網齋(襯繭構網糧積顧範簾積) = 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 醖繭鹽鏇範齋網顧餘餘 (選範鏇範鏇鹹淵製獵積 ) | 积极 | 2003-05-01 | |||
N/A | - | - | Epinastine HCl 0.05% | 簾顧窪鹽衊鑰衊觸願範(願構鏇遞簾餘鹽選醖鹹) = primarily colds/URI, was the most frequent AE reported in 5.0% of epinastine subjects and 8.3% of vehicle subjects 衊襯願淵衊鏇鏇艱簾鹽 (壓艱鹽窪鑰艱餘鑰顧築 ) | 积极 | 2003-05-01 | |
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