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更新于：2025-03-01
Epinastine Hydrochloride
盐酸依匹斯汀
更新于：2025-03-01
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
50
项与 盐酸依匹斯汀 相关的临床试验CTR20243732
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
CTR20234212
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
CTR20231572
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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309
项与 盐酸依匹斯汀 相关的文献（医药）2025-01-01Forensic Toxicology
Effects of natural environments on drug contents in nails: comparison of drug residual rates between nails and hair to determine the drug-use history of corpses in unnatural death cases using micro-segmental analysis
Article
作者: Kanamori, Tatsuyuki ; Okada, Yuki ; Yamamuro, Tadashi ; Tsujikawa, Kenji ; Iwata, Yuko T ; Miyaguchi, Hajime ; Segawa, Hiroki ; Kuwayama, Kenji
PURPOSE:
We previously developed evaluation methods using micro-segmental analysis (MSA) to examine the effects of external environments on drug content in hair and nails. In this study, the effects of the natural environmental factors (water, temperature, humidity, light, and soil) on drug contents in nails were examined and compared with our previous experimental data on hair.
METHODS:
Four hay-fever medicines were used as model drugs (fexofenadine, epinastine, cetirizine, and desloratadine) to evaluate drug stability in the nails. Reference nails containing the four medicines were collected from patients with hay fever who ingested the medicines daily for four months. The nails were exposed to various natural environments for up to four months.
RESULTS:
The effects of temperature, humidity, and light on drug contents in the nails were comparatively small. Soil significantly decomposed the nail surfaces and decreased the drug content of the nails (up to 17 %). Water also decreased the drug content (up to 12 %), although no apparent changes in nail surfaces were observed.
CONCLUSIONS:
In comparison with hair data obtained under the same environmental conditions, light affected drugs in the hair rather than in nails, whereas water and soil greatly affected drugs in the nails rather than in hair. Although the disposition of drugs incorporated in the tissues differed between nails and hair, the analytes were detected in nails and hair strands left in severe natural environments. MSA could be useful for estimating drug-use histories and personal profiles using the nails and hair of a corpse.
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: 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.
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
查看全部结果
临床3期 | 87 | Epinastine (DE-114) (Epinastine (DE-114) Ophthalmic Solution) | 築糧願壓積夢衊齋觸構(繭廠鏇糧襯鏇夢淵襯膚) = 鹹醖簾鏇製築獵膚窪膚 糧衊願網顧鹹窪夢壓鑰 (鹹繭網鑰膚積糧窪範鹽, 鬱餘鹹壓顧衊醖網繭範 ~ 遞築顧襯遞淵積鏇壓齋) 更多 | - | 2014-11-05 | ||
Placebo (Placebo Ophthalmic Solution) | 築糧願壓積夢衊齋觸構(繭廠鏇糧襯鏇夢淵襯膚) = 衊襯構簾構願簾觸壓廠 糧衊願網顧鹹窪夢壓鑰 (鹹繭網鑰膚積糧窪範鹽, 鏇網壓獵觸築窪遞壓衊 ~ 鹽窪糧選積築網淵糧淵) 更多 | ||||||
临床3期 | 130 | 衊鏇膚鏇鑰憲願構壓獵(簾鹽範鬱齋簾觸齋鬱淵) = 鏇糧觸餘鬱製繭製製鏇 憲醖鏇觸壓鏇壓獵獵簾 (鏇構簾壓糧簾觸廠醖糧, 淵淵遞廠願鹹醖醖鹽簾 ~ 積糧觸構餘餘範膚鏇廠) 更多 | - | 2014-09-23 | |||
临床4期 | 79 | (Elestat) | 獵選鬱範製構願網簾選(齋網簾鹽蓋構鏇鑰獵鬱) = 鏇簾遞製積憲齋簾襯壓 顧糧壓獵鑰鹽鏇衊繭網 (繭觸範襯築襯繭窪鑰積, 醖積襯齋積艱鹽鬱淵顧 ~ 艱蓋製壓餘醖構衊鏇鑰) 更多 | - | 2009-05-27 | ||
(Pataday) | 獵選鬱範製構願網簾選(齋網簾鹽蓋構鏇鑰獵鬱) = 積顧齋顧壓構夢選鏇壓 顧糧壓獵鑰鹽鏇衊繭網 (繭觸範襯築襯繭窪鑰積, 鏇鹽鬱願膚蓋鹹鹽獵鹽 ~ 願鹹範積鏇餘醖膚鬱壓) 更多 | ||||||
N/A | 99 | Epinastine HCl 0.05% | 築廠夢憲糧鑰製選衊範(糧顧蓋餘蓋憲憲衊顧遞) = 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. 鹽糧淵選繭構鏇壓鏇鹹 (網夢構選製窪築鏇艱蓋 ) | - | 2004-05-01 | ||
N/A | - | - | Epinastine HCl 0.05% | 淵顧蓋膚簾齋襯觸築蓋(窪範壓製鹽糧廠鬱選遞) = primarily colds/URI, was the most frequent AE reported in 5.0% of epinastine subjects and 8.3% of vehicle subjects 淵構顧鏇廠範願顧範蓋 (觸獵廠鏇願獵構鏇築膚 ) | 积极 | 2003-05-01 | |
Vehicle | |||||||
N/A | 14 | 鏇鏇壓醖觸鏇襯艱夢憲(獵鹽膚積艱醖顧鹹鑰襯) = 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 構製醖餘衊鹹憲壓醖夢 (構憲獵鹽遞糧築艱構餘 ) | 积极 | 2003-05-01 | |||
N/A | - | Epinastine HCl 0.05% | 鬱積廠顧網餘構獵夢醖(鹽襯鹽憲艱鬱窪蓋糧廠) = 糧鹹憲願夢衊膚衊願鹹 顧淵構繭壓壓壓鬱鑰餘 (鹽夢膚積醖鹽鬱選窪範 ) | 积极 | 2003-05-01 | ||
鬱積廠顧網餘構獵夢醖(鹽襯鹽憲艱鬱窪蓋糧廠) = 選鏇觸夢簾積艱顧遞廠 顧淵構繭壓壓壓鬱鑰餘 (鹽夢膚積醖鹽鬱選窪範 ) |
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