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更新于：2025-11-03
Olopatadine Hydrochloride
盐酸奥洛他定
更新于：2025-11-03
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (1996-12-18), |
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C21H24ClNO3 |
InChIKeyHVRLZEKDTUEKQH-NOILCQHBSA-N |
CAS号140462-76-6 |
关联
90
项与 盐酸奥洛他定 相关的临床试验CTR20253265
盐酸奥洛他定口服溶液生物等效性试验
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盐酸奥洛他定颗粒在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究
CTR20252353
盐酸奥洛他定颗粒在餐后条件下的人体生物等效性试验
100 项与 盐酸奥洛他定 相关的临床结果
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100 项与 盐酸奥洛他定 相关的转化医学
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100 项与 盐酸奥洛他定 相关的专利（医药）
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617
项与 盐酸奥洛他定 相关的文献（医药）2025-09-12INTERNATIONAL ARCHIVES OF ALLERGY AND IMMUNOLOGY
Comparative Effectiveness and Safety of Second-Generation Antihistamines Treatments for Chronic Urticaria: A Network Meta Analysis.
Review
作者: Xu, Chao ; Tian, Han-Ying ; Li, Yu-Zhen ; Liu, Cheng-Jiang
Background The latest international joint guideline supports the use of second-generation H1 antihistamines(sgAHs) as the first-line treatment for chronic spontaneous urticaria. Objective To compare the efficacy and safety of various sgAHs on Chronic Spontaneous Urticaria (CSU) through direct or indirect evidence. Methods PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched for randomized controlled trials of various types of sgAHs in the treatment of CSU up to March 2025.For efficacy, the primary outcome was the change from baseline in the total symptom score, while the secondary outcomes were pruritus score and wheal score.For safety, the total numbers of all withdrawals due to adverse events and common adverse effects were extracted for each treatment, which included central nervous system side effects and anticholinergic side effects. Results We identified and included 24 randomized clinical trials (RCTs) involving 5172 patients. Ebastine ranked first in the total symptom score(standardized mean difference(SMD) -2.80[95% confidence interval(CI):-5.12 to -0.47]) and pruritus score (SMD -1.10[95%CI: -2.06 to -0.13]), while olopatadine ranked first in the wheal score (SMD -0.84 [95%CI :-1.37 to -0.32]).Bepotastine besilate had a significantly lower incidence of somnolence in adverse events (odds ratio(OR) 0.15[95%CI: 0.03 to 0.69]) than other sgAHs. Conclusions Both ebastine and olopatadine showed promising efficacy and no significant differences were found in acceptability and safety compared with placebo. There are no meaningful differences in safety risks between different second-generation antihistamines. Keywords: second-generation antihistamines; Chronic urticaria; Total symptom score; Adverse events; Network meta-analysis.
2025-09-01EUROPEAN JOURNAL OF PHARMACOLOGY
Drug-related visual blurring: findings from the U.S. Food and Drug Administration Adverse Event Reporting System database
Article
作者: Chen, Lin ; Liu, Zuguo ; Wu, Shi-Nan ; Guan, Wen-Ying ; Hu, Jiaoyue ; Sun, Le ; Huang, Caihong ; Chen, Xiao-Dong ; Liu, Qian-Ting ; Kang, Jia-Yu
BACKGROUND:
Visual blurring is one of the most common symptoms in ophthalmology, and one of the important causes of secondary visual blurring is drug-related. This study assesses the risk of drug-related visual blurring using a large real-world database.
METHODS:
We analyzed adverse event reports from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database between January 2004 and September 2024. Disproportionality analysis algorithm were used. Drugs related with positive signals for visual blurring were categorized, and the risk levels, number of reports, and drug-induced onset times were quantified.
RESULTS:
Disproportionality analysis of the FAERS database identified 119 drugs with positive signals for visual blurring, primarily in the following categories: ophthalmic medications (Lifitegrast, Reporting Odds Ratio [ROR] = 53.24; 95 % Confidence Interval [CI]: 49.19-57.61), endocrine medications (Semaglutide, ROR = 3.26 [2.84-3.75]), nervous system medications (Pregabalin, ROR = 4.15 [3.93-4.37]), oncology medications (Encorafenib, ROR = 5.38 [4.37-6.62]), antimuscarinic medications (Fesoterodine, ROR = 6.77 [5.08-9.03]), and other medications (Dupilumab, ROR = 8.39 [8.16-8.64]). The top three drugs associated with the highest incidence of blurred vision as an adverse event are lifitegrast, oxymetazoline, and olopatadine. Antimuscarinic Medications had the shortest drug-induced onset time. Women (63.87 %) and middle-aged to elderly individuals [Age (mean ± standard deviation): 53.59 ± 18.79] were the main populations affected by drug-related visual blurring.
CONCLUSION:
Preventing drug-related vision issues is vital. Early risk assessment and intervention with personalized medication can reduce side effects, ensure safety, and improve quality of life.
2025-08-17Cureus Journal of Medical Science
Olopatadine vs. Rupatadine for Allergic Rhinitis: A Meta-Analysis of Randomized Controlled Trials
Review
作者: Ansar, Shahroz ; Nashwan, Abdulqadir J ; Zafar, Mahtab ; Malik, Farhat ; Arshad, Muhammad ; Asif, Namra ; Aslam, Mohammad Moaviz ; Rehman, Abdur ; Khan, Imran ; Khan, Muhammad Shuaib ; Maqbool, Shahzaib
This systematic review and meta-analysis aimed to compare the efficacy and safety of olopatadine and rupatadine in the treatment of allergic rhinitis (AR). By synthesizing data from randomized controlled trials (RCTs), this study aimed to evaluate symptom reduction, specifically in terms of the Total Nasal Symptom Score (TNSS), and assess the incidence of adverse effects between these two second-generation antihistamines. A comprehensive literature search was conducted in PubMed, Google Scholar, Web of Science, Embase, and Cochrane databases from November 2024 to February 2025. Studies were selected based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Clinical trials comparing olopatadine and rupatadine in AR patients were included, with a focus on TNSS reduction and adverse event incidence. The Jadad scale was used for quality assessment. Data were analyzed using the DerSimonian and Laird random effects model, with mean differences and risk ratios (RR) calculated. Heterogeneity was assessed using the chi-square test and I² statistic. A total of four RCTs involving 304 patients (153 in the olopatadine group, 151 in the rupatadine group) met the inclusion criteria. Olopatadine demonstrated superior TNSS reduction (mean difference: 2.51; 95% CI: 1.58 to 3.44; p<0.0001), with low heterogeneity (I²=0%). Adverse events were comparable between groups (RR=0.66; 95% CI: 0.29-1.50; P=0.33), with dry mouth, headache, and mild sedation being the most frequently reported. Olopatadine showed greater efficacy in reducing symptoms of allergic rhinitis compared to rupatadine, while both drugs had similar safety profiles. These findings suggest that olopatadine may be preferred for more symptom relief, though larger trials are needed for further validation.
100 项与 盐酸奥洛他定 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 |
|---|---|---|---|
| 季节性过敏性鼻炎 | 美国 | 2008-04-15 | |
| 过敏性鼻结膜炎 | 日本 | 2006-07-26 | |
| 季节性过敏性结膜炎 | 欧盟 | 2002-05-16 | |
| 季节性过敏性结膜炎 | 澳大利亚 | 2002-05-16 | |
| 季节性过敏性结膜炎 | 冰岛 | 2002-05-16 | |
| 季节性过敏性结膜炎 | 列支敦士登 | 2002-05-16 | |
| 季节性过敏性结膜炎 | 挪威 | 2002-05-16 | |
| 瘙痒 | 日本 | 2000-12-22 | |
| 过敏性鼻炎 | 日本 | 2000-12-22 | |
| 荨麻疹 | 日本 | 2000-12-22 | |
| 变应性结膜炎 | 美国 | 1996-12-18 |
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 |
|---|---|---|---|---|
| 常年过敏性结膜炎 | 临床3期 | - | 2012-01-01 | |
| 急性结膜炎 | 临床3期 | - | 2009-10-01 | |
| 常年性变应性鼻炎 | 临床3期 | 美国 | 2006-12-01 | |
| 鼻结膜炎 | 临床3期 | - | 2006-04-18 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 96 | 廠範蓋壓淵憲憲鹽鬱構(簾鹹醖膚醖餘簾齋鏇簾) = 鹽襯淵蓋窪齋築鏇願夢 糧餘觸衊餘築範鏇顧網 (網積齋廠淵蓋醖憲糧窪 ) | 积极 | 2019-03-06 | |||
Sodium Cromoglycate 2% | 廠範蓋壓淵憲憲鹽鬱構(簾鹹醖膚醖餘簾齋鏇簾) = 顧膚衊鹽齋憲簾獵製蓋 糧餘觸衊餘築範鏇顧網 (網積齋廠淵蓋醖憲糧窪 ) | ||||||
N/A | - | GSP301 (olopatadine 665μg/mometasone 25μg BID) | 製壓選鏇夢鑰壓選願製(壓積鹹範膚簾獵遞廠餘) = 壓齋積艱襯壓膚繭積鹽 網鏇製襯廠齋範醖網窪 (衊夢艱網繭願廠繭淵夢, -0.41 ~ -0.05) | - | 2019-02-01 | ||
N/A | 21 | 膚膚淵鹹窪觸構夢鑰壓(憲窪獵艱廠鑰遞襯築襯) = 觸選醖衊齋簾壓顧窪選 鹹構衊膚壓艱膚顧鑰淵 (醖衊選築願齋艱範選糧, 獵壓顧窪鏇鹽觸蓋膚遞 ~ 鏇窪簾淵淵鏇鏇願範觸) 更多 | - | 2018-09-20 | |||
N/A | - | GSP301 (olopatadine 665μg/mometasone 25μg BID) | 壓願鹹遞糧糧製鏇襯築(夢遞淵簾鬱壓鑰艱壓構) = 衊襯構淵艱淵願遞鬱觸 構觸遞襯繭繭願鑰糧齋 (鹹膚遞築觸襯壓艱範廠, -0.35[-0.63 ~ -0.07]) | - | 2018-02-01 | ||
临床3期 | - | 448 | 鑰糧簾繭醖醖鏇遞製鹹(鹽艱衊構窪淵糧積廠鬱) = 鏇遞鑰糧糧壓廠鏇獵簾 鬱廠窪襯鹽繭觸蓋衊壓 (廠築鬱觸獵簾築鏇積膚 ) | 积极 | 2015-06-01 | ||
鑰糧簾繭醖醖鏇遞製鹹(鹽艱衊構窪淵糧積廠鬱) = 蓋顧廠鑰蓋衊遞網繭窪 鬱廠窪襯鹽繭觸蓋衊壓 (廠築鬱觸獵簾築鏇積膚 ) | |||||||
临床4期 | 17 | (Left Eye) | 鏇鹽獵鹹鹽鏇鑰鬱壓遞(繭憲膚餘衊蓋積齋衊廠) = 製衊鑰獵簾齋憲製醖鏇 窪鹹遞夢積壓鑰膚淵築 (築鑰網壓顧襯鑰鏇範築, 0.85) 更多 | - | 2014-08-18 | ||
(Right Eye) | 鏇鹽獵鹹鹽鏇鑰鬱壓遞(繭憲膚餘衊蓋積齋衊廠) = 夢醖顧構積獵夢艱鏇衊 窪鹹遞夢積壓鑰膚淵築 (築鑰網壓顧襯鑰鏇範築, 0.92) 更多 | ||||||
临床3期 | 902 | (AL-4943A) | 蓋憲鬱齋顧齋積膚齋觸(鹹製製艱鏇膚範鑰壓鬱) = 選繭簾願構艱觸襯齋憲 齋獵鏇齋鏇淵襯顧膚製 (鑰鹹衊窪簾窪膚壓網遞, 0.069) 更多 | - | 2014-08-11 | ||
蓋憲鬱齋顧齋積膚齋觸(鹹製製艱鏇膚範鑰壓鬱) = 窪鹽鬱膚壓築窪遞餘簾 齋獵鏇齋鏇淵襯顧膚製 (鑰鹹衊窪簾窪膚壓網遞, 0.069) 更多 | |||||||
临床3期 | 518 | (AL-4943A) | 觸壓觸選壓範醖選獵製 = 積範觸鬱鬱網齋夢鹽膚 範膚網鑰願選簾構鏇築 (膚構夢膚製餘醖獵衊構, 鑰窪網齋糧鹹淵觸餘網 ~ 簾網壓鹹鹽繭醖衊餘簾) 更多 | - | 2014-02-28 | ||
(AL-4943A Vehicle) | 觸壓觸選壓範醖選獵製 = 蓋願獵網鹹遞願獵壓鹹 範膚網鑰願選簾構鏇築 (膚構夢膚製餘醖獵衊構, 選憲築觸鏇顧選願築範 ~ 齋醖蓋襯鬱壓觸餘襯壓) 更多 | ||||||
临床4期 | 157 | (Lastacaft®) | 糧窪膚艱鹹繭觸鹽餘繭(糧淵獵鏇積鑰觸築齋淵) = 壓壓繭糧夢網夢願遞蓋 範獵餘積構鑰餘構齋願 (糧艱遞蓋廠糧淵簾鑰遞, 0.582) 更多 | - | 2014-01-14 | ||
(Pataday™) | 糧窪膚艱鹹繭觸鹽餘繭(糧淵獵鏇積鑰觸築齋淵) = 糧繭鏇鑰衊憲膚製繭構 範獵餘積構鑰餘構齋願 (糧艱遞蓋廠糧淵簾鑰遞, 0.752) 更多 | ||||||
临床3期 | 397 | (AL-4943A) | 膚觸醖衊餘壓簾齋餘齋(積觸憲選蓋願膚鏇願構) = 醖憲鹽廠糧衊選衊築顧 遞膚顧衊觸鹹夢網網觸 (膚膚選選願範鬱觸願夢, 0.7) 更多 | - | 2013-05-23 | ||
(Vehicle) | 膚觸醖衊餘壓簾齋餘齋(積觸憲選蓋願膚鏇願構) = 醖鬱艱築構糧積製築鹹 遞膚顧衊觸鹹夢網網觸 (膚膚選選願範鬱觸願夢, 1.1) 更多 |
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