预约演示
更新于：2025-08-29
Loteprednol Etabonate/Tobramycin
氯替泼诺妥布霉素
更新于：2025-08-29
概要
基本信息
药物类型 小分子化药 |
别名 LE-T、LE-Tobramycin、Loteprednol Etabonate and Tobramycin + [3] |
作用方式 抑制剂、激动剂 |
作用机制 30S subunit抑制剂(30S核糖体亚基抑制剂)、GR激动剂(糖皮质激素受体激动剂)、cPLA2α 激动剂(胞内磷脂酶A2 激动剂) |
在研适应症 |
非在研适应症 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2004-12-14), |
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C24H31ClO7 |
InChIKeyDMKSVUSAATWOCU-HROMYWEYSA-N |
CAS号82034-46-6 |
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关联
6
项与 氯替泼诺妥布霉素 相关的临床试验NCT02974387
Randomized, Single Blinded Controlled Trial for Evaluation of the Safety and Efficacy of Loteprednol Versus Fluorometholone After Photorefractive Keratectomy for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
NCT01028027
A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis
NCT00834171
A Retrospective Evaluation of the Intraocular Pressure Spikes With Loteprednol and Loteprednol/Tobramycin
100 项与 氯替泼诺妥布霉素 相关的临床结果
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100 项与 氯替泼诺妥布霉素 相关的转化医学
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100 项与 氯替泼诺妥布霉素 相关的专利（医药）
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11
项与 氯替泼诺妥布霉素 相关的文献（医药）2021-12-01Ophthalmology and therapy3区 · 医学
Review of Loteprednol Etabonate 0.5%/Tobramycin 0.3% in the Treatment of Blepharokeratoconjunctivitis
3区 · 医学
ReviewOA
作者: Mah, Francis S ; Karpecki, Paul M
Use of a combination corticosteroid and antibiotic in a single formulation is common in the treatment of ocular inflammatory conditions for which corticosteroid therapy is indicated and there exists a risk of superficial bacterial infection. Loteprednol etabonate (LE) is a corticosteroid engineered to maintain potent anti-inflammatory activity while minimizing the risk of undesirable class effects of corticosteroids, such as elevated intraocular pressure and cataract. Tobramycin is a broad-spectrum aminoglycoside antibiotic that is considered generally safe and well tolerated. An ophthalmic suspension combining LE 0.5% and tobramycin 0.3% (LE/T) is approved in the US and several other countries. Use of a combination therapy increases convenience, which may promote patient adherence. A systematic literature review was conducted to examine the efficacy and safety of LE/T for ocular inflammatory conditions within the scope of its labeled indications. Results of published studies indicate that LE/T is effective in the treatment of blepharokeratoconjunctivitis in adults, with similar efficacy as dexamethasone 0.1%/tobramycin 0.3%, but is associated with a lower risk of clinically significant increases in intraocular pressure as demonstrated in both efficacy and safety studies and studies with healthy volunteers. Furthermore, studies in children with blepharitis or blepharoconjunctivitis indicate LE/T was well tolerated in this population, although efficacy vs vehicle was not demonstrated, potentially due to improvements in all groups overall and/or limited sample size. Separately, tobramycin demonstrated potent in vitro activity against most bacterial species associated with blepharitis. In conclusion, published data demonstrate the utility of LE/T for the treatment of the various clinical manifestations of blepharokeratoconjunctivitis in adults.
2021-01-08Journal of ophthalmology4区 · 医学
Topical Steroids and Antibiotics for Adult Blepharokeratoconjunctivitis (BKC): A Meta-Analysis of Randomized Clinical Trials
4区 · 医学
ReviewOA
作者: Sun, Ya-jie ; Zhao, Lu ; Pan, Zhi-qiang
Purpose. A meta-analysis was conducted to evaluate the efficacy and safety of topical treatments (including steroids and antibiotics) for adults with blepharokeratoconjunctivitis (BKC). Methods. The following databases were searched for relevant randomised controlled trials (RCTs): China National Knowledge Infrastructure (CNKI), Web of Science, MEDLINE, PubMed, Embase, and Cochrane Central Register of Controlled Trials database (CENTRAL). Two reviewers selected studies and analyzed the risk of bias independently. The treatments were loteprednol 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T). The efficacy outcome measures were change from baseline (CFB) in composite scores of ocular symptoms and signs; the CFB in the signs composite scores for blepharitis, conjunctivitis, and keratitis at each visit; the total ocular adverse event incidence (AEs); and the incidence of intraocular pressure (IOP) increase after treatment. Prepost mean differences (MDs) were compared for continuous outcome variables, and incidences were analyzed for dichotomous data. The pooled effect sizes were analyzed using 95% confidence intervals (CIs) in a fixed-effect model. Heterogeneity was evaluated using the Q-test and I2 statistic. Results. The CFB to final visit in ocular symptoms and signs of BKC was not statistically different between the two treatments (95% CI, −0.33 to 1.50; MD = 0.58;). The CFB in signs composite scores for blepharitis (95% CI, −0.16 to 0.48; MD = 0.16;), conjunctivitis (95% CI, −0.55 to 1.76; MD = 0.61;), and keratitis (95% CI, 0.00–0.28; MD = 0.14;) was also similar with the two treatments. LE/T was a safer intervention than DM/T, with fewer overall adverse events (95% CI, 0.34–0.80; RR = 0.52;) and significantly less elevation of intraocular pressure (IOP) (95% CI, 0.32–0.70; RR = 0.47;). Conclusions. DM/T and LE/T are both effective treatments for BKC, but LE/T may be a safer intervention.
2017-03-04Ocular immunology and inflammation3区 · 医学
Loteprednol Etabonate 0.5%/Tobramycin 0.3% Compared with Dexamethasone 0.1%/Tobramycin 0.3% for the Treatment of Blepharitis
3区 · 医学
Article
作者: DeCory, Heleen H. ; Comstock, Timothy L.
PURPOSE:
To compare the efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions in reducing select signs of blepharitis.
METHODS:
Data were pooled from two studies (one from the USA; one from China) of adults (n = 627) with blepharokeratoconjunctivitis treated with LE/T or DM/T four times daily for 2 weeks (safety population). Efficacy analyses included 495 eyes (247 LE/T, 248 DM/T) with any baseline sign of blepharitis.
RESULTS:
At Day 15, the least squares mean change from baseline in composite blepharitis severity was similar between LE/T (-2.86) and DM/T (-2.99) (90% CI for mean treatment difference: -0.35, 0.11). Intraocular pressure (IOP) increases ≥10 mmHg over baseline were reported for 1 US patient (DM/T group) and 19 Chinese patients (6 LE/T; 13 DM/T).
CONCLUSIONS:
LE/T was similarly effective in reducing the signs of blepharitis compared with DM/T, but demonstrated a better safety profile with respect to changes in IOP.
100 项与 氯替泼诺妥布霉素 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 眼部炎症 | 美国 | 2004-12-14 |
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 |
|---|---|---|---|---|
| 睑缘炎 | 临床3期 | 新加坡 | 2009-10-01 | |
| 睑缘炎相关角结膜病变 | 临床3期 | 新加坡 | 2009-10-01 | |
| 角膜炎 | 临床3期 | 新加坡 | 2009-10-01 |
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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 | 357 | (Loteprednol and Tobramycin) | 蓋艱衊襯淵襯膚餘鬱顧(製鏇廠製壓鏇鹹蓋糧醖) = 鬱齋顧鑰衊繭齋齋簾製 構鹹鹽窪蓋鏇鏇淵夢憲 (憲網膚壓醖積憲憲遞憲, 4.56) 更多 | - | 2011-09-15 | ||
(Tobramycin and Dexamethasone) | 蓋艱衊襯淵襯膚餘鬱顧(製鏇廠製壓鏇鹹蓋糧醖) = 糧觸淵觸齋獵憲艱廠遞 構鹹鹽窪蓋鏇鏇淵夢憲 (憲網膚壓醖積憲憲遞憲, 4.71) 更多 | ||||||
临床4期 | 137 | (Loteprednol Etabonate and Tobramycin) | 網鏇製願製鬱憲壓襯鹹(積艱糧鑰鬱鬱網遞糧選) = 鑰積選顧積積製膚鏇廠 構膚範膚繭鹽積願艱遞 (獵艱遞膚憲獵壓襯觸糧, 3.29) 更多 | - | 2011-08-11 | ||
(Loteprednol Etabonate) | 網鏇製願製鬱憲壓襯鹹(積艱糧鑰鬱鬱網遞糧選) = 網鹽醖簾鬱鏇鏇網憲構 構膚範膚繭鹽積願艱遞 (獵艱遞膚憲獵壓襯觸糧, 3.98) 更多 |
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