オープン・アングル・グラウコマ (UKGTS) のラタノプロスト:ランダム化,多センター,プラセボ対照試験
David F Garway-Heath1, David P Crabb2, Catey Bunce1
1National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
Lancet (London, England)
|December 24, 2014
まとめ
ラタノプロスト眼滴は,プラセボと比較して,開角緑内障患者の視野を有意に保ちます. この最初のプラセボ対照試験は,薬の有効性を実証しています.
科学分野:
- オフタルモロジック (眼科)
- クリニック・トライアル 臨床試験
- グラウコマの研究研究
背景:
- オープン・アングル・グラウコマの治療は,眼内圧を下げることで視力喪失を予防することを目的としています.
- 以前の試験ではプラセボ対照薬がなく,観察期間が長かった.
- この研究は,視覚機能の保存に関するプラセボ対照試験の必要性に対処しています.
研究 の 目的:
- ラタノプロストとプラセボを投与された開角緑内障患者の視野保存を評価する.
- ラタノプロストの視力損失を予防する効果をランダム化され,プラセボ対照の設定で評価する.
主な方法:
- ランダム化,トリプルマスク,プラセボ対照試験で,新たに開角緑内障と診断された516人の患者が参加しました.
- 参加者は,ラタノプロスト0.005%の眼滴またはプラセボを1日1回受けるように割り当てられました.
- 主なアウトカムは24ヶ月以内に視野の悪化までの時間でした.
主要な成果:
- ラタノプロスト群は,24ヶ月後,プラセボ群の0.9mmHgと比較して,平均3.8mmHgの眼内圧低下を示した.
- 視野の保存はラタノプロスト群で有意に長かった (調整された危険比0.44,p=0.0003).
- 研究薬に重篤な有害事象は認められませんでした.
結論:
- これは,オープンアングルグラオコマにおける眼内圧縮薬による視野保存を実証した最初のランダム化プラセボ対照試験です.
- ラタノプロストは,視覚機能を効果的に保ち,開角緑内障の管理におけるその使用をサポートします.
- 研究の設計は,比較的短い観察期間で重要な差異を評価することを可能にしました.
関連する概念動画
Open Angle Glaucoma: Treatment
1.1K
In open-angle glaucoma, the iridocorneal angle remains open, but the trabecular meshwork becomes stiff, slowing down the outflow of aqueous humor. This causes a buildup of aqueous humor in the anterior chamber, leading to a sudden increase in intraocular pressure. The treatment for open-angle glaucoma focuses on reducing the elevated intraocular pressure by either decreasing the secretion of aqueous humor or increasing its outflow.
Drugs such as carbonic anhydrase inhibitors, α2- and...
Drugs such as carbonic anhydrase inhibitors, α2- and...
1.1K
Angle Closure Glaucoma: Treatment
1.7K
Angle-closure glaucoma, or closed-angle glaucoma, is an eye condition where the iris bulges out and blocks the iridocorneal angle, resulting in a buildup of aqueous humor and increased intraocular pressure. Immediate medical attention is necessary due to the sudden onset of symptoms. The treatment for angle-closure glaucoma includes short-term and long-term approaches. Short-term treatment involves using eye drops like pilocarpine to lower intraocular pressure by increasing aqueous humor...
1.7K
Glaucoma: Overview
1.7K
Glaucoma is an eye condition characterized by increased intraocular pressure that damages the retina and optic nerve, leading to irreversible blindness if left untreated. The human eye has various components, including the cornea, iris, pupil, lens, and optic nerve. Aqueous humor is secreted by the epithelium of the ciliary body in the posterior chamber and flows through the trabecular meshwork and canal of Schlemm, maintaining normal intraocular pressure. The trabecular meshwork and the canal...
1.7K
Ophthalmic Drug Delivery Systems
252
Ophthalmic drug delivery faces major limitations due to poor absorption across the corneal membrane. This process is primarily driven by diffusion and is influenced by two main factors: the physicochemical properties of the drug and tear drainage. Most ophthalmic drugs, such as pilocarpine, epinephrine, atropine, and local anesthetics, are weak bases. They are typically formulated at an acidic pH to enhance chemical stability. However, this leads to high ionization, reducing their ability to...
252
Blinding
4.2K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
4.2K


