1%和2%的rebamipide透明溶液在干眼疾病中的有效性和安全性:一个多中心随机试验
Youngsub Eom1,2, So Hyang Chung3, Tae-Young Chung4
1Department of Ophthalmology, Korea University College of Medicine, Seoul, Republic of Korea.
BMC ophthalmology
|August 3, 2023
概括
这项研究发现,1%和2%的雷巴米皮德眼液有效地改善了眼膜分解时间,并稳定了干眼病 (DED) 患者的角膜染色. 这两种度都为DED症状提供了治疗益处.
科学领域:
- 眼科医生 眼科 眼科
- 干眼疾病研究 干眼疾病研究
- 药理疗法 药理疗法 药理疗法
背景情况:
- 干眼病 (DED) 影响着相当一部分人口,造成不适和视力损伤.
- 目前对DED的治疗方法旨在缓解症状并改善眼睛表面的健康.
- 雷巴米皮德是一种粘膜模仿剂,在治疗眼睛表面疾病方面表现出潜力.
研究的目的:
- 评估1%和2%的rebamipide透明溶液在治疗干眼疾病中的有效性.
- 为了比较不同度的rebamipide与安慰剂的治疗效果.
- 评估rebamipide对关键DED临床标志物的影响.
主要方法:
- 一项随机对照试验,涉及220名被诊断患有DED的患者.
- 参与者被分配接受1%的rebamipide,2%的rebamipide或安慰剂眼滴溶液.
- 治疗是每天四次进行12周,有效性通过膜分解时间 (TBUT),染色分数,施密尔1测试和眼睛表面疾病指数 (OSDI) 来评估.
主要成果:
- 与安慰剂组相比,1%和2%的rebamipide组在TBUT中表现出显著的改善.
- 2%的rebamipide组显示出角膜染色得分的减少比安慰剂更大.
- 虽然两种rebamipide度都改善了Schirmer 1测试结果,但只有安慰剂组没有表现出改善. 在所有组中,OSDI得分在所有组中都得到改善,而没有显著的组间差异.
结论:
- 1%和2%的rebamipide透明溶液代表了治疗干眼疾病的有效治疗选择.
- 雷巴米皮德治疗显著提高了膜的稳定性,并有助于稳定角膜染色.
- 这些发现支持rebamipide在改善DED患者眼表面健康的关键客观指标方面的临床实用性.
相关概念视频
Blinding
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.
Ophthalmic Drug Delivery Systems
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...


