CYSTEAMINE VS. CYSTAMINE TREATMENT OF CORNEAL CRYSTAL ACCUMULATION

成功的半胱胺对照临床试验。 安慰剂已证明半胱胺滴眼液对 肾病患者的晶体摘除 胱氨酸病。因为半胱胺制剂是 在室温下，因为室温下的半胱胺 氧化二硫代半胱胺，有人提出 对这种更稳定的化合物进行安全和 功效。到目前为止，还没有关于 二硫化物的临床疗效，尽管目前 据推测，这种化合物将具有药理作用 在相似的浓度下有效。没有动物模型可供选择 胱氨酸病的存在；因此，临床疗效可以 只有通过有限的人体临床试验才能确定。 然而，在试验之前，关于毒性的经验是 是必要的，并在兔子身上进行了一项研究 测定二硫化合物的毒性范围。 在一项双盲研究中观察了24只兔子 对于半胱胺二硫化物的眼睛毒性测试， 半胱胺。有完整的数据可用，但总而言之， 对0.5%和1%的反应基本上是 与安慰剂没有什么不同。半胱胺2.0% 显示出临床和组织病理学证据 眼缘炎和结膜炎。这项研究是为了执行 一项随机、对照、双盲的临床试验 半胱胺与半胱胺在清除中的等效性 从角膜中提取晶体，并保持“晶体-- 游离“或近乎无晶状体的角膜。

A successful controlled clinical trial of cysteamine vs. placebo has proven the efficacy of cysteamine eyedrops in removing crystals from patients with nephropathic cystinosis. Because th cysteamine preparation is dispensed at room temperature and because room temperature cysteamine oxidizes the disulfide cysteamine, it has been suggested that this more stable compound be studied for safety and efficacy. To date, there have been no studies on the clinical efficacy of the disulfide, although current speculation is that the compound will be pharmacologically active at similar concentrations. No animal model for cystinosis exists; therefore, clinical efficacy can be determined only through limited human clinical trials. Before trials, however, experience with toxicity was necessary, and a study was performed in rabbits to determine the range of toxicity of the disulfide compound. Twenty-four rabbits were observed in a double-blind study for ocular toxicity testing of cysteamine disulfide, cystamine. Complete data are available, but, in summary, the reaction to 0.5 percent and 1 percent was essentially no different from the placebo. Cysteamine 2.0 percent showed both clinical and histopathologic evidence of blepharitis and conjunctivitis. This study is to perform a randomized, controlled, double-masked clinical trial of cysteamine vs. cystamine for equivalency in removing crystals from the cornea and in maintaining a "crystal- free" or near crystal-free cornea.