我国青光眼临床试验开展的必要性及其面临问题

Glaucoma clinical trials in China

大样本、多中心、随机对照的青光眼临床试验对于指导眼科医师开展青光眼临床研究具有重要作用，其研究结果常作为制订青光眼临床诊疗指南或青光眼工作模式的科学依据。青光眼是重要的致盲眼病之一，其对视神经的损害不可逆转。目前我国青光眼患病率为1．95％～3．60％，面对艰巨的青光眼防治任务，有计划地开展适合我国国情的青光眼临床试验十分必要。虽然我国在开展青光眼临床试验方面已经积累了较多经验，但是与发达国家相比，仍存在较大的差距，主要表现在试验资金短缺、操作规范不够统一、质量参差不齐等方面。因此，很有必要就上述问题进行评述，以引起相关机构和临床眼科医师的高度重视。

Large scale, multicenter, and randomized controlled glaucoma clinical trials are very important clinical research. The results of scientific evidences are useful to make clinical guideline of glaucoma prevention and management or working mode. Glaucoma is the second leading cause of blindness in the world, which is associated with irreversible damage to optic disc. At present, glaucoma prevalence in China was approximately 1. 95% to 3. 60%. In order to effectively prevent and treat glaucoma, it＇s necessary to promote and design glaucoma clinical trials that fit in our national medical care system. Much experience of carrying out clinical glaucoma trials has been obtained and achieved in the past. However, there is still a big gap between China and developed countries in such aspects as funding deficiency, disunity of operational standardization, quality irregularity and so on. This article presents a synthesis of modern principle data concerning glaucoma clinical trials in domestics and abroad aiming at emphasizing the importance of this issue.