中国遗传性视网膜疾病基因治疗手术安全性管理和视功能评价指标设定专家共识  

Expert consensus on the operative safety management and visual function evaluation index setting of gene therapy for inherited retinal diseases in China

作　　者：中华医学会眼科学分会眼底病学组 中国医师协会眼科医师分会眼底病专业委员会 许迅[2] 孙晓东[2] 李彤[2] Fundus Disease Group of Chinese Medical Association Ophthalmology Branch;Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch;Sun Xiaodong;Xu Xun

机构地区：[1]不详 [2]上海交通大学附属第一人民医院,国家眼部疾病临床医学研究中心

出　　处：《中华眼底病杂志》2022年第8期626-635,共10页Chinese Journal of Ocular Fundus Diseases

摘　　要：遗传性视网膜疾病(IRD)是一组严重的视网膜退行性疾病,可造成严重视功能损害,是儿童及工作年龄人群不可逆盲重要病因。基因治疗是临床上全新治疗手段,同时也是IRD目前唯一明确有效的治疗手段,但其在临床研究和应用中仍存在风险,如何在围手术期进行规范管理,降低治疗的潜在风险是保障治疗安全有效的关键措施之一。目前针对IRD基因治疗的围手术期管理尚未形成系统的规范化指导意见。因此,为了规范IRD基因治疗的围手术期管理,中华医学会眼科学分会眼底病学组及中国医师协会眼科医师分会眼底病专业委员会组织国内相关专家,结合国内外研究经验,经过反复讨论,提出了我国IRD基因治疗的围手术期管理的规范化意见,以供临床医师在临床研究和实践中参考应用。Inherited retinal diseases(IRDs)are a group of severe retinal degenerative diseases leading to permanent visual impairment.IRDs are the major cause of irreversible blindness in children and working age groups.Gene therapy is a new clinical treatment method and currently the only clear and effective treatment for IRDs,while,there are still risks in clinical research and application.How to standardize perioperative management and reduce the potential risks of treatment is one of the keys to ensure the safety and effectiveness of treatment.However,there is no systematic and standardized guidance on the perioperative management for IRDs gene therapy.Therefore,in order to standardize the perioperative management,the Fundus Disease Group of Ophthalmology Society of Chinese Medical Association and Chinese Medical Doctor Association organized domestic experts to put forward standardized opinions on the perioperative management of IRDs gene therapy in China after repeated discussion and combined with domestic and foreign research experience,so as to provide clinicians with reference and application in clinical research and practice.

关 键 词：眼疾病 遗传性 视网膜疾病 基因治疗 围手术期管理 多数赞同 

分 类 号：R774.1[医药卫生—眼科] R450[医药卫生—临床医学]