原发性干燥综合征(primary Sj?gren’s syndrome，SS)是一种主要累及外分泌腺体的自身免疫性疾病，患者通常因为严重的干眼症状首先就诊于眼科，大多数临床医师对原发性干燥综合征相关性干眼(Sj?gren’s syndrome dry eye disease，SS-DED)认识不足，可能导致漏诊和误诊。侵入性极小的客观检查及生物标志物的发展，将有助于发现SS-DED的真面目，并可能从新的角度阐释其发病机制，为其诊断、分类及治疗提供新的思路。SS-DED的治疗没有特效的药物，大多数患者需接受多种方法的治疗，以了解哪些方法最有效。
Primary Sj?gren’s syndrome is an autoimmune disease that mainly affects exocrine glands. Patients usually refer to ophthalmologists because of severe dry eye symptoms. Most clinicians have insufficient knowledge with dry eye disease associated with primary Sj?gren’s syndrome probably leading to misdiagnosis or missing the diagnosis.The diagnosis of Sj?gren’s syndrome dry eye disease (SS-DED) is difficult, but the extremely invasive objective examination and the development of biomarkers will help to understand this disease and explain its pathogenesis from a new perspective. There is no specific treatment for the SS-DED, and most patients should receive multiple treatments to select the optimal treatment.
目的：探讨眼科住院医师规范化培训中睑板腺囊肿诊疗的培训效果及存在的问题，以期改进培训方式。方法：以2020年4月在中山大学中山眼科中心培训的154名学员为对象，进行问卷调查，采用SPSS 20.0统计学软件进行数据分析。结果：共76名专业型硕士(专硕)、78名住院医师培训(住培)学员完成了问卷调查。专硕具有睑板腺囊肿诊断、保守治疗及手术主刀经验的比例分别为40.8%、11.8%、7.9%；住培则显著高于前者，分别为79.5%(P<0.001)、60.3%(P<0.001)和21.8%(P=0.016)。对于关键诊疗环节的判断，90.8%的专硕选择了临床诊断(P=0.007)，94.9%的住培则选择治疗方案(P<0.001)。去除囊壁、术中意外与破溃皮肤的处理是专硕难以掌握的手术步骤(P<0.001)；而住培仅为去除囊壁(P<0.001)。结论：睑板腺囊肿诊疗水平在眼科住院医师规范化培训中亟待提高，并根据各类型学员的临床能力和认知差异，进行分级分类培训。
Objective: To explore the teaching effect of diagnosis and treatment on chalazion in the standardized training of ophthalmology residents and its existing problems, in order to improve the quality of the training systems. Methods: A self-designed questionnaire survey was conducted with 154 ophthalmology residents in Zhongshan Ophthalmic Center in April 2020, and the investigative data was analyzed using SPSS 20.0. Results: Totally 76 medical postgraduates and 78 ophthalmology residents completed the questionnaire survey. The proportions of medical postgraduates who had individual experience on diagnosis, conservative and surgical treatment of chalazion were 40.8%, 11.8%, and 7.9%. Compared to the former, ophthalmology residents had significantly higher proportion, with 79.5% (P<0.001), 60.3% (P<0.001), and 21.8% (P=0.016), respectively. For judging the important aspect of diagnosis and treatment process, the medical postgraduates chose the clinical diagnosis (90.8%) (P=0.007), while the ophthalmology residents paid more attention on treatment options (94.9%) (P<0.001). In the surgical procedures, removal of cyst wall, management of intraoperative accidents and skin ulcers are all their difficult skills to master for medical postgraduates (P<0.001), while only removal of cyst wall for residents (P<0.001). Conclusion: The training level of diagnosis and treatment of chalazion still needs to be improved in the standardized training of ophthalmology residents. The training should be carried out according to the clinical competence and cognition differences of various types of students.
眼附属器淋巴组织增生性疾病作为一类疾病的总称，包括了良性淋巴组织增生、非典型性淋巴组织增生、IgG4相关眼病以及多种恶性淋巴瘤在内的数十种疾病类型。临床诊断此类疾病应将患者眼部体征、影像学检查与病理学检查紧密结合。随着免疫表型及分子病理等检测技术的进步，此类疾病之间的鉴别诊断正逐渐清晰。本文就眼附属器淋巴组织增生性疾病进行系统性描述，并重点探讨该类疾病的病理鉴别诊断。
Ocular adnexal lymphoproliferative disease, as a general term, contains reactive lymphoid hyperplasia, atypical lymphoid hyperplasia, IgG4 related ocular disease and malignant lymphoma. The clinical diagnosis of this kind of disease should integrate patient’s symptoms, imaging features and pathology characteristics. Development of immunophenotyping, molecular pathology and other detection technology will help with the differential diagnosis of ocular adnexal lymphoproliferative disease. This article is going to discuss the etiology, epidemiology,diagnosis and treatment of ocular adnexal lymphoproliferative disease, with a focus on the clinicopathological differential diagnosis of such disease.
目的：借助于人工智能(artificial intelligence,AI)眼底筛查远程接转诊系统，探索“患者-社区-医院”远程筛查模式，推进眼科分级诊疗和双向转诊实施，为地市级医疗机构开展眼底疾病人工智能筛查工作提供一定的经验借鉴。方法：通过AI辅助远程筛查基层医疗机构的4886例患者，完成眼科检查并经AI初判、人工复核形成眼底诊断结论。通过医联体和专科联盟模式，对基层医疗机构的4886例患者的AI诊断系统结果和上级医师审核结果进行对照分析，分析AI诊断系统在眼科常见病种筛查中的推广应用的可信度和可行性。结果：AI检出DR的灵敏度为94.70%，特异度96.06%；DME的灵敏度96.43%，特异度96.55%；AMD的灵敏度77.55%，特异度95.74%；同时，其在病理性近视、白内障、青光眼等常见病种眼底筛查中也有一定作用。结论：AI辅助远程筛查系统对于绝大多数眼底疾病有较高的敏感性和特异性，适用于眼底疾病的筛查工作，利于基层医院或社区医院对于眼底疾病的初步诊断，落实眼科分级诊疗，有借鉴推广意义。
Objective: With the help of artificial intelligence (AI) based fundus screening remote referral telemedicine system,it enables us to explore the remote screening mode of patient-community-hospital, and promote the two-way referral and ophthalmic graded diagnosis. This investigation provides certain practice experiences for prefecture-level medical institutions to carry out AI screening for fundus diseases. Methods: Ophthalmologic examination was performed on 4,886 patients in primary medical institutions through AI-aided remote screening, and the final fundus diagnosis conclusion was formed after AI preliminary judgment and manual review. Through the Medical Consortium and specialty alliance model, the results of the AI diagnosis system and the audit results of superior physicians for 4 886 patients in primary care institutions were compared and analyzed, and the credibility and feasibility of the AI diagnosis system application in the screening of common ophthalmic diseases were discussed. Results: The sensitivity and specificity of AI detection of diabetic retinopathy were 94.70% and 96.06%, respectively. In the diabetic macular edema classification, the sensitivity and specificity were 96.43% and 96.55%, respectively. In the age-related macular degeneration classification, the sensitivity and specificity were 77.55% and 95.74%, respectively. Meanwhile, it also plays a role in screening common fundus diseases such as pathological myopia, cataract and glaucoma. Conclusion: The AI-aided remote screening system has high sensitivity and specificity for most of fundus diseases, indicating it is promising for fundus diseases screening in primary medical institutions. It is conducive for primary hospitals or community hospitals to carry out the initial diagnosis of fundus diseases, as well as the implementation of graded diagnosis and treatment of ophthalmology, which has reference and promotion significance.
在大力发展精准医疗的时代背景下，北京大学第三医院眼科中心率先建立干眼精准医疗平台。通过规范和优化干眼诊疗流程，为患者提供个性化的治疗方案和预防指导意见，有效提高了干眼诊断的精确性与治疗的有效性，同时提升了干眼门诊接诊效能，改善了患者就诊体验。本文将从干眼精准医疗平台体系的建设内容、标准化的检查流程、个性化的诊疗方案等方面进行阐述，并结合实际临床案例，综合分析北京大学第三医院在干眼精准医疗方面进行的探索，展望干眼精准医疗平台的前景与未来。
In the era of developing precision medicine, the Ophthalmic Center of Peking University Third Hospital has taken the lead in establishing a dry eye precision medical platform. By standardizing and optimizing the diagnosis and treatment process of dry eye, this center provides personalized treatment plan and prevention guidance for patients, effectively improves the accuracy of dry eye diagnosis and the effectiveness of treatment, at the same time,improves the reception efficiency of dry eye clinic, and improves the patient’s clinic experience. In this paper, the construction content, standardized inspection process and personalized diagnosis and treatment scheme of dry eye precision medicine platform system will be described. Combined with the actual clinical cases, the exploration of the Peking University Third Hospital in dry eye precision medicine will be comprehensively analyzed, and the future of dry eye precision medical platform will be prospected.
泪膜的不同组成成分通过相互作用共同维持眼球表面的湿润，从而维持眼部健康。当这些组成成分出现病理性改变，将会不同程度的影响泪膜稳态，从而导致干眼的发生。而瞬目运动一定程度上影响着泪膜组成成分的分布，随着对干眼相关机制研究的逐步深入，以泪膜为导向的诊断(tear-film-oriented diagnosis，TFOD)的新概念被提出，并被逐渐被接受。我们可以通过泪膜破裂方式来确定眼球表面所缺乏的组成成分，并在此基础上对干眼进行诊断，从而定向补充泪膜缺失成分，重新恢复泪膜稳态。本文将着重分析瞬目、泪膜形成及泪膜破裂机制之间的关系，从而进一步明确泪膜定向诊断的新概念及发展方向。
Different components of the tear film work together to maintain the wettability of the ocular surface, thus maintaining eye health. When the pathological changes of these components occur, the tear film homeostasis will be affected to varying degrees, leading to dry eye. Blinking movement affects the distribution of tear film components to some extent. With the continuous development of research and understanding of the concept and mechanism of dry eye, new concepts of tear-film-oriented diagnosis (TFOD) have been gradually proposed and widely accepted. We can determine the components lacking on the surface of the eye through the tear film breakup patterns (BUPs). On this basis, dry eye is diagnosed, so as to replenish the lacking components of tear film directionally and restore the stability of tear film. This paper will focus on analyzing the relationship between blinking, tear film formation and tear film break-up mechanism, so as to further clarify the new concept and development direction of tear-film oriented diagnosis.
近视性黄斑病变(myopic maculopathy，MM)是近视最常见的并发症，也是影响病理性近视视功能下降的主要原因。目前，MM的分类系统尚不能完全解释患者黄斑部发生的多种变化，迫切需要一个全面、统一的分类系统来协助沟通和比较临床试验以及国际多中心研究的结果。随着眼底成像技术的发展与应用，最新的近视性黄斑病变分类，即ATN分类系统[萎缩(A)、牵拉(T)、和新生血管(N)]结合眼底照片与光学相干断层扫描(optical coherence tomography，OCT)图片，把黄斑病变分为3类，每一类又根据其严重程度进行分级，这对MM的诊断和治疗提供了较大的临床价值。
Myopic maculopathy (MM) is the most common complication of myopia, which is also the main cause of poor visual function in pathologic myopia. Presently, the classification system of MM cannot properly explain the numerous changes that occur in the patient’s macula. Therefore, a comprehensive and unified classification system is urgently needed to facilitate in communicating and comparing the results of clinical trials and international multicenter studies. With the development and application of fundus imaging technology, the latest classification of MM, namely ATN (atrophy, A; traction, T; neovascularization, N) classificationsystem, which combines fundus photographs and optical coherence tomography (OCT) images, classifies macular lesions into 3 categories according to its severity, generating greater clinical value for the diagnosis and treatment of MM.
目的：探讨PDCA循环管理模式在优化白内障日间患者诊疗流程中的应用与成效。方法：选取中山大学中山眼科中心白内障病区2018年9月至2019年12月收治的白内障日间患者400例作为试验对象，选择2018年9月至2019年4月200例患者作为优化前组，选择实施PDCA循环管理模式后的2019年5月至2019年12月的200例患者作为优化后组。统计并比较两组患者实施前后的术前检查时长、住院时长、术后第1天复诊路径及患者满意度。结果：PDCA循环管理法实施了7个月后，患者术前检查时长由优化前的(2.94±2.12) h降至(2.09±0.93) h，住院时长由优化前的(22.73±1.14) h 降至(5.22±1.29) h，差异均具有统计学意义( P <0.001)；患者满意度由优化前的92%上升至96%(P<0.05)；术后第1天，患者复查所需行走的路径缩短，由以前的172 m降至129 m。结论：实施PDCA循环管理模式能有效地改善白内障日间患者的诊疗流程，缩短患者诊疗时间，提高患者的满意度，值得临床推广。
Objective: To explore the application and effect of Plan-Do-Check-Act (PDCA) cycle management mode in optimizing the diagnosis and treatment process of cataract patients with daytime surgery. Methods: A total of 400 cases of patients with daytime surgery admitted to Department of Cataract, Zhongshan Ophthalmic Center,Sun Yat-sen University from September 2018 to December 2019 were selected as the experimental subjects. 200 patients from September 2018 to April 2019 were selected as the pre-optimization group, and 200 patients from May 2019 to December 2019 after the implementation of the PDCA cycle management mode were selected as the post-optimization group. Time of preoperative examination, length of hospital stay, the follow-up path in the first day after surgery and patient satisfaction were statistically compared between the two groups before and after implementation. Results: Seven months after the implementation of PDCA cycle management mode, the preoperative examination time decreased from (2.94±2.12) h to (2.09±0.93) h, and the length of hospital stay decreased from (22.73±1.14) h to (5.22±1.29) h, and the differences were statistically significant (P<0.001); the patients’ satisfaction increased from 92% to 96% (P<0.05); the follow-up path in the first day after operation was changed from the 13th floor (172 m) to the 3rd floor (129 m). Conclusion: The implementation of PDCA cycle management mode can effectively improve the diagnosis and treatment process of cataract patients with daytime surgery, shorten the diagnosis and treatment time and improve the satisfaction of patients, so it is worthy of clinical promotion.
视神经脊髓炎相关性视神经炎(neuromyelitis optica spectrum disorder optic neuritis，NMO-ON)是一种常见的视神经炎(optic neuritis，ON)类型。女性非白种人占优势，损伤严重，双侧受累较多，视力预后差。我国有很大部分特发性ON最终诊断为NMO-ON。在相关实验室、光学相干断层扫描(optical coherence tomography，OCT)、磁共振(magnetic resonance imaging，MRI)等技术支持下，目前对NMO-ON的认识有了很大的进步，治疗方式除了皮质类固醇外还有免疫球蛋白、血浆置换及免疫抑制剂等。但提高NMO-ON的诊疗水平还有很长的路，更好地认识NMO-ON有助于更快速的诊断、更规范的治疗、更良好的预后。我们可以联合神经科开展多中心大样本量前瞻性的临床对照研究。
Neuromyelitis optica spectrum disorder- optic neuritis (NMO-ON) is a common type of optic neuritis (ON). This affliction is predominant in female non-Caucasians, with severe injury, more bilateral involvement, and poor visual prognosis. In China, a large proportion of idiopathic ON is ultimately diagnosed as NMO-ON. Our understanding of NMO-ON has made great progress under the technical support, such as the relevant laboratory, optical coherence tomography (OCT), magnetic resonance imaging (MRI). In addition to corticosteroids, immunoglobulin, plasmapheresis and immunosuppressive agents are also available for treatment. However, there is still a long way to improve the diagnosis and treatment level of NMO-ON. A better understanding of NMO-ON contributes to faster diagnosis, more standardized treatment, and better prognosis. We should cooperate with the neurology department to conduct a multi-center, large sample size prospective clinical control study.
本文根据上海鹰瞳医疗科技有限公司的创新产品《糖尿病视网膜病变眼底图像辅助诊断软件》在国家药品监督管理局(NMPA，原CFDA)历时两年半的上市前创新申报与注册申报经历，介绍了人工智能类医疗器械产品的产品研发、注册申报流程及相关重点难点，并且列明了在整个过程中需要遵循和参考的法律法规，为此类产品的上市前注册工作提供参考。
Based on the NMPA premarket application through two and a half years for the computer aided diagnosis software using fundus images of diabetic retinopathy, which is an innovative medical device of Shanghai EagleVision Medical Technology Co., Ltd. (Airdoc), this article introduced the development process, the premarket application, and the key points in the application of this artificial intelligence device, also lists the related regulations and guidelines as references to provide some ideas for the follow-up premarketing application of such kind of products.
