目的：宏观了解2015—2020年中国眼科药物临床试验情况，为我国眼科药物的研发和临床研究提供最新数据参考，为相关决策提供依据。方法：自国家药品监督管理总局药物临床试验登记与信息公示平台登记数据库提取2015—2020年登记的眼科药物临床试验和相关试验药物信息，汇总分析眼科药物临床试验数量、试验分期、试验范围、适应证、药物类型等。结果：2015年1月1日至2020年12月31日共登记98项眼科临床试验。统计每年眼科药物临床试验登记数量，2020年登记的数量最多(28项，占28.57%)；申办方类型中，国内制药企业(75项，占76.53%)发起的眼科药物临床试验数量远高于外资制药企业(23项，占23.47%)；试验分期中，I期临床试验最多(35项，占35.71%)，III期次之(30项，占30.61%)；药物类型中，生物制品数量最多(55项，占56.12%)，化学药物次之(36项，占36.73%)。结论：近6年来，我国眼科药物临床试验进入蓬勃发展时期，尤其是眼底科领域，近2年发展迅速。在创新药领域，国内制药企业已成为眼科新药研发的中坚力量。但创新药大部分集中在眼底科领域，在青光眼、干眼等领域仍需要继续创新。
Objective: To get a macro understanding of the clinical trials of ophthalmic drugs in China from 2015 to 2020, provide the latest data reference for development of ophthalmic drugs and clinical research in China, and provide the basis for relevant decision-making. Methods: The number of clinical trials and related investigational products from 2015 to 2020 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies. Characteristics on number, stage, scope, indications, type were summarized and depicted. Results: There were 98 ophthalmic clinical trials registered in China from January 1, 2015 and December 31, 2020. The year of 2020 hit the highest record of registered ophthalmic clinical trials for 28, accounting for 28.57%. Among sponsor, 75 (accounting for 76.53%) were initiated by domestic pharmaceutical enterprises, much higher than initiated by foreign pharmaceutical enterprises (23, accounting for 23.47%). Among stage, the quantity of phase I (35, accounting for 35.71%) was the largest, followed by phase III (30, accounting for 30.61%). Among type, the quantity of biological product was the largest (55, accounting for 56.12%), followed by chemical product (36, accounting for 36.73%). Conclusion: The past 6 years have seen vigorous growth of ophthalmic clinical trials, particularly in the last 2 years in the field of fundus. Domestic pharmaceutical enterprises have become the central pillar of ophthalmic drugs renovation. However, their focus is limited to fundus, innovation is still needed in areas such as glaucoma xerophthalmia.
目的：探究角膜移植日间手术患者的延续护理需求现状及其影响因素。方法：采用便利抽样法抽取行角膜移植日间手术的173例患者，采用课题组自行设计的一般资料调查表、角膜移植日间手术患者延续护理需求调查问卷进行调查。采用独立样本t检验、单因素方差分析、多元线性回归进行统计分析。结果：角膜移植日间术后患者延续护理需求得分为88.13±15.55，其中，对疾病相关知识的需求得分最高，为4.39±0.66，对心理护理的需求得分最低，为2.72±1.18；在延续护理实施方式方面，74.6%患者倾向于电话随访，只有5.8%倾向于上门服务；在影响因素方面，婚姻状况、视力、家庭月收入、文化程度是延续护理需求的影响因素。结论：角膜移植日间术后患者的延续护理需求较高，应根据患者延续护理需求及影响因素进行个性化指导，以提高角膜移植手术的成功率和减少并发症的发生。
Objective: To explore transition care needs among patients with keratoplasty in day ward and analyze the influencing factors. Methods: Using convenience sampling method, 173 patients undergoing keratoplasty in day ward were selected, and they were investigated by using a self-designed general information questionnaire and a questionnaire of transitional care needs of patients with keratoplasty in day ward. T-test, one-way analysis of variance (ANOVA), multiple linear regression were used to analyze the data. Results: The total score of transitional care needs among patients with keratoplasty in day ward was 88.13±15.55. The demand for disease related knowledge was the highest (4.39±0.66), the demand for mental nursing was the lowest (2.72±1.18). In terms of the way of implementation, 74.6% patients preferred telephone follow-up and only 5.8% preferred door-to-door service. Single-factor analysis showed that marital status, vision, monthly income, educational level were the factors influencing the demand for transitional care (P<0.05). Conclusion: Patients with keratoplasty in day ward have a high demand for transitional care. In order to improve the success rate of keratoplasty and reduce the incidence of complications, personalized guidance should be given according to patients’ transitional care needs and influencing factors.
角膜异物是眼科急诊中常见病之一，不及时处置或处置不当会导致角膜不同程度的损伤，严重者可引起角膜感染、角膜穿孔等并发症，严重损害视功能。因此安全、高效地剔除角膜异物至关重要。本文从角膜异物的特点、伤后首诊时间、角膜合并感染以及角膜异物的剔除方法等方面对角膜异物剔除术预后的影响进行回顾总结，旨在为医护人员行角膜异物剔除时提供有用参考。
Corneal foreign body is one of common diseases in ophthalmic emergency. Improper handling can cause different degree of corneal injuries, even corneal infection, perforation and endophthalmitis. Therefore, it is essential to eliminate corneal foreign bodies safely and effectively. This article mainly summarizes the influence of the characteristics of the corneal foreign bodies, the first diagnosis time after injury, corneal co-infection and the methods of weeding out the corneal foreign bodies upon the clinical prognosis of corneal foreign body removal, aiming to provide useful reference for medical practitioners in removing corneal foreign bodies.
目的：评价不同操作者使用视网膜自动图像分析(automated retinal image analyzer，ARIA)软件测量糖尿病患者视网膜血管管径和迂曲度的重复性和再现性。方法：采用前瞻性诊断性试验研究设计，由2名熟练操作者应用ARIA软件对49名糖尿病患者以视盘为中心的45°数码眼底彩照进行视网膜血管半自动分析。通过测量距离视盘0.5~1.0个视盘直径内的视网膜动静脉血管参数，各选取6条最粗的动静脉综合计算得到中央动脉管径当量(central retinal artery equivalent，CRAE)、视网膜中央静脉管径当量(central retinal vein equivalent，CRVE)、视网膜动静脉比值(arteriole-to-venule ratio，AVR)、平均视网膜动脉迂曲度(mean retinal arteriolar tortuosity，MRAT)、平均视网膜静脉迂曲度(mean retinal venular tortuosity，MRVT)。在此基础上，评价同一操作者与不同操作者间测量结果的重复性和再现性，并绘制Bland-Altman图进行一致性分析。结果：操作者A两次测量的CRAE、CRVE、AVR差异无统计学意义(t= -0.089、-1.425、1.214，均P>0.05)，重复性良好(ICC≥0.725)且高度正相关(r≥0.721)。操作者A与操作者B对同一受试者2次测量的CRAE、CRVE、AVR差异无统计学意义(t= -1.169、-0.050、0.941，均P>0.05)，再现性良好(ICC≥0.750)且高度正相关( r≥0.697)。同一操作者和不同操作者间的MR AT、MRVT差异无统计学意义(P≥0.05)，Spearman非参数相关性分析重复性和再现性较好(r≥0.571，r≥0.588，均P<0.01)。结论：利用ARIA软件测量糖尿病患者视网膜血管管径及迂曲度具有良好的重复性和再现性。
Objective: To assess the repeatability and reproducibility in measurements of retinal vessel diameter and tortuosity in diabetic patients using the Automated Retinal Image Analyzer (ARIA). Methods: A prospective diagnostic trial was performed; 2 skilled researchers performed a semi-automatic analysis of retinal vessels in digital color fundus photography (45° field of view centered on the optic disc) from 49 diabetic patients using ARIA software. Six largest arterioles and venules coursing through an area of 0.5–1.0 disc diameter surrounding the optic disc were selected. Then the retinal vessel parameters were calculated into the central retinal artery equivalent (CRAE), central retinal vein equivalent (CRVE), arteriole-to-venule ratio (AVR), mean retinal arteriolar tortuosity (MRAT) and mean retinal venular tortuosity (MRVT). To evaluate the repeatability of those values in 2 measurements by the same researcher and the reproducibility between different researchers. Bland-Altman analysis was employed to assess the agreement of the outcomes. Results: There was no significant difference in the CRAE, CRVE, and AVR values in the two-time measurements of researcher A (t= -0.089, -1.425 and 1.214, all P>0.05). It also showed a good repeatability and a highly positive correlation (ICC≥0.725, r≥0.721). There was no significant difference in those measurements between researcher A and B (t= -1.169, -0.050, 0.941, all P>0.05). It also showed a good reproducibility and a highly positive correlation (ICC≥0.750, r≥0.697). Results showed that there was no significant difference in the MRAT and MRVT values both in intraobserver and interobserver measurements (P≥0.05). Besides, Spearman’s nonparametric correlation analysis showed good repeatability and reproducibility (r≥0.571, r≥0.588, all P<0.01). Conclusion: ARIA software yields good repeatability and reproducibility in the measurements of retinal vessel diameter and tortuosity in diabetic patients.
过敏性结膜炎经典的发病机制包括了IgE介导的I型超敏反应以及T淋巴细胞介导的IV型超敏反应，其中肥大细胞、肥大细胞脱颗粒释放的组胺、嗜酸性粒细胞等在过敏性结膜炎病理发展中发挥了重要作用。然而，临床发现针对上述机制的治疗药物临床疗效欠佳，有相当数量的过敏性结膜炎患者无法获得较好的生存质量，因此研究和阐明过敏性结膜炎的新机制，寻找新的治疗手段和药物靶点具有重要的临床意义。目前研究发现Th17细胞等多种炎性细胞和IL-17等细胞因子、过敏原介导神经调节机制、菌群失调机制、脂质介质作用方面可能与过敏性结膜炎发病相关，这对过敏性结膜炎新机制的研究有着重大的临床意义。本文将对过敏性结膜炎发病机制的新进展进行综述，以期为过敏性结膜炎的治疗提供新思路。
The classic pathogeneses of allergic conjunctivitis include type I hypersensitivity and type IV hypersensitivity, in which mast cells, eosinophils and some active substances such as histamine play important role. However, sincethe therapeutic drugs have not achieved satisfactory efficacy in clinical practices, a significant number of patients fail to achieve a good quality of life. The pathogenesis of allergic conjunctivitis remains to be further studied.Current studies have identified a variety of inflammatory cells such as Th17 cell and cytokines such as IL-17, the mechanisms of neuromodulation, flora dysregulation mechanisms, and lipid mediators that may be involved in the pathogenesis of allergic conjunctivitis, which has significant clinical implications for the study of mechanisms of allergic conjunctivitis. In this article, we will review the recent research progress of the pathogenesis of allergic conjunctivitis in order to provide new ideas for the treatment of allergic conjunctivitis.
睑板腺功能障碍(meibomian gland dysfunction，MGD)是一种慢性、弥漫性的睑板腺病变，通常以睑板腺终末导管的阻塞或分泌的睑脂数量或质量发生改变为特征，临床上可以引起泪膜异常、角膜上皮损害、眼部刺激等干眼表现。MGD病因复杂且受多种因素影响，因此MGD发病机制的研究对于指导临床工作至关重要。本文对研究MGD的动物模型进行了介绍，并根据一些基础研究对MGD相关的细胞及分子机制等方面进行综述。
Meibomian gland dysfunction (MGD) is a chronic and diffuse disease of the eyelid gland. It is usually characterized by obstruction of the terminal duct of the eyelid gland or changes in the quantity/quality of the eyelid fat secreted. It can clinically cause dry eye symptoms such as abnormal tear film, corneal epithelial damage and eye irritation. The etiology of MGD is complex and affected by a variety of factors. Therefore, the study on the pathogenesis of MGD is of great importance to guide clinical work. This article introduces the animal research model of MGD, and reviews the cellular and molecular mechanisms related to MGD based on some basic research.
目的：探讨基因多态性与2型糖尿病(type 2 diabetes mellitus，T2DM)患者发生增生性糖尿病性视网膜病变(proliferative diabetic retinopathy，PDR)的相关性。方法：2019年1月至2020年9月桂林医学院附属医院收治的700名T2DM患者，分为无糖尿病性视网膜病变(non-diabetic retinopathy，NDR)组(n=386)与PDR组(n=314)。收集临床基本资料，抽取患者外周血，使用竞争性等位基因特异性聚合酶链反应(kompetitive allele specific polymerase chain reaction，KASP)基因分型检测法检测两组患者血清中的内皮素-1(endothelin 1，EDN1)基因的rs5370位点和补体因子H(complement factor H，CFH)基因的rs800292位点基因型。用logistic回归分析这2个基因位点的多态性与广西汉族T2DM患PDR的关系。结果：收缩压、使用胰岛素治疗以及肾小球滤过率(glomerular filtration rate，GFR)的分析结果显示两组间差异有统计学意义(P收缩压=0.025，P胰岛素=0.001，PGFR=0.013)。排除以上混杂因素后，EDN1基因的rs5370位点上TT基因型与PDR易感性呈正相关(P=0.03，OR=2.973；adj.P=0.011，OR=2.718)；CFH基因的rs800292位点上AA基因型与PDR易感性呈正相关(P=0.037，OR=1.949；adj.P=0.044，OR=2.058)。结论：收缩压增高、GFR降低可能与T2DM患者发生PDR相关。EDN1基因的rs5370位点与CFH基因的rs800292位点的多态性与广西汉族人群的PDR易感性显著相关。
Objective: To investigate the relationship between gene-polymorphisms and proliferative diabetic retinopathy in patients who have type 2 diabetes mellitus (T2DM). Method: A total of 700 hospitalized T2DM patients were included in this study from January 2019 to September 2020. They were divided into two groups: the no-diabetic retinopathy (NDR) group (n=386) and the proliferative diabetic retinopathy (PDR) group (n=314). Basic clinical data were collected, and clinical indexes affecting diabetic retinopathy were analyzed. Two tag SNPs rs5370 in endothelin 1 (EDN1) and rs800292 in complement factor H (CFH) were examined using kompetitive allele-specific polymerase chain reaction (KASP) genotyping assays. Logistic regression was used to analyse the relationship between the polymorphisms of these two SNPs and PDR in a Guangxi Han population with T2DM. Results: Significant differences were found through the analysis of the systolic blood pressure—whether using insulin or not—and the glomerular filtration rate (GFR) between the two groups (Psystolic blood pressure=0.025, Pinsulin=0.001, PGFR=0.013) The TT genotype of rs5370 was determined to be associated with an increased risk of PDR (P=0.03, OR=2.973; adj.P=0.011, OR=2.718). The AA genotype of rs800292 was also determined to be associated with an increased risk of PDR (P=0.037, OR=1.949; adj.P=0.044, OR=2.058). Conclusion: Increased systolic blood pressure and decreased GFR may be associated with PDR in patients with T2DM. The rs5370 polymorphism of the EDN1 gene and the rs800292 polymorphism of the CFH gene are significantly associated with the risk of PDR in Guangxi’s Han population.
目的：了解近5年世界干眼研究的文献分布特征，并分析这一领域的研究趋势及研究热点。方法：以Web of Science核心数据库(WoSCC)为基础，采用文献计量学方法对干眼相关的全球研究趋势进行评估。通过VOSviewer v.1.6.16构建知识图谱，可视化了该领域的出版物、国家/地区分布、国际合作、作者、来源期刊和研究热点。另外，用CiteSpace IV来捕获爆发的关键词，探索热点的兴起和没落时间，以发现研究前沿。结果：在2016—2020年间共检索到2 567篇同行评议文章，其中美国是发表文献数量最多的国家，文献产量最高的机构是日本的庆应义塾大学。Kazuo Tsubota是该领域发表论文最多的作者，MA Lemp是被引次数最多的作者。Ocular Surface是干眼研究中发表文章最多的杂志。被引用最多的文献主要是TFOS Dr y Eye Workshop II发表的干眼系列报道。关键词聚类分析得出6大类：1)致病机制和病理生理；2)定义和分类；3)流行病学研究；4)治疗；5)继发性干眼；6)诊断。目前的研究前沿是眼痛、瑞巴派特、小切口角膜基质透镜取出术(small incision lenticule extraction，SMILE)手术和泪膜动力学。结论：本研究通过对国际干眼领域近5年的文献进行文献计量学分析，可视化呈现了最近这一领域的研究现状、热点及前沿。干眼研究的前沿主题是眼痛、瑞巴派特、SMILE手术和泪液动力学。
Objective: To understand the literature distribution characteristics of dry eye research in the world in the last 5 years, and to analyze the research trend and hotspots in this field. Methods: Based on the Web of Science Core Collection (WoSCC) database, a bibliometric analysis was conducted to evaluate the global research trends related to dry eye. Knowledge mappings were constructed by VOSviewer v.1.6.16 to visualize the publications, the distribution of countries, international collaborations, author productivity, source journals, and research hotspots in this fifield. In addition, CiteSpace IV was used to capture the keywords of outbreaks and to explore the rise and fall of hotspots. Research frontiers could be discovered by this analysis. Results: In total, 2 567 peer-reviewed articles were retrieved on dry eye research from 2016 to 2020. The United States ranked the highest among countries withthe most publications. The most productive institution was the Keio University. Kazuo Tsubota contributed the largest number of publications in this field, and MA Lemp was the most cited author. Ocular Surface was the most prolific journal in dry eye research. The top-cited references were mainly about the reports of the International Workshop on Meibomian Gland Dysfunction (MGD). The most cited literature was mainly dry eye series reports by TFOS Dry Eye Workshop II. Six categories were obtained by cluster analysis: 1) pathogenic mechanism and pathophysiology; 2) definition and classification; 3) epidemiological study; 4) treatment; 5) secondary dry eye; 6) diagnosis. Current research foreword is ocular pain, rebamipide, small incision lenticule extraction (SMILE) surgery, and tear film dynamics. Conclusion: Through the bibliometrics analysis of the international literature in the field of dry eye in the past five years, this study visualized the current research status, hotspots, and frontier in this field. Leading topics in dry eye research are eye pain, rebamipide, SMILE surgery, and tear dynamics.
目的：探讨多元化宣教在提高眼科日间手术患者眼部用药正确率及满意度的应用效果。方法：采用便利抽样的方法，选取中山大学中山眼科中心2020年10至12月收治的200例眼科日间手术患者眼部用药的执行者为对象，将10至11月收治的100例日间手术患者眼部用药的执行者纳入对照组，将12月收治的100例日间手术患者眼部用药的执行者纳入试验组。对照组采取传统宣教方式，试验组应用多元化宣教模式进行健康教育。采用自制的健康教育需求调查表调查眼部用药执行者的健康教育需求，采用眼部用药执行评价表、健康宣教满意度调查表评价干预效果。结果：采用多元化宣教方式干预后，试验组患者眼部用药正确率(94%)高于对照组(35%)，差异具有统计学意义(P<0.05)。试验组对多元化宣教满意度得分明显高于对照组，差异具有统计学意义(P<0.05)。结论：多元化宣教模式可提高眼科日间手术患者眼部用药正确率，提高患者及家属的满意度，值得临床推广应用。
Objective: To explore the effect of diversified education on improving the accuracy and satisfaction of eye medication in patients undergoing ophthalmic ambulatory surgery. Methods: A total of 200 practitioners of administering eye medication after undergoing ambulatory surgery in Zhongshan Ophthalmic Center, Sun Yat-sen University from October to December 2020 were investigated by convenience sampling, 100 practitioners admitted from October to November were included in the control group, and 100 practitioners were included in the experimental group. The control group adopted the traditional method of education, while the experimental group applied diversified education mode to carry out health education. The health education needs of the patients were investigated by the self-made health education needs questionnaire, and the effect of intervention wasevaluated by the eye medication implementation evaluation form and health education satisfaction questionnaire. Results: After the intervention, the correct rate of eye medication in experimental group (94%) was higher than the control group (35%) with a statistical difference (P<0.05). The satisfaction score about diversified education in experimental group was significantly higher than the control group with a statistical difference (P<0.05).Conclusion: Diversified education model can improve the accuracy of administering eye medication in patientsundergoing ophthalmic ambulatory surgery, and the satisfaction in patients and their families is significantly improved. It is worthy of clinical application.
目的：分析眼科超说明书用药使用情况，为眼科临床合理用药提供有效、安全的循证参考依据。方法：考察并收集21家爱尔眼科医院集团眼科中心城市及省会级医院备案的超说明书用药情况，同时抽查处方、医嘱用药，对超说明书用药情况进行充分论证评估，参考广东省、山东省等超说明书用药共识、文献，进行统计、分析和归纳，并征求相关眼科临床专家意见。结果：梳理指南、共识及期刊论文等循证医学证据，得出超说明书用药推荐级别1级8项、2级29项、3级24项，并编写了供集团内使用的《眼科医院眼科超药品说明书用药参考目录(2021年版)》，便于临床参考使用。在眼科常用有32种超说明书药品，61项超说明书用药，其中超给药途径32项(52.5%)、超适应证用药13项(21.3%)、超适应证合并超给药途径14项(23.0%)。超说明书品种及超说明用药项目数均以抗菌药物最多，分别为13个(40.6%)品种，26项(42.6%)。结论：眼科因特殊的给药途径，超说明书用药比较普遍，而如抗菌药物注射剂使用眼内注射或滴眼等超说明书用药方式对某些急性眼内感染性疾病起到了很好的治疗效果。规范眼科超说明书用药，是防范医疗风险的必要措施。
Objective: To investigate off-label ophthalmic medications, and provide an effective and safe evidence-based reference for the rational use of ophthalmic drugs. Methods: On the basis of collecting the off-label drug use recorded in 21 Aier Eye Hospital Group which including ophthalmic central cities and provincial capital level hospitals, and spot checking the prescription and doctor’s order drug use, this article conducted full demonstration and evaluation of off-label drug use which referred to the off-label drug used consensus of Guangdong and Shandong, and other literature on the off-label drug use in ophthalmology. The paper conducted statistics, analysis and induction, and solicited the opinions of relevant ophthalmology clinical experts. Results: Sorting out the evidence of the guides,consensus, journal papers and other evidence-based medicine in ophthalmic medication, recommending 8 items of level 1, 29 items of level 2, and 24 items of level 3, we compiled the “Reference catalogue for the off-label drug use in ophthalmic hospital (2021 edition)” within the group which can providing reference for clinical use. There were 61 off-label drugs commonly used in ophthalmology, involving 32 drugs. Among them, 32 items (52.5%) were used by over administration route, 13 items (21.3%) were used by over indication, and 14 items (23.0%) were used by over indication and administration route. Antibacterial drugs were the most frequently used in the varieties and items of off-label drug use, accounting for 13 (40.6%) and 26 (42.6%) respectively. Conclusion: Ophthalmic off-label medications are common owing to the special route of administration. Such as intraocular injection or eye drop have played a good role in the treatment of some ocular infectious diseases. Standardizing the off-label drug use of ophthalmology is an effective measure to reducing medical risks.
