糖尿病视网膜病变(diabetes retinopathy, DR)是糖尿病常见的眼部并发症，其病理过程复杂，涉及多种细胞及炎症因子。Müller细胞作为视网膜主要支持细胞，在DR中不仅产生白介素-17(interleukin-17, IL-17)，还作为其主要靶点发挥作用，通过谷氨酸代谢异常、血管内皮生长因子(vascular endothelial growth factor, VEGF)分泌增加及调控参与DR的病理过程，加重炎症反应。IL-17主要由辅助性T细胞17(T helper cell 17, Th17)分泌，通过促进多种炎症介质(如细胞因子、趋化因子和金属蛋白酶)的分泌，增强炎症反应，导致视网膜微血管损害和神经元凋亡，促进DR的发展。高糖环境下，Müller细胞功能受损，IL-17进一步加剧其功能障碍形成恶性循环。研究表明，阻断IL-17及核因子-κB激活剂1(Nuclear factor-kappa B activator 1, Act1)/肿瘤坏死因子受体关联因子6(tumor necrosis factor receptor associated factor 6, TRAF6)/核因子-κB(Nuclear factor-kappa B, NF-κB)信号通路可减轻DR的病理改变，为DR的治疗提供了新的思路。因此，深入研究IL-17与Müller细胞在DR中的相互作用机制，对于研究该疾病的发病机制及开发精准有效的治疗策略具有重要意义。
Diabetes retinopathy (DR) is a common ocular complication of diabetes, characterized by a complex pathological process involving multiple cells and inflammatory factors. Müller cells, as the primary supporting cells of the retina, not only produce interleukin-17 (IL-17) but also serve as a primary target in DR. They participate in the pathological process of DR by contributing to abnormal glutamate metabolism, increased secretion of vascular endothelial growth factor (VEGF), and regulatory functions, thereby exacerbating the inflammatory response. IL-17 is primarily secreted by T helper cell 17 (Th17) cells and enhances the inflammatory response by promoting the secretion of various inflammatory mediators (such as cytokines, chemokines, and metalloproteinases), leading to retinal microvascular damage and neuronal apoptosis, which accelerates the progression of DR. In a high-glucose environment, Müller cell function is impaired, and IL-17 further exacerbates this dysfunction, creating a vicious cycle. Studies have shown that blocking the IL-17 and Act1/TRAF6/NF-κB signaling pathways can mitigate the pathological changes associated with DR, providing new insights for the treatment of this disease. Therefore, conducting in-depth research on the interaction mechanism between IL-17 and Müller cells in DR is of great significance for exploring the pathogenesis of this disease and developing precise and effective treatment strategies.
糖尿病视网膜病变是最为常见的糖尿病微血管并发症，主要由糖尿病引起的机体代谢紊乱导致。而然在临床工作中发现，部分患者通过单纯控制血糖以延缓糖尿病视网膜病变进展，所取得效果不甚理想，一些其他因素对于糖尿病视网膜病变的发生、发展，也起到不可忽视的作用。研究表明，在并发高脂血症的糖尿病视网膜病变患者中，胆固醇代谢异常是诱发视网膜病变的主要原因之一。胆固醇代谢异常通过减弱肝脏X受体，导致胆固醇在视网膜上不断积累，降低视网膜血管内皮功能，从而造成视网膜缺血、缺氧环境的形成，又可通过增加炎症因子和细胞黏附分子-1的表达，使原本病态的糖尿病视网膜血管变得更加脆弱，该文总结了糖尿病视网膜病变的病理因素，对比分析当前糖尿病视网膜病变的主要治疗手段，通过分析胆固醇逆向转运(cholesterol reverse transport,RCT)途径转运对糖尿病视网膜病变发生、发展的影响，发现降低高血脂可提高糖尿病视网膜病变的治愈率，这将为糖尿病视网膜病变的临床防治工作提供新思路。
Diabetic retinopathy is the most common diabetic microvascular complication, which is mainly caused by metabolic disorders caused by diabetes. However, in clinical work, it is found that some patients do not achieve satisfactory results in delaying the progress of diabetic retinopathy by simply controlling blood sugar, and some other factors contribute to the occurrence and development of diabetic retinopathy. Also played a role that can not be ignored. Studies have shown that abnormal cholesterol metabolism is one of the main causes of retinopathy in diabetic retinopathy patients with hyperlipidemia. Abnormal cholesterol metabolism leads to the accumulation of cholesterol in the retina and the decrease of retinal vascular endothelial function by weakening the X receptor in the liver, resulting in the formation of retinal ischemia and hypoxia environment. it can also increase the expression of inflammatory cytokines and cell adhesion molecule-1 to make the originally morbid retinal vessels more fragile. This paper summarizes the pathological factors of diabetic retinopathy. By comparing and analyzing the main treatment methods of diabetic retinopathy at present, and by analyzing the influence of cholesterol reverse transport (cholesterolreversetransport,RCT) pathway on the occurrence and development of diabetic retinopathy, it is found that reducing hyperlipidemia can improve the cure rate of diabetic retinopathy, which will provide new ideas for the clinical prevention and treatment of diabetic retinopathy.
糖尿病视网膜病变是糖尿病引起的微血管病变之一，是不可逆性致盲的眼病。根据其病程可分为根据其病程可分为非增殖期和增殖期，其中还包括糖尿病性黄斑水肿。全科医师需要检测量裸眼视力、矫正视力和眼压，通过裂隙灯显微镜评估眼前节以及眼底检查来评估眼部整体情况。控制血糖、血压、血脂对改善预后很重要。需要重视餐前、餐后血糖，糖化血红蛋白和代谢记忆，一线降血压药物包括血管紧张素转化酶抑制剂和血管紧张素Ⅱ受体阻断剂，调脂药物首选他汀类，而非诺贝特有额外的视网膜保护作用。干预生活方式，宣教，早期发现也同样重要。全科医师需要进行眼底筛查和评分，及时转诊至眼科治疗。眼科治疗包括全视网膜激光光凝术、经平坦部玻璃体切除术、玻璃体抗血管内皮生长因子药物注射术。
Diabetic retinopathy is one of the microvascular diseases caused by diabetes, it is an irreversible blindness eye disease. According to its course, it can be divided into non-proliferative diabetic retinopathy and proliferative diabetic retinopathy, including diabetic macular edema. Te general practitioner needs to measure the uncorrected visual acuity, corrected visual acuity intraocular pressure, use the slit lamp microscope to exam the anterior segment and fundus to evaluate the overall condition of the eye. Controlling blood glucose, blood pressure and blood lipid is very important to improve the prognosis. Attach importance to pre- and postprandial blood glucose, glycosylated hemoglobin and metabolic memory should be carried out. The first-line antihypertensive drugs are angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. Statins are the first choice for lipid-lowering drugs, fenofibrate has additional protective efect of retinal. Intervention in lifestyle, education and early detection are is important. Te general practitioner needs to perform fundus screening and scoring, timely refer to ophthalmology department for treatment. Ophthalmic treatment includes panretinal laser photocoagulation, pars plana vitrectomy, and intravitreal injection of anti-vascular endothelial growth factor drugs.
目的：分析湖南地区汉族人群中2型糖尿病患者的人口学特征及生化指标，寻找糖尿病视网膜病变的高危因素。方法：釆用病例对照研究，统计湖南地区正常人群、2型糖尿病但无视网膜病变患者、2型糖尿病视网膜病变患者的人口学特征及生化指标的相关数据，进行成组t检验及logistic回归分析，探讨分析糖尿病视网膜病发生的易感因素。所有研究对象均为汉族。结果：对照组[非糖尿病(non-diabetes mellitus，NDM)组]和2型糖尿病未合并视网膜病变[(non-diabetic retinopathy，NDR)]组之间性别分布、年龄分布、BMI、舒张压、HbA1c、总胆固醇、高密度脂蛋白(high-density lipoprotein，HDL)、尿酸及总胆红素差异无统计学意义(均P>0.05)。NDM组中腹围、收缩压、空腹血糖、三酰甘油、肌酐和低密度脂蛋白(low-density lipoprotein，LDL)值均低于NDR组，差异有统计学意义(均P<0.05)。NDM组中BMI、腹围、收缩压、舒张压、空腹血糖、HbA1c、总胆固醇、三酰甘油、肌酐和LDL值均低于2型糖尿病合并视网膜病变组(diabetic retinopathy，DR)组，差异有统计学意义(均P<0.05)。NDR组收缩压、舒张压、HbA1c、总胆固醇、三酰甘油和肌酐值均低于DR组，差异有统计学意义(均P<0.05)。结论：收缩压超过150 mmHg，舒张压超过90mmHg，糖化血红蛋白超过9%，血清肌酐超过100 μmol/L，三酰甘油超过3 mmol/L均为糖尿病患者发生视网膜病变的高危易感因素。
Objective: To analyze the demographic characteristics and biochemical indexes of type 2 diabetic patients in Han population in Hunan, and to find the high-risk factors of diabetic retinopathy. Methods: The data of demographic characteristics and biochemical indexes of normal population, type 2 diabetic patients but without retinopathy and type 2 diabetic retinopathy in Hunan were analyzed. Group t test and logistic regression analysis were used to analyze the susceptibility factors of diabetic retinopathy. All the subjects were Han population. Results: There were no significant differences in gender distribution, age distribution, BMI, diastolic blood pressure, HbA1c,total cholesterol, high-density lipoprotein, uric acid and total bilirubin between the control group [non-diabetes mellitus (NDM) group] and the type 2 diabetic without retinopathy group [non-diabetic retinopathy (NDR)group] (all P>0.05). The abdominal circumference, systolic blood pressure, fasting blood glucose, triglyceride,creatinine and low-density lipoprotein in NDM group were all lower than those in NDR group, and the differences were statistically significant (all P<0.05). BMI, abdominal circumference, systolic blood pressure, diastolic blood pressure, fasting blood glucose, HbA1c, total cholesterol, triglyceride, creatinine and LDL in NDM group were all lower than those in type 2 diabetic retinopathy (DR) group, and the differences were statistically significant (all P<0.05). The comparison between the NDR group and the DR group showed that the values of systolic blood pressure,diastolic blood pressure, HbA1c, total cholesterol, triglyceride and creatinine in the NDR group were all lower than those in the DR group, and the differences were statistically significant (all P<0.05). Conclusion: SBP ≥150 mmHg,DBP ≥90 mmHg, HbA1c ≥9%, serum creatinine ≥100 μmol/L, triglyceride ≥3 mmol/L are the high-risk factors of diabetic retinopathy.
目的：分析不同程度2型糖尿病视网膜病变的血清生化全套指标，探讨各生化指标与糖尿病性视网膜病变(diabetic retinopathy，DR)程度的相关性。方法：回顾性收集2018年5月至2020年10月在福建医科大学附属第二医院就诊的2型糖尿病患者。根据眼底情况分为3组：糖尿病不伴视网膜病变(non-diabetic retinopathy，NDR)组(17例)、糖尿病伴非增殖性视网膜病变(non-proliferative diabetic retinopathy，NPDR)组(29例)、糖尿病伴增殖期视网膜病变(proliferative diabetic retinopathy，PDR)组(34例)。采用SPSS 24.0分析比较3组血清生化全套各指标水平，对差异指标与DR相关性采用Pearson相关分析与多重线性回归分析。结果：3组年龄差异无统计学意义(P>0.05)；3组的总蛋白、白蛋白、白球比、钙浓度差异均有统计学意义(均P<0.05)。组间比较发现NPDR和PDR组总蛋白、白蛋白、白球比、钙浓度低于NDR组，差异有统计学意义(P<0.05)。Pearson相关分析显示总蛋白(r=?0.290)、白蛋白(r=?0.304)，钙浓度(r=?0.252)与DR呈负相关(均P<0.05)，多重线性回归提示总蛋白、白蛋白及血钙浓度是DR保护因素(P<0.05)。结论：血清指标总蛋白、白蛋白及血钙浓度与DR成负相关，在生理范围内将这些指标维持相对较高的水平，或许可以为糖尿病视网膜病变的防治提供新思路。
Objective: To analyze the serum biochemical indexes of different degrees of type 2 diabetic retinopathy, and the correlation between biochemical indexes and the degree of diabetic retinopathy (DR). Methods: Patients with type 2 diabetes admitted to the Fujian Medical University 2nd Affiliate Hospital from May 2018 to October 2020 were retrospectively collected. The patients were divided into 3 groups according to fundus conditions: non-diabetic retinopathy (NDR) group (n=17), diabetes with non-proliferative diabetic retinopathy (NPDR) group (n=29),diabetes with proliferative diabetic retinopathy (PDR) group (n=34). SPSS 24.0 was used to compare the levels of a complete set of serum biochemical indexes in the three groups. Pearson correlation analysis and multiple linear regression analysis were used for the correlation between the different indexes and DR. Results: There was no statistically significant difference in age between the three groups. The differences in total protein, albumin, white sphere ratio, and calcium concentration of the three groups were statistically significant (P<0.05). The comparison between the groups showed that the total protein, albumin, white sphere ratio, and calcium concentration in the NPDR and PDR groups were lower than those in the NDR group. The difference was statistically significant (P<0.05). Pearson correlation analysis showed that total protein (r=?0.290), albumin (r=?0.304), andcalcium concentration (r=?0.252) were negatively correlated with DR (all P<0.05). Multiple linear regression indicated total protein, albumin and blood calcium concentration were the protective factors of DR (P<0.05).Conclusion: This study found that serum levels of total protein, albumin, and blood calcium levels are negatively correlated with DR. Maintaining a relatively high level of these indexes within the physiological range may provide new ideas for the prevention and treatment of diabetic retinopathy.
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：探讨2型糖尿病(type 2 diabetes mellitus，T2DM)患者二甲双胍治疗与糖尿病性视网膜病变(diabetic retinopathy，DR)的相关性。方法：回顾2015年9月至2020年8月在中日友好医院眼科就诊的1 891例T2DM患者的临床资料，对病程≥10年的324例T2DM患者的一般资料、内科疾病史、糖尿病治疗史、眼科检查和实验室血生化指标进行回顾性病例研究。根据是否接受二甲双胍治疗分为二甲双胍治疗组与非二甲双胍治疗组，根据眼底检查结果同时结合DR临床诊断标准，将DR分为无明显DR、非增生性DR及增生性DR。采用logistic多因素回归分析判断年龄、性别、糖尿病发病年龄、糖尿病病程、高血压病程、高血脂病程、吸烟年数、体重指数、胰岛素治疗及空腹血糖、糖化血红蛋白、总胆固醇、三酰甘油、尿酸和血肌酐水平对结局变量的影响。结果：在DR的发病风险方面，二甲双胍治疗组与非二甲双胍治疗组的差异无统计学意义(P>0.05)。对T2DM患者DR发生及不同分期的相关变量行单因素及多因素分析，结果显示吸烟年数、空腹血糖及肌酐均与DR发病呈正相关(均P<0.05)，而年龄与DR发病呈负相关(P<0.01)，糖尿病发病年龄与DR发生呈显著负相关(OR=0.95，95%CI：0.92~0.98，P=0.0003)。在二甲双胍治疗的T2DM患者中，二甲双胍的疗程(OR=1.02，95%CI：0.96~1.08，P>0.05)及平均剂量(OR=1.50，95%CI：0.79~2.84，P>0.05)与DR的发生与进展均无显著相关性；女性DR发生与进展的风险较男性低(P<0.05)；合并胰岛素治疗与DR发生呈明显正相关(OR=3.11，95%CI：1.59~6.07，P<0.01)；吸烟年数长、糖化血红蛋白及尿酸水平高于正常范围均与DR的发生与进展呈正相关(P<0.05)。在口服二甲双胍患者中，未使用胰岛素治疗组和联合使用胰岛素组的DR发病风险有显著差异(P<0.01)；而未口服二甲双胍患者中，胰岛素治疗与DR发生呈正相关(OR=12.43，95%CI：3.75~41.19，P<0.0001)。结论：病程10年以上T2DM患者中，二甲双胍治疗与DR发生与进展均无显著相关性。
Objective: To investigate the correlation between metformin therapy and diabetic retinopathy (DR) in patients with type 2 diabetes mellitus (T2DM). Methods: The clinical data of 1 891 patients with type 2 diabetes mellitus attending the ophthalmology department of China-Japan Friendship Hospital from September 2015 to August 2020 were reviewed. A retrospective study was performed on 324 cases of these T2DM patients with disease duration ≥10 years. Medical records of all patients including general information, history of medical disease, diabetes treatment, ophthalmologic examination and blood biochemical indices were collected. According to whether metformin treatment was received or not, the patients were divided into a metformin-treated and a non-metformin-treated groups. DR is classified into non-obvious DR, non-proliferative DR and proliferative DR according to the fundus examination and the clinical diagnostic criteria of DR. Logistic multiple regression analysis was used to determine the effects of age, sex, age of DM onset, duration of DM, duration of hypertension,duration of hyperlipidemia, years of smoking, body mass index, insulin treatment and fasting glucose, glycated hemoglobin, total cholesterol, triglycerides, uric acid and blood creatinine levels on DR. Results: There was no statistically significant difference in the risk of developing DR between the metformin-treated and non-metformin-treated groups (P>0.05). Univariate and multifactorial analyses of variables related to the occurrence and different stages of DR in patients with T2DM showed that years of smoking, fasting glucose and creatinine were positively associated with DR (P<0.05), while age was negatively associated with DR (P<0.01), and age of DM onset was significantly negatively associated with DR (OR=0.95, 95%CI: 0.92 to 0.98, P=0.0003). In T2DM patients treated with metformin, neither the duration of metformin (OR=1.02, 95%CI: 0.96 to 1.08, P>0.05) nor the mean dose(OR=1.50, 95%CI: 0.79 to 2.84, P>0.05) was significantly associated with developing DR. The risk of developing DR was lower in women than in men (P<0.05); combined insulin therapy was significantly positively correlated with the risk of DR (OR=3.11, 95%CI: 1.59 to 6.07, P<0.01); long-term smoking, glycosylated hemoglobin and uric acid levels higher than normal were positively associated with DR (P<0.05). In metformin users, there was a significant difference in the risk of developing DR between the no-insulin treatment group and the combined insulin group (P<0.01); and among patients not using metformin, insulin therapy was positively associated with the occurrence of DR (OR=12.43, 95%CI: 3.75 to 41.19, P<0.0001). Conclusion: There was no significant association between metformin treatment and DR among patients with T2DM for >10 years.
目的：探讨光学相干断层扫描血管成像(optical coherence tomography angiography，OCTA)在糖尿病性视网膜病变中的应用。方法：选取2021年中山大学附属第七医院眼科63例糖尿病患者为研究对象，分为无糖尿病性视网膜病变(T0，21眼)、轻度非增殖期(T1，21眼)、中重度非增殖期(T2，14眼)及增殖期(T3，7眼)。收集各组生化指标，包括空腹血糖、糖化血红蛋白、谷丙转氨酶、谷草转氨酶、碱性磷酸酶、血清尿素氮、肌酐、尿素氮肌酐比值，及OCTA数据，即中心视网膜厚度、Angiography3×3及Angiography6×6血管线性密度及血管灌注密度等。采用单因素方差分析比较各组间差异。结果：T2组、T3组与T0组相比，T3组与T1组相比，糖尿病病程延长；T3组与其他各组相比，尿素氮升高；T1组、T2组、T3组与T0组相比，T3组与T1组相比，6 mm ×6 mm外层血流线性密度减少；与T0组相比，T1组、T2组及T3组6 mm ×6 mm完整血流线性密度减少；与T0相比，T2组、T3组6 mm ×6 mm外层血流灌注密度减少；与T0组相比，T3组6 mm ×6 mm完整血流灌注密度减少；T2组、T3组与T0组相比，T3与T1相比，3 mm ×3 mm内层血流线性密度明显减少；T3组与T0组及T1组相比，3 mm ×3 mm完整血流线性密度减少。结论：随着糖尿病性视网膜病变的进展，患者的尿素氮及肌酐逐渐升高，OCTA的血流线性密度及血流灌注密度逐渐减少。与血流灌注密度相比，血流线性密度对于早期糖尿病性视网膜病变筛查可能更为敏感。而利用Angiography6×6模式可能可以更早地发现糖尿病性视网膜病变的视网膜血流变化。
Objective: To explore the applications of optical coherence tomography angiography (OCTA) in diabetic retinopathy. Methods: A total of 63 diabetic patients in the Department of Ophthalmology, Seventh Affiliated Hospital of Sun Yat-sen University in 2021 were divided into 4 groups: the patients without diabetic retinopathy (T0, n=21), mild non-proliferative diabetic retinopathy (T1, n=21), moderate-to-severe non-proliferative diabetic retinopathy (T2, n=14) and proliferative diabetic retinopathy (T3, n=7). Biochemical Indicators were collected in all patients, such as fasting plasma glucose (FPG), glycated hemoglobin A1c (HbA1c), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), the blood urea nitrogen (BUN), creatinine (CRE) and the ratio of blood urea nitrogen and creatinine (BUN/CRE). The Macular Cube 521×128, Angiography3×3, and Angiography6×6 models of OCTA were used to obtain central retinal thickness (CRT), vascular density (VD) and perfusion density (PD) of each group. The data of all subjects was applied to do one-way ANOVA. Results: Prolonged duration of diabetes in T2 and T3 compared to T0 and in T3 compared to T1. Elevated BUN in T3 compared to all other groups. When T1, T2 and T3 were compared to T0, and T3 was compared to T1, the VD of the 6 mm ×6 mm outer layer decreased. Reduced VD of intact 6 mm ×6 mm region in T1, T2 and T3 compared to T0. Declining PD of the 6 mm ×6 mm outer layer in T2 and T3 compared to T0. Diminished PD of whole 6 mm ×6 mm area at T3 compared to T0. The VD of 3 mm ×3 mm inner layer was significantly reduced in T3 compared to T0 and T1. The VD of 3 mm ×3 mm intact area gradually dwindled in T3 compared with T0 and T1 (P<0.05). Conclusion: With the progression of diabetic retinopathy, the levels of BUN and CRE gradually increased, and the OCTA-derived vascular density and perfusion density gradually decrease. Vascular density may be more sensitive for early diabetic retinopathy screening than perfusion density.The use of the Angiography6×6 model may result in an earlier detection of changes in retinal blood flow in diabetic retinopathy.
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.
脂质代谢异常是糖尿病性视网膜病变可能的危险因素。糖尿病性视网膜病变被认为是致盲的主要原因。近年来研究认为总胆固醇、三酰甘油等血脂与糖尿病性视网膜病变及糖尿病黄斑水肿的进展有关，降脂药物的应用能够延缓糖尿病性视网膜病变进展。随着色谱分离和质谱分析等脂质组学分析方法的发展，除了常规的血清脂质标志物以外的各种脂质成分也被发现可能与糖尿病性视网膜病变进展有关。现总结脂质及其衍生物在糖尿病性视网膜病变发病机制中的作用，阐述糖尿病性视网膜病变脂质代谢治疗的潜在靶点和前景。
Abstract Abnormal lipid metabolism is a possible risk factor for diabetic retinopathy. Diabetic retinopathy is considered to be the main cause of blindness. In recent years, studies have shown that serum lipids, such as total cholesterol, triglycerides, are related to the progress of diabetic retinopathy and diabetic macular edema, and lipid-lowering drugs can delay the progress of diabetic retinopathy. With the development of lipidomics analysis methods such as chromatographic separation and mass spectrometry, lipid components other than conventional serum lipid markers have also been found to be related to the progression of diabetic retinopathy. The review summarizes the role of lipids and their derivatives in the pathogenesis of diabetic retinopathy, and highlights the potential targets and prospects of lipid metabolism treatment for diabetic retinopathy.
