目的：观察视网膜激光光凝术(laser photocoagulation，LP)及玻璃体腔注射雷珠单抗(intravitreal ranibizumab，IVR)对病变位于II区的阈值前病变1型早产儿视网膜病变(retinopathy of prematurity，ROP)的疗效。方法：收集2015年10月至2019年12月厦门市儿童医院收治的病变位于II区的阈值前病变1型44例(81眼)。根据手术方式分为LP组、IVR组。观察各组术后病变消退、视网膜血管化情况、全身及眼部并发症，分析不同手术方式的效果。结果：LP组20例(37只眼)行视网膜激光光凝治疗，术后未出现复发，首次治愈率100%；术后(3.42±1.57)周病情控制，术后(9.84±4.75)周可观察到周边视网膜血管化。IVR组24例(44只眼)注射雷珠单抗，39只眼行单次手术后病情控制，首次治愈率88.6%，5眼术后病情未控制。术后(2.95±2.58)周病情控制，术后(14.19±4.95)周可观察到周边视网膜血管化。两组手术方式首次治愈率、视网膜血管化时间差异有统计学意义(P<0.05)。结论：视网膜LP及IVR治疗病变位于II区的阈值前病变1型均有较好疗效，IVR复发率较高，手术方式的选择需慎重。

Objective: To observe the efficacy of laser photocoagulation (LP) and intravitreal ranibizumab (IVR) injection in the treatment of type 1 prethreshold retinopathy of prematurity (ROP) with lesions located in zone II. Methods:Forty-four patients (81 eyes) with type 1 prethreshold retinopathy of prematurity with lesions located in zone II staying in our hospital from October 2015 to December 2019 were collected and divided into LP group and IVR group according to the operation method. Through observation of the postoperative disease involution, retinal vascularization, systemic and ocular complications in each group, the effects of different surgical methods were analyzed. Results: In LP group, 20 patients (37 eyes) underwent retinal laser photocoagulation treatment, with no recurrence occurred after the operation; the cure rate after the first operation was 100%; the disease was controlled at (3.42±1.57) weeks after the operation; and peripheral retinal vascularization was observed at (9.84±4.75) weeks after the operation. In IVR group, 24 patients (44 eyes) were injected with ranibizumab; 39 eyes were under control after a single operation; the cure rate after the first operation was 88.6%; and 5 eyes were not under control after surgery. The disease was controlled for an average of (2.95±2.58) weeks after operation; peripheral retinal vascularization was observed at (14.19±4.95) weeks after operation; there were statistically significant differences in the cure rate after the first operation and retinal vascularization time between the two groups. Conclusion:Retinal laser photocoagulation and IVR have good effects in the treatment of type 1 prethreshold retinopathy of prematurity with lesions located in zone II. However, the recurrence rate using IVR is relatively high. Therefore,the surgical method needs to be cautious and still requires clinical observation.

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.

Purtscher样视网膜病变是一种少见的视网膜血管性疾病，该文分析了13例Purtscher样视网膜病变的临床特征。典型的眼底表现包括 Purtscher斑22眼、棉絮斑22眼、视网膜出血13眼、黄斑水肿22眼、视盘水肿12眼和假樱桃红斑10眼。荧光素血管造影异常表现包括毛细血管无灌注区21眼，毛细血管前闭塞22眼。13例患者中有9例使用糖皮质激素、免疫抑制剂，4例使用改善循环、营养神经等治疗。随访2周至5年，4例患者(6眼)在随访期间出现神经上皮萎缩并持续低矫正视力(<0.1)。基于文献回顾，讨论了Purtscher样视网膜视力恢复不佳可能与黄斑水肿及无灌注区形成有关。

Purtscher-like retinopathy is a rare retinal vascular disease. In this study,the clinical characteristics of 13 cases of Purtscher-like retinopathy were analyzed. Typical fundus abnormalities included Purtscher flecken (22 eyes), cotton-wool spots (22 eyes), retinal hemorrhages (13 eyes), macular edema (22 eyes), swelling of optic disk (12 eyes), and falsecherry red spots (10 eyes). The abnomal manifestations of fluorescein angiography included non perfusion area of capillaries (21 eyes), and precapillary occlusion (22 eyes). Among 13 patients, 9 patients were treated with glucocorticoids and immunosuppressive drugs, and 4 patients were treated with circulation-improving and neurotrophic drugs. During the follow-up period of two months to five years, four patients (six eyes) experienced neuroepithelial atrophy and persistent low vision (<0.1). Based on literature review, we proposed that the prognosis of vision in Purtscher-like retinopathy may be associated with macular edema and the formation of capillary non-perfusion.

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), and

calcium 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：观察急性中心性浆液性脉络膜视网膜病变(central serous chorioretinopathy，CSC)的自然病程中渗漏点的形态及变化。方法：本研究为前瞻性研究，使用光学相干断层扫描(optical coherence tomography，OCT)观察从发病到发病后5~13个月的CSC患者的渗漏点的OCT形态，测量并计算Hall层、脉络膜全层各自厚度及比值，并进行比较。结果：共20例患者[男14例，女6例，年龄33~59(中位数41)岁]纳入研究。随访时间为5~13个月。在19例患者中观察到微小视网膜色素上皮脱离(pigment epithelium detachment，PED)。1例患者可见视网膜色素上皮(retinal pigment epithelium， RPE)小凸起。在随访期间，仅1例患者的PED完全恢复，其他19例患者在视网膜下液被完全吸收时，RPE和Bruch膜之间仍存在微小分离。渗漏点处的Haller层/脉络膜厚度显著高于中央凹处(初诊时0.806±0.08 vs 0.863±0.06，P=0.003；最后1次随访时为0.801±0.07 vs 0.851±0.06，P=0.004)。结论：本研究观察到在急性CSC患者自然病程中，即使视网膜下液吸收，OCT显示渗漏点处仍存在持续的PED，更厚的Haller层及更薄的内层脉络膜，这些发现为CSC的发病机制提供了更多线索。

Objective: To observe the morphology and changes of leakage points in the natural course of acute central serous chorioretinopathy (CSC). Methods: This study was a prospective study, using optical coherence tomography to observe the OCT morphology of leakage points in CSC patients from onset to 5 to 13 months after onset, measuring the thickness and ratio of Hall layer and the whole choroid, and then compare them. Results: A total of 20 patients were included in the study, including 14 males and 6 females, aged from 33 to 59, with the median being 41 years old. The follow-up time ranged from 5 months to 13 months. Minute retinal pigment epithelial detachments (PED) were observed in 19 patients. A small bulge of retinal pigment epithelium (RPE) was observed in 1 patient. During the follow-up, only one patient totally recovered. Small separation between RPE and Bruch membrane still exit even subretinal fluid were absorbed completely in the other 19 patients. The thickness of Haller layer or choroid at the leakage point was significantly higher than that of the fovea (0.806±0.08 vs 0.863±0.06, P=0.003, at the first visit; 0.801±0.07 vs 0.851±0.06, P=0.004, at the last follow-up). Conclusion: This study observed that in the natural course of acute CSC patients, even if the subretinal fluid was absorbed, OCT still showed that there was persistent PED at the leakage point, thicker Haller layer and thinner inner choroid layer. These findings provided more clues to the pathogenesis of CSC.

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 (P_{systolic blood pressure}=0.025, P_insulin=0.001, P_GFR=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.