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.
目的：观察玻璃体腔内注射不同剂量康柏西普治疗早产儿视网膜病变(retinopathy of prematurity，ROP)的疗效以及术后的眼压变化。方法：前瞻性随机对照研究。将2018年1月1日至2021年6月30日在厦门市妇幼保健院确诊为Ι型阈值前期ROP、阈值期ROP、急进性ROP(aggressive ROP，A-ROP)的患儿纳入研究。随机分为减量组和常量组，分别玻璃体腔注射10 mg/mL康柏西普注射液0.015 mL(含康柏西普0.15 mg)和0.025 mL(含康柏西普0.25 mg)。测量并记录注射前5min、注射后5min、30min、1h、12h及24 h的眼压情况。术后1周开始随访眼底情况。疗效评价分为一次治愈、复发和加重。结果：共49例98眼纳入研究，常量组27例54眼，一次治愈成功率79.6%(43/54)，复发率16.7%(9/54)，加重率3.7%(2/54)；减量组2 2例44眼，一次治愈成功率68.2%(30/44)，复发率27.3%(12/44)，加重率4.5%(2/44)；两组间差异无统计学意义(χ 2=1.672，P=0.196)。治疗前5min两组眼压差异无统计学意义(P=0.494)；注药后5 min、1 h、12h两组眼压差异有统计学意义(均P<0.05)；注药后24 h两组间的眼压差异无统计学意义(P=0.101)。常量组注药前5 min和注药后24 h眼压差异有统计学意义(P=0.03)，减量组注药前5 min和注药后24h眼压差异无统计学意义(P=0.84)。结论：减量剂量康柏西普(0.15mg)治疗ROP有效，疗效与常规剂量(0.25 mg)相近，且术后眼压升高幅度较低，更快恢复至术前水平，更安全。
Objective: To evaluate the effectiveness of intravitreal injection of various doses of conbercept in the treatment of retinopathy of prematurity (ROP) and change of intraocular pressure (IOP) after operation. Methods: It was a prospective randomized controlled study. Children who were diagnosed with pre-threshold ROP, threshold phrase ROP, and aggressive ROP (A-ROP) in Xiamen Maternity and Child Healthcare Hospital from January 1, 2018 to June 30, 2021 were included in the study. The children were randomly divided into a reduction group and a constant group, and received intravitreal injection of10 mg/mL conbercept at 0.015 mL (containing 0.15 mg of conbercept) and 0.025 mL (containing 0.25 mg of conbercept) respectively. IOP was measured and recorded 5 min before injection, 5 min, 30 min, 1 h, 12 h and 24 h after injection. The fundus condition was followed up 1 week after the operation. The efficacy evaluation is divided into one cure, recurrence and exacerbation. Results: A total of 98 eyes of 49 cases were included in thestudy. For 27 cases of 54 eyes in the constant group, the one-time cure success rate was 79.6% (43/54), the recurrence rate was 16.7% (9/54), and the exacerbation rate was 3.7% (2/54). In the reduction group, there were 22 cases (44 eyes). The one-time cure success rate was 68.2% (30/44), the recurrence rate was 27.3% (12/44), and the exacerbation rate was 4.5% (2/44). There was no significant difference between the two groups (χ2=1.672,P=0.196). There was no significant difference in IOP between the 2 groups 5 min before treatment (P=0.494). There were statistically significantdifferences in IOP between the 2 groups at 5 min after injection, 1 h after injection, and 12 h after injection (all P<0.05). There was no difference in IOP between the two groups 24 h after injection (P=0.101). There was a statistically significant difference in IOP between 5 min before and 24 h after injection in the constant group (P=0.03), and there was no significant difference in IOP between 5 min before and 24 h after injection in the reduction group (P=0.84). Conclusion: Reduced dose of conbercept (0.15 mg) is effective in the treatment of ROP, and the efficacy is similar to that of conventional dose (0.25 mg). The reduction can help lower the increase of postoperative IOP, returning to the preoperative level more rapidly and safely.
目的：研究早产儿视网膜病变患儿经不同治疗措施后屈光状态的改变。方法：将72例(127眼)早产儿视网膜病变患儿按治疗方式分为3组：激光光凝组、注药(抗血管内皮生长因子药物)组和自然消退组。并于治疗前，治疗后1、4、7、12个月对其进行睫状肌麻痹检影验光，对比分析3组的球镜和等效球镜的差异。结果：在治疗后1、4、7及12个月，三组患儿的球镜度和等效球镜度的差异有统计学意义(P<0.05)：注药组的球镜和等效球镜小于自然退化组及激光组(均P0.05)。治疗后12个月时激光光凝组、注药组和自然消退组近视发生率分别是2.4%、7.8%和2.0%，差异无统计学意义(P=0.356)。结论：经不同治疗措施的ROP患儿近视发生率无明显差异，但经玻璃体腔注射抗VEGF药物的ROP患儿正视化进程更快。
Objective: To observe the changes of refractive statues in infants with retinopathy of prematurity retinopathyof prematurity (ROP) after different treatments. Methods: According to different treatment methods, 72 cases(127 eyes) of infants with ROP were divided into 3 groups: laser photocoagulation group, intravitreal injectionof anti-vascular endothelial growth factor (VEGF) drugs group and natural regression group. Their sphere andspherical equivalent were measured by retinoscopy optometrist after the ciliary muscles paralyzed. The data beforetreatments and 1, 4, 7 and 12 months after treatments were recorded and analyzed. Results: The differences ofsphere and spherical equivalent among three groups were statistically significant: intravitreal injection of VEGFdrugs group was lower than natural regression group and the laser photocoagulation group, but there was no significant difference between natural regression group and laser photocoagulation group. Incidence of myopiaof laser photocoagulation, intravitreal injection of VEGF drugs, natural regression group were 2.4%, 7.8%, 2.0%,which was not statistically significant. Conclusion: There was no significant difference about the incidence rate ofmyopia among the three groups, but the emmetropization in infants with ROP after intravitreal injection of anti-VEGF drugs might be faster in the future.
幽门螺杆菌(Helicobacter pylori，H P)感染是中心性浆液性脉络膜视网膜病变(central serous chorioretinopathy，CSC)的一个危险因素，但是在HP感染和CSC相关性的研究仍存在争议，目前有两种观点：一是认为HP感染可能是CSC的一个危险因素，二是认为两者之间并没有相关性。本文将就对HP感染是否为CSC危险因素文献进行综述，同时探讨其发病机制。
Helicobacter pylori (HP) infection is a risk factor for central serous chorioretinopathy (CSC). But the existing studies tend to support two distinctively different trends regarding the link between HP infection and CSC. The first group tend to support that: HP infection may be a risk of CSC, and the second tend to claim to no correlation between the two. This paper will review the literature on whether HP infection is a risk factor for CSC and discuss its pathogenesis.
糖尿病视网膜病变(diabetic retinopathy，DR)在糖尿病肾病(diabetic nephropathy，DN)人群，特别是终末期糖尿病肾病(end stage diabetic nephropathy，ESRD)患者中的发病率和严重程度明显高于糖尿病人群。其中ESRD的一项重要治疗手段——血液透析(Hemodialysis，HD)可能会增加机体氧化应激反应、出血风险以及视神经的缺血缺氧，加重DR的发生发展；但另一方面也可通过清除尿毒症毒素、控制血压以及清除多余体液等途径改善糖尿病和DN对眼部的损伤。
The incidence and severity of diabetic retinopathy (DR) in patients with diabetic nephropathy (DN), especially those with end-stage renal disease (ESRD), were higher than those with diabetes. Hemodialysis (HD), an important treatment of ESRD, may aggravate DR by increasing the oxidative stress, fundus hemorrhage and hypoxia of the optic nerve. On the other hand, HD can improve the ocular damage caused by diabetes mellitus and DN by removing uremia toxin, controlling blood pressure and removing excess body fluid.
