糖尿病视网膜病变眼底图像辅助诊断软件的NMPA注册经验

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.     

A giant early second‐trimester placental chorioangioma associated with isolated proteinuria and histopathologically confirmed placental insufficiency,a novel association: A case report

We present a case of giant chorioangioma at 18 weeks of gestation leading to fetal hypertrophic cardiomyopathy without other evidences of fetal volume overload and late‐onset isolated proteinuria. Oligohydramnios developed at term and placental insufficiency was confirmed on histopathological examination and a nonanemic nonthrombocytopenic normal weight healthy baby was delivered.     

终末期糖尿病肾病血液透析危险因素分析及护理对策

目的探讨影响终末期糖尿病肾病(DN)血液透析患者生活质量和长期存活的各种危险因素及护理对策。方法选择38例终末期DN血液透析患者和同期38例相同各年龄段非糖尿病血液透析患者,分别观察血生化改变、存活率、内瘘使用情况及并发症。结果DN组1年和2年存活率分别为76.3%和60.5%;主要并发症是高血压、心力衰竭、心律失常、感染、透析时低血压,与非DN组比较有显著性差异。结论终末期DN患者较非糖尿病患者应更早进行血透;加强护理,减少并发症发生是提高生活质量和长期存活的关键。     

胰岛素泵治疗2型糖尿病中联用生长抑素的研究

2型糖尿病(T2DM)发病的两个主要环节是胰岛素抵抗和β细胞功能衰竭。目前研究的是针对糖尿病胰腺β细胞如何更好保护其功能,甚至恢复其功能、延缓其衰竭,以达到更好的临床治疗效果。本研究前瞻性观察胰岛素泵联用生长抑素治疗新诊断T2DM患者C肽恢复情况。现报告如下。1研究对象     

百令胶囊辅助治疗糖尿病肾病的Meta分析

目的 系统评价百令胶囊辅助治疗糖尿病肾病的有效性和安全性.方法 计算机检索PubMed、中国学术期刊全文数据库(CNKI)、维普中文期刊全文数据库(VIP)、中国生物医学文献数据库(CBM)和万方数据库中有关百令胶囊单独或联合其他药物治疗糖尿病肾病的临床随机对照试验(RCT),检索时间从各数据库建库至2020年1月,按...     

Neuroprotective Effects of Nicotinamide (Vitamin B3) on Neurodegeneration in Diabetic Rat Retinas

The loss of inner retinal neurons is an initial event in diabetic retinopathy. In diabetic retinas, oxidative stress is increased, which could lead to increased oxidative DNA damage. Nicotinamide is a precursor to nicotinamide adenine dinucleotide, which contributes to the DNA damage response. We investigated whether nicotinamide plays a neuroprotective role in diabetic retinal neurodegeneration in terms of DNA repair. Male Sprague Dawley rats with streptozotocin-induced diabetes were orally administered nicotinamide (500 mg/kg/day) for 4 or 12 weeks. Oxidative stress exhibited by dihydroethidium was upregulated at 4 and 12 weeks after onset of diabetes, and nicotinamide treatment reduced oxidative stress at 4 weeks after induction of diabetes. Oxidative DNA damage measured by 8-hydroxy-2′-deoxyguanosine (8-OHdG) increased at 4 and 12 weeks after induction of diabetes and decreased following nicotinamide treatment. The elevated expression of glial fibrillary acidic protein (GFAP) induced by diabetes was attenuated by nicotinamide treatment. In Western blot analysis, the increased expression of cleaved PARP-1 in diabetes was attenuated by nicotinamide treatment at 12 weeks after induction of diabetes. The diabetes-induced apoptosis of inner retinal cells detected by the TUNEL assay was reduced by nicotinamide treatment. In conclusion, nicotinamide attenuated retinal neurodegeneration in diabetes, probably by reducing oxidative DNA damage and supporting DNA repair.     

线粒体自噬信号通路在年龄相关性眼病中的研究进展

线粒体自噬是一种特殊形式的自噬,通过选择性清除功能失调和多余的线粒体,从而为细胞产生能量并调节能量稳态。同时,线粒体自噬具有促进细胞分化和延缓衰老等生理功能,其调控机制一旦失调或出现障碍将会导致生理性衰老和一系列与年龄相关的疾病发生。有研究发现,在多种年龄相关性眼病中存在着不同水平的线粒体自噬,如Fuchs内皮角膜营养不良、老年性白内障和原发性开角型青光眼等。本综述旨在概述线粒体自噬的相关信号通路及线粒体自噬在年龄相关性眼病中的研究进展。     

糖尿病黄斑水肿的诊断和治疗进展

糖尿病黄斑水肿(DME)的发病率正逐渐上升,其作为导致糖尿病患者视力不可逆丧失的主要原因,一直受到医学研究者的关注。目前,在应用诸如光学相干断层扫描和抗血管内皮生长因子等针对DME的诊疗方法的同时,多种新兴的解决方案正在被研发。因此,本文将对现有DME的诊断和治疗方案进行总结讨论,以期为未来DME诊疗标准的统一奠定基础。     

黄芩苷调节IL-33/ST2信号通路对糖尿病视网膜病变大鼠视网膜新生血管生成的影响

目的 探讨黄芩苷调节白细胞介素(IL)-33/基质裂解素2(ST2)信号通路对糖尿病视网膜病变(DR)大鼠视网膜新生血管生成的影响。方法 SD大鼠随机分为对照组(正常大鼠,灌胃生理盐水)、DR模型组(大鼠建立DR模型后,灌胃生理盐水)和黄芩苷低、中、高剂量组(大鼠建立DR模型后,分别灌胃75 mg·kg^-1、150 mg·kg^-1、300 mg·kg^-1黄芩苷),所有大鼠均以右眼为实验眼。FFA检查各组大鼠视网膜血管生成情况,ELISA检测各组大鼠血清血管内皮生长因子(VEGF)、Ang-1、IL-6、IL-33、肿瘤坏死因子-α(TNF-α)水平,Western blot检测各组大鼠视网膜组织中IL-33、ST2蛋白表达水平。结果 与对照组相比,DR模型组大鼠血清VEGF、Ang-1、IL-6、IL-33、TNF-α水平及视网膜组织中IL-33、ST2蛋白表达水平均显著升高(均为P<0.05),右眼眼底新生血管增多,荧光素渗漏明显;与DR模型组相比,黄芩苷低、中、高剂量组大鼠血清VEGF、Ang-1、IL-6、I...