artificial tears

人工泪液
  • 文章类型: Case Reports
    主要目的是研究用人工泪液治疗是否影响白内障手术前干眼受试者的角膜曲率测量的变异性。次要目标是研究用人工泪液治疗是否改善屈光精度,以及非干眼受试者的屈光精度是否优于干眼受试者。
    三组前瞻性随机对照试验。
    根据DEWSII进行干眼诊断,干眼症患者在白内障手术前两周随机分为不治疗(A1组)或人工泪液治疗(A2组),第三组(B组,非干眼)作为对照。使用三种不同的光学生物测定仪在基线时进行两次,在白内障手术时两周后进行两次。比较A2组的角膜曲率测量的平均变异性(平均K和矢量差异的大小)和两周后异常值的百分比与基线的变化。在白内障手术后8周计算屈光和散光预测误差,并对所有三组进行比较。
    一百三十一名受试者可用于分析。从基线到白内障手术时间,A2组的角膜曲率测量的平均变异性或异常值百分比没有统计学上的显着差异。任何组之间的屈光精度(绝对误差和散光预测误差)没有统计学上的显着差异。
    干眼(治疗和未治疗)的受试者获得了与非干眼受试者相同的屈光精度和异常值百分比。用人工泪液治疗两周似乎不足以显着影响白内障手术前干眼患者的生物特征测量的变异性。DEWSII标准在白内障环境中可能不是最佳的。
    UNASSIGNED: The primary objective was to investigate if treatment with artificial tears affected the variability of keratometry measurements for subjects with dry eyes prior to cataract surgery. The secondary objectives were to investigate whether treatment with artificial tears improved refractive precision and whether subjects with non-dry eyes had better refractive precision than subjects with dry eyes.
    UNASSIGNED: Prospective randomized controlled trial with three arms.
    UNASSIGNED: Dry eye diagnostics according to DEWS II were performed, and subjects with dry eyes were randomized to no treatment (group A1) or treatment with artificial tears two weeks prior to cataract surgery (group A2), with the third group (Group B, non-dry eyes) as a control. Keratometry was performed twice at baseline and twice after two weeks at the time of cataract surgery with three different optical biometers. The change in mean variability of keratometry (average K and magnitude of vector differences) and percentages of outliers after two weeks versus baseline were compared for group A2. The refractive and astigmatism prediction errors were calculated eight weeks after cataract surgery and compared for all three groups.
    UNASSIGNED: One hundred thirty-one subjects were available for analysis. There was no statistically significant difference in the mean variability of keratometry or percentages of outliers for group A2 from baseline to the time of cataract surgery. There was no statistically significant difference in refractive precision (absolute error and astigmatism prediction error) between any groups.
    UNASSIGNED: Subjects with dry eyes (treated and non-treated) achieved the same refractive precision and percentages of outliers as subjects with non-dry eyes. Treatment with artificial tears for two weeks appeared inadequate to significantly affect variability in biometric measurements for patients with dry eyes prior to cataract surgery. DEWS II criteria for DED may not be optimal in a cataract setting.
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  • 文章类型: Journal Article
    目的:本研究评估了在安装双聚合物羟丙基瓜尔胶/透明质酸钠(DPHG/SH)与单聚合物SH后,有干眼症状的患者的泪膜稳定性。
    方法:纳入最近诊断为轻度至中度干眼症(OSDI评分23-32分)的患者。对于每个病人来说,右眼随机接受DPHG/SH或0.15%SH.就在滴到右眼后,对方的眼睛收到了另一个眼药水。第一次非侵入性角膜造影第一次分手时间(NIKBUT),在滴眼剂给药前测量平均NIKBUT和泪液半月板高度(TMH),在1分钟,15分钟,30分钟,60分钟,90分钟,滴注后120分钟。
    结果:共有29名年龄为22.8±2.2岁的患者参与了研究(21名女性)。在任何时间点,对于第一NIKBUT(p=0.45)和平均NIKBUT(p=0.24)变量,未观察到眼睛接受DPHG/SH和单一聚合物SH之间的差异。DPHG/SH和单一聚合物SH都增加了TMH(时间效应p<0.001),但组间无差异(p=0.95)。
    结论:DPHG/SH和单一聚合物SH溶液均可润滑眼睛表面,然而,在给药后两个小时内,NIKBUT和TMH评估没有差异。
    OBJECTIVE: This study evaluated the tear film stability in patients with symptoms of dry eye after installation of dual polymer hydroxypropyl guar/sodium hyaluronate (DPHG/SH) vs single polymer SH.
    METHODS: Patients with recently diagnosed mild to moderate dry eye disease (OSDI score 23-32 points) were included. For each patient, the right eye was randomized to receive DPHG/SH or 0.15% SH. Just after the administration of the drop to the right eye, the fellow eye received the other eye drop. The first non-invasive Keratograph first break-up time (NIKBUT), average NIKBUT and tear meniscus height (TMH) were measured before administration of the eye drops, at 1-min, 15 min, 30 min, 60 min, 90 min, and 120 min after instillation.
    RESULTS: A total of 29 patients aged 22.8 ± 2.2 years participated in the study (21 women). No differences between the eye receiving DPHG/SH and single polymer SH were observed for the first NIKBUT (p = 0.45) and average NIKBUT (p = 0.24) variables at any time point. Both DPHG/SH and single polymer SH increased the TMH (p of time effect < 0.001), but with no difference between groups (p = 0.95).
    CONCLUSIONS: Both DPHG/SH and single polymer SH solutions provide lubrication of the eye surface, however, with no difference in NIKBUT and TMH evaluations for up to two hours following administration.
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  • 文章类型: Journal Article
    该临床试验是作为医疗装置的营销程序的一部分进行的,该医疗装置包含含有具有二核苷酸的卤虫提取物的人工泪液。这些分子先前通过增强水溶液的产生而证明了促分泌特性,粘液,和眼泪的脂类成分。
    在动物模型中确认含有卤虫提取物的人工泪液的功效后,本研究评估其对干眼参与者的疗效和安全性.
    对36名干眼参与者(41.6±20.6年)进行了一项随机对照临床试验。一半的参与者用盐溶液作为安慰剂治疗四周,另一半用含有卤虫的人工泪液治疗,随机分配。经过两周的清洗期,再交叉治疗4周。参与者在基线和一周后进行评估,两周,还有四个星期.疗效变量为:眼睛干燥频率(主要),眼睛舒适,视觉满意度,泪液分泌,撕碎时间,角膜染色,结膜染色,和结膜充血.安全变量是:高对比度和低对比度视力,眼内压,和眼底图像分析。
    与基线相比,治疗4周后,盐水溶液在任何研究变量中均无显著变化(p≥0.05).然而,用卤虫局部滴注人工泪液4周可显着改善眼睛干燥频率(p=0.014)和角膜染色(p=0.010)。临床试验期间未报告全身或眼部不良事件。
    在轻度至中度干眼症参与者中局部滴注含有卤虫的人工泪液四周,轻微改善了他们与眼睛干燥频率相关的症状,并减少了角膜损伤,没有观察到不良副作用。
    UNASSIGNED: This clinical trial was conducted as part of the marketing procedures for a medical device comprising artificial tears containing Artemia salina extract with dinucleotides. These molecules previously demonstrated secretagogue properties by enhancing the production of aqueous, mucinous, and lipidic components of the tears.
    UNASSIGNED: After confirming the efficacy of artificial tears containing Artemia salina extract in an animal model, this study proceeded to evaluate their efficacy and safety on dry eye participants.
    UNASSIGNED: A randomised controlled clinical trial was performed on 36 dry eye participants (41.6 ± 20.6 years). Half of the participants were treated with saline solution as a placebo for four weeks, while the other half were treated with artificial tears containing Artemia salina, randomly assigned. After a wash-out period of two weeks, the treatments were crossed for another four weeks. Participants were assessed at baseline and after one week, two weeks, and four weeks. Efficacy variables were: eye dryness frequency (primary), eye comfort, visual satisfaction, tear secretion, tear break-up time, corneal staining, conjunctival staining, and conjunctival hyperaemia. Safety variables were: high- and low-contrast visual acuity, intraocular pressure, and eye fundus images analysis.
    UNASSIGNED: Compared with the baseline, the saline solution showed no significant changes in any of the studied variables after four weeks of treatment (p ≥ 0.05). However, the topical instillation of the artificial tears with Artemia salina for four weeks significantly improved eye dryness frequency (p = 0.014) and corneal staining (p = 0.010). No systemic or ocular adverse events were reported during the clinical trial.
    UNASSIGNED: The topical instillation of artificial tears containing Artemia salina in mild to moderate dry eye participants for four weeks slightly improved their symptoms related to eye dryness frequency and reduced corneal damage, with no undesirable side effects observed.
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  • 文章类型: Journal Article
    比较0.05%环孢素和人工泪液对白内障手术后干眼症的影响。
    这个前景,双面蒙面,随机临床试验纳入了60例符合条件的白内障患者中的60只眼,这些患者完成了这项研究.白内障手术后,患者随机接受环孢素0.05%或人工泪液,每天四次,持续1个月。临床评估包括屈光,远距矫正视力,泪液破裂时间(TBUT),Schirmer\'stest,和视觉模拟量表(VAS)。采用独立样本t检验比较两组变量的均值。
    患者平均年龄为64.15±9.17(范围,45-90),其中53%(n=32)为女性。两组患者的平均年龄差异无统计学意义(P=0.308)。术后一个月,环孢素0.05%组的TBUT值显著较高(P=0.004).Schirmer结果(P=0.095)和VAS问卷得分(P=0.374)在两组间无统计学差异。两组视力结果比较差异无统计学意义(P>0.05)。
    环孢菌素0.05%在改善白内障手术后泪液稳定性方面优于人工泪液。它可以为临床环境中干眼症状的管理提供更有效的治疗选择。
    UNASSIGNED: To compare the effects of cyclosporine 0.05% and artificial tears on dry eye disease following cataract surgery.
    UNASSIGNED: This prospective, double-masked, randomized clinical trial enroled 60 eyes of 60 eligible cataract patients who completed the study. Patients were randomized to receive either cyclosporine 0.05% or artificial tear four times daily for 1 month following cataract surgery. Clinical assessments included refraction, corrected distance visual acuity, tear break-up time (TBUT), Schirmer\'s test, and the visual analogue scale (VAS). An independent sample t-test was used to compare the means of the variables between the two groups.
    UNASSIGNED: Mean patient age was 64.15±9.17 (range, 45-90), of which 53% (n=32) were female. There was no significant difference in mean age (P=0.308) between the two groups. One month postoperatively, the cyclosporine 0.05% group had a significantly higher TBUT value (P=0.004). Schirmer\'s result (P=0.095) and the VAS questionnaire scores (P=0.374) did not show a statistically significant difference between the two groups. There was no significant difference in the visual outcomes (P>0.05).
    UNASSIGNED: Cyclosporine 0.05% was superior to artificial tears in improving tear stability after cataract surgery in the management of immediate postoperative dry eye. It may provide a more effective therapeutic option for the management of dry eye symptoms in the clinical setting.
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  • 文章类型: Journal Article
    背景:周围肥厚性上皮下角膜混浊(PHSCO)是一种可能严重影响视力的角膜疾病。这项研究的主要目的是检验泪液分泌的假设,药物治疗和全身性疾病与PHSCO有关。
    方法:这是一个回顾性研究,在眼科进行的病例对照研究,美因茨约翰内斯·古腾堡大学医学中心。我们分析了诊断为PHSCO的患者的医疗记录。性,年龄,Schirmer的测试II,评估了一般用药和病史,并与Gutenberg健康研究(GHS)中年龄和性别相匹配的对照组进行比较.
    结果:纳入112例PHSCO患者的109只眼。88例患者为女性,平均年龄为55.3±14.7岁(23-89岁),24例患者为男性,平均年龄为59.3±12.6岁(38-84岁)。83例患者(74.1%)双眼受累。与GHS对照组相比,PHSCO患者的Schirmer检验II显着降低(p<0.001)。PHSCO患者使用人工泪液和类固醇滴眼液的频率更高(p<0.001),并且远视程度高于健康对照组(p=0.01)。PHSCO和健康对照之间的全身性疾病或药物治疗没有显着差异。
    结论:PHSCO患者泪液分泌减少和更频繁使用人工泪液提示PHSCO与干眼病之间存在联系。研究结果不支持我们的假设,即PHSCO与全身性疾病相关。有趣的是,PHSCO患者使用β受体阻滞剂的频率低于对照组.
    BACKGROUND: Peripheral hypertrophic subepithelial corneal opacification (PHSCO) is a corneal disease that may severely affect vision. The major goal of this study was to test the hypothesis that tear secretion, medication and systemic diseases are associated with PHSCO.
    METHODS: This is a retrospective, case-control study conducted at the Department of Ophthalmology, University Medical Center of the Johannes Gutenberg University Mainz. We analysed medical records of patients diagnosed with PHSCO. Sex, age, Schirmer\'s test II, general medication and medical history were assessed and compared to an age- and sex-matched control group from the Gutenberg Health Study (GHS).
    RESULTS: One hundred ninety-five eyes of 112 patients with PHSCO were included. Eighty-eight patients were female with a mean age of 55.3 ± 14.7 years (23-89 years) and 24 patients were male with a mean age of 59.3 ± 12.6 years (38-84 years). In 83 patients (74.1%) both eyes were involved. The Schirmer\'s test II was significantly reduced in patients with PHSCO compared to the GHS control group (p < 0.001). Patients with PHSCO were more frequently administered artificial tears and steroid eye drops (p < 0.001) and were more hyperopic than healthy controls (p = 0.01). Systemic diseases or medication did not differ markedly between PHSCO and healthy controls.
    CONCLUSIONS: Reduced tear secretion and more frequent use of artificial tears in patients with PHSCO suggest a link between PHSCO and dry eye disease. The results of the study do not support our hypothesis that PHSCO is associated with systemic diseases. Interestingly, patients with PHSCO were less frequently on β-blockers than control subjects.
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  • 文章类型: Journal Article
    背景:华沙的血液学和输血医学研究所(IHTM)自1991年以来生产了用于治疗干眼综合征(DES)的自体血清滴眼液(ASEDs)。2019年,IHTM为接受长期治疗的患者引入了同种异体眼泪(alloSED)。
    方法:114例应用alloSED的患者纳入研究。他们被要求在使用ASED和每次捐赠的100单位alloSED滴剂之前和之后完成OSDI问卷。OSDI指数评估DES严重程度(0没有症状;100严重)。我们还比较了IL-1β的含量,ASED(38个样品)和alloSED(15个血清样品)中的IL-2、IL-6、IL-10和VEGF。研究数据涵盖2019-2022年期间。
    结果:114名患者参与了这项研究。我们比较了ASED和alloSED的有效性。平均,OSDI从68.42±5,86(应用前)下降到51.05±19,06(应用后)。来自完成和返回的问卷(在IHTM准备)的数据(41/114)显示了使用血清滴剂的最常见适应症,包括没有潜在疾病的DES,继发于GvHD(移植物抗宿主病)的DES,干燥综合征(SS)。该研究报告了与疾病实体如SS相关的较高细胞因子水平。应用高细胞因子水平的滴剂后,患者报告不良反应,如眼睑下的沙子,视力受损,和更糟糕的眼睛润滑。
    结论:具有可接受的低促炎细胞因子值和足够高水平的VEGF生长因子的AlloSED可能有助于减轻炎症性眼部症状。
    BACKGROUND: The Institute of Hematology and Transfusion Medicine (IHTM) in Warsaw has produced autologous serum eye drops (ASEDs) for the treatment of Dry Eye Syndrome (DES) since 1991. In 2019, IHTM introduced allogeneic tears (alloSEDs) for patients on long-term treatment.
    METHODS: 114 patients who applied alloSEDs were included in the study.They were asked to complete the OSDI questionnaire before and after using ASEDs and 100 units of alloSEDs drops from each donation. The OSDI index rates DES severity (0 no symptoms; 100 severe). We also compared the content of IL-1β, IL-2, IL- 6, IL-10 and VEGF in ASEDs (38 samples) and alloSEDs (15 serum samples). The study data covered the 2019-2022 period.
    RESULTS: 114 patients participated in the study. We compared the the effectiveness of ASEDs and alloSEDs. The average, OSDI dropped from 68.42 ± 5,86 (before application) to 51.05 ± 19,06 (after application). Data from the questionnaires (prepared at IHTM) completed and returned (41/114) present the most common indications for the use of serum drops, including DES with no underlying disease, DES secondary to GvHD (Graft versus Host Disease), Sjögren\'s Syndrome (SS). The study reported higher cytokine levels associated with disease entities such as SS. After application of drops with high cytokine levels, patients reported adverse reactions such as sand under the eyelids, impaired visual acuity, and worse eye lubrication.
    CONCLUSIONS: AlloSEDs with acceptably low values of pro-inflammatory cytokines and sufficiently high levels of VEGF growth factor may contribute to alleviation of inflammatory eye symptoms.
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  • 文章类型: Journal Article
    目的:干眼病(DED)是一种常见的眼表疾病,通常以泪膜高渗透压和不稳定为特征。这篇综述概述了DED的分类,随后全面讨论了最新的局部用药和全身用药,以及为每位患者选择最合适方案的临床建议.
    方法:对电子数据库进行了广泛的文献检索,比如PubMed,Scopus,和WebofScience,使用包括“干眼症”在内的关键词,“\”眼表疾病,\"\"医疗管理,\"\"人工泪液,\"\"局部免疫调节剂,“和”睑板腺功能障碍。\"
    结果:DED的根本原因可能从水性泪液产生不足到泪液蒸发增加。最近的文献通过检查泪膜的脂质,对DED的病理生理学有了更深入的了解。水性,和粘蛋白层。然而,尽管有这些进步,有症状的DED患者的医疗管理尚未充分反映其病理生理学的现代化知识。
    结论:为了制定治疗DED的合理化策略,更新治疗方案的知识是至关重要的,他们的行动机制,以及基于DED类型和根本原因的指示。
    OBJECTIVE: Dry eye disease (DED) is a prevalent ocular surface disease that is conventionally characterized by tear film hyperosmolarity and instability. This review presents a summarized classification of DED, followed by a comprehensive discussion of the most recent topical and systemic medications and clinical recommendations for selecting the most appropriate option for each patient.
    METHODS: An extensive literature search was conducted on electronic databases, such as PubMed, Scopus, and Web of Science, using keywords including \"dry eye syndrome,\" \"ocular surface disease,\" \"medical management,\" \"artificial tears,\" \"topical immunomodulators,\" and \"meibomian gland dysfunction.\"
    RESULTS: The underlying reasons for DED can range from insufficient aqueous tear production to increased tear evaporation. Recent literature has provided a more in-depth understanding of the pathophysiology of DED by examining the tear film\'s lipid, aqueous, and mucin layers. However, despite these advancements, medical management of patients with symptomatic DED has not fully reflected this modernized knowledge of its pathophysiology.
    CONCLUSIONS: To develop a rationalized strategy for treating DED, it is crucial to have updated knowledge of therapeutic options, their mechanisms of actions, and indications based on the DED type and underlying causes.
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  • 文章类型: Journal Article
    介绍:氢键网络在影响人工泪液(AT)中氧氟沙星的几种理化性质中起着重要作用,包括密度,pH值,粘度,和自扩散系数。氧氟沙星抗生素与Ats混合物的活性不仅取决于其浓度,而且还受到氢键网络强度的影响,这突出了在配制适当剂量的氧氟沙星抗生素滴眼液时考虑诸如过量眼泪产生和干眼状况等因素的重要性。目标:研究氧氟沙星-ATs混合物的理化性质,作为理解氢键对氧氟沙星抗生素滴眼液抗菌活性影响的模型。用不同浓度的氧氟沙星测定氧氟沙星-Ats混合物的抗菌活性。方法:使用1H-NMR分析氧氟沙星-ATs混合物,拉曼,和紫外可见光谱,随着氧氟沙星浓度的变化,研究其在ATs中的解离动力学,模仿它的行为在人的眼睛的眼泪。调查包括对1H-NMR光谱数据的全面分析,自扩散系数,拉曼光谱,紫外-可见光谱,液体粘度,酸度,提供对物理化学性质的全面评估。结果:NMR化学位移分析,线宽,自扩散系数曲线揭示了不同的模式,在ATs中解离的氧氟沙星摩尔分数约为0.6的峰或最小值,表明与氢键网络有很强的相关性。此外,pH数据显示出与粘度相似的趋势,表明氢键网络对质子离子浓度的影响。通过对鼠伤寒沙门氏菌的生长速率分析来评估氧氟沙星-ATs混合物的抗菌活性,考虑摩尔分数为0.1、0.4、0.6、0.8和0.9的不同浓度。结论:与摩尔分数为0.1和0.4的混合物相比,氧氟沙星摩尔分数为0.6的抗生素-ATs混合物的活性较低,尽管浓度较低。混合物的活性不仅取决于浓度,而且还受到氢键网络强度的影响。这些发现强调了在设计用于滴眼液制剂的适当剂量的氧氟沙星抗生素时考虑泪液过度分泌和干眼问题的重要性。
    Introduction: The hydrogen-bonded networks play a significant role in influencing several physicochemical properties of ofloxacin in artificial tears (ATs), including density, pH, viscosity, and self-diffusion coefficients. The activities of the ofloxacin antibiotic with Ats mixtures are not solely determined by their concentration but are also influenced by the strength of the hydrogen bonding network which highlight the importance of considering factors such as excessive tear production and dry eye conditions when formulating appropriate dosages of ofloxacin antibiotics for eye drops. Objectives: Investigating the physicochemical properties of ofloxacin-ATs mixtures, which serve as a model for understanding the impact of hydrogen bonding on the antimicrobial activity of ofloxacin antibiotic eye drops. Determine the antimicrobial activities of the ofloxacin-Ats mixture with different concentration of ofloxacin. Methods: The ofloxacin-ATs mixtures were analyzed using 1H-NMR, Raman, and UV-Vis spectroscopies, with variation of ofloxacin concentration to study its dissociation kinetics in ATs, mimicking its behavior in human eye tears. The investigation includes comprehensive analysis of 1H-NMR spectral data, self-diffusion coefficients, Raman spectroscopy, UV-Vis spectroscopy, liquid viscosity, and acidity, providing a comprehensive assessment of the physicochemical properties. Results: Analysis of NMR chemical shifts, linewidths, and self-diffusion coefficient curves reveals distinct patterns, with peaks or minima observed around 0.6 ofloxacin mole fraction dissociated in ATs, indicating a strong correlation with the hydrogen bonding network. Additionally, the pH data exhibits a similar trend to viscosity, suggesting an influence of the hydrogen bonding network on protonic ion concentrations. Antibacterial activity of the ofloxacin-ATs mixtures is evaluated through growth rate analysis against Salmonella typhimurium, considering varying concentrations with mole fractions of 0.1, 0.4, 0.6, 0.8, and 0.9. Conclusions: The antibiotic-ATs mixture with a mole fraction of 0.6 ofloxacin exhibited lower activity compared to mixtures with mole fractions of 0.1 and 0.4, despite its lower concentration. The activities of the mixtures are not solely dependent on concentration but are also influenced by the strength of the hydrogen bonding network. These findings emphasize the importance of considering tear over-secretion and dry eye problems when designing appropriate doses of ofloxacin antibiotics for eye drop formulations.
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  • 文章类型: Journal Article
    干眼病(DED)是一种慢性眼表病症,通常特征在于泪液产生减少和泪液蒸发快速,其影响泪膜稳定性和体内平衡。DED的常见症状包括眼部不适,视觉障碍,干燥度,和瘙痒。人工泪液是DED管理的主体,并且补充泪膜的一层或多层。人工泪滴可作为粘度增强剂(缓和剂/润滑剂)的组合,湿润剂,和缓冲液有或没有防腐剂。人工泪液,作为组分的组合(聚合物/缓和剂/增粘剂),与单一成分相比,可以为DED的多因素体征和症状的管理提供协同作用。这篇综述描述了配方成分,物理化学性质,作用机制,以及羟丙基瓜尔胶-透明质酸(HPG-HA)双聚合物润滑剂滴眼液(SYSTANE™HYDRATION)的临床前和临床证据摘要。双聚合物滴眼剂由双缓和剂(丙二醇和聚乙二醇400)和聚合物羟丙基瓜尔胶(HPG)和透明质酸(HA)组成。当滴入眼表时,HPG与硼酸根离子形成交联凝胶基质,延长缓和剂的保留时间,从而提供持久的润滑和眼表保护。此外,HA稳定泪膜,增加角膜润湿性,并由于其吸湿性和粘弹性而减少眨眼期间的摩擦。临床前证据表明,HPGHA双聚合物润滑剂滴眼液可通过细胞水合和表面保留来防止干燥,细胞屏障保护,长时间润滑,和促进角膜上皮再形成。临床科学证据表明,HPGHA双聚合物润滑剂滴眼液在治疗DED中是安全有效的。具体来说,减少DED的症状和体征,减少白内障手术后的干眼症状,改善健康眼睛的泪膜质量。
    Dry eye disease (DED) is a chronic ocular surface disorder often characterized by decreased tear production and rapid tear evaporation that affect tear film stability and homeostasis. The common symptoms of DED include ocular discomfort, visual disturbances, dryness, and itching. Artificial tears are the mainstay of DED management and supplement one or more layers of the tear film. Artificial tear drops are available as a combination of viscosity-enhancing agents (demulcents/lubricants), humectants, and buffers either with or without preservatives. Artificial tears, as a combination of components (polymers/demulcents/viscosity-enhancing agents), can provide synergistic action compared with a single component for the management of multifactorial signs and symptoms of DED. This review describes the formulation components, physicochemical properties, mechanism of action, and summary of preclinical and clinical evidence on the hydroxypropyl guar-hyaluronic acid (HPG-HA) dual-polymer lubricant eye drops (SYSTANE™ HYDRATION). The dual-polymer eye drops consist of dual demulcents (propylene glycol and polyethylene glycol 400) and the polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA). When instilled on the ocular surface, HPG forms a cross-linked gel matrix with borate ions that prolongs the retention of demulcents, thus providing long-lasting lubrication and ocular surface protection. Additionally, HA stabilizes the tear film, increases corneal wettability, and reduces friction during blinks due to its hygroscopic and viscoelastic properties. Preclinical evidence demonstrates that HPG HA dual-polymer lubricant eye drops provide protection against desiccation by cell hydration and surface retention, cell barrier protection, prolonged lubrication, and promotion of corneal re-epithelialization. Clinical scientific evidence demonstrates that HPG HA dual-polymer lubricant eye drops are safe and effective in the management of DED. Specifically, they reduce the signs and symptoms of DED, reduce dry eye symptoms post-cataract surgery, and improve tear film quality in healthy eyes.
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  • 文章类型: Journal Article
    背景:该研究旨在评估使用丙二醇-羟丙基-瓜尔胶(PG-HPG)纳米乳液润滑剂滴眼液对干眼症表现的多症状缓解,在患有干眼病(DED)的受试者中。
    方法:这是一个后营销,prospective,在美国进行的单臂研究。年龄≥18岁的受试者,双眼泪液破裂时间(TBUT)≤10s,干眼症问卷-5(DEQ-5)\“水汪汪的眼睛\”症状评分1-4,灼热/刺痛的症状,由干眼对日常生活的影响确定的疼痛和疲劳的眼睛-症状困扰(IDEEL-SB)问卷,包括IDEEL-SB评分16-65。要求受试者在第0、14±2和28±2天完成IDEEL-SB和DEQ-5,并每天四次自我施用一滴PG-HPG,共28±2天。主要终点是疼痛症状在第28天的基线变化,刺痛/燃烧,和疲惫的眼睛在IDEEL-SB;和症状水汪汪的眼睛在DEQ-5。评估的其他终点是基线和第28±2天的角膜染色和TBUT;第28±2天的症状缓解(5点Likert量表)和安全性。
    结果:在119名受试者中,95人完成了研究(平均±SD年龄61.2±13.0岁;女性69.5%)。在第28天,眼睛疼痛/疼痛症状的平均IDEEL-SB评分从基线显着降低(从基线变化-1.0±1.1),灼伤/刺痛的眼睛(从基线变化-1.1±0.9),和疲劳的眼睛(从基线变化-1.1±1.0)(所有p<0.0001)。在第28天,水汪汪眼症状的平均DEQ-5评分从基线显著降低(从基线的变化-0.9±1.0,p<0.0001)。第28天的角膜染色与基线相当。TBUT从基线改善至第28天。在李克特的音阶上,超过50%的受试者报告疼痛症状缓解,刺痛,燃烧的眼睛。三名(3.1%)受试者报告了因治疗引起的不良事件(非眼部)。
    结论:PG-HPG纳米乳润滑剂滴眼液在28天内显著改善DED患者的多种干眼症状,没有新的安全问题。
    背景:ClinicalTrials.gov标识符,NCT05056155。
    BACKGROUND: The study aimed to evaluate multi-symptom relief of dry eye manifestations with the use of propylene glycol-hydroxypropyl-guar (PG-HPG) nanoemulsion lubricant eye drops, among subjects with dry eye disease (DED).
    METHODS: This was a post-marketing, prospective, single-arm study conducted in the USA. Subjects aged ≥ 18 years, with tear breakup time (TBUT) ≤ 10 s for both eyes, dry eye questionnaire-5 (DEQ-5) \"watery eyes\" symptom score 1-4, symptoms of burning/stinging, sore and tired eyes as determined by impact of dry eye on everyday living-symptom bother (IDEEL-SB) questionnaire, and IDEEL-SB score 16-65 were included. Subjects were required to complete IDEEL-SB and DEQ-5 at days 0, 14 ± 2, and 28 ± 2, and self-administer one drop of PG-HPG four times daily for 28 ± 2 days. Primary endpoints were change from baseline at day 28 in symptoms of sore, stinging/burning, and tired eyes on IDEEL-SB; and symptom of watery eyes on DEQ-5. Other endpoints evaluated were corneal staining and TBUT at baseline and day 28 ± 2; symptom relief (5-point Likert scale) at day 28 ± 2, and safety.
    RESULTS: Of 119 subjects enrolled, 95 completed the study (mean ± SD age 61.2 ± 13.0 years; female 69.5%). Mean IDEEL-SB scores reduced significantly from baseline at day 28 for symptoms of aching/sore eyes (change from baseline - 1.0 ± 1.1), burning/stinging eyes (change from baseline - 1.1 ± 0.9), and tired eyes (change from baseline - 1.1 ± 1.0) (all p < 0.0001). Mean DEQ-5 score for watery eye symptoms significantly reduced from baseline at day 28 (change from baseline - 0.9 ± 1.0, p < 0.0001). Corneal staining at day 28 was comparable to baseline. TBUT improved from baseline to day 28. On a Likert scale, more than 50% of subjects reported relief from symptoms of sore, stinging, and burning eyes. Three (3.1%) subjects reported treatment-emergent adverse events (non-ocular).
    CONCLUSIONS: PG-HPG nanoemulsion lubricant eye drops significantly improved multiple dry eye symptoms in subjects with DED over 28 days, with no new safety concerns.
    BACKGROUND: ClinicalTrials.gov Identifier, NCT05056155.
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