论著

青光眼患者药物重整服务的临床实践

Clinical practice of medication reconciliation services in glaucoma patients

:522-527
 
目的:通过为青光眼患者提供安全、有效、经济、合理的规范化药学服务,探讨药物重整在青光眼患者中的临床应用价值,并评估药物重整服务在眼科专科用药方面的可行性。方法:采用前瞻性研究设计,纳入武汉大学附属爱尔眼科医院2023年8月-2024年1月青光眼住院患者308例, 临床药师通过收集用药史、医嘱审核、用药偏差纠正、用药教育等多种方式实施药物重整服务。结果:在308例患者中,104例患者存在需重整的用药问题,重整率为33.8%,重整医嘱共198条,在这些重整医嘱中,用药依从性问题占57.0%,用药安全性问题占18.1%,用药差错占24.9%。经过药物重整,患者用药依从性提升至95.1%(χ²=27.210,P<0.05),安全性问题降至1.3%(χ²=22.565,P<0.05),用药差错率降至1.9%(χ²=26.251,P<0.05)。结论:药物重整可提高青光眼患者的用药合理性及依从性,是保障患者用药安全、合理的有效药学服务手段。
Objective: To introduce medication reconciliation (MR) services for glaucoma patients, with the aim of delivering safe, effective, and cost-effective pharmaceutical care. This study also evaluates the clinical value of MR in glaucoma management and assesses its feasibility within ophthalmic specialized medication practices. Methods: In this prospective study, 308 hospitalized glaucoma patients were enrolled between August 2023 and January 2024. Clinical pharmacists conducted medication reconciliation using standardized procedures, which encompassed comprehensive medication history collection, medication order review, correction of discrepancies, and structured discharge counseling. Results: Among the 308 patients, MR interventions was required in 104 cases (33.80%), identifying 198 medication related issues. Of these, 57.0% pertained to medication adherence problems, 18.1% involved medication safety concerns, and 24.9% related to medication appropriateness. Following medication reconciliation, medication adherence improved to 95.1% (χ²=27.210, P<0.05), the incidence of adverse drug reactions declined to 1.3% (χ²=22.565, P<0.05), and medication appropriateness issues decreased to 1.9% (χ²=26.251, P<0.05). Conclusions: MR significantly enhances medication appropriateness and adherence in glaucoma management. This evidence-based pharmaceutical care model effectively ensures medication safety and therapeutic efficacy, offering practical insights for extending MR to other chronic ophthalmic conditions.
综述

区块链在药物临床试验中的应用

Application of blockchain technology in clinical drug trial

:46-49
 
当前,药物临床试验面临着两大难题:数据真实性及相关人员操作规范性。现阶段国内外在药物临床试验方面的监管主要以事后监查为主,在数据质量管理以及操作规划标准的监查方面存在一定的时延性。而区块链通过非对称加密、哈希算法及智能合约等技术,可以在保证受试者隐私信息的前提下,提高政府相关监督机构的监管效率,提升药物临床试验数据管理的透明度;同时,与物联网的紧密结合可以实现对标准操作规范的进一步核查,与人工智能的结合有望实现受试者的自动招募。
Clinical drug trials are confronted with two major issues: first, data authenticity, for instance, if any data falsification is conducted during the whole trial; second, whether the standard of procedure is accordingly conducted throughout the whole trial or not. Currently, both domestic and overseas clinical drug trials are not supervised without delay (ex-post inspection). Blockchain technology can improve the efficiency of Food and Drug Administration and the transparency of trials while the rights and safety of human research subjects are guaranteed by the integrated technology such as chained structure, asymmetry key algorithm, hash algorithm, and smart contract. Furthermore, with the assistance of internet of things (IoT) and artificial intelligence (AI), the actual supervision over the whole trial and automatic recruitment of human research subjects are expected to achieve.
综述

白内障的药物治疗及研究进展

Pharmacological treatment and research progress of cataracts

:565-573
 
白内障是全球第一大致盲眼病,表现为由多种原因导致的晶状体病变,进而出现视物模糊的现象,严重者会进一步丧失视力。白内障的类型较多,发病机制尚未完全阐释清楚,氧化应激是目前公认的主要影响因素。药物治疗一直是白内障患者临床治疗的一大难题,目前市面上还没有能够真正逆转白内障的药物,现有的药物仅能在一定程度上缓解白内障的进展。手术治疗仍是现阶段唯一有效的治疗方式,但经济因素和术后并发症的风险限制了部分患者通过手术恢复视力。白内障的治疗一直是眼科领域研究的重点,目前研究主要集中在两个战略方向上:优化手术技术并结合更优的围术期药物治疗方案以减少并发症,以及对疾病机制进行基础研究以促进新靶点药物的发现。有效的药物治疗一直是目前临床治疗的一大缺口,近年来研究者在白内障机制探索和新药研发上取得了显著进展,多个新的治疗靶点以及相关治疗药物不断被发现,但相关药物真正进入临床还面临着诸多挑战。文章主要从机制研究进展、药物治疗现状和前景较好的白内障药物临床研究进展等进行综述,旨在为新的白内障药物研发提供最新的参考。
Cataracts remain the leading cause of blindness globally. They manifest as lens opacification triggered by various factors, leading to blurred vision. In severe cases, patients may eventually lose their vision entirely. There are many types of cataracts, and their pathogenesis has not been fully clarified. Currently, oxidative stress is widely acknowledged as the primary influencing factor. Pharmacological intervention remains a significant clinical challenge in cataract management. At present, there are no drugs on the market capable of truly reversing cataracts; existing medications can only alleviate the progression of the condition to a certain extent. Surgical treatment remains the only effective approach at this stage. However, economic limitations and the risks of postoperative complications hinder its accessibility for certain patient groups. The treatment of cataracts has consistently been a research hotspot in the field of ophthalmology. Current research mainly centers on two strategic approaches: optimizing surgical techniques alongside improved perioperative pharmaceutical regimens to minimize complications, and conducting basic researches on disease mechanisms to facilitate drug discovery. Effective drug treatment has long been a major gap in current clinical treatment. In recent years, significant progress has been achieved in the exploration of cataract mechanisms and the development of new drugs. Despite the remarkable advancements in uncovering cataract pathogenesis and identifying novel therapeutic targets in recent years, substantial challenges remain in translating these discoveries into clinically applicable medications. This article reviews the progress in mechanism research, the current state of pharmacological interventions, and the clinical research developments of several promising cataract drugs, aiming to provide the latest reference for the research and development of new cataract drugs.
综述

减重药物对眼部的影响

The effects of the weight-loss drugs on the eyes

:585-594
 
全球范围内,肥胖或超重问题持续加剧,据《2024年世界肥胖报告》及近期数据,预计2035年受超重或肥胖影响的成年人将达33亿,我国成人肥胖或超重患病率已超50%且呈上升趋势。肥胖会增加2型糖尿病、心血管疾病等多种疾病风险,减轻5%~15%体重可改善相关并发症,因此减重关注度日益提升,除运动和饮食控制外,减重药物与手术等手段不断涌现。然而减重药物在减轻体质量(体重)的同时,其潜在的危害不容忽视,有研究表明减重药物可对眼部产生不良影响:导致眼压升高使患者出现眼睛疼痛、视力模糊的症状;影响眼部血液循环和营养供应,发生炎症感染;出现眼睛疲劳干涩,对糖尿病性视网膜病变产生影响等。本文聚焦目前主流的三类减重药物——非中枢性减重药物(以脂肪酶抑制剂为代表)、中枢性减重药物(含拟儿茶酚胺类制剂和5-羟色胺受体激动剂)、兼有减重效果的降糖药物(包括GLP-1RA、GLP-1/GIP双受体激动剂、二甲双胍等),详细论述其应用及对眼部的不良反应。同时,也提及部分药物可能对眼部产生的益处,如二甲双胍、GLP-1RA或对青光眼、糖尿病视网膜病变有潜在保护作用。本文旨在为用药人群、相关医护及从业人员提供理论指导,强调使用减重药物时需警惕眼部风险,平衡疗效与安全性。
Globally, the problem of obesity or overweight continues to intensify. According to the "2024 World Obesity Report" and recent data, it is estimated that by 2035, the number of adults affected by overweight or obesity will reach 3.3 billion. In China, the prevalence of obesity or overweight among adults has exceeded 50% and is on the rise. Obesity increases the risk of various diseases such as type 2 diabetes and cardiovascular diseases. Reducing body weight by 5% to 15% can improve related complications. Therefore, the focus on weight loss is increasing. Besides exercise and dietary control, weight loss drugs and surgeries are constantly emerging. However, while weight loss drugs can reduce body weight, their potential harms should not be ignored. Studies have shown that weight loss drugs can have adverse effects on the eyes: causing increased intraocular pressure, leading to symptoms such as eye pain and blurred vision; affecting blood circulation and nutrient supply to the eyes, resulting in inflammation and infection; causing eye fatigue and dryness, and having an impact on diabetic retinopathy, etc. This article focuses on the three main types of weight loss drugs currently available - non-central weight loss drugs (represented by fat enzyme inhibitors), central weight loss drugs (including catecholamine-like preparations and 5-hydroxytryptamine receptor agonists), and hypoglycemic drugs with weight loss effects (including GLP-1RA, GLP-1/GIP dual receptor agonists, metformin, etc.), and elaborates on their applications and adverse reactions to the eyes. At the same time, it also mentions the potential benefits that some drugs may have on the eyes, such as metformin and GLP-1RA, which may have a protective effect on glaucoma and diabetic retinopathy. This article aims to provide theoretical guidance for drug users, related medical staff, and professionals, emphasizing the need to be vigilant about eye risks when using weight loss drugs and to balance efficacy and safety.
论著

基于医院小儿眼科常见病种分析儿童眼科药物临床试验现状

Analysis of the current situation of clinical trials of ophthalmic drugs in children based on the common diseases of pediatric ophthalmology in hospital

:408-415
 

目的:结合医院小儿眼科常见病种调研国内儿童眼用制剂药物临床试验开展现状,为儿童眼用制剂药物临床试验的发展提供参考。方法:基于国家药物临床试验登记与信息公示平台和医院信息系统,结合郑州市第二人民医院儿童眼科病种,分析儿童眼科药物临床试验开展情况。 结果:医院门诊就诊患者以屈光不正最多(占68.49% ),其次是结膜炎(占11.25%),再次是斜视(占8.60%)。平台共检索到相关临床试验165项,儿科专用药物临床试验25项,其中延缓青少年近视方面试验24个,小儿结膜炎试验1个,其他病种药物临床试验检测结果为0;药物临床试验中以I期和Ⅲ期临床试验为主;延缓青少年近视方面试验已完成试验8项,其他都在进行中。结论:儿童眼科疾病的药物治疗尚有巨大的临床需求未满足,直接关系到了儿童健康权益保障与生命安全维护。当前国内儿童眼用制剂研发呈现企业参与度低、创新动力不足的现状,其核心制约因素在于项目少、难度大、涉及更多的伦理问题。建议通过政产学研协同创新,系统性推进儿童眼用制剂的研发进展,切实解决我国儿童眼病治疗用药难的问题,为儿童视觉健康提供有力保障。

Objective:Combined with the common diseases of pediatric ophthalmology in our hospital, the current situation of clinical trials of ophthalmic preparations for children in China was investigated to provide reference for the development of clinical trials of ophthalmic preparations for children in China. Methods:Based on the national drug clinical trial registration and information publicity platform and hospital information system, combined with the pediatric ophthalmic diseases in our hospital, the development of pediatric ophthalmic drug clinical trials was analyzed. Results:Among the outpatients in our hospital, ametropia was the most common ( 68.49 % ), followed by conjunctivitis ( 11.25 % ) and strabismus ( 8.60 % ). A total of 165 clinical trials and 25 clinical trials of pediatric drugs were retrieved from the platform, including 24 trials on delaying juvenile myopia, 1 trial on pediatric conjunctivitis, and 0 clinical trial on other diseases. Drug clinical trials were mainly phase I and phase III clinical trials. Eight trials have been completed to delay juvenile myopia, and others are in progress. Conclusions:There is still a huge clinical demand for the drug treatment of children 's eye diseases, which is directly related to the protection of children 's health rights and life safety. At present, the research and development of children 's ophthalmic preparations in China presents the current situation of low enterprise participation and insufficient innovation motivation. The core constraints are fewer projects, greater difficulty, and more ethical issues. It is suggested to systematically promote the research and development of ophthalmic preparations for children through the collaborative innovation of government, industry, university and research, so as to effectively solve the problem of difficult medication for children 's eye diseases in China and provide a strong guarantee for children 's visual health.
综述

人工智能在眼科药物研发的契机与挑战

Opportunities and challenges of artificial intelligence in ophthalmic drug discovery and development

:595-602
 
近年来随着人类生活方式的改变、用眼频率的增加,眼科药物的市场需求持续增长,但是目前眼病治疗仍面临“缺医少药”的困境。由于新药研发面临成本高、周期长、成功率低的风险,眼科药物创新迭代的进程日趋缓慢。人工智能(artificial intelligence,AI)作为一种全新的技术手段,有望赋能眼科药物研发的全过程,包括药物靶点发现、化合物筛选、药物动力学模型创新与临床试验开展等,以期为眼科药物研发“降本增效”。且随着大数据体系的完善、硬件计算力的提升以及生命科学与智能科学的深度融合,AI在眼科药物研发中的作用将进一步得到提升,助力眼科药物研发实现从精准化到智能化的跨越。
With the change of human lifestyle and overuse of eyes in recent years, the market demand for ophthalmic drugs continues to grow. However, the ocular therapy is still facing the shortage of doctors and drugs. Due to the risk of high cost, long lead time and low success rate, the process of novel ophthalmic drug innovation and iteration is getting slower. As an emerging technology, artificial intelligence is expected to enable the whole process of ophthalmic drug discovery and development, including drug target discovery, compound screening, pharmacokinetic model innovation and clinical trials, thus reducing R&D costs and increase efficiency for ophthalmic drug discovery and development. In addition, with the improvement of big data, hardware calculation and the deep integration of life science and intelligent science, the role of artificial intelligence in ophthalmic drug discovery and development will be significant improved , contributing to achieve the leap from precision to intelligence.
“筑梦·铸人”专题

玻璃体腔注射抗VEGF药物治疗湿性年龄相关性黄斑变性的5年回顾性研究

Intravitreal injection of anti-VEGF agents in wet age-related macular degeneration: a 5-year retrospective study

:537-543
 
目的:调查抗VEGF药物治疗湿性年龄相关性黄斑变性(wet age-related macular degeneration, wAMD)5年的疗效。方法:2011年至2021年于北京医院眼科诊断为wAMD的患者共84人103只眼进行回顾性分析。抗VEGF治疗采用3+PRN方案。观察5年来的最佳矫正视力(best-corrected visual acuity,BCVA)、玻璃体腔注射次数、随访次数和病灶的解剖学变化。结果:治疗5年后平均BCVA为38.1个字母,与基线相比下降9.4个字母,差异有统计学意义(P<0.001)。23.3%的患眼5年后可维持初始视力。5年内平均注射次数为13.8次,第1年注射次数最多,平均为4.3次。5年内平均随访次数为24.3次,仅有34.0%的患眼可遵循每次随访间隔≤3个月。5年后有68.0%的患眼出现纤维瘢痕,27.2%的患眼出现地图样萎缩,69.0%(71/103)的患眼存在持续的色素上皮脱离(pigment epithelial detachment,PED)。年龄、基线BCVA、是否初始治疗、随访年限、注射次数、中心视网膜厚度 (central retina thickness,CRT)、地图样萎缩等对BCVA有显著影响。结论:多数患者在抗VEGF治疗1年内可维持视力,但5年以上维持效果不佳。早期诊治、提高注射频率,可能是未来改善预后的研究方向。
Objective:To investigate the efficacy of anti-VEGF injection in the treatment of wet age-related macular degeneration (wAMD) for 5 years. Methods: A total of 84 patients (103 eyes) wAMD diagnosed in Department of Ophthalmology in Beijing Hospital from 2011 to 2021 were analyzed retrospectively. 3 + PRN regimen was applied for anti-VEGF treatment. The changes of best corrected visual acuity (BCVA), the number of intravitreal injections and the number of follow-up visits, and the anatomical changes of the lesions in the past 5 years were collected. Results: The average BCVA after 5 years was 38.1 letters, indicating a decrease of 9.4 letters comparing to baseline, which was statistically significant (P<0.001). 23.3% of the eyes could maintain the baseline BCVA after 5 years. The average injection times within 5 years was 13.8, and the injection was concentrated in the first year, with an average of 4.3. The average number of follow-up visits within 5 years was 24.3, and only 34.0% of the affected eyes could keep the follow-up interval ≤3 months. After 5 years, 68.0% of the eyes developed fibrous scar, 27.2% developed geographic atrophy, and 69.0% (71/103) had consistent pigment epithelial detachment. Factors significantly affect BCVA include: age, baseline BCVA, initial treatment, follow-up time, injection times, central retinal thickness, geographic atrophy and so on. Conclusion: Most patients can maintain vision within the first year after anti-VEGF treatment, but the efficacy is poor for more than 5 years. Early diagnosis and treatment, and increased injection frequency may be the research direction for improving prognosis in the future.
综述

药物治疗单纯疱疹病毒基质型角膜炎的研究进展

Research progress in drug treatment of herpes simplex virus stromal keratitis

:651-657
 
单纯疱疹病毒基质型角膜炎是引起角膜盲的主要原因之一,目前以局部使用糖皮质激素联合口服抗病毒药物治疗为主。传统治疗存在生物利用度低、药物不良反应等缺点,因此亟需寻找替代药物、开发新剂型。环孢素A和他克莫司等免疫抑制剂疗效明显、不良反应少,可能是糖皮质激素的潜在替代品。α干扰素联合阿昔洛韦可缩短病程,而单独使用效果有限。基质再生剂具有新的抗病毒机制,值得进一步研究。此外,纳米载体递送系统,如脂质体、纳米胶束、立方液晶纳米粒,由于能够增强药物角膜穿透性和延长药物释放,在治疗基质型单纯疱疹性角膜炎方面具有巨大潜力。
Herpes simplex virus stromal keratitis is one of the leading causes of corneal blindness. A topical corticosteroid
agent in conjunction with an oral antiviral agent is the preferred treatment, which has the disadvantages of low bioavailability and drug side effects. Therefore, there is an urgent need to find alternative drugs and develop new dosage forms. Immunosuppressants such as cyclosporine A and tacrolimus have obvious curative effects and few side effects, and may be potential substitutes for glucocorticoids. Interferon-α combined with acyclovir can shorten the course of disease, but the effect is not obvious when used alone. Matrix regenerating agents have new antiviral mechanisms and deserve further study. In addition, nanocarriers delivery systems, such as liposomes, nanomicelles and cubosomes, have great potential in the treatment of herpes simplex virus stromal keratitis due to their ability to enhance drug corneal penetration and prolong drug release.
其他期刊
  • 眼科学报

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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  • Eye Science

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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