This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections.

开始日期2025-12-31

申办/合作机构

iRenix Medical, Inc.

NCT05780931

/ Not yet recruitingN/AIIT

Development of New Approaches to Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration

This study will help develop new methods of rehabilitating Veterans with vision loss due to Age-related macular degeneration.

开始日期2025-08-01

申办/合作机构

VA Office of Research and Development

[+1]

NCT05992415

/ Not yet recruitingN/AIIT

New York City Eye Study (NYCES)

Dr. Lisa A. Hark (PI and Study Chair) and an interdisciplinary team have designed the New York City Eye Study (NYCES) to promote eye and vision health equity and address eye health disparities in adults age 21+ (PAR-23-009/NOT-EY-22-004).

开始日期2025-07-01

申办/合作机构

Columbia University

100 项与视网膜疾患相关的临床结果

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100 项与视网膜疾患相关的转化医学

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0 项与视网膜疾患相关的专利（医药）

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214,347

项与视网膜疾患相关的文献（医药）

2025-12-31·Annals of Medicine

Occurrence and associated factors of self-reported medical errors among Chinese physicians and nurses: a cross-sectional survey

Article

作者: Wang, Qianjin ; Zhang, Xiaoyu ; Hao, Yuzhu ; Xu, Huixue ; Deng, Qijian ; Wu, Min ; Wang, Yunfei ; Yan, Kewen ; Li, Zejun ; Liu, Liyan ; Li, Manyun ; Liu, Yueheng ; He, Li ; Wang, Xin ; Wu, Qiuxia ; Peng, Pu ; Liu, Tieqiao

BACKGROUNDMedical errors (MEs) significantly threaten patient safety globally. This study aimed to explore multidimensional factors associated with self-reported MEs among Chinese physicians and nurses.METHODSA cross-sectional online survey using snowball sampling collected 7197 valid responses from Chinese physicians and nurses between October 2020 and April 2022. A self-reported question assessed MEs within the past three months. Sociodemographic characteristics, work-related factors, and mental distress were collected. Data were analyzed using stepwise logistic regression.RESULTS1285 (17.9%) physicians and nurses self-reported MEs during the previous 3 months. Factors associated with higher odds of self-reported MEs included male sex (OR: 1.44, 95% CI: 1.23-1.69), physician status (OR: 1.48, 95% CI: 1.26-1.73), history of mental illness (OR: 1.49, 95% CI: 1.16-1.91), longer weekly working hours (OR: 1.20-1.23, 95% CI: 1.03-1.47), workplace violence experience (OR: 1.54-1.75, 95% CI: 1.30-2.17), and dissatisfaction with the medical practice environment (OR: 1.20, 95% CI: 1.05-1.37). Conversely, being married (OR: 0.74, 95% CI: 0.62-0.89), holding a bachelor's degree or higher (OR: 0.82, 95% CI: 0.70-0.97), and having more years of professional practice (OR: 0.96, 95% CI: 0.95-0.97) were associated with lower odds of self-reported MEs. Self-reported MEs were significantly and positively correlated with burnout (OR: 1.40, 95% CI: 1.20-1.62), depressive symptoms (OR: 1.38-1.45, 95% CI: 1.04-1.84), perceived stress (OR: 1.28-1.62, 95% CI: 1.06-2.02), and excessive daytime sleepiness (OR: 1.27-1.46, 95% CI: 1.10-1.79).CONCLUSIONSSelf-reported MEs are relatively common among Chinese physicians and nurses, and are associated with various factors. Poor workplace conditions and mental distress are linked to an increased risk of MEs. Implementing effective interventions to improve workplace conditions and mental health is crucial for reducing MEs.

2025-12-31·Journal of CME

Revolutionizing Diabetic Retinopathy Screening: Integrating AI-Based Retinal Imaging in Primary Care

Article

作者: Rogers, Faith ; Beals, Dean ; Pogroszewski, Stan ; Kummerle, Dale ; Simon, Lesley

Diabetic retinopathy (DR) is a public health issue affecting millions in the United States and Europe. However, despite strong recommendations for screening at regular intervals by many professional societies, including the American Diabetes Association and the American Academy of Ophthalmology, screening rates remain suboptimal, with only 50-70% of patients with diabetes adhering to recommended annual eye exams. Barriers to screening include lack of awareness, socioeconomic factors, health care system fragmentation, and workforce shortages, among others. Artificial intelligence (AI)-based retinal screening tools offer promising solutions to improve DR detection in primary care settings. We describe a quality improvement and continuing medical education programme, starting in 2020, which has so far deployed 198 AI-equipped cameras in 5 health systems, covering approximately 151,000 patients with diabetes. To date, over 20,000 screenings were completed, with more than mild DR detected in more than 3,450 people, leading to specialist referrals for follow-up care. Notably, negative screenings potentially represent deferred specialist care. While AI adoption in healthcare presents challenges, its potential benefits in improving patient care and optimising resources are significant. Integrating AI-based DR screening with a comprehensive education and process improvement initiative in primary care practices warrants serious consideration, promising to enhance patient outcomes.

2025-12-01·Journal of Clinical Immunology

Prime Editor Gene Therapy and TREX1 Mosaicism in Retinal Vasculopathy with Cerebral Leukoencephalopathy

Article

作者: Fu, Jiayuan ; Holley, Joe A ; Laue-Gizzi, Hanka ; Miner, Jonathan J ; Hardy, Todd A ; Poddar, Subhajit ; Chauvin, Samuel D ; Kumble, Lindsay ; Miner, Cathrine A

AbstractTREX1 mutations underlie a variety of human diseases, including retinal vasculopathy with cerebral leukoencephalopathy (RVCL or RVCL-S), a catastrophic adult-onset vasculopathy that is often confused with multiple sclerosis, systemic vasculitis, or systemic lupus erythematosus. Patients with RVCL develop brain, retinal, liver, and kidney disease around age 35–55, leading to premature death in 100% of patients expressing an autosomal dominant C-terminally truncated form of TREX1. We previously demonstrated that RVCL is characterized by high levels of DNA damage, premature cellular senescence, and risk of early-onset breast cancer before age 45. Here, we report human TREX1 mosaicism causing organ-limited RVCL in the retina, as well as a gene therapy to synthetically create TREX1 mosaicism as a potential treatment for RVCL. In our patient with organ-limited disease, the mosaic TREX1 mutant allele underwent germline transmission to 3 children, who developed severe multi-organ disease at ~ age 40, unlike their mosaic parent, who has organ-limited disease at age 74. Additionally, we describe our TREX1 prime editor gene therapy that corrects the most common RVCL-causing TREX1 variant in cell culture and in mice. Thus, TREX1 mosaicism causes organ-limited RVCL with a normal lifespan, suggesting that a gene therapy to create TREX1 mosaicism in adults may someday become useful as a treatment for patients with RVCL.

8,184

项与视网膜疾患相关的新闻（医药）

2025-01-20

·PipelineReview

Formycon receives EU approval for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand names AHZANTIVE® and Baiama

PLANEGG-MARTINSRIED, Germany I January 20, 2025 I Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea ® 1 , under the brand names AHZANTIVE ® 2 and Baiama ® 3 . The approval encompasses the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO). The decision of the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from November 2024 and applies to all countries in the European Economic Area (EEA), including the 27 member states of the European Union (EU) as well as Iceland, Liechtenstein, and Norway. Dr. Stefan Glombitza, CEO of Formycon AG , commented: “The EU approval of FYB203, our biosimilar for Eylea ® , marks another milestone for Formycon and is based on the expertise and dedication of our entire team. As our second ophthalmic biosimilar, FYB203 significantly expands therapeutic options for patients with severe retinal diseases. With AHZANTIVE ® and Baiama ® , we are improving access to high-quality and affordable therapies that contribute sustainably to enhancing patients’ quality of life.” Aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, thereby impairing vision. In 2023, the reference product Eylea ® achieved global sales of approximately USD 9 billion 4 , highlighting the significance and necessity of a cost-effective alternative like FYB203. In mid-January 2025, Formycon and Teva Pharmaceuticals International GmbH (Teva) signed a licensing agreement for the semi-exclusive commercialization of FYB203 across major parts of Europe and Israel. Concurrently, Formycon has concluded an agreement with Teva for product supply. FYB203 was already approved by the U.S. Food and Drug Administration (FDA) in June 2024. 1) Eylea ® is a registered trademark of Regeneron Pharmaceuticals Inc. 2) AHZANTIVE ® is a registered trademark of Klinge Biopharma GmbH 3) Baiama ® is a registered trademark of Klinge Biopharma GmbH 4) Source: https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/ About Formycon: Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe, the USA, and the MENA-region. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA and European Commission approval; FYB202 is also approved in the UK and Canada. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG, headquartered in Munich, is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX and TecDAX selection indices. Further information can be found at: https://www.formycon.com/ About Biosimilars: Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030. SOURCE: Formycon

上市批准引进/卖出生物类似药

2025-01-20

·药时代

欧盟 2024 年推荐药物批准量创 15 年来新高

欧洲药品管理局（EMA）于1 月 16 日发布《2024 年人用药》报告，总结了其人用药委员会在 2024 年的行动情况：共推荐批准 114 个新药，其中 46 个是含有新活性成分的药品。这是 15 年来发布推荐批准意见数量最多的一年。 EMA 首席医疗官表示，癌症仍然是 2024 年获得批准最多的治疗领域，其次是免疫学、风湿病学、血液和凝血障碍以及内分泌学。 Thirstrup 强调了去年发布的几项推荐批准意见，他表示这些意见有助于解决未满足的需求，其中包括默沙东的 Welireg，用于治疗 von Hippel-Lindau 罕见病，该病的特征是可能癌变的肿瘤和囊肿。 EMA 还推荐了 ARS 制药公司的 EURneffy，这是一种 EpiPen 的替代品，用于严重过敏反应的肾上腺素鼻喷雾剂。虽然并不是新的活性物质，但喷雾形式更加方便，可由非医务人员使用。 Thirstrup 还表示，未来，减肥药的标签扩展，以及正在开发的抵消肌肉损失或肌肉减少症副作用的新候选药物可能是重点关注领域。他指出，人用药委员会正在进行一项有关是否应将与肥胖相关的心脏代谢指征作为 GLP-1 的新指征，或是否应将临床数据添加到产品标签上，以便处方医生了解最新研究。此外，有几家公司正在测试旨在与 GLP-1 药物联合使用以保持肌肉量的候选药物，包括 Scholar Rock 的以肌生长抑制素为重点的方法和 Veru 的口服选择性雄激素受体调节剂。 EMA 在 2024 年还给出了 28 个新生物类似药推荐批准意见，涵盖范围广泛的疾病，包括几种类型的癌症、骨质疏松症、黄斑变性以及涉及异常免疫应答的疾病，如斑块状银屑病、溃疡性结肠炎和克罗恩病。 EMA还推荐了几种新疫苗，包括一种预防基孔肯雅病的疫苗和一种针对呼吸道合胞病毒（RSV）引起的下呼吸道疾病的新mRNA疫苗，并将用于保护12-17岁青少年的猴痘疫苗的使用范围延长。封面图来源：123rf 往期推荐美国第二轮【医保谈判】名单公布！要对减肥药下手了 2025JPM大会，都释放了哪些信号？国内获批上市！首款Nectin-4 ADC又跨了一大步点击，查看更多精彩!

上市批准疫苗抗体药物偶联物信使RNA

2025-01-19

·药事纵横

改良新药潜力股-植入剂技术

植入式给药系统（IDDS）是一类经手术植入或经特殊装置导入皮下或靶部位的控制释药系统。然而，植入式给药系统生产工艺复杂，技术要求高，因此目前全球植入式给药系统上市产品较少，且主要集中在医疗水平高的欧美国家。随着国家政策利好、企业研发能力增强，未来我国植入式给药系统市场发展潜力大。本文对植入剂的相关技术和产品进行总结，以期为植入产品的研发提供参考。一、植入剂优势植入剂系指由原料药物与辅料制成的供植入人体内的无菌固体制剂。植入剂一般采用特制的注射器植入，也可以手术切开植入。植入剂在体内持续释放药物，并应维持较长的时间。其优势包括： 1长效作用：应用控释给药方式．血药浓度比较平稳是持续时间可长达数月其至数年，避免一些物的迅速代谢，延长其体内半衰期。 2恒释作用：由于聚合物的阻滞作用．系统中的药物呈现恒定释放，有效避免药物突释，可以维持恒定的血药浓度，消除间歇给药和药量不均匀而产生的峰、谷现象．减少了药物的毒副作用。 3减毒作用：采用立体定位技术．能将植入剂植入病灶部位，使药物更接近于靶组织，可在局部达到有效的药物浓度，机体其他部位的血药浓度很低，减少了对机体的毒害作用。 4高生物利用度：用皮下植入方式给药，避免首过效应和胃肠道降解，药物很容易吸收进入体循环，因而生物利用度高；难以用其他途径给药的药物可通过植入途径给药。 5可及时中止给药：若发现有严重的过敏反应或副作用可随时终止给药，一旦去处植入物，机体可很快恢复，这种可逆性在计划生育实践中非常有用。二、植入剂的类型近年来，随着理论和技术的发展，IDDS 的应用逐渐增加，主要分为皮下埋植型、注射植入型和智能植入型等。 1.皮下埋植剂指药物分散于载体材料中，以柱、棒、丸、片等形式经手术植入给药根据载体材料不同，又可分为生物不降解型和生物降解型。非生物降解型植入剂是早期研究及应用的植入体系之一，由在体内不可生物降解的载体材料通过一定制备方法制成，常用材料为硅橡胶、聚氨酯、聚丙烯酸酯、聚乙烯酸乙烯酯共聚物等。然而，非生物降解型植入给药系统在释药周期结束后，需通过手术进行收集并将其取出，这一过程亦常常造成患者身体的不适和二次伤害。可生物降解型所用载体材料在体内可自发降解为单体小分子，降解机制包括水解、酶解、氧化、物理降解等过程，释药结束后不需要再通过手术将其取出，大大提高了患者的依从性。目前最常用的材料为人工合成的聚酯如聚乳酸、聚乙醇酸、聚乳酸-乙醇酸共聚物、聚己内酯等。 2注射给药植入剂注射给药植入剂是将高分子材料注射于人体，使聚合物在生理条件下产生分散状态或构象的可逆变化，使注射剂由液态向凝胶转化，形成半固态的药库，并通过其降解过程长期稳定控制药物释放。与传统的预成型植入剂相比，该剂型具有生产相对简便、对机体损伤小、患者依从性好等优点，可用于全身性及局部药物递送、组织工程、整形外科等。但往往需要使用有机溶剂，如 N-甲基吡咯烷酮、环己烷、丙酮等，可选择的范围较小。 2.3植入泵制剂植入泵是具有微型泵的植入剂，通过将泵或者导管植入到作用部位，依靠自身或外部环境的推动力缓慢注入药物。与非降解型/降解型植入系统相比，释药速率更稳定（一般可达零级释放），并可以根据临床需求更准确地调节给药速率；动力源可长期使用并可通过皮下注射等方式向泵中补充药液，避免了多次注射；但普遍成本较高，部分装置外挂，影响患者依从性。三、植入剂相关产品介绍植入剂长期、稳定释药的特点，使得它在一些疾病的治疗方面有其它制剂不可代替的优越性，特别适合慢性及需要长期治疗的疾病，提高患者顺应性。目前主要应用于生殖健康，眼科，肿瘤等领域，代表性药物如下： 1.生殖健康 1.1Testopel®(睾酮颗粒)皮下植入含有75mg睾酮。此外，每个颗粒含有以下无活性成分:硬脂酸0.97mg和聚乙烯吡咯烷酮 2mg。睾丸素丸由结晶睾丸素组成。当植入皮下时，微丸会缓慢释放激素，产生长效的雄激素效应。 1.2 NEXPLANON，依托孕烯植入剂，商品名称: 依伴侬。依托孕烯植入剂，非活性成分:硫酸钡、硬脂酸镁、乙烯-醋酸乙烯共聚物(28%醋酸乙烯)。是一种长效避孕药, 含68mg依托孕烯，释放率在植入后5-6周内为60-70μg/天,第1年末下降到约35-45μg/天,第2年末下降到30-40μg/天,第3年末下降到25-30μg/天。皮下植入1支植入剂,提供长达三年的避孕效果。使用者可以在任何时候取出植入剂,但同一支植入剂不可持续埋植超过3年。无论是要求取出或是满3年取出,都应由熟悉取出技术的医生进行。 1.3 SUPPRELIN LA是一种无菌的，不可生物降解的，扩散控制的，水凝胶聚合物储层，水凝胶聚合物储层是由2-羟乙基甲基丙烯酸酯、2-羟丙基甲基丙烯酸酯、三甲基丙烷三甲基丙烯酸酯、苯甲酸甲醚、Perkadox-16和Triton X-100组成的亲水筒。 Supprelin LA被设计为在12个月内每天递送约65微克醋酸组氨瑞林。Supprelin LA植入物看起来像一个小而薄的柔性管，由一个3.5 cm × 3mm的圆柱形水凝胶聚合物储层内的50 mg醋酸histrelin药物芯组成。。每个植入物被包装在一个玻璃小瓶中，其中含有2毫升无菌1.8%氯化钠溶液，以便在插入后立即释放药物。 2.眼科 2.1 RETISERT®(醋酸氟轻松玻璃体内植入物)0.59 mg是一种无菌植入物，旨在以0.6 ug/天初始速率向眼后段局部释放醋酸氟轻松，在第一个月减少到0.3-0.4ug/天的稳定状态，持续约30个月。每个RETISERT由一片含有0.59毫克活性成分醋酸氟轻松和以下非活性成分:硬脂酸镁、微晶纤维素和聚乙烯醇组成。药物在玻璃体内可持续释放2至3年，药物浓度在封闭的玻璃体腔内呈稳定的线性下降，但这些装置仍然留在玻璃体腔内，需手术取出。 2.2 Ozurdex®是一种无菌玻璃体内植入物，在NOVADUR®固体聚合物缓释给药系统中含有0.7 mg (700 mcg)地塞米松，不含抗菌防腐剂。NOVADUR®系统含有两种聚D, l -丙交酯-羟基乙酸酯(PLGA)聚合物辅料。这两种聚合物材料都具有相同的PLGA主链，但它们之间的末端基团不同。一种聚合物Resomer RG 502是酯端，另一种Resomer®RG 502h是酸端。Ozurdex®预加载到一次性使用的DDS®涂抹器中，以便将棒状植入物直接注射到玻璃体中。Ozurdex在玻璃体腔内抑制黄斑水肿的作用可以维持3-6个月。 2.3 ILUVIEN是一种无菌、可注射的、非生物降解的玻璃体内植入物，每个ILUVIEN由一个浅棕色的3.5mm x 0.37mm植入物组成，含有0.19 mg有效成分氟轻松以下非活性成分:聚酰亚胺管、聚乙烯醇、硅酮胶和注射用水。 ILUVIEN预加载到一次性涂抹器中，以便将植入物直接注射到玻璃体中。初始释放速率为0.25 μg/天，ILUVIEN是美国FDA批准的唯一一款缓释长达3年的治疗DME的皮质类固醇眼内植入剂。 2021年4月14日，欧康维视生物出资1,000万美元获得Alimera重磅品种ILUVIEN在大中华区、韩国及东南亚11个国家独家商业化权利。 2.4 DURYSTA 是一种无菌的前房内植入物，在固体聚合物缓释给药系统 (DDS) 中含有 10 ug 比马前列素（一种前列腺素类似物）。给药系统由聚（D,L-丙交酯）、聚（D,L-丙交酯-共-乙交酯）、聚（D,L-丙交酯）酸末端和聚乙二醇 3350 组成。DURYSTA 预装在单个- 使用 DDS 涂药器将杆状植入物直接注射到眼睛的前房中。适用于降低开角型青光眼 (OAG) 或高眼压症 (OHT) 患者的眼内压 (IOP)。 3.肿瘤 3.1 ZOLADEX是一种无菌的、可生物降解的产品，含有3.8毫克醋酸戈舍瑞林，相当于3.6mg戈舍瑞林分散在D, l -乳酸和乙醇酸共聚物的基质中(植入物总重量为18.0 mg，)。ZOLADEX设计为无菌的白色至乳白色1毫米直径的圆柱体，预装在一个特殊的一次性注射器中用于皮下注射，持续释放超过28天。 3.2 GLIADEL®WAFER为一种白色至灰白色的一角硬币大小的薄膜，包含生物可降解聚合物聚苯丙生20和7.7mg卡莫司汀（carmustine，BCNU），卡莫司汀是治疗恶性胶质瘤的常用静脉给药的化疗药物。当手术切除脑瘤时，在经手术创建的空腔中可最多植入8片本品。在植入处，Gliadel将缓慢溶解，直接向肿瘤部位释放高浓度卡莫司汀，使扩撒到其它部位的药物减至最少。Gliadel适应证是新诊断为高度恶性胶质瘤的患者的手术和放疗辅助药物，也可作为多形性胶质母细胞瘤（GBM）复发患者的手术辅助用药。国内企业山东蓝金生物研制的卡莫司汀植入剂也已进入临床。 3.3氟尿嘧啶植入剂，国内自主研发第一个抗肿瘤植入剂新药,于2001年获新药证书,中人氟安应用高分子骨架及膜层技术精确控制氟尿嘧啶释放速度。植入剂植入人体后，组织液中水分子逐渐渗入药粒，微囊之间的药物以较快速度释出，24小时内于植药区域形成一个较高的药物浓度；随着水分子逐层渗入药物微囊内形成药物溶液，囊内的药物在浓度梯度的作用下逐渐向膜外扩散，形成较稳定的释放速度。5天释放总药量的50％左右，15天释放总药量的75—80％以上。一次植入可有效作用15—21天。 4 其他 4.1 SINUVA鼻窦种植体是一种皮质类固醇洗脱(糠酸莫米松)种植体，聚(l -乳酸-co-e-己内酯)包被糠酸莫米松，嵌入含有聚(dl -乳酸-羟基乙酸酯)和聚乙二醇(非活性成分)的生物可吸收聚合物基质中，用于治疗18岁筛窦手术患者的鼻息肉。SINUVA鼻窦植入物被装入输送系统，并在内镜下放置于筛窦内，在90天内逐渐释放皮质类固醇。 4.2 Scenesse是全球首个获批准用于治疗EPP患者的提供系统性光保护作用以预防光毒性的药物。辅料为聚（DL-丙交酯-共乙交酯），它通过刺激皮肤中黑色素生成、提高皮肤中黑色素水平，而提供光保护作用，可作为一种光保护剂屏蔽光照和紫外线辐射（UVR）对皮肤的影响。使用方法为每2个月1次，植入皮下后可在2天内观察到皮肤色素沉着，药效长达2个月。 4.3 Xaracoll®采用Collarx®技术，以高纯度的胶原蛋白基质为载体，通过冻干技术形成海绵状胶原蛋白多孔基质，药物分布在基质的孔洞内。冻干的胶原蛋白多孔基质是可生物降解和可生物再吸收的，随着胶原蛋白在手术部位被缓慢吸收，药物在体内溶解扩散，实现对药物的缓慢控释效果。Xaracoll在手术过程中直接放入手术部位，即刻释放药物，持续24小时。 4.4用于抗成瘾，对于成瘾性的治疗，需要使用抗成瘾药长期治疗，缓释植入剂，一方面可减少给药次数，另一方面，也可消除病人对是否继续用药的困惑。如纳曲酮植入剂的作用原理为将纳曲酮药物以分子形式均匀分散在特定的释放介质中，通过皮下植入给药，缓慢均衡地释放药物，长时间地占据阿片受体，拮抗阿片类药物所产生的欣快感，逐步恢复神经突触和神经递质的正常分布，最终解除精神依赖和抗阿片类药物复吸。2021年4月，深圳善康研发、湖南赛沃生产的纳曲酮植入剂获得CDE审核同意，纳入“突破性治疗品种公示”名单，拟定适应症为用于阿片类物质依赖患者脱毒后的防复吸治疗。相比于国际企业，我国植入式给药系统企业在规模、技术、研发等方面仍存在较大差距。我国植入式给药系统布局企业主要包括山东蓝金生物、深圳思沃生命科技、安徽中人科技等。鉴于植入制剂长期给药和靶向给药特点，作为改良新药优势显著，随着国内研发技术进步，植入式给药系统市场关注度也将持续提升。参考文献： [1]于鲲梦,平其能,孙敏捷.植入型给药系统的应用与发展趋势[J].药学进展,2020,44(5):10. [2]胡瑜兰 ,张钧寿.植入剂应用的研究进展[J].国外医药.合成药.生化药.制剂分册;2001，01. [3] 冷斌;刘洪臣.植入型给药系统的分类与应用[J]。中国医学装备，2007，05. [4]Kleiner L W, Wright J C, Wang Y B. Evolution of implantable and insertable drug delivery systems[J/OL]. J Control Release, 2014, 181: 1-10 [5]Haghjou N, Soheilian M, Abdekhodaie M J. Sustained release intraocular drug delivery devices for treatment of uveitis[J]. J Ophthalmic Vis Res, 2011, 6(4): 317-329. 药事纵横征稿启事

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