PERi-operative Selective Decontamination of the Digestive Tract to Prevent Severe Infectious Complications After Esophagectomy: a Randomized Multicenter Clinical Trial in Patients With Primary Resectable Esophageal Carcinoma (cT1-4, N0-3, M0)

The primary aim of the PERSuaDER-trial is to evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia

开始日期2024-06-01

申办/合作机构

Radboud University Medical Center

[+2]

ChiCTR2400081616 / Suspended临床4期IIT

Microbiological efficacy of tobramycin inhalation solution with acute exacerbation of bronchiectasis with pseudomonas aeruginosa infection: a single-center, randomized clinical trial

开始日期2024-03-22

申办/合作机构-

CTRI/2024/02/062498 / Not yet recruiting临床2/3期IIT

RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFICACY OF MATRU STANYA AASCHOTANA WITH TOBRAMYCIN EYE DROP IN KUKUNAKA (OPTHALMIA NEONATARUM) IN NEONATES - Nil

开始日期2024-02-14

申办/合作机构-

100 项与妥布霉素相关的临床结果

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100 项与妥布霉素相关的转化医学

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100 项与妥布霉素相关的专利（医药）

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7,813

项与妥布霉素相关的文献（医药）

2024-12-31·Virulence

Tobramycin-resistant small colony variant mutant of Salmonella enterica serovar Typhimurium shows collateral sensitivity to nitrofurantoin

Article

作者: Xu, Jin-Peng ; Zhang, Yue-Jun ; Wang, Chang-Zhen ; Sun, Jian ; Fang, Liang-Xing ; Long, Teng-Fei ; Zhou, Yu-Feng ; Chu, Yue-Fei ; Liao, Xiao-Ping ; Liang, Liu-Yan ; Zhong, Long-Gen

The increasing antibiotic resistance poses a significant global health challenge, threatening our ability to combat infectious diseases. The phenomenon of collateral sensitivity, whereby resistance to one antibiotic is accompanied by increased sensitivity to another, offers potential avenues for novel therapeutic interventions against infections unresponsive to classical treatments. In this study, we elucidate the emergence of tobramycin (TOB)-resistant small colony variants (SCVs) due to mutations in the hemL gene, which render S. Typhimurium more susceptible to nitrofurantoin (NIT). Mechanistic studies demonstrate that the collateral sensitivity in TOB-resistant S. Typhimurium SCVs primarily stems from disruptions in haem biosynthesis. This leads to dysfunction in the electron transport chain (ETC) and redox imbalance, ultimately inducing lethal accumulation of reactive oxygen species (ROS). Additionally, the upregulation of nfsA/B expressions facilitates the conversion of NIT prodrug into its active form, promoting ROS-mediated bacterial killing and contributing to this collateral sensitivity pattern. Importantly, alternative NIT therapy demonstrates a significant reduction of bacterial load by more than 2.24-log₁₀ cfu/g in the murine thigh infection and colitis models. Our findings corroborate the collateral sensitivity of S. Typhimurium to nitrofurans as a consequence of evolving resistance to aminoglycosides. This provides a promising approach for treating infections due to aminoglycoside-resistant strains.

2024-12-31·Gut Microbes

Comparison of Crohn’s disease-associated adherent-invasive Escherichia coli (AIEC) from France and Hong Kong: results from the Pacific study

Article

作者: Bonnet, Richard ; Xu, Zhilu ; Beyrouthy, Racha ; Chevarin, Caroline ; Sulakvelidze, Alexander ; Colombel, Jean-Frédéric ; Barnich, Nicolas ; Robin, Frederic ; Ng, Siew C ; Buisson, Anthony ; Martin, Lucas

Association between ileal colonization by Adherent-Invasive Escherichia coli (AIEC) and Crohn's disease (CD) has been widely described in high-incidence Western countries but remains unexplored in Asian countries with a fast increase in CD incidence. In the PACIFIC study, we compared the characteristics of AIEC pathobionts retrieved from ileal biopsies of CD patients enrolled in France (FR) and Hong Kong (HK). The prevalence of AIEC was similar in France (24.5%, 25/102) and Hong Kong (30.0%, 18/60) (p = 0.44). No difference was observed between the two populations of AIEC regarding adhesion and invasion levels. When tested for antibiotic resistance, the proportion of AIEC strains resistant to ampicillin, piperacillin, tobramycin, and gentamicin was significantly higher in HK AIEC strains compared to French strains. AIEC strains from FR or HK population were both able to persist in the mice intestine (DSS-treated CEABAC10 mice model). Moreover, genomic analysis of 25 FR and 17 hK AIEC strains using next-generation sequencing revealed the co-existence of several virulence factors associated with enteric E. coli pathotypes, although no single virulence factor was significantly associated with either country of origin or AIEC status. In vitro, all AIEC strains (FR and HK) were sensitive to the EcoActive™ phage cocktail, suggesting that it could be a promising option to target AIEC in CD across the world.

2024-12-10·LANGMUIR

Enhanced Photocatalytic Degradation of Environmental Pollutants Using a Triphenylamine-Based Polymer: Synthesis, Characterization, and Mechanistic Insights

Article

作者: Sharma, Shikha ; Dhariwal, Neeraj ; Pritee ; Thakur, Sanjeeve ; Yadav, Preety

Conjugated porous organic polymers have sparked growing research attention as photocatalysts owing to their high surface area, tunable pores, and capacity to collect and transfer light energy via their delocalized backbone. However, the synthesis methods for preparing these polymers require difficult experimental setups, such as high polymerization temperature, inert atmosphere, and use of transition metal catalysts. In the present work, a triphenylamine-based conjugated porous polymer (TPA-BPA) has been synthesized employing tris(4-aminophenyl)amine (TPA) and biphenyldicarboxaldehyde (BPA) as precursors via a one-pot Schiff base reaction in ambient conditions in the absence of the metal catalyst. The synthesized TPA-BPA polymer has been characterized using Fourier transform infrared spectroscopy, ¹³C cross-polarization magic angle spinning nuclear magnetic resonance, Brunauer-Emmett-Teller (BET), thermogravimetric analysis, field emission scanning electron microscopy, high-resolution transmission electron microscopy, valence band X-ray photoelectron spectroscopy, X-ray photoelectron spectroscopy, cyclic voltammetry, powder X-ray diffraction, electron paramagnetic resonance (EPR), and diffuse reflectance spectroscopy (DRS) techniques. The DRS analysis revealed that TPA-BPA has an optical band gap of 2.1 eV, demonstrating its semiconductive nature. The EPR study has shown that the synthesized polymer exhibits an intense radical signal at g = 2.00, confirming free radical generation upon photoexcitation and facilitating the breakdown of organic contaminants by photocatalysis. TPA-BPA possesses an exceptional porous structure with a surface area of 36 m²/g, as confirmed by BET studies, and high thermal stability up to 420 °C. It has been confirmed by photocatalytic studies that TPA-BPA shows effective degradation of methyl orange (92%), Congo red (91.5%), tobramycin (96%), and hydroquinone (85%) under visible light irradiation in 60 min. Owing to these observations, TPA-BPA can be an excellent candidate as a photocatalyst for environmental remediation. These findings pave the way for large-scale manufacturing of metal-free conjugated porous polymers as photocatalysts with variable photoelectrical characteristics.

147

项与妥布霉素相关的新闻（医药）

2024-12-10

·Business Wire

Sound Pharma Announces Positive Phase 3 Results for the Treatment of Meniere’s Disease with SPI-1005

SEATTLE--( BUSINESS WIRE )--Sound Pharmaceuticals is pleased to announce that the pivotal Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory compound (ebselen), for the treatment of Meniere’s Disease (STOPMD-3), achieved its co-primary endpoints for efficacy involving improvements in hearing loss and speech discrimination. Meniere’s disease (MD) is an inner ear disorder that involves fluctuating hearing loss and tinnitus, and episodic vertigo and/or dizziness. There are no FDA-approved medical treatments for MD, nor for the treatment of hearing loss, tinnitus, vertigo, or dizziness. SPI-1005 is an oral capsule containing 200 mg ebselen that has shown safety and efficacy in several Phase 2 clinical trials involving multiple hearing loss and tinnitus indications including MD. STOPMD-3 enrolled adult subjects (N=221) with a history of definite MD and active symptoms into a randomized double-blind placebo-controlled trial (RCT) in which subjects received 28 days of either SPI-1005 (400 mg twice daily) or placebo treatment with monthly follow-up assessments of auditory and vestibular function through 84 days. Compliant patients could immediately enter an open label extension (OLE) of SPI-1005 treatment for up to 12 months. During OLE, subjects continued to receive SPI-1005 and had their auditory and vestibular function reassessed every 3 months. In both the intent-to-treat and per-protocol RCT analysis, the SPI-1005 group showed higher rates of improvement in low frequency hearing loss (≥10 dB gain at one low frequency from baseline) using pure-tone audiometry (LFPTA) and speech discrimination (≥4-word increase from baseline) using the words-in-noise (WIN) test than the placebo group at day 28, 56, and 84 of follow-up. On day 84, the SPI-1005 group showed a significant rate of LFPTA improvement over placebo (57.9% vs 36.5%, an increase of 58.6% over placebo, p-value=0.0037). When LFPTA criteria were increased to require a ≥10 dB gain at two adjacent low frequencies from baseline, the SPI-1005 group showed a significant rate of improvement of 204.4% over placebo (41.1% vs 13.5%, p-value <0.0001). On day 84, the SPI-1005 group showed a significant rate of WIN improvement of 54.4% over placebo (42.1% vs. 27.1%, p=0.0336). During OLE, responder rates involving LFPTA and WIN continued to improve, and patient reported outcome measures for tinnitus, vertigo, aural fullness, and dizziness severity all improved significantly from baseline (≥30% on average, p-value <0.001). “We would like to thank all of our investigators and study participants for contributing to this pivotal Phase 3 trial success involving SPI-1005,” said Dr. Jonathan Kil, MD, CEO of Sound Pharmaceuticals. A presentation of the full RCT/OLE data analysis as well as additional post-hoc analysis will occur at the Association for Research in Otolaryngology Midwinter Meeting in Orlando FL, February 22-26. About Meniere’s Disease (MD) MD is diagnosed by episodic vertigo or dizziness, fluctuating low frequency hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling of the inner ear involving the endolymphatic duct. Patients are typically diagnosed between 40-65 years of age, and the auditory symptoms of hearing loss and tinnitus often involve only one ear. Some patients experience aural fullness or pressure in the affected ear that can also contribute to dizziness. As patients age, the hearing loss and tinnitus become worse resulting in severe to profound hearing loss and intractable tinnitus. For the definite diagnosis of MD, the American Academy of Otolaryngology-Head & Neck Surgery guidance requires audiometric documentation of low frequency hearing loss (i.e., ≥30 dB) in at least one ear using pure tone audiometry. Loss of speech discrimination, especially in noisy environments or when tinnitus is present, is common in MD and other forms of sensorineural hearing loss. MD is currently managed with low salt diets, thiazide diuretics, and oral or locally injected steroids. Unfortunately, this standard of care has not proven effective and is not FDA-approved for the treatment of MD. About the STOPMD-3 trial STOPMD-3 screened 254 participants for eligibility at 11 sites, including some of the leading academic centers in the US. Eligible participants (221) were randomized to either SPI-1005 treatment (400 mg twice daily for 28 days) or matching placebo treatment and followed up to day 84. 201 participants continued on to SPI-1005 OLE for 1-6-months (153 completed) and 107 participants continued on to 7-12-months (82 completed). To our knowledge, STOPMD-3 is the longest continuous treatment trial involving an investigational new drug ever completed for a hearing loss or tinnitus indication including MD. STOPMD-3 was led by Dr. Paul Lambert, Distinguished University Professor and Chair Emeritus of the Dept. of Otolaryngology-HNS at MUSC in Charleston, SC, and the past President of the American Neurotologic Society. Dr. Lambert, Dr. Shaun Nguyen, director of clinical trial research in the Dept. of Otolaryngology-HNS at MUSC, and their colleagues also led the successful Phase 2b RCT involving SPI-1005 and MD patients. About SPI-1005 SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx) activity and is effective in reducing neuroinflammation across the central and peripheral nervous system. GPx activity is critical to several cell types and tissues in the inner ear, retina, prefrontal cortex of brain, lung, and kidney, and is often reduced during exposures to environmental insults or aging. Loss of GPx activity has been shown to result in sensorineural hearing loss in multiple animal models. SPI-1005 is being developed for several neurotologic indications including noise-induced hearing loss and two types of ototoxicity (hearing loss, tinnitus, dizziness, or vertigo) caused by aminoglycoside antibiotics (such as tobramycin or amikacin) or platinum-based chemotherapy (such as cisplatin or carboplatin). To date, no significant drug-drug interactions have been observed across multiple study populations including bipolar mania and treatment-resistant depression. About Sound Pharmaceuticals A privately-held biotechnology company is testing SPI-1005 under five other active Investigational New Drug Applications involving several neurotologic indications including the prevention and treatment of aminoglycoside-induced ototoxicity co-funded by the CF Foundation and hearing preservation in cochlear implant patients co-funded by MED-EL. Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov or www.soundpharma.com . Please contact info@soundpharma.com for further information.

临床结果临床2期临床3期

2024-12-10

·GlobeNewswire-Health Care

Microbix Assisting EMQN with Novel Genetic-Test EQA Program

For Rapid Identification of Patients Susceptible to Antibiotic-Induced Hearing LossMISSISSAUGA, Ontario and MANCHESTER, United Kingdom, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, and EMQN CIC (EMQN), a global supplier of laboratory external quality assessment (“EQA”) schemes for human genomic testing, announce the go-live of a program to support the accurate identification of patients who carry a gene-variant associated with increased susceptibility to hearing loss following treatment with a widely-used class of antibiotics. This first-of-its kind EQA program is intended to help ensure the proficiency of Point-of-Care Testing (“POCT”) and acute-care labs that are assessing whether patients carry the MT-RNR1 m.1555A>G gene variant. It is estimated that one in 500 persons carry this variant that can lead to profound and irreversible hearing loss upon exposure to aminoglycoside antibiotics. This class of antibiotics include Gentamycin, Kanamycin, Streptomycin, and Tobramycin, which are used to treat a wide range of “gram negative” bacterial infections. Of particular concern are newborn babies who are suspected to be at risk of bacterial sepsis – a life-threatening condition that can lead to death from multi-organ failure if not treated promptly with appropriate antibiotic drugs and other acute medical care. Microbix-produced quality assessment products (“QAPs™”), formatted onto Copan® FLOQSwabs®, are being used in this EMQN EQA program to help assess the proficiency and accuracy of such acute care genetic testing. The QAPs provide samples that participants can process like cheek or buccal swabs, enabling them to verify the accuracy of MT-RNR1 assays in their POCT. With a subscription to this EMQN program, participants will receive three samples every two months (18 per year), helping them to ensure the accuracy of their testing on an ongoing basis and thereby make the most reliable diagnoses possible. Sean Sales, Operations Director at EMQN, commented, “It has been a pleasure to have Microbix’s assistance in making the QAPs for this groundbreaking and important new EQA program. Acute care physicians need the information to be able to evaluate the risk-benefit of antibiotic treatments and no patient should have to face a lifetime of hearing loss when tests to identify this risk are available.” Cameron Groome, CEO and President at Microbix also commented, “We’re pleased to help enable the creation of EQA for this clinically-important decision-making. Our expertise was joined to that of EMQN and Copan to ensure that accurate testing and properly-directed treatment is available for patients worldwide. This QAP marks Microbix’s entry into supporting the accuracy of genetic tests, adding to our established presence in infectious diseases and emerging role in oncology.” UK and international labs can enroll in this EQA program (code POCT MT-RNR1 25) via EMQN CIC at https://www.emqn.org/our-eqa-schemes/ and enquiries about Microbix QAPs can be directed to customer.service@microbix.com. About EMQN CICEMQN is a Manchester, UK based company that provides quality assurance tools and specialized knowledge to the human genomic testing community through External Quality Assessment (EQA) schemes. Its work helps guarantee the best possible molecular diagnostic procedure, analytical performance, and clinical interpretation. EMQN’s highly qualified peer group of assessors take pride in their thought leadership position and are committed to regularly publishing best practice guidelines and other information for the molecular diagnostics field. EMQN is accredited by the United Kingdom Accreditation Service (UKAS) to the international standard for EQA scheme providers, ISO 17043. About Microbix Biosystems Inc.Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and sales now targeting C$ 2.0 million or more per month. It makes and exports a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides IVDR compliant CE marked products across the EU. Forward-Looking InformationThis news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of the tests, the EQA program, EMQN, Copan, or their relevance, Microbix’s products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain, and actual performance may be affected by a number of material factors, some of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information. Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings. For further information, please contact Microbix at: Cameron Groome, CEO(905) 361-8910Jim Currie, CFO(905) 361-8910Deborah Honig, Investor RelationsAdelaide Capital Markets(647) 203-8793 ir@microbix.com Copyright © 2024 Microbix Biosystems Inc. Microbix®, DxTM™, Kinlytic®, and QAPs™ are trademarks of Microbix Biosystems Inc.Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.

2024-11-22

·米内网

10亿眼科明星药集采止跌！TOP20洗牌，康弘、兴齐……国产品牌突围，恒瑞、信达新药来袭

精彩内容近期，眼科用药市场波澜再起。成都康弘药业集团的玻璃酸钠滴眼液、苏州乐珠制药的盐酸氮䓬斯汀滴眼液等4个产品同日获批。今年以来，眼科用药已有20个品种（133个受理号）获批上市。米内网数据显示，眼科用药在近年中国公立医疗机构终端销售规模均超过100亿元，2024年上半年同比下滑6.21%。5个国采品种中仅玻璃酸钠滴眼液正增长，从TOP20来看，康柏西普眼用注射液领跑，康弘、兴齐等国产品牌突围。眼科用药有52个品种（270个受理号）报产在审，辰欣佛都药业、扬州中宝药业等企业冲击首仿，5个新药亮眼。 4个眼科用药同日获批，兴齐、齐鲁、万汉制药领跑过评榜 11月以来眼科用药获批情况来源：米内网中国申报进度（MED）数据库 11月21日，国家药监局官网显示，华熙生物科技的玻璃酸钠滴眼液、成都康弘药业集团的玻璃酸钠滴眼液、苏州乐珠制药的盐酸氮䓬斯汀滴眼液和地夸磷索钠滴眼液同日获批，视同过评。在此之前，妥布霉素滴眼液第2家过评企业诞生，苏州乐珠制药和浙江莎普爱思药业均以仿制4类报产同日获批，视同过评。今年以来，眼科用药已有20个品种（133个受理号）获批上市，数量超过2023年全年。过评企业数10家及以上的眼科用药来源：米内网中国申报进度（MED）数据库截至目前，眼科用药有24个品种（256个品规）过评，7个品种有10家及以上企业过评，其中，玻璃酸钠滴眼液（41家）最为火热，其次是盐酸莫西沙星滴眼液（40家）、地夸磷索钠滴眼液（30家）。 8个品种独家过评，分别为成都普什制药的氯化钠滴眼液、沈阳兴齐眼药的环孢素滴眼液(Ⅱ)、四川禾亿制药的盐酸利多卡因眼用凝胶、兆科(广州)眼科药物的贝美素噻吗洛尔滴眼液、Maxmind的拉坦前列素滴眼液、汇禹远和(海南)药业的复方托吡卡胺滴眼液、山东绅联药业的盐酸环喷托酯滴眼液、苏州欧康维视生物的盐酸西替利嗪滴眼液，其中，山东绅联药业的盐酸环喷托酯滴眼液和苏州欧康维视生物的盐酸西替利嗪滴眼液均在今年获批。过评5个及以上眼科用药的集团来源：米内网中国申报进度（MED）数据库从集团过评品种数来看，沈阳兴齐眼药、齐鲁制药、中山万汉制药领跑，各有8个；远大健康、成都普什制药、欧康维视生物各有6个；扬子江药业、众生药业、莎普爱思药业、苏州乐珠制药等6家各有5个。 10亿明星药集采止跌！TOP20洗牌，康弘、兴齐……国产品牌突围米内网数据显示，近年中国公立医疗机构终端眼科用药（化学药+生物药）销售规模均超过100亿元，2024年上半年同比下滑6.21%，眼部血管病变治疗药、抗感染药、抗炎药是3大畅销小类。2024年上半年中国公立医疗机构终端眼科用药TOP5集团来源：米内网中国公立医疗机构药品终端竞争格局从集团格局来看，诺华集团、康弘药业、参天制药、沈阳兴齐眼药、拜耳位居前五，其中，康弘药业和沈阳兴齐眼药两家国内药企逆势上扬，销售额增速分别为25.74%和4.82%。 2024年上半年中国公立医疗机构终端眼科用药产品TOP20来源：米内网中国公立医疗机构药品终端竞争格局产品TOP20中，13个产品销售额超过1亿元，康柏西普眼用注射液是超10亿元的重磅品种，右旋糖酐羟丙甲纤维素滴眼液为新上榜产品。从在销企业数来看，妥布霉素滴眼液最多，有21家；其次是玻璃酸钠滴眼液和左氧氟沙星滴眼液均超过10家。目前，眼科用药已有5个产品纳入国采，左氧氟沙星滴眼液（第三批）、玻璃酸钠滴眼液（第四批）、地夸磷索钠滴眼液（第九批）均在产品TOP20之列。5个集采产品中仅有玻璃酸钠滴眼液正增长，4个产品均有下滑，地夸磷索钠滴眼液跌幅最大。近年中国公立医疗机构终端玻璃酸钠滴眼液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局玻璃酸钠滴眼液在中国公立医疗机构终端销售额峰值超过10亿元，受集采影响连续下滑后，2023年止跌回升，2024年上半年同比增长近5%，是眼科用药TOP3产品。该产品目前有54家企业拥有生产批文，参天制药、URSAPHARM、成都普什制药的市场份额位居前三。 2024年上半年中国公立医疗机构终端眼科用药品牌TOP20来源：米内网中国公立医疗机构药品终端竞争格局品牌TOP20中，成都康弘生物的康柏西普眼用注射液、诺华的雷珠单抗注射液、拜耳的阿柏西普眼内注射溶液位居前三，爱尔康的右旋糖酐羟丙甲纤维素滴眼液和沈阳兴齐眼药的加替沙星眼用凝胶则是新上榜品牌。 4个品牌增速超过20%，其中，成都康弘生物的康柏西普眼用注射液、沈阳兴齐眼药的环孢素滴眼液(Ⅱ)、珠海亿胜生物制药的牛碱性成纤维细胞生长因子滴眼液3个均是独家产品。从品牌数量来看，诺华最多，有4个上榜；参天制药和沈阳兴齐眼药各有2个上榜。辰欣、兆科……冲击首仿，恒瑞、信达新药来袭 11月22日，CDE官网显示，江苏福邦药业的玻璃酸钠滴眼液以仿制4类报产在审。在此之前，辰欣佛都药业的盐酸奥布卡因滴眼液、深圳市宇健生物医药|中山万汉制药的地夸磷索钠滴眼液同日报产在审。截至目前，眼科用药有52个品种（270个受理号）报产在审，地夸磷索钠滴眼液最火，有27家企业，其次是玻璃酸钠滴眼液，有20家。从企业数量来看，14家企业有5个及以上产品报产在审，其中，莎普爱思药业和宁波视方医药科技各有7个，沈阳兴齐眼药、兆科药业、石家庄格瑞药业等8家各有6个。国内无仿制药获批且报产在审的眼科用药来源：米内网中国申报进度（MED）数据库曲伏噻吗滴眼液、氟比洛芬钠滴眼液、盐酸依匹斯汀滴眼液等眼科用药国内暂无仿制药获批，辰欣佛都药业、扬州中宝药业、兆科(广州)眼科药物等企业有望拿下首仿。眼科用药新药报产在审情况来源：米内网中国申报进度（MED）数据库此外，信达生物制药(苏州)的替妥尤单抗注射液、山东博安生物技术的阿柏西普眼内注射溶液等5个眼科用药新药报产在审，其中，成都盛迪医药的SHR8058滴眼液为化药1类新药。资料来源：国家药监局官网、米内网数据库等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准一致性评价医药出海

100 项与妥布霉素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00063	妥布霉素	S01AA12 J01GB01	DB00684

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
支气管扩张	中国	健康元药业集团股份有限公司	2022-10-11
囊性纤维化	日本	Viatris Pharmaceutical GK	2012-09-28
囊性纤维化	日本	Viatris Healthcare GK	2012-09-28
肺部感染	欧盟	Viatris Healthcare (Pty) Ltd.	2011-07-20
肺部感染	冰岛	Viatris Healthcare (Pty) Ltd.	2011-07-20
肺部感染	列支敦士登	Viatris Healthcare (Pty) Ltd.	2011-07-20
肺部感染	挪威	Viatris Healthcare (Pty) Ltd.	2011-07-20
假单胞菌感染	美国	Mylan Specialty LP	1997-12-22
急性支气管炎	日本	Towa Pharmaceutical Co., Ltd.	1986-03-01
膀胱炎	日本	Towa Pharmaceutical Co., Ltd.	1986-03-01
出血性败血症	日本	Towa Pharmaceutical Co., Ltd.	1986-03-01
腹膜炎	日本	Towa Pharmaceutical Co., Ltd.	1986-03-01
肺炎	日本	Towa Pharmaceutical Co., Ltd.	1986-03-01
肾盂肾炎	日本	Towa Pharmaceutical Co., Ltd.	1986-03-01
脓皮症	日本	Towa Pharmaceutical Co., Ltd.	1986-03-01
继发感染	日本	Towa Pharmaceutical Co., Ltd.	1986-03-01
睑缘炎	日本	Nitto Medic Co., Ltd.	1981-12-07
结膜炎	日本	Nitto Medic Co., Ltd.	1981-12-07
角膜溃疡	日本	Nitto Medic Co., Ltd.	1981-12-07
泪囊炎	日本	Nitto Medic Co., Ltd.	1981-12-07

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
铜绿假单胞菌感染	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2010-04-01
铜绿假单胞菌感染	临床3期	埃及	Novartis Pharmaceuticals Corp.	2010-04-01
铜绿假单胞菌感染	临床3期	法国	Novartis Pharmaceuticals Corp.	2010-04-01
铜绿假单胞菌感染	临床3期	德国	Novartis Pharmaceuticals Corp.	2010-04-01
铜绿假单胞菌感染	临床3期	希腊	Novartis Pharmaceuticals Corp.	2010-04-01
铜绿假单胞菌感染	临床3期	匈牙利	Novartis Pharmaceuticals Corp.	2010-04-01
铜绿假单胞菌感染	临床3期	意大利	Novartis Pharmaceuticals Corp.	2010-04-01
铜绿假单胞菌感染	临床3期	罗马尼亚	Novartis Pharmaceuticals Corp.	2010-04-01
铜绿假单胞菌感染	临床3期	俄罗斯	Novartis Pharmaceuticals Corp.	2010-04-01
铜绿假单胞菌感染	临床3期	瑞士	Novartis Pharmaceuticals Corp.	2010-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02528123 (CTgov)	N/A	近视	114	Small incision lenticule extraction+Tobramycin+Proxymetacaine 0.5%+Oxybuprocaine 0.4%+dexamethasone+Ofloxacin	鏇鏇範願簾襯廠獵願願(鹹製觸餘糧衊憲淵顧簾) = 製鬱壓觸選壓構膚遞醖窪選鬱鏇製鹽艱糧範積 (憲壓淵夢構鹽鏇窪襯築, 觸鑰簾鹹窪醖簾夢網繭 ~ 壓製壓鹽糧簾製繭範獵) 更多	-	2024-04-23
NCT03705962 (CTgov)	临床3期	开放性骨折 \| 感染	11	Tobramycin (Antibiotic)	夢網積膚壓憲構鏇淵廠(膚範鬱艱遞鏇襯繭製壓) = 膚製壓齋糧窪壓艱遞壓醖衊鑰獵選艱繭顧夢糧 (積製膚餘顧夢鑰夢鹹齋, 簾醖齋網齋鏇鑰艱醖衊 ~ 鏇淵窪構蓋廠衊鹹餘積) 更多	-	2023-06-15
				Placebo: normal saline (Normal Saline)	夢網積膚壓憲構鏇淵廠(膚範鬱艱遞鏇襯繭製壓) = 簾齋顧憲製觸簾窪鬱願醖衊鑰獵選艱繭顧夢糧 (積製膚餘顧夢鑰夢鹹齋, 壓獵願醖糧觸齋構範夢 ~ 網壓醖夢夢糧獵獵遞餘) 更多
NCT02478710 (AAINTVAP, CTgov)	临床4期	呼吸机相关性肺炎	16	Aerosolized Placebo (Aerosolized Placebo)	廠積壓獵顧繭獵餘憲蓋(網構觸鑰範糧餘餘淵鏇) = 願醖餘顧壓壓糧膚繭顧廠願鏇鹹憲蓋蓋顧艱憲 (夢選窪窪鏇築艱構鬱鹽, 鬱簾鹽鏇鏇範夢構鏇願 ~ 蓋構鹽齋廠壓鹽範鹽選) 更多	-	2023-05-22
				Tobramycin+Vancomycin (Aerosolized Tobramycin or Vancomycin)	廠積壓獵顧繭獵餘憲蓋(網構觸鑰範糧餘餘淵鏇) = 鏇鑰選遞鑰蓋蓋構網選廠願鏇鹹憲蓋蓋顧艱憲 (夢選窪窪鏇築艱構鬱鹽, 獵鹹觸網選淵觸構艱網 ~ 願鹽鬱衊鹽齋遞鏇簾糧) 更多
NCT02657473 (The BATTLE study, Pubmed \| Respir Res)	临床2/3期	非囊性支气管扩张维持	58	Tobramycin inhalation solution (TIS)	醖顧鬱簾網築餘網餘製(獵獵繭選願構夢壓蓋壓): RR = 0.74 (95% CI, 0.49 ~ 1.14), P-Value = 0.15	-	2022-12-03
				Placebo
NCT02918409 (CTgov)	临床4期	囊性纤维化	51	Colistin (Standard Colistin Arm)	築積糧觸糧觸觸廠製網(膚膚壓範繭簾繭鑰鹽積) = 選壓繭鬱蓋鑰蓋夢窪鑰鹽廠鹽簾選願範艱鹽齋 (觸積積繭製觸鹽襯壓網, 構餘築夢製齋鏇網構鹹 ~ 獵獵鏇觸醖製蓋範製蓋) 更多	-	2022-10-06
				Colistin (Modified Colistin Arm)	築積糧觸糧觸觸廠製網(膚膚壓範繭簾繭鑰鹽積) = 築膚壓餘糧廠餘壓壓壓鹽廠鹽簾選願範艱鹽齋 (觸積積繭製觸鹽襯壓網, 築窪築襯淵願顧遞願網 ~ 願鹹鏇製選壓膚鬱壓簾) 更多
NCT03673956 (CTgov)	临床1/2期	慢性鼻窦炎	19	Tobramycin (Tobramycin Topical Antibiotic Nasal Saline Rinse)	襯範窪膚憲憲艱願觸觸(遞襯選顧鏇積襯觸廠製) = 選鏇築繭壓糧顧鑰觸艱網築製廠遞憲糧繭鹽獵 (膚淵壓築獵範廠餘築廠, 廠窪鬱簾獵積觸窪鏇齋 ~ 觸襯糧艱糧齋築艱齋構) 更多	-	2022-04-20
				Levofloxacin (Levofloxacin Topical Antibiotic Nasal Saline Rinse)	襯範窪膚憲憲艱願觸觸(遞襯選顧鏇積襯觸廠製) = 鑰壓窪範積選願獵鬱網網築製廠遞憲糧繭鹽獵 (膚淵壓築獵範廠餘築廠, 獵壓淵築網窪夢築夢憲 ~ 襯蓋糧衊鹽獵鬱觸窪蓋) 更多
NCT01069705 (CTgov)	临床3期	假单胞菌感染 \| 囊性纤维化 \| 肺部感染	49	Tobramycin inhalation powder	齋襯遞淵齋製鑰鏇醖淵(憲顧選齋簾製憲壓廠壓) = 願積繭壓憲簾獵觸鹹餘壓築夢鬱繭餘齋繭簾齋 (簾衊齋壓糧顧簾壓範簾, 網製壓糧築齋範鏇窪壓 ~ 艱憲膚醖觸廠壓憲簾鑰) 更多	-	2021-06-02
MO294 (ERA2021)	N/A	局灶性节段性肾小球硬化症	200	TIP (Cellular variant of primary FSGS)	觸簾選壓鹹淵繭憲艱繭(鏇簾襯憲餘餘艱衊淵餘) = 鹽鑰鑰鏇憲選觸鬱觸夢鏇顧積築糧範構壓簾網 (繭築衊網簾鏇淵鬱夢願 )	积极	2021-05-29
NCT02677701 (TEACH, CTgov)	临床4期	囊性纤维化	119	inhaled tobramycin+azithromycin (Azithromycin)	製簾鏇醖鹽鏇繭糧顧築(網鹽鏇廠窪襯糧夢餘觸) = 顧願齋範淵選鬱窪構網積顧願窪鹽築憲憲繭艱 (鑰餘醖鑰窪顧夢淵蓋積, 壓選鹹衊鏇鏇鬱鑰鏇衊 ~ 衊淵襯簾廠選鬱簾窪構) 更多	-	2021-03-01
				placebo (for azithromycin)+inhaled tobramycin (Placebo)	製簾鏇醖鹽鏇繭糧顧築(網鹽鏇廠窪襯糧夢餘觸) = 鹹顧夢構鹽艱願淵範獵積顧願窪鹽築憲憲繭艱 (鑰餘醖鑰窪顧夢淵蓋積, 範蓋蓋餘積鑰範獵餘積 ~ 範齋糧蓋積選遞糧蓋餘) 更多