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2024-10-21

申办/合作机构

Radboud University Medical Center

[+2]

CTRI/2024/09/074195

/ Not yet recruitingN/A

Phenotypic Detection and Genotypic Characterization of colistin resistance in Gram-negative bacilli - NIL

开始日期2024-09-30

申办/合作机构-

100 项与硫酸多粘菌素E 相关的临床结果

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100 项与硫酸多粘菌素E 相关的转化医学

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100 项与硫酸多粘菌素E 相关的专利（医药）

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11,311

项与硫酸多粘菌素E 相关的文献（医药）

2025-12-31·Journal of Immunotoxicology

Anti-inflammatory effect of Plantago asiatica crude extract in rat gout arthritis model

Article

作者: Zhou, Yue ; Dai, Li ; Xu, Haixia ; Hu, Jun ; Qian, Bingjun

Plantago asiatica L., a perennial herb in the family Plantaginaceae, has been shown to impart several pharmacologic activities, including anti-oxidative, anti-inflammatory, and diuretic effects. In the study here, the anti-gout(y) arthritis (GA) effects of a crude extract from P. asiatica L. (PAE) were investigated in a rat GA model. For this, PAE was prepared by ethanol extraction and analyzed for phytochemicals by RP-HPLC and Q-TOF-MS. Thereafter, potential therapeutic effects of the PAE were investigated in rats; Wistar rats (male, 8 wk-of-age) were randomly allocated into four groups (n = 9/group) and intra-articularly injected with 3 mg monosodium urate (MSU) in saline solution to establish a GA model. For the study, rats received oral dosings of 0.3 mg colchicine/kg or 1 g PAE/kg (w/w) before and after gout was established. At fixed times after the treatments, assessment of joint swelling ratios and pathological changes in the joints, as well as of select cytokine expression in the blood, was done. RP-HPLC results showed the PAE contained at least 8 'active' ingredients, with plantamajoside, verbascoside, and cymaroside being the most abundant. In comparison to in control rats, MSU induced joint space narrowing, ankle joint swelling, and increased levels of pro-inflammatory interleukin (IL)-1β, IL-17a, tumor necrosis factor (TNF)-α, and interferon (IFN)-γ, and reductions in anti-inflammatory IL-10 in the blood. PAE treatment significantly reversed patho- genic joint space narrowing and swelling, reversed the MSU-induced changes in inflammatory factors, and in general imparted effects very similar to those seen with colchicine (COL; known non-steroidal anti-inflammatory drug for clinical treatment of GA). Collectively, these findings provide experimental evidence supporting the potential applicability of PAE to treat gouty arthritis.

2025-12-01·Molecular Biology Reports

Prevalence of New Delhi Metallo-β-lactamase (blaNDM) gene in a selected population of drug-resistant clinical isolates

Article

作者: Latif, Kunza ; Ahmed, Iftikhar ; Hyder, Muhammad Zeeshan ; Saeed, Muhammad ; Shafiq, Muhammad ; Ahmad, Aftab

OBJECTIVESDrug-resistant Enterobacterales carrying carbapenem-resistant genes cause severe infections in clinical settings worldwide. Among these, the New Dehli Metallo-β-lactamase (bla_NDM) gene is significantly prevalent and associated with high morbidity. This study was designed to investigate the susceptibility profiling of Carbapenem-Resistant-Enterobacterales (CRE), prevalence of bla_NDM and its variants, and associated risk factors.METHODSCRE isolates from a tertiary care hospital, in Islamabad, Pakistan, were identified and the susceptibility testing was performed using disc diffusion method. MICs were determined for imipenem, tigecycline, and colistin through E-strips and microbroth dilution method respectively. For molecular characterization and typing of the bla_NDM gene, PCR products were sequenced, and the phylogenetic analysis was performed using MEGA ver 6.0 software.RESULTSAmong 5,134 clinical samples, 42.13% (n = 2,163) yielded pathogens including 42.58% (n = 921) Enterobacterales. On further screening, 39.52% (n = 364) of Enterobacterales were identified as CRE. The bla_NDM gene was detected in 75.27% (n = 274) in CRE isolates, comprising bla_NDM-1 (44%), bla_NDM-5 (53%), and bla_NDM-7 (3%) variants. Tigecycline (86.7%) and colistin (100%) were most effective antimicrobial agents with MICs ranging from 0.064 to 8 and 0.125-1 µg/ml respectively. bla_NDM-1-harboring bacteria exhibited high antimicrobial resistance compared to bla_NDM-5 and bla_NDM-7. Cefiderocol was 75.6% and ceftazidime/avibactam with aztreonam was 97.08% effective against bla_NDM-harboring bacteria. The phylogenetic analysis indicated that bla_NDM variants showed close genetic relationships and homology to the previously described sequences in GenBank databases having diverse connection with worldwide sequences.CONCLUSIONThe high prevalence of bla_NDM in our study has of great concern for clinical practice and public health. Clinicians are left with few therapeutic options. However, ceftazidime/avibactam with aztreonam may show therapeutic success. Continuous surveillance is crucial to monitorgenetic variations of continuously evolving bla_NDM gene, which is essential for effective clinical management.

2025-12-01·Molecular Biology Reports

Green synthesis of silver nanoparticles using Acroptilon repens aqueous extract and their antibacterial efficacy against multidrug-resistant Acinetobacter baumannii

Article

作者: Shamsoddini, Seyed Mahdi ; Karizi, Shohreh Zare ; Shahbazi, Shahla ; Davoudi, Mahdieh

BACKGROUNDAcinetobacter baumannii is a critical pathogen associated with hospital-acquired infections, particularly in burn and intensive care unit (ICU) patients, and is notorious for its high level of antibiotic resistance. This study aims to evaluate the antibacterial potential of silver nanoparticles (AgNPs) synthesized using Acroptilon repens extract as a promising alternative treatment for combating multidrug-resistant A. baumannii.METHODS AND RESULTSTwelve clinical isolates of A. baumannii were identified through biochemical testing. Antibiotic susceptibility testing using the Kirby-Bauer disk diffusion method revealed universal resistance to ceftazidime, amikacin, imipenem, gentamicin, ciprofloxacin, and piperacillin-tazobactam, while all isolates remained sensitive to colistin (p ≤ 0.05). AgNPs were synthesized using A. repens extract and characterized through transmission electron microscopy (TEM), scanning electron microscopy (SEM), particle size analysis (PSA), UV-Vis spectroscopy, X-ray diffraction (XRD), and Fourier-transform infrared spectroscopy (FT-IR). TEM analysis showed that the AgNPs had a spherical morphology with an average particle size of approximately 30 nm, while SEM confirmed their spherical shape and size distribution, ranging from 10 to 130 nm, with a mean size of 38.89 nm. UV-Vis spectroscopy confirmed the successful formation of AgNPs, indicated by a distinct broad absorption peak between 400 and 480 nm. XRD analysis validated the crystalline nature of the nanoparticles, with characteristic peaks at 2θ values of 38.21°, 46.28°, 64.57°, and 77.49°, corresponding to the (111), (200), (220), and (311) planes of face-centered cubic (fcc) silver. Antibacterial activity was evaluated by determining the minimum inhibitory concentration (MIC), which ranged from 50 to 400 µg/mL. The highest inhibitory activity was observed at 400 µg/mL. Gene expression analysis using quantitative real-time PCR (qRT-PCR) demonstrated downregulation of the oprD and carO porin genes following AgNP treatment. However, these reductions were not statistically significant (p = 0.302 and p = 0.198, respectively).CONCLUSIONSAgNPs synthesized from A. repens demonstrated strong antibacterial activity against multidrug-resistant A. baumannii. While downregulation of porin genes was observed, further investigation is required to elucidate the underlying mechanisms of action and assess their potential clinical applications. These findings support the potential of AgNPs as an alternative therapeutic strategy for addressing A. baumannii infections resistant to conventional antibiotics.

项与硫酸多粘菌素E 相关的新闻（医药）

2025-01-16

·辉瑞制药

新型抗菌药物Xacduro®首处开启抗感染精准治疗新纪元

2025年1月15日，新型抗菌药物Xacduro®（舒巴坦钠-度洛巴坦钠）全国首张处方在上海开出，标志着目前首个且唯一专门针对碳青霉烯类耐药的鲍曼不动杆菌（CRAB）而开发的新型酶抑制剂复方制剂Xacduro®正式惠及患者，抗感染治疗进入精准治疗时代。此次Xacduro®全国首张处方由上海闸新中西医结合医院医疗院长王椿教授开出。王椿教授表示：“作为‘超级细菌’之一的鲍曼不动杆菌，其引起的医院获得性肺炎（HAP）/呼吸机相关性肺炎（VAP）的总死亡率约为42.6%1。在世界卫生组织发布的急需开发抗菌药物的细菌重点病原体清单中，CRAB被列为‘关键优先级’病原体，即是对公共卫生构成最严重威胁的抗生素耐药的细菌病原体之一2。Xacduro®作为精准应对耐碳青霉烯类药物鲍曼不动杆菌感染的新型抗菌药物，有望满足这类超级细菌感染临床治疗的迫切需求，拯救患者生命。” 鲍曼不动杆菌是一种常见的院内感染致病菌，可造成人体各个部位的局部和全身感染3，是HAP/VAP的最常见病原体之一4。CRAB感染的全球致死人数在所有病原体-药物组合中排名第二5，对公共卫生造成严重威胁。在我国，CRAB也是细菌耐药性导致死亡的主要原因之一5。根据最新的中国细菌耐药监测网（CHINET）报告显示，中国鲍曼不动杆菌对碳青霉烯类抗生素的耐药率已升至约74%6。既往由CRAB感染引起的HAP/VAP的治疗方案非常有限，缺乏治疗CRAB感染的金标准疗法7。 “CRAB感染治疗难度大，患者病死率高，特别是在重症患者或伴有多种基础疾病的人群中，感染 CRAB 后往往会使原有病情恶化，增加了死亡风险。由于对包括碳青霉烯在内的多种抗生素耐药，可供临床选择的有效抗菌药物非常有限。为应对这一超级细菌带来的临床挑战，亟需针对耐药机制的、有明确临床疗效证据的新型抗菌药物。”王椿教授说。鲍曼不动杆菌具有多种耐药机制，其产生β-内酰胺酶可水解破坏β-内酰胺类抗生素的β-内酰胺环，使其失去抗菌活性，是对β-内酰胺类抗生素最普遍的耐药机制7。 Xacduro®是由舒巴坦钠（一种β-内酰胺类抗生素)和度洛巴坦钠(一种非β-内酰胺类β-内酰胺酶抑制剂)组合而成。舒巴坦钠本身对鲍曼不动杆菌具有内在抗菌活性，同时它也是一种A类酶的β内酰胺酶抑制剂。度洛巴坦钠是一种新型β-内酰胺酶抑制剂，可以有效抑制A、C和D类酶。二者结合，有效地保护了舒巴坦钠，恢复其对 CRAB 的抗菌活性8。 “新型抗菌药物的上市为临床提供了针对CRAB中重度感染治疗的精准治疗方案，为临床医生提供了更多选择，改善患者治疗结局。”王椿教授表示。当前，超级细菌耐药问题严重，受到全球各国重视。碳青霉烯类耐药的鲍曼不动杆菌在我国检出率呈逐渐增长态势，造成了巨大的健康与经济负担。 CRAB的传播与其特殊的生存和繁殖机制密切相关。CRAB能够通过医疗设备、医院各类设施表面等多种途径进入患者体内，在人流密集、环境封闭的空间里，这种细菌能长期存活。此外，抗生素的不当使用也是造成细菌耐药性增强的重要原因。 “面对耐药菌带来的严重威胁，我们必须行动起来。合理用药，实现抗感染精准治疗，把药用好，才能让患者不会因为耐药菌感染而失去生命。”王椿教授说。 “感染性疾病的治疗依靠抗菌药物，如何科学合理地选用合适的 ‘武器’杀灭‘敌人’是一个非常复杂的判断过程，感染治疗方案选择的精准程度将直接关系到患者的治疗效果。”王椿教授认为，新型酶抑制剂复方制剂通过选择性杀死单个或极少数细菌、针对特定耐药表型细菌或破坏特定发病机制，在未来的临床中的广泛应用，会最大限度地减少超级耐药菌的出现。据悉，Xacduro®（舒巴坦钠-度洛巴坦钠）将在北京、广州、杭州、南京、成都等多个城市上市，加速惠及更多患者。静脉输注型组合药物Xacduro®（舒巴坦钠-度洛巴坦钠）是由舒巴坦钠（一种β-内酰胺类抗生素）和度洛巴坦钠（一种非β-内酰胺类β-内酰胺酶抑制剂）组合而成。舒巴坦钠-度洛巴坦钠于2023年、2024年分别由美国食品药品监督管理局和中国国家药品监督管理局批准，用于治疗由鲍曼-醋酸钙不动杆菌复合体敏感分离株引起的18岁及以上患者的医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎。舒巴坦钠-度洛巴坦钠在中国获批是基于ATTACK研究（NCT03894046）的积极结果，该研究是一项全球3期注册性研究，评估了舒巴坦钠-度洛巴坦钠对比多粘菌素E用于治疗鲍曼不动杆菌感染患者的有效性和安全性。在该研究中，舒巴坦钠-度洛巴坦钠在研究主要终点，即碳青霉烯类耐药不动杆菌感染患者的28天全因死亡率方面，与多粘菌素E相比具有统计学上的非劣效性，并且在临床治愈率和微生物学反应率方面显著优于多粘菌素E。舒巴坦钠-度洛巴坦钠在整个临床研究项目中均表现出良好的安全性特征。在辉瑞，我们通过科学和全球资源为人们提供治疗方案，以延长其生命，显著改善其生活。在医疗卫生产品的探索、研发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。我们在全球的产品组合包括创新药品和疫苗。每天，辉瑞在发达和新兴市场的员工都在推进人类健康，推动疾病的预防、治疗和治愈，以应对挑战我们这个时代的顽疾。辉瑞还与医疗卫生服务方、政府和社区合作，支持并促进世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家全球卓越的创新生物制药公司的责任是一致的。175年来，辉瑞一直致力于为所有依赖我们的人带来改变。 1 Lim SMS, et al. J Infect. 2019 Dec;79(6):593-600 2 WHO Bacterial Priority Pathogens List, 2024 3 Moubareck CA, et al. Antibiotics (Basel). 2020 Mar; 9(3), 119 4 CHINET 2023年细菌耐药监测结果 5 GBD 2021 Antimicrobial Resistance Collaborators. Lancet . 2024 Sep 13:S0140-6736(24)01867-1. Online ahead of print. 6 China Diagnosis and Treatment Guideline for hospital-acquired pneumonia and ventilator-associated pneumonia, 2018 7 Moubareck CA, et al. Antibiotics (Basel). 2020 Mar; 9(3), 119 8 Mcleod SM, et al Future Microbiol.2024;19(7):563-576 内容来源于网络，如有侵权，请联系删除。

微生物疗法临床研究

2024-12-29

·GlobeNewswire-Health Care

Basilea is awarded additional CARB-X funding to develop new drug candidate from a novel class of antibiotics

Additional funding awarded following successful drug candidate nomination USD 7.3 million to support progression of antibiotic BAL2420 (LptA inhibitor) towards first-in-human clinical studies December 23, 2024 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it was awarded an additional USD 7.3 million from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership dedicated to supporting the early development of antibacterial products. The new funding supports the progression of Basilea’s novel antibiotic candidate BAL2420 (LptA inhibitor) towards the start of first-in-human clinical studies, which is expected mid-2026. Dr. Laurenz Kellenberger, Chief Scientific Officer of Basilea, said: "We are very pleased by CARB-X’s continued support for the development of this promising first-in-class drug candidate. LptA inhibitors have the potential to address an unmet medical need in the hospital-based treatment of severe infections, caused by Gram-negative bacteria. We look forward to working with CARB-X to bring BAL2420 to patients." BAL2420 belongs to one of the very few novel classes of antibiotics in development. It is targeting LptA, which is part of the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. LptA inhibitors have shown potent and rapid bactericidal activity in vitro and in vivo against Gram-negative bacteria of the Enterobacteriaceae family, such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy.1 Enterobacteriaceae have been highlighted by the World Health Organization (WHO) as priority pathogens, against which new antibiotics are urgently needed.2 Basilea has acquired the LptA antibiotics program from Spexis AG in early 2024. In April this year, Basilea announced that it was awarded an initial CARB-X grant of up to USD 0.9 million to support early preclinical activities. The successful completion of these activities resulted in the nomination of BAL2420 as a drug candidate and also led to a final milestone payment from Basilea to Spexis. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; Antibacterials branch; under agreement number 75A50122C00028; and by awards from Wellcome (WT224842) and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list. Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: December 22, 2024) The content above comes from the network. if any infringement, please contact us to modify.

合格传染病产品

2024-12-07

·药闻康策

一文了解注射用抗细菌药核心医院市场格局

☝ 点击上方一键预约 ☝ 最新最热的医药健康新闻政策前言近年来，在国家大力推广“合理用药”的背景下，在我国主要医疗机构已经普及了正确的抗生素使用理念，“能口服不注射，能肌注不静注”，这也意味着大体上口服抗生素用于门急诊或住院的普通症状中，而注射产品更多出现在住院、手术或其他相对危重症的场景中。根据法伯核心医院市场数据显示，2023年我国核心医院注射用抗细菌药物市场*规模超510亿元，同比降低6.2%。随着第五批国家集采开始纳入更多注射剂品种，该细分领域的核心医院*市场格局也在持续变化。补充说明 *本分析所述的药品范围（按照药物解剖学、治疗学及化学分类法ATC2编码）：J01全身用抗细菌药，本文纳入分析的仅为注射剂型（粉针剂、注射液等），不包括口服类药物。 *核心医院：100张床以上的医院百亿注射用抗细菌药，五年复合增长-12.6% 全身用抗感染药物根据致病微生物主要可分为抗细菌药物（抗生素）、抗病毒药物、抗真菌药物等，作为销售占比超过80%的最大类别，抗细菌药又可分为青霉素类（广谱；中、窄谱等）、头孢菌素类（各代别及酶抑制剂复合物等）、大环内酯类、喹诺酮类和碳青霉烯类（属于其他β内酰胺类）等，且其中超过75%为注射剂型。根据法伯核心医院市场数据显示，在注射用抗细菌药市场中，2023年头孢菌素和青霉素类药物在核心医院销售额超过100亿元，占比分别为42.3%和20.7%（表1）。表1-注射用抗细菌药主要分类及2023年在核心医院销售额数据来源：法伯核心医院市场数据市场规模方面，法伯数据显示，2023年我国核心医院注射用抗细菌药物销售额达517亿元，同比降低6.2%，2019-2023年该领域整体市场规模呈现缩小的趋势，五年复合增长率-12.6%（图1）。图1-2019-2023年核心医院注射用抗细菌药市场规模数据来源：法伯核心医院市场数据进一步关注该领域的头部分子，2023年头孢哌酮舒巴坦和哌拉西林他唑巴坦以绝对的优势，在核心医院市场排名前两位，销售额分别达87.3和72.4亿元，且均实现了增长。位列第三的亚胺培南西司他丁销售额超31亿元，同比增长10.1%。除了亚胺培南西司他丁之外，2023年增速较大的分子还包括多粘菌素E、左氧氟沙星，以及头孢呋辛。此外，头部分子中的半数已被纳入历次国家集采（图2）。图2-2023年核心医院注射用抗细菌药头部分子规模及增速数据来源：法伯核心医院市场数据超20个分子纳入集采，市场规模大幅缩减目前，注射用抗真细药物市场共24个分子被纳入历次VBP，其中头孢菌素类被纳入的分子最多。回顾国家集采各批次特点，从品种剂型来看，最初口服常释剂是主流，后续随着集采常态化和一致性评价工作的不断深入，所纳入品种的剂型愈加丰富：第二批新纳入了缓控释剂型和咀嚼片；第三批新纳入了颗粒剂、口崩片、滴眼剂和口服溶液剂；第四批首次纳入了吸入剂；到第五批注射剂成为超过口服常释剂的主力剂型。表2-国家集中带量采购注射用抗细菌药物品种数据来源：法伯整理因此可以看到，在已纳入集采的注射用抗细菌药物品种中，仅莫西沙星注射剂于第三批纳入，其他均在第五批及之后纳入，其中注射用头孢曲松、注射用头孢他啶、注射用头孢哌酮钠舒巴坦钠、注射用头孢噻肟钠和克林霉素磷酸酯注射液各有10个厂家中标，原研仅辉瑞的注射用替加环素在第七批VBP中标（表2）。图3-2023年核心医院注射用抗细菌药各批次VBP品种占比数据来源：法伯核心医院市场数据根据法伯核心医院数据显示，2023年核心医院中注射用抗细菌药物集采品种合计占比达60.9%（图3）。对于以院内市场布局为主的注射剂药物，集采降价对其市场规模带来显著影响，截至2023年末已充分执行的注射用抗细菌药VBP品种，销售额较2019年均明显下降。以第三、五、七批品种为例，注射用头孢米诺、克林霉素磷酸酯注射液和注射用盐酸头孢吡肟的降幅均大于80%（图4）。图4-部分注射用抗细菌药VBP品种核心医院市场销售额变化23vs19 数据来源：法伯核心医院市场数据内资整体份额占优，辉瑞默沙东领衔市场企业格局方面，多年来注射用抗细菌药物市场一直是内资企业份额占优。根据法伯核心医院市场数据显示，2019年内资企业在该领域份额达74.1%，此后持续下降，到2022年降至65%（图5）。图5-2019-2023核心医院注射用抗细菌药内外资销售额占比及增速数据来源：法伯核心医院市场数据值得关注的是，外资企业虽然占比不高，但是整体规模增速优于内资，且目前注射用抗细菌药物市场主要由辉瑞和默沙东两大外资企业领衔。根据法伯核心医院市场数据显示，2022-2023年上述两家企业在核心医院市场稳居该领域第一、二名，合计占据近25%市场份额。此外，上榜TOP10榜单的外资企业还有VANCOCIN ITALIA S.R.L.和日本住友制药。其余六家内资企业中，上药第一生化制药、华北制药、西南制药、瑞阳制药所占份额均超3%（表3）。表3-2023年核心医院抗真菌市场销售额TOP10企业数据来源：法伯核心医院市场数据集采影响下，注射用抗细菌药市场格局变化随着越来越多的注射用抗细菌药物纳入VBP，该领域核心市场内外资企业格局也在被持续重塑。作为注射用抗细菌药物市场的“领头羊”，辉瑞多年来以明显的销售额优势稳核心医院第一名。虽然在集采的影响下，许多国内仿制药企抢占了部分药物的市场份额，但是整体仍未能撼动辉瑞在该领域的地位。目前，辉瑞的阿奇霉素、利奈唑胺、替加环素、头孢哌酮舒巴坦、哌拉西林他唑巴坦已相继纳入集采，其中仅注射用替加环素（商品名：泰阁）在第七批中标，另有奥赛康药业、福安药业、正大天晴、赛隆药业等七家仿制药企中标。根据法伯核心医院市场数据显示，在VBP的影响下，2023年核心医院注射用替加环素市场规模同比降低74.8%，中标原研辉瑞的份额有所提升，内资企业由此前的正大天晴主导变成各仿制药企分食市场（图6）。图6-核心医院注射用替加环素市场规模及企业格局变化数据来源：法伯核心医院市场数据除了注射用替加环素外，辉瑞的第五批未中标品种注射用阿奇霉素（商品明：希舒美）和利奈唑胺葡萄糖注射液（商品名：斯沃）在核心医院的市场规模均受到集采冲击，不过鉴于其超70亿元大品种注射用头孢哌酮钠舒巴坦钠（商品名：舒普深），以及超10亿品种注射用哌拉西林钠他唑巴坦钠（商品名：特治星）相对较晚纳入集采，截至2023年末由集采带来的影响尚不显著，加之2019-2023年复合增长超170%的注射用头孢他啶阿维巴坦钠（商品名：思福妥）尚未纳入集采，根据法伯核心医院数据显示，相较于2019年，2023年辉瑞在注射用抗细菌药核心医院市场依旧实现了1.2%的复合增长。相较于辉瑞，另一个在注射用抗细菌药物领域处于市场主导地位的外资企业默沙东，虽然相关品种数量不多，但是旗下注射用亚胺培南西司他丁钠（商品名：泰能）和注射用厄他培南（商品名：怡万之）均尚未纳入集采，后者2023年在核心医院销售额同比增长超55%。法伯数据显示，2019-2023年默沙东在注射用抗细菌药核心市场销售额持续稳定，五年复合增长0.2%。而在2022年排名还仅次于默沙东的日本住友制药则因集采受到较大影响，旗下注射用美罗培南（商品名：美平）于第七批集采落标，包括石药欧意、罗欣药业、圣华曦药业等在内的六家仿制药企中标。根据法伯核心医院市场数据显示，2023年核心医院注射用美罗培南市场规模同比降低60.7%，虽然日本住友制药在该细分领域保住了份额优势（图7），但是从整体注射用抗细菌药市场来看，其排名已从2022年的第三降至2023年的第九。未来，随着更多注射剂型纳入集采，抗细菌药物市场格局又将怎样变化，我们拭目以待。图7-核心医院注射用美罗培南市场规模及企业格局变化数据来源：法伯核心医院市场数据 (来源：法伯科技Pharbers）药闻康策新媒体矩阵微信公众号点击下方一键关注【免责声明】 1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

微生物疗法

100 项与硫酸多粘菌素E 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02138	硫酸多粘菌素E	J01XB01 A07AA10	DB00803

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
志贺氏菌感染	中国	扬州制药有限公司	1984-01-01
肠炎	中国	扬州制药有限公司	1984-01-01

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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


ISN WCN2024	N/A	电解质不平衡	-	COLISTIN (Patients with AKI)	鑰鑰製遞鏇鑰構鏇夢鏇(選製簾鏇襯窪繭築壓繭) = 醖廠製艱餘築築觸鹹窪繭夢鹹網淵鬱遞糧餘願 (鏇鏇簾醖範壓憲鹹夢網 ) 更多	-	2024-04-01
				COLISTIN (Patients without AKI)	憲衊壓夢選觸構選鬱齋(壓鑰顧糧窪窪夢鏇鹽築) = 襯觸範鏇鹽築蓋鏇積築鬱願觸鹹顧膚壓齋觸築 (積襯遞鑰構蓋顧膚積蓋 ) 更多
WCD2023	N/A	天疱疮	-	Colistin	壓築簾積鏇糧願築鑰鬱(淵襯簾鹽選膚觸簾夢網) = A diagnosis of BLS was made and colistin was stopped on day 12 after resolution of UTI and negative cultures. Electrolytes were restored after 9 days of stopping colistin. 醖顧淵醖醖鏇鬱顧選糧 (製蓋鑰願糧齋餘鹹鏇築 )	-	2023-07-03
ISN WCN2023	N/A	急性肾损伤	150	AKI before Colistin	鑰鹹餘鏇鑰廠蓋鹹窪鹹(鹹淵窪醖醖構築獵襯觸) = 觸艱鏇襯獵齋夢顧範膚憲餘鹽築壓觸淵蓋淵遞 (鹹選網獵膚顧鹹鹽獵製 ) 更多	积极	2023-03-01
				No AKI on Colistin	鑰鹹餘鏇鑰廠蓋鹹窪鹹(鹹淵窪醖醖構築獵襯觸) = 遞廠鏇糧獵顧繭鏇顧鑰憲餘鹽築壓觸淵蓋淵遞 (鹹選網獵膚顧鹹鹽獵製 ) 更多
NCT02918409 (CTgov)	临床4期	囊性纤维化	51	Colistin (Standard Colistin Arm)	顧製窪鑰遞鹽鹽廠選積(簾膚襯築廠淵簾網夢鏇) = 遞鹹膚蓋範鑰製醖積選獵糧襯襯觸網夢夢顧蓋 (餘積淵襯廠獵廠築網艱, 鹹網築築簾範淵顧積選 ~ 蓋製遞淵蓋齋顧築願醖) 更多	-	2022-10-06
				Colistin (Modified Colistin Arm)	顧製窪鑰遞鹽鹽廠選積(簾膚襯築廠淵簾網夢鏇) = 鹹積鹽衊壓蓋醖構構簾獵糧襯襯觸網夢夢顧蓋 (餘積淵襯廠獵廠築網艱, 遞壓獵構網廠鹽構鹽襯 ~ 觸鹽網艱鑰淵壓衊製鹹) 更多
NCT01597973 (OVERCOME, CTgov)	临床3期	肺炎 \| 脓毒症	467	placebo	齋顧齋糧蓋艱廠餘選齋(膚廠觸鏇膚築齋齋淵築) = 願製憲鹹醖齋獵鏇壓積鬱顧網艱簾觸遞廠選艱 (餘築顧簾餘製襯網鬱齋, 齋餘齋觸鑰鏇蓋繭蓋膚 ~ 選壓積餘鏇獵蓋糧繭憲) 更多	-	2021-11-30
ASN2019	N/A	肿瘤 \| 感染	115	Colistin	(齋鹹壓繭範廠網鏇壓鬱) = 淵範齋顧醖壓顧繭觸鹽窪夢築蓋繭壓鏇餘顧積 (選築襯觸壓壓鹹艱憲構 ) 更多	不佳	2019-11-05
NCT03622918 (Pubmed \| J Glob Antimicrob Resist)	N/A	鲍氏不动杆菌感染 \| 肺炎	9	Colistin/rifampicin combination therapy	(積鑰糧廠鑰襯膚齋網鹽) = 醖獵壓範網壓蓋繭鹽觸鏇製齋壓願蓋衊醖繭艱 (網蓋網遞衊觸積鑰淵窪 )	-	2019-06-01
				Colistin monotherapy	(積鑰糧廠鑰襯膚齋網鹽) = 憲襯淵衊醖襯鹽簾築範鏇製齋壓願蓋衊醖繭艱 (網蓋網遞衊觸積鑰淵窪 )
ASN2018	N/A	肾脏毒性	-	Bolus-mimicking regimen of colistin	網艱憲遞顧鏇鏇鑰糧齋(鏇顧廠願簾鹹憲製衊膚) = 糧鏇遞窪齋觸鹽觸鬱選蓋衊選醖築製鏇鑰蓋淵 (觸願願膚齋鹹獵夢願蓋 )	积极	2018-10-23
				Continuous infusion regimen of colistin	網艱憲遞顧鏇鏇鑰糧齋(鏇顧廠願簾鹹憲製衊膚) = 觸艱獵鹹觸壓簾齋鏇遞蓋衊選醖築製鏇鑰蓋淵 (觸願願膚齋鹹獵夢願蓋 )
ERS2017	N/A	嗜麦芽寡养单胞菌二线	20	Colistin	鹹衊夢願構壓窪獵鬱簾(願廠衊艱齋遞鬱淵壓蓋) = 艱製醖餘艱顧糧壓鬱夢鏇蓋衊廠艱齋構艱衊築 (糧範積製繭顧鏇鹽淵膚 )	-	2017-09-01
				N-acetylcysteine	鹹衊夢願構壓窪獵鬱簾(願廠衊艱齋遞鬱淵壓蓋) = 獵鬱憲鬱網簾襯壓餘構鏇蓋衊廠艱齋構艱衊築 (糧範積製繭顧鏇鹽淵膚 )
ERS2016	N/A	铜绿假单胞菌感染	49	Inhaled colistin	獵膚壓顧夢襯糧顧蓋憲(膚壓觸鑰糧築顧範夢製) = 築簾夢襯廠範觸簾糧築顧觸構衊顧積遞製鬱壓 (繭願製獵衊襯廠鑰選鹹 ) 更多	积极	2016-09-01