更新于：2024-06-24

Ertapenem Sodium

厄他培南钠

更新于：2024-06-24

概要

概要

基本信息

药物类型

小分子化药

别名

(1R,5S,6S,8R,2'S,4'S)-2-(2-(3-carboxyphenylcarbamoyl)pyrrolidin-4-ylthio)-6-(1-hydroxyethyl)-1-methylcarbapenem-3-carboxylic acid、(4R,5S,6S)-3-((3S,5S)-5-((3-carboxyphenyl)carbamoyl)pyrrolidin-3-ylthio)-6-((R)-1-hydroxyethyl)-4-methyl-7-oxo-1-aza-bicyclo[3.2.0]hept-2-ene-2-carboxylic acid、ertapenem

+ [12]

靶点

PBPs

作用机制

PBPs抑制剂(细菌青霉素结合蛋白家族抑制剂)

治疗领域

感染神经系统疾病心血管疾病+ [5]

在研适应症

菌血症细菌感染复杂的皮肤和软组织感染+ [11]

非在研适应症

医院获得性肺炎细菌性肺炎传染性皮肤病+ [1]

原研机构

Merck & Co., Inc.

在研机构

Merck Sharp & Dohme BVSun Pharmaceutical Industries (Europe) BVMerck Sharp & Dohme (Australia) Pty Ltd.

+ [3]

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2001-11-21),

社区获得性肺炎复杂腹腔感染复杂皮肤和皮肤结构感染+ [2]

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C22H25N3Na2O7S

InChIKeyICBBVMASSIBEJY-SHZCTIMHSA-N

CAS号153832-38-3

关联

项与厄他培南钠相关的临床试验

NCT04886284 / Recruiting临床2期IIT

Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia (CERT)

There is a variety of in vitro, in vivo (animal model), and human case series data which suggests that the addition of ertapenem to cefazolin could improve outcomes in methicillin-susceptible S. aureus bacteremia. No randomized controlled trial has been performed.
This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119)

开始日期2024-05-20

申办/合作机构-

NCT05645757 / Completed临床1期IIT

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777) In Healthy Adult Subjects

This is a Phase 1, single center study to investigate the safety, tolerability, and pharmacokinetics (PK) of three dose-level groups of WCK 6777 (ERT and ZID combination), and two dose-level groups of ERT alone and ZID (WCK 5107) alone in 52 healthy adult male and female subjects aged 18 to 45 years old (both inclusive). Seven treatment cohorts will be evaluated in this study. WCK 6777 will be evaluated in three cohorts - Cohorts 1, 4 and 7- of 8 subjects each (6 study drug combinations and 2 placebos); ERT will be evaluated alone in two cohorts - Cohorts 2 and 5- of 8 subject each (6 ERT and 2 placebos); and ZID will be evaluated in two cohorts, Cohorts 3 and 6, of 6 subjects each (all ZID). The study will be placebo-controlled and double-blinded in all cohorts except Cohorts 3 and 6. No placebo subjects are included in standalone ZID cohorts, since adequate safety data for higher doses of ZID alone in comparison with placebo are available from completed Phase 1 studies of WCK 5107 (ZID) alone and the ZID-only arms of WCK 5222 (cefepime + ZID) studies. The primary objective is to assess the safety and tolerability of three dose-escalating regimens of WCK 6777 ( ERT and ZID combination) and two-dose escalating regimens of standalone ERT or ZID following single daily doses for 7 days in healthy adult subjects.

开始日期2023-04-19

申办/合作机构

National Institute of Allergy & Infectious Diseases

ChiCTR2100046176 / Recruiting早期临床1期IIT

Ertapenem to prevent perineal incision infection after levator anus external abdomen perineum combined proctectomy (ELAPE): a single-arm, single-center clinical trial

开始日期2021-06-01

申办/合作机构

福建医科大学

100 项与厄他培南钠相关的临床结果

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100 项与厄他培南钠相关的转化医学

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100 项与厄他培南钠相关的专利（医药）

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2,052

项与厄他培南钠相关的文献（医药）

2024-03-01·Journal of global antimicrobial resistance

Characterization of a blaNDM-1-positive Citrobacter freundii strain isolated from earthworms

Article

作者: Zhang, Yanyan ; Zhang, Rong ; Lei, Lei ; Zhu, Yanyan ; Ju, Xiaoyang ; Wu, Yuchen ; Xiong, Panfeng

OBJECTIVES:

Earthworms are one of the key components of soil, and they play a crucial role in the transformation of various nutrients and pollutants in the soil. The purpose of this study is to characterize the NDM-1-producing C. freundii isolated from soil-dwelling earthworms near a hospital, exploring their potential role as carriers of carbapenem-resistant genes.

METHODS:

Isolates were isolated from the intestines of earthworms and identified by MALDI-TOF MS. The presence of NDM enzyme was verified through the CARBA-5 Assay. Whole genome sequencing was conducted using the Illumina NovaSeq PE150 platform. Antimicrobial susceptibility testing and conjugation experiment were performed for phenotypic analysis.

RESULTS:

This isolate exhibited a multidrug-resistant profile, including resistance to imipenem, meropenem, and ertapenem and successfully transferred bla_NDM-1 gene to Escherichia coli. Whole genomic sequencing showed that bla_NDM-1 gene was located on an IncFII_Y-type plasmid. Phylogenetic analysis revealed a close relationship between the QY221001 strain obtained from earthworms and the human isolate F2021 in the NCBI database, both of which were collected in Hangzhou, China.

CONCLUSION:

To our knowledge, this is the first report of an NDM-1-producing bacteria isolated from the intestine of an earthworm. Our finding suggested that earthworms could be a potential reservoir of carbapenem resistance genes, emphasizing the importance of enhanced environmental monitoring of antimicrobial resistance.

2024-03-01·American journal of infection control

Trends and patterns of antibiotics use in Serbia from 2006 to 2021: Pre-COVID-19 period versus COVID-19 pandemic

Article

作者: Vukajlovic, Ivana ; Ristić, Zorica Stanojević ; Drakul, Dragana ; Arsovic, Aleksandra ; Jovanovic, Verica ; Gazibara, Tatjana ; Plavsa, Dragana ; Sokolovic, Dragana ; Milic, Marija ; Dotlic, Jelena ; Saponjic, Vladan ; Filimonovic, Jelena ; Joksimovic, Bojan ; Dimitrijevic, Dragana

BACKGROUND:

Global rise in antibiotic utilization has been strongly associated with the resistance of bacteria to antibiotics. The COVID-19 saw an increase in the use of antibiotics in some countries. The aim of this study was to evaluate antibiotic utilization from 2006 to 2021 in the Republic of Serbia.

METHODS:

Data on antibiotic use were retrieved from the national annual reports on the official website of the Medicines and Medical Devices Agency of Serbia during the period 2006 to 2021. To evaluate trends in the use of antibiotics in Serbia, linear, and joint regression analyses were performed.

RESULTS:

The analysis of the antibiotics use over a sixteen-year period included a total of 50 antibiotics. A significant increase during the COVID-19 pandemic was observed for glycylcyclines that is, new-generation tetracyclines (tigecycline), third-generation cephalosporins (ceftazidime, ceftriaxone, and cefixime), respiratory fluoroquinolones (levofloxacin and moxifloxacin), carbapenems (ertapenem), and oxazolidinones (linezolid) utilization. Moreover, an almost negligible use of new β-lactam/β-lactamase inhibitors during the prepandemic period increased significantly during the COVID-19 pandemic period.

CONCLUSIONS:

A significant increasing trend in the use of specific antibiotics classified as the "Watch" and "Reserve" antibiotics during the pandemic period was observed.

2024-03-01·Journal of global antimicrobial resistance

Multidrug-resistant pathogens contaminate river water used in irrigation in disenfranchised communities

Article

作者: Bisha, Bledar ; Tajani, Anahita Ghorbani ; Kassem, Issmat I ; Fiorella, Kathryn J ; El Omari, Khaled ; Abbara, Aula ; Hamze, Monzer ; Cazer, Casey L ; Hassan, Jouman ; Osman, Marwan ; Naas, Thierry ; Cummings, Kevin J ; Karah, Nabil ; Daaboul, Dina

OBJECTIVES:

The contamination of fresh surface waters poses a significant burden on human health and prosperity, especially in marginalized communities with limited resources and inadequate infrastructure. Here, we performed in-depth genomic analyses of multidrug-resistant bacteria (MDR-B) isolated from Al-Oueik river water that is used for irrigation of agricultural fields in a disenfranchised area that also hosts a makeshift Syrian refugee camp.

METHODS:

A composite freshwater sample was filtered. Faecal coliforms were counted and extended spectrum cephalosporins and/or ertapenem resistant bacteria were screened. Isolates were identified using MALDI-TOF-MS and analysed using whole-genome sequencing (WGS) to identify the resistome, sequence types, plasmid types, and virulence genes.

RESULTS:

Approximately 10⁶ CFU/100 mL of faecal coliforms were detected in the water. Four drug-resistant Gram-negative bacteria were identified, namely Escherichia coli, Klebsiella pneumoniae, Enterobacter hormaechei, and Pseudomonas otitidis. Notably, the E. coli isolate harboured bla_NDM-5 and a YRIN-inserted PBP3, representing an emerging public health challenge. The K. pneumoniae isolate carried bla_SHV-187 as well as mutations in the gene encoding the OmpK37 porin. Enterobacter hormaechei and P. otitidis harboured bla_ACT-16 and bla_POM-1, respectively.

CONCLUSION:

This report provides comprehensive genomic analyses of MDR-B in irrigation water in Lebanon. Our results further support that irrigation water contaminated with faecal material can be a reservoir of important MDR-B, which can spread to adjacent agricultural fields and other water bodies, posing both public health and food safety issues. Therefore, there is an urgent need to implement effective water quality monitoring and management programs to control the proliferation of antibiotic-resistant pathogens in irrigation water in Lebanon.

项与厄他培南钠相关的新闻（医药）

2024-06-15

·梅斯医学

「亚胺培南 + 万古霉素」都无效的肺炎，最后只用了它就搞定了？

导语社区获得性肺炎(community acquired pneumonia,CAP)是全球主要的传染病负担，是入住ICU的常见病因，指在医院外罹患的感染性肺实质炎症，包括具有明确潜伏期的病原体感染在人院后于潜伏期内发病的肺炎。临床统计约22%～42%的CAP患者需要住院治疗，其中17%～21%的住院患者为重症社区获得性肺炎（SCAP）。SCAP病的原学调查研究表明，SCAP患者最常见的病原体包括肺炎链球菌、流感嗜血杆菌和嗜肺军团杆菌等，在免疫功能低下的患者中，肺孢子菌、肺炎克雷伯菌、肺炎链球菌、流感嗜血杆菌和铜绿假单胞菌是最常见的病原体。 SCAP是一种严重且危及生命的感染，治疗方案的核心必须是有效覆盖所有可能的致病菌。许多国家制定了SCAP的诊断和治疗指南，不同的指南有不同的患者分层标准和治疗药物，但总的原则是相同的，即：覆盖解释患者病变特征和当地流行致病菌以及抗生素耐药性的最可能的所有致病菌。病例分享 55 岁男性，既往体健，因发热咳嗽 3 天入院。患者 3 天前发热，热峰 40 ℃，伴干咳、胸闷、乏力与反应迟钝、小便失禁。查体：体温 36.0 ℃，血压 105/56 mmHg，R 35 次/分，指脉氧 92%（面罩无创通气中，氧浓度 60%），嗜睡，呼之能应，两肺湿罗音，心率 90 次/分，律齐，无杂音，下肢无浮肿。实验室检查：血常规：WBC 4.05 × 109/L，N% 85.4%，淋巴细胞计数 0.38 ×109/L，CRP > 220 mg/L，PCT 14.99 ng/mL 。血生化：AST 283 U/L，ALT 91 U/L，LDH > 2150 U/L，BUN 15 mmol/L ，Cr 295 μmol/L，Na+132.7 mmol/L。血气分析：PH 7.37，PaO266 mmHg（FiO2 60%），PaCO256 mmHg；新冠核酸检测（-）、流感检测（-）。胸部 CT：提示左肺上叶与右肺中叶炎症。诊断：重症社区获得性肺炎、呼吸衰竭。后因氧合持续恶化，急诊气管插管机械通气后收入呼吸科。当时的值班医生分析，重症社区获得性肺炎（SCAP）病情危重，死亡率较高。使用碳青霉烯类药物联合万古霉素/利奈唑胺，覆盖广谱耐药革兰氏阴性菌和耐药革兰氏阳性菌（包括MRSA），大包围合情合理，因此选择亚胺培南/西司他丁联合万古霉素经验性抗菌治疗。问以上方案是否合理？不合理！答《中国成人社区获得性肺炎诊断和治疗指南（2016年版）》推荐（1）对于无基础疾病的青壮年重症CAP患者，推荐使用青霉素类/酶抑制剂复合物（阿莫西林/克拉维酸、氨苄西林/舒巴坦、阿莫西林/舒巴坦等）、第三代头孢菌素（静脉注射：头孢曲松、头孢唑肟、头孢噻肟等；口服：头孢地尼、头孢泊肟酯、头孢克肟等）、头霉素类（头孢西丁、头孢替尼、头孢美唑、头孢米诺等）、氧头孢烯类（拉氧头孢、氟氧头孢）、厄他培南等碳青霉烯类联合大环内酯类或单用呼吸喹诺酮类静脉治疗。（2）对于老年或有基础疾病的重症CAP患者，推荐青霉素类/酶抑制剂复合物、第三代头孢菌素或其酶抑制剂复合物、厄他培南等碳青霉烯类联合大环内酯类，或联合呼吸喹诺酮类。（3）对于年龄≥65岁或有基础疾病的住院CAP患者，应考虑肠杆菌科细菌感染的可能。进一步评估产ESBL（超广谱β-内酰胺酶）菌感染的风险。高危患者的经验性治疗包括头霉素类、哌拉西林/他唑巴坦、头孢哌酮/舒巴坦或厄他培南等。（4）对于具有铜绿假单胞菌感染危险因素的CAP，推荐使用具有抗假单胞菌活性的β-内酰胺类药物(头孢他啶、头孢吡肟、哌拉西林、氨曲南、哌拉西林/他唑林)、替卡西林/克拉维酸、头孢哌酮/舒巴坦、亚胺培南/西司他丁、头孢哌酮、美罗培南等），具有抗假单胞菌活性喹诺酮类（环丙沙星、左氧氟沙星），具有抗假单胞菌活性的β-内酰胺类联合喹诺酮类或氨基糖苷类（阿米卡星、庆大霉素等），具有抗假单胞菌活性活性β-内酰胺类、氨基糖苷类、喹诺酮类三药联合。该患者为青壮年，无基础疾病，指南没有推荐使用亚胺培南/西司他丁，也没有推荐万古霉素、利奈唑胺等抗MRSA药物。该患者入院后最初接受经验性亚胺培南/西司他丁联合万古霉素抗菌治疗，但高热持续，氧合状况未见改善。第5天，肺泡灌洗液报告检出嗜肺军团菌，病原学诊断：军团菌肺炎，故患者改用阿奇霉素抗菌治疗。患者病情好转，体温逐渐恢复正常，最终顺利拔管出院。《2019 ATS/IDSA临床实践指南：成人社区获得性肺炎的诊断和治疗》推荐（1）对于无耐甲氧西林金黄色葡萄球菌（MRSA）或铜绿假单胞菌感染风险的重症CAP患者，推荐使用β-内酰胺类药物（氨苄西林/舒巴坦、头孢曲松、头孢噻肟、头孢洛林）联合口服大环内酯类药物（阿奇霉素、克拉霉素）或呼吸道喹诺酮类药物（左氧氟沙星、吉米沙星、莫西沙星）。（2）有MRSA或铜绿假单胞菌危险因素的成人CAP患者应选择抗MRSA药物（万古霉素、利奈唑胺）、抗铜绿假单胞菌药物（哌拉西林/他唑巴坦、头孢他啶、头孢吡肟、亚胺培南、氨曲南、美罗培南）。目前，我国市场上销售的碳青霉烯类抗生素有5个品种：亚胺培南、帕尼培南、比阿培南、美罗培南和厄他培南。碳青霉烯类抗菌药物抗菌谱广，抗菌活性强，对需氧菌和厌氧菌均具有抗菌作用，特别是多重耐药革兰氏阴性杆菌，如产ESBL肠杆菌科细菌有很强的抗菌活性。近年来，我国碳青霉烯类抗菌药物临床应用中出现了一些不合理的现象，耐青霉烯耐药革兰阴性杆菌感染的发病率呈快速上升趋势，尤其是碳青霉烯耐药肺炎克雷伯菌、碳青霉烯耐药鲍曼不动杆菌、碳青霉烯耐药大肠埃希菌和碳青霉烯耐药铜绿假单胞菌等因其高耐药性和快速传播能力，给临床诊疗和感染防控带来巨大挑战。《抗菌药物临床应用指导原则（2015年版）》中明确了碳青霉烯类抗菌药物临床应用的适应证具有多重耐药性但对此类药物敏感的需氧革兰氏阴性杆菌引起的严重感染，包括肺炎克雷伯菌、阴沟肠杆菌、大肠埃希菌、柠檬酸杆菌、铜绿假单胞菌、粘质沙雷菌等肠杆菌科细菌、不动杆菌属等细菌所致血流感染、下呼吸道感染等。 2021年，BMJ发表的综述《Management of pneumonia in critically ill patients》表明，与非大环内酯类药物相比，β-内酰胺类药物联合大环内酯类药物可显著改善重症CAP患者预后。与氟喹诺酮类药物相比，β-内酰胺类药物联合大环内酯类药物治疗可降低重症肺炎患者的14天和30天死亡率。联合治疗的优点是覆盖非典型病原体，并可能受益于大环内酯类药物的免疫调节作用，以减轻细菌毒力因子和过度的全身炎症反应。 CAP的经验性抗感染治疗必须以临床微生物思维为基础，避免抗菌药物的过度使用，并及时考虑特殊病原体感染或非感染性肺部疾病。综上所述，对于重症CAP患者，初始治疗为大环内酯类或氟喹诺酮类药物与β-内酰胺类药物联合治疗。β-内酰胺的选择基于假单胞菌风险因素的存在，对于MRSA的额外覆盖基于特定风险因素的存在决定。根据 IDSA/ATS 指南的建议，只有在患者存在MRSA危险因素（既往MRSA呼吸道隔离、过去90天内住院和过去90天内使用非肠道抗生素，以及当地确认的MRSA的危险因素）时，才针对MRSA进行抗菌治疗，使用药物如万古霉素或利奈唑胺。参考文献： [1]瞿介明,曹彬.中国成人社区获得性肺炎诊断和治疗指南(2016年版)[J].中华结核和呼吸杂志,2016,39(04):253-279. [2]郑旭婷,陈佰义.社区获得性肺炎经验性抗感染治疗的临床微生物思维[J].中华结核和呼吸杂志,2021,44(06):588-591. [3]中华人民共和国国家卫生健康委员会.抗菌药物临床应用指导原则（2015 年版）[J].chrome-extension://ibllepbpahcoppkjjllbabhnigcbffpi/http://www.nhc.gov.cn/ewebeditor/uploadfile/2015/09/20150928170007470.pdf. [4]中华人民共和国国家卫生健康委员会.碳青霉烯类抗菌药物临床应用专家共识[J]. http://www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=95f65ca473b44746b24590e94468b8ff. [5]郑旭婷,陈佰义.社区获得性肺炎经验性抗感染治疗的临床微生物思维[J].中华结核和呼吸杂志,2021,44(06):588-591. [6]黄丹,徐中良.2016—2020年医院碳青霉烯类抗菌药物与常见碳青霉烯耐药革兰阴性杆菌调查分析[J].临床合理用药杂志,2022,15(14):40-43.DOI:10.15887/j.cnki.13-1389/r.2022.14.012. [7]C Cillóniz, Torres A , Niederman M S . Management of pneumonia in critically ill patients[J]. BMJ (Clinical research ed.), 375:e065871. 编辑：Yan

微生物疗法

2024-04-25

·BioSpace

FDA Approves UTILITY’s New Antibiotic for Uncomplicated UTI in Women

Pictured: FDA signage at its office in Washington, DC/iStock, JHVEPhoto The FDA on Wednesday approved the use of UTILITY therapeutics’ oral antibiotic pivmecillinam, which will now carry the brand name Pivya, for the treatment of adult women with uncomplicated urinary tract infections. In its approval announcement, the FDA noted that uncomplicated urinary tract infections (UTIs) are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract. The regulator added that approximately one-half of all women experience at least one UTI in their lifetime. Pivya is indicated for patients whose UTIs are caused by susceptible strains of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. UTILITY is working to make Pivya available in the U.S. in 2025, according to reporting from The New York Times. The antibiotic’s approval “will provide an additional treatment option for uncomplicated UTIs,” Peter Kim, director of the Division of Anti-Infectives at the FDA’s Center for Drugs Evaluation and Research, said in a statement. “Uncomplicated UTIs are a very common condition … and one of the most frequent reasons for antibiotic use.” The FDA’s approval on Wednesday was supported by data from three clinical trials, which compared Pivya to placebo, another oral antibacterial agent as well as to the anti-inflammatory drug ibuprofen. All three studies primarily evaluated Pivya’s composite response rate, which included clinical cure and microbiological response. In the placebo study, Pivya treatment elicited a 62% composite response rate at eight to 14 days after enrollment. Only 10% of placebo counterparts achieved the composite response endpoint. When compared with another antibacterial agent, Pivya elicited a 72% composite response rate versus 76% in those who received the other drug. In the third trial, 66% of patients treated with Pivya achieved composite response compared to only 22% of those who were given ibuprofen. In terms of safety, Pivya was overall well-tolerated and its most common side effects were nausea and diarrheas. The antibiotic carries warnings for hypersensitivity reactions, carnitine depletion, Clostridioides difficile-associated diarrhea and severe cutaneous adverse reactions. It should not be taken by patients with known histories of severe hypersensitivities against beta-lactam drugs. Pivya can also interfere with a newborn screening test for the rare metabolic disorder isovaleric acidemia. Pivya’s active ingredient pivmecillinam is an aminopenicillin, which is a specific subclass of beta-lactams that work by disrupting the synthesis of the bacterial cell wall. According to UTILITY’s website, pivmecillinam has already been commercially approved for more than 40 years outside the U.S. and has long been used to successfully treat UTIs. Pivmecillinam has also been recommended as the frontline treatment option in many countries. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

临床结果上市批准临床3期

2024-04-15

·信狐药迅

长春金赛抗IL-1β抗体金纳单抗首次报上市| 新受理（4.7-4.14）

本周药品注册受理数据，分门别类呈现，一目了然。(4.7-4.14）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号磷酸奥司他韦口腔崩解片北京星昊医药股份有限公司;北京星昊盈盛药业有限公司2.2CXHS2400027磷酸奥司他韦口腔崩解片北京星昊医药股份有限公司;北京星昊盈盛药业有限公司2.2CXHS2400026水合氯醛糖浆成都倍特得诺药业有限公司2.2CXHS2400025注射用金纳单抗长春金赛药业有限责任公司1CXSS2400040注射用金纳单抗长春金赛药业有限责任公司1CXSS2400039信迪利单抗注射液信达生物制药(苏州)有限公司2.2CXSS2400038新药临床申请药品名称企业注册分类受理号SGB-9768注射液苏州圣因生物医药有限公司1CXHL2400373PZH2113 胶囊漳州片仔癀药业股份有限公司1CXHL2400372PZH2113 胶囊漳州片仔癀药业股份有限公司1CXHL2400371JNJ-88998377口服片强生(中国)投资有限公司1CXHL2400370JNJ-88998377口服片强生(中国)投资有限公司1CXHL2400369JNJ-88998377口服片强生(中国)投资有限公司1CXHL2400368NS-136片纽欧申医药(上海)有限公司1CXHL2400366NS-136片纽欧申医药(上海)有限公司1CXHL2400365WD-890片浙江文达医药科技有限公司1CXHL2400361WD-890片浙江文达医药科技有限公司1CXHL2400360WD-890片浙江文达医药科技有限公司1CXHL2400359WD-890片浙江文达医药科技有限公司1CXHL2400358TQB3702片正大天晴药业集团股份有限公司1CXHL2400357GH21胶囊勤浩医药(苏州)有限公司1CXHL2400364GH21胶囊勤浩医药(苏州)有限公司1CXHL2400363D-1553片上海正大天晴医药科技开发有限公司1CXHL2400362YH001胶囊杭州禹泓医药科技有限公司1CXHL2400355YH001胶囊杭州禹泓医药科技有限公司1CXHL2400354注射用Y-3南京宁丹新药技术有限公司1CXHL2400350HMPL-500胶囊和记黄埔医药(上海)有限公司1CXHL2400349HMPL-500胶囊和记黄埔医药(上海)有限公司1CXHL2400348ZX-8177片南京征祥医药有限公司1CXHL2400347ZX-8177片南京征祥医药有限公司1CXHL2400346ACE-16229210片优领医药科技(上海)有限公司1CXHL2400345ACE-16229210片优领医药科技(上海)有限公司1CXHL2400344ACE-16229210片优领医药科技(上海)有限公司1CXHL2400343西奥罗尼胶囊深圳微芯生物科技股份有限公司1CXHL2400342西奥罗尼胶囊深圳微芯生物科技股份有限公司1CXHL2400341RS-C1001片青岛睿森生物科技有限公司1CXHL2400340RS-C1001片青岛睿森生物科技有限公司1CXHL2400339KY386注射用浓溶液深圳开悦生命科技有限公司1CXHL2400338LN2227山东新时代药业有限公司2.2CXHL2400367BY029口服溶液北京柏雅联合药物研究所有限公司2.2CXHL2400356MEI-002注射液迈诺威(无锡)医药科技有限公司2.3CXHL2400353MEI-002注射液迈诺威(无锡)医药科技有限公司2.3CXHL2400352硝羟喹啉片江苏亚虹医药科技股份有限公司2.4CXHL2400351重组呼吸道合胞病毒疫苗(CHO细胞)成都华任康生物科技有限公司1.3CXSL2400228T3011疱疹病毒注射液苏州亦诺微医药科技有限公司1CXSL2400230T3011疱疹病毒注射液苏州亦诺微医药科技有限公司1CXSL2400229STSP-0902注射液舒泰神(北京)生物制药股份有限公司1CXSL2400227STSP-0902滴眼液舒泰神(北京)生物制药股份有限公司1CXSL2400226STSP-0902滴眼液舒泰神(北京)生物制药股份有限公司1CXSL2400225STSP-0902滴眼液舒泰神(北京)生物制药股份有限公司1CXSL2400224注射用LM-2417礼新医药科技(上海)有限公司1CXSL2400223VAY736注射液Novartis Pharma AG1JXSL2400070AK129注射液康方汇科(上海)生物有限公司1CXSL2400220IMC-002宜明凯尔生物医药技术(上海)有限公司1CXSL2400219RD118注射液南京驯鹿生物技术股份有限公司1CXSL2400218CM355北京天诺健成医药科技有限公司1CXSL2400217IMC-002宜明凯尔生物医药技术(上海)有限公司1CXSL2400216U87注射液上海优卡迪生物医药科技有限公司1CXSL2400222注射用SKB518四川科伦博泰生物医药股份有限公司1CXSL2400215注射用MK-2870默沙东研发(中国)有限公司1CXSL2400214注射用人脐带间充质干细胞艾尔普再生医学科技(深圳)有限公司1CXSL2400212泰它西普注射液荣昌生物制药(烟台)股份有限公司2.1;2.2CXSL2400213仿制药申请药品名称企业注册分类受理号硝普钠注射液湖南恒生制药股份有限公司3CYHS2401109西咪替丁注射液石家庄迪斯凯威医药科技有限公司3CYHS2401106水合氯醛灌肠剂宏越科技(湖州)有限公司3CYHS2401094依巴斯汀口服溶液合肥国药诺和药业有限公司3CYHS2401093左氧氟沙星注射液陕西博森生物制药股份集团有限公司3CYHS2401087盐酸普萘洛尔注射液北京布霖生物科技有限公司3CYHS2401085氟哌啶醇注射液上海理想制药有限公司3CYHS2401083吡格列酮二甲双胍片北京北陆药业股份有限公司3CYHS2401078氯化钾颗粒成都通德药业有限公司3CYHS2401070琥珀酸亚铁片北京斯利安药业有限公司3CYHS2401069盐酸肾上腺素注射液嘉实(湖南)医药科技有限公司3CYHS2401066米诺地尔搽剂杭州端本医药科技有限公司3CYHS2401064米诺地尔搽剂杭州端本医药科技有限公司3CYHS2401063草酸艾司西酞普兰口服溶液安徽四环科宝制药有限公司3CYHS2401061聚乙二醇钠钾散雅安迅康药业有限公司3CYHS2401059间苯三酚口腔崩解片浙江赛默制药有限公司3CYHS2401057复方聚乙二醇(3350)电解质散成都倍特药业股份有限公司3CYHS2401055复方聚乙二醇(3350)电解质散成都倍特药业股份有限公司3CYHS2401054复合磷酸氢钾注射液浙江赛默制药有限公司3CYHS2401053注射用水溶性维生素内蒙古白医制药股份有限公司3CYHS2401073醋酸钙片河北华晨药业集团有限公司3CYHS2401040二羟丙茶碱注射液湖北欣泽霏药业有限公司3CYHS2401037硫酸沙丁胺醇注射液海南皇隆制药股份有限公司3CYHS2401033帕米膦酸二钠注射液广州艾奇西新药研究有限公司3CYHS2401043甲硫酸新斯的明注射液广州市联瑞制药有限公司3CYHS2401025注射用奥氮平齐鲁制药有限公司3CYHS2401024腺苷钴胺胶囊华北制药股份有限公司3CYHS2401022阿仑膦酸钠口服溶液山东朗诺制药有限公司3CYHS2401018复合磷酸氢钾注射液华夏生生药业(北京)有限公司3CYHS2401015盐酸肾上腺素注射液湖南海誓生物医药有限公司3CYHS2401032腺苷钴胺胶囊杭州沐源生物医药科技有限公司3CYHS2401029硫酸吗啡缓释片威海路坦制药有限公司4CYHS2401098利培酮口腔崩解片北京星昊医药股份有限公司4CYHS2401111利培酮口腔崩解片北京星昊医药股份有限公司4CYHS2401110硫酸特布他林雾化吸入用溶液吉林敖东药业集团延吉股份有限公司4CYHS2401108阿达帕林凝胶江苏知原药业股份有限公司4CYHS2401107注射用丁二磺酸腺苷蛋氨酸石家庄四药有限公司4CYHS2401105普拉洛芬滴眼液广州大光制药有限公司4CYHS2401104利格列汀片甘李药业山东有限公司4CYHS2401103硫酸镁钠钾口服用浓溶液山东如至生物医药科技有限公司4CYHS2401102头孢托仑匹酯颗粒海南葫芦娃药业集团股份有限公司4CYHS2401101头孢托仑匹酯颗粒海南葫芦娃药业集团股份有限公司4CYHS2401100培哚普利氨氯地平片(III)武汉熙瑞医药科技有限公司4CYHS2401099达格列净二甲双胍缓释片(III)北京伟林恒昌医药科技有限公司4CYHS2401097达格列净二甲双胍缓释片(I)北京伟林恒昌医药科技有限公司4CYHS2401096注射用阿糖胞苷合肥亿帆生物制药有限公司4CYHS2401092注射用阿糖胞苷合肥亿帆生物制药有限公司4CYHS2401091帕拉米韦氯化钠注射液山东齐都药业有限公司4CYHS2401090帕拉米韦氯化钠注射液山东齐都药业有限公司4CYHS2401089美沙拉秦肠溶片浙江贝得药业有限公司4CYHS2401088碘普罗胺注射液上海司太立制药有限公司4CYHS2401095厄贝沙坦氢氯噻嗪片江西施美药业股份有限公司4CYHS2401079西甲硅油乳剂河南中杰药业有限公司4CYHS2401084恩格列净片烟台鲁银药业有限公司4CYHS2401086利丙双卡因乳膏湖北人福成田药业有限公司4CYHS2401082注射用厄他培南广东万泰科创药业有限公司4CYHS2401081利丙双卡因乳膏深圳市泰力生物医药有限公司4CYHS2401080硫酸镁钠钾口服用浓溶液珠海横琴国研医药科技有限公司4CYHS2401077布洛芬混悬液湖南状元制药有限公司4CYHS2401072布洛芬混悬液湖南状元制药有限公司4CYHS2401071罗替高汀贴片北京泰德制药股份有限公司4CYHS2401068左氧氟沙星片浙江昂利康制药股份有限公司4CYHS2401067伊布替尼胶囊昆山龙灯瑞迪制药有限公司4CYHS2401065注射用硫酸艾沙康唑四川宏明博思药业有限公司4CYHS2401062聚乙二醇钠钾散雅安迅康药业有限公司4CYHS2401060注射用硫酸艾沙康唑海南通用三洋药业有限公司4CYHS2401052甲苯磺酸艾多沙班片浙江诺得药业有限公司4CYHS2401051甲苯磺酸艾多沙班片浙江诺得药业有限公司4CYHS2401050艾考糊精腹膜透析液成都诺和晟鸿生物制药有限公司4CYHS2401049米拉贝隆缓释片南京易亨制药有限公司4CYHS2401048盐酸乌拉地尔注射液山东达冠医药科技有限公司4CYHS2401076盐酸乌拉地尔注射液山东达冠医药科技有限公司4CYHS2401075精氨酸布洛芬颗粒石家庄四药有限公司4CYHS2401074多替拉韦钠片上海迪赛诺医药集团股份有限公司4CYHS2401058硫酸镁钠钾口服用浓溶液浙江凯润药业股份有限公司4CYHS2401056盐酸决奈达隆片齐鲁制药有限公司4CYHS2401042左氧氟沙星片湖南状元制药有限公司4CYHS2401041复方电解质注射液(II)辰欣药业股份有限公司4CYHS2401039复方电解质注射液(II)辰欣药业股份有限公司4CYHS2401038普拉替尼胶囊基石药业(苏州)有限公司4CYHS2401036氨甲环酸注射液海南爱科制药有限公司4CYHS2401035氨甲环酸注射液海南爱科制药有限公司4CYHS2401034硫酸氨基葡萄糖胶囊天津天士力圣特制药有限公司4CYHS2401047米拉贝隆缓释片山东朗诺制药有限公司4CYHS2401046盐酸尼卡地平注射液海南爱科制药有限公司4CYHS2401045富马酸伏诺拉生片裕松源药业有限公司4CYHS2401044比拉斯汀片江苏悦兴药业有限公司4CYHS2401027依非米替片(I)安徽贝克生物制药有限公司4CYHS2401026乳酸钠林格注射液华夏生生药业(北京)有限公司4CYHS2401021哌柏西利胶囊北京双鹭药业股份有限公司4CYHS2401020哌柏西利胶囊北京双鹭药业股份有限公司4CYHS2401019氧河南众益气体有限公司4CYHS2401016卡贝缩宫素注射液长春圣金诺生物制药有限公司4CYHS2401031注射用伏立康唑北京吉洛华制药有限公司4CYHS2401030注射用丁二磺酸腺苷蛋氨酸福建省宝诺医药研发有限公司4CYHS2401028富马酸福莫特罗吸入溶液成都海德康药业有限公司4CYHS2401023普拉洛芬滴眼液山东辰欣佛都药业股份有限公司4CYHS2401017Sabin株脊髓灰质炎灭活疫苗(Vero细胞)北京民海生物科技有限公司3.3CXSS2400041氟轻松氢醌维A酸乳膏杭州中美华东制药有限公司3CYHL2400075甘露醇山梨醇注射液南京恩泰医药科技有限公司3CYHL2400074利多卡因丁卡因乳膏江苏盈科生物制药有限公司3CYHL2400070氟比洛芬凝胶贴膏北京阳光诺和药物研究股份有限公司4CYHL2400076洛索洛芬钠凝胶贴膏海南赛立克药业有限公司4CYHL2400073氟比洛芬凝胶贴膏海南赛立克药业有限公司4CYHL2400072氮䓬斯汀氟替卡松鼻喷雾剂山东京卫制药有限公司4CYHL2400071QL2108注射液齐鲁制药有限公司3.3CXSL2400221进口申请药品名称企业注册分类受理号注射用双羟萘酸帕瑞肽微球Recordati Rare Diseases5.1JXHS2400032注射用双羟萘酸帕瑞肽微球Recordati Rare Diseases5.1JXHS2400031注射用双羟萘酸帕瑞肽微球Recordati Rare Diseases5.1JXHS2400030注射用牛肺表面活性剂Lyomark Pharma GmbH5.1JXHS2400029注射用牛肺表面活性剂Lyomark Pharma GmbH5.1JXHS2400028注射用罗特西普Celgene Corporation3.1JXSS2400036注射用罗特西普Celgene Corporation3.1JXSS2400035泊沙康唑口服混悬液Deva Holding A.S5.2JYHS2400015BI 1819479 片Boehringer Ingelheim International GmbH1JXHL2400089BI 1819479 片Boehringer Ingelheim International GmbH1JXHL2400088Capivasertib片AstraZeneca AB2.4JXHL2400087Capivasertib片AstraZeneca AB2.4JXHL2400086Amycretin片Novo Nordisk A/S1JXSL2400073Amycretin片Novo Nordisk A/S1JXSL2400072Amycretin片Novo Nordisk A/S1JXSL2400071BSI-992注射液Biosion USA, Inc.1JXSL2400069BAY 3018250Bayer AG1JXSL2400068帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2400074Ravulizumab注射液Alexion Pharmaceuticals Inc.3.1JXSL2400075中药相关申请药品名称企业注册分类受理号益气消瘤颗粒广东方盛融大药业有限公司1.1CXZL2400019不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

100 项与厄他培南钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04049	厄他培南钠	J01DH03	DB00303

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
菌血症	中国	Merck Sharp & Dohme BV	2005-09-12
细菌感染	中国	Merck Sharp & Dohme BV	2005-09-12
复杂的皮肤和软组织感染	中国	Merck Sharp & Dohme BV	2005-09-12
肾盂肾炎	中国	Merck Sharp & Dohme BV	2005-09-12
泌尿道感染	中国	Merck Sharp & Dohme BV	2005-09-12
糖尿病足感染	欧盟	Merck Sharp & Dohme BV	2002-04-18
糖尿病足感染	冰岛	Merck Sharp & Dohme BV	2002-04-18
糖尿病足感染	列支敦士登	Merck Sharp & Dohme BV	2002-04-18
糖尿病足感染	挪威	Merck Sharp & Dohme BV	2002-04-18
妇科感染	欧盟	Merck Sharp & Dohme BV	2002-04-18
妇科感染	冰岛	Merck Sharp & Dohme BV	2002-04-18
妇科感染	列支敦士登	Merck Sharp & Dohme BV	2002-04-18
妇科感染	挪威	Merck Sharp & Dohme BV	2002-04-18
腹腔感染	欧盟	Merck Sharp & Dohme BV	2002-04-18
腹腔感染	冰岛	Merck Sharp & Dohme BV	2002-04-18
腹腔感染	列支敦士登	Merck Sharp & Dohme BV	2002-04-18
腹腔感染	挪威	Merck Sharp & Dohme BV	2002-04-18
手术伤口感染	欧盟	Merck Sharp & Dohme BV	2002-04-18
手术伤口感染	冰岛	Merck Sharp & Dohme BV	2002-04-18
手术伤口感染	列支敦士登	Merck Sharp & Dohme BV	2002-04-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肺炎	临床3期	-	Merck Sharp & Dohme Corp.	2005-07-01
脓毒症	临床3期	-	Merck Sharp & Dohme Corp.	2004-09-01
医院获得性肺炎	临床2期	-	Merck Sharp & Dohme Corp.	2002-03-01
细菌性肺炎	临床2期	-	Merck Sharp & Dohme Corp.	2002-01-01
传染性皮肤病	临床2期	-	Merck Sharp & Dohme Corp.	2002-01-01
软组织感染	临床2期	-	Merck Sharp & Dohme Corp.	2002-01-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03925402 (Pubmed)	N/A	菌血症	1,032	Ertapenem	淵衊鬱積蓋選鏇網築窪(憲遞鹹膚淵鑰構夢願夢) = 餘鏇蓋衊鑰夢糧衊選獵構壓網壓顧網顧窪壓繭 (窪網築遞鹹窪廠顧選願 )	-	2023-05-30
				Class 2 carbapenems	淵衊鬱積蓋選鏇網築窪(憲遞鹹膚淵鑰構夢願夢) = 構遞糧範廠夢糧醖鏇鏇構壓網壓顧網顧窪壓繭 (窪網築遞鹹窪廠顧選願 )
NCT02505386 (PHACINERTA, Pubmed \| J Antimicrob Chemother)	临床4期	-	26	ertapenem (Intravenous (IV) administration)	襯遞獵築繭鬱窪願範繭(窪範顧願鬱鹹窪糧艱艱) = 鹹構壓構網範願齋鏇憲窪艱夢繭繭願選遞鹽膚 (淵淵顧選製齋醖齋構壓 ) 更多	-	2019-12-01
				ertapenem (Subcutaneous (SC) administration)	襯遞獵築繭鬱窪願範繭(窪範顧願鬱鹹窪糧艱艱) = 蓋鹹衊醖築製製願艱鹽窪艱夢繭繭願選遞鹽膚 (淵淵顧選製齋醖齋構壓 ) 更多
NCT02159859 (CTgov)	临床2期	终末期肾脏病	7	Ertapenem	鏇鹹觸構選簾築網廠夢(觸襯鹹艱網網構製廠繭) = 夢顧觸鬱積鹹鹽憲鏇觸遞餘積構構願廠鑰選鹹 (觸壓蓋簾齋獵壓壓觸積, 壓築醖築築壓襯鹹積鏇 ~ 選遞繭構艱觸衊餘願廠) 更多	-	2017-06-15
NCT01297842 (Pubmed \| BMC Infect Dis)	临床4期	肠杆菌科感染	-	De-escalation group (ertapenem)	艱繭鹽顧壓夢衊醖淵獵(構鑰糧膚膚醖蓋顧艱壓) = 鏇壓顧遞膚選淵鏇鹹鏇範觸鬱壓範廠網範廠醖 (獵願顧鹹觸鹹艱繭廠夢 ) 更多	积极	2017-03-01
				Control group (group 2 carbapenem)	艱繭鹽顧壓夢衊醖淵獵(構鑰糧膚膚醖蓋顧艱壓) = 簾顧構壓廠繭憲壓餘鏇範觸鬱壓範廠網範廠醖 (獵願顧鹹觸鹹艱繭廠夢 ) 更多
NCT00535652 (CTgov)	临床4期	结肠憩室病 \| 直肠癌 \| 结肠癌	23	Ertapenem	窪積鑰糧壓遞選夢顧窪(網襯齋鑰齋網艱積網鏇) = 繭製餘襯鹹窪鏇憲膚艱艱淵鏇繭憲齋鑰築憲蓋 (膚餘襯鹹糧衊糧淵繭糧, 積獵壓淵鏇壓遞繭蓋觸 ~ 壓淵餘蓋醖選鑰蓋獵築) 更多	-	2016-12-16
NCT01370616 (Pubmed \| J Antimicrob Chemother) 人工标引	临床3期	糖尿病足感染	565	Ertapenem	鹹鏇壓製餘願餘襯壓顧(餘觸願淵糧構艱鏇廠廠) = 蓋襯淵壓獵積膚衊網鏇憲製鹹鬱壓壓艱構膚鹽 (積鹹築衊膚製簾襯窪蓋 ) 更多	非劣	2016-06-01
				piperacillin/tazobactam	鹹鏇壓製餘願餘襯壓顧(餘觸願淵糧構艱鏇廠廠) = 構壓簾網醖遞觸範獵廠憲製鹹鬱壓壓艱構膚鹽 (積鹹築衊膚製簾襯窪蓋 ) 更多
NCT01370616 (CTgov)	临床3期	糖尿病足感染	565	Piperacillin/tazobactam-matching placebo+Amoxicillin/clavulunate potassium+Ertapenem sodium (Ertapenem Sodium)	窪憲遞鑰衊繭齋餘窪製(網衊廠餘衊觸艱襯簾鹹) = 鬱壓選選構選鑰築醖憲顧鹹衊糧齋蓋構糧鑰夢 (膚壓選積膚衊憲廠鹽壓, 觸壓衊襯餘夢製夢積膚 ~ 鹽醖淵餘艱鏇齋衊鹹願) 更多	-	2014-12-02
				Amoxicillin/clavulunate potassium+Piperacillin/tazobactam sodium (Piperacillin/Tazobactam Sodium)	窪憲遞鑰衊繭齋餘窪製(網衊廠餘衊觸艱襯簾鹹) = 窪糧繭簾廠繭艱憲襯膚顧鹹衊糧齋蓋構糧鑰夢 (膚壓選積膚衊憲廠鹽壓, 醖獵鑰網醖膚鏇遞襯齋 ~ 廠鏇顧壓餘壓願願繭鏇) 更多
NCT00630513 (T.E.A. Study, Pubmed \| BMC Gastroenterol)	临床4期	腹腔感染	142	Ertapenem	網鏇夢壓艱選鏇顧構獵(膚壓廠鏇積顧衊憲製觸) = 網鏇遞鏇齋窪窪鬱醖醖鏇鬱廠窪蓋衊網齋網遞 (築鑰廠鏇範衊鑰選鏇築 )	积极	2013-04-30
NCT01254344 (CTgov)	临床3期	手术伤口感染	599	Ertapenem (Ertapenem)	繭壓鹹艱鑰鹹獵遞範衊(鏇鑰構膚齋範鏇顧範積) = 餘製鑰繭獵積繭淵襯廠簾獵廠獵壓鑰獵選餘網 (齋願窪獵願膚鑰鑰憲鹹, 願淵選醖願觸蓋淵糧構 ~ 鹹鹽夢艱鑰艱觸範窪遞) 更多	-	2012-11-16
				Metronidazole+Ceftriaxone (Ceftriaxone/Metronidazole)	繭壓鹹艱鑰鹹獵遞範衊(鏇鑰構膚齋範鏇顧範積) = 餘鬱鑰鹽夢鹽簾鹽蓋選簾獵廠獵壓鑰獵選餘網 (齋願窪獵願膚鑰鑰憲鹹, 窪醖願醖築範選壓膚鹹 ~ 齋糧鏇鑰鏇醖願膚窪積) 更多
NCT00877370 (CTgov)	临床4期	急性肾损伤	8	ertapenem	觸憲網遞構積願衊壓齋(蓋獵觸窪襯蓋範憲網醖) = 壓網積窪製繭襯齋繭淵製顧築齋餘廠顧衊憲憲 (繭艱醖淵憲壓製範窪窪, 艱淵繭製製積襯襯願壓 ~ 製鏇艱壓獵淵獵夢鑰夢) 更多	-	2012-09-28