盐酸万古霉素(Vancomycin Hydrochloride) - 药物靶点：Peptidoglycan_在研适应症：艰难梭菌腹泻，睑缘炎，结膜炎_专利_临床

概要

基本信息

药物类型

化学药

别名

Vancomycin hydrochloride (JP17/USP)、VCM、バルデナフィル塩酸塩水和物

+ [25]

靶点

Peptidoglycan

作用方式

抑制剂

作用机制

肽聚糖抑制剂、细胞壁抑制剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

OHKURA Pharmaceutical Co., Ltd.

浙江创新生物有限公司

ANI Pharmaceuticals, Inc.

+ [6]

非在研机构

Savara, Inc.

权益机构

Eli Lilly & Co.Iroko Pharmaceuticals, Inc.Merus Labs International, Inc.

+ [7]

最高研发阶段批准上市

首次获批日期

(1954-01-01),

革兰氏阳性细菌感染

最高研发阶段(中国)-

特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (日本)

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结构/序列

分子式C66H76Cl3N9O24

InChIKeyLCTORFDMHNKUSG-XTTLPDOESA-N

CAS号1404-93-9

Sequence Code 525276648

关联

425

项与盐酸万古霉素相关的临床试验

NCT04993027

/ Not yet recruiting临床2期IIT

Topical Vancomycin for Infection Prophylaxis in Total Hip and Knee Arthroplasty

11% of the general population undergo total hip arthroplasty (THA) in their lifetime and 7% undergo total knee arthroplasty (TKA), with these rates expected to rise up to 50% by 2026. Periprosthetic joint infection (PJI) remains one of the most common complications, accounting for 30% of THA/TKA revision surgeries. Topical delivery of antibiotic powder may reduce the incidence of PJI but its potential drawbacks include wound healing complications, reduced osteoblast activity, third body wear, and antibiotic resistance. In THA and TKA, topical administration of vancomycin powder for the primary prevention of PJI has been studied in observational studies, but conclusions are limited due to the low incidence of PJI and high number of patients required to detect a significant difference. Investigators therefore propose a randomized controlled trial (RCT) investigating the impact of topical vancomycin compared to standard care on PJI rates following THA and TKA.
Aim: To determine whether topical vancomycin is a safe and effective intervention for the primary prevention of PJI after THA and TKA.
Study Design: This is a pilot multi-centre RCT to evaluate the study design and assess feasibility prior to implementation across Canada. Investigators aim to recruit 50 THA and 50 TKA patients.
Inclusion Criteria THA or TKA Patients aged 18 years or older Patients must complete 1 year follow-up Exclusion Criteria Patients undergoing surgery for inflammatory arthritis, post-traumatic arthritis, or avascular necrosis History or septic arthritis based on history or synovial aspirate Prior major operation on the affected joint Current immunosuppressive medications Vancomycin allergy or history of a vancomycin-related complication Recruitment: surgeons introduce study to the patients, research staff will conduct recruitment.
Intervention: Patients will be randomized preoperatively and remain blinded to their treatment arm. Patients allocated to the control group will have all standard care infection prophylaxis interventions. Patients allocated to the vancomycin group will undergo all the standard care measures in addition to 1g of powdered vancomycin applied to the wound.
Follow-up: Patients will complete follow-up at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year visits.
Primary outcome: PJI in the same joint. Secondary outcome: PJI in THA and TKA subgroups:
Reoperation on the same joint Superficial and non-infectious wound complications All complications

开始日期2025-12-30

申办/合作机构

University of Calgary

NCT06979609

/ Not yet recruiting临床2/3期IIT

Secondary Prophylaxis of Recurrent Clostridioides Difficile Infections During Systemic Antibiotics With Vancomycin: A Randomized Controlled Trial

Re-exposure to systemic antibiotics (i.e., antibiotics absorbed into the bloodstream) is common after a Clostridioides difficile infection (CDI) and is the strongest risk factor for a recurrent episode. Oral vancomycin to prevent a recurrence during antibiotic re-exposure may reduce this risk but the data supporting this practice are limited. The aim of this trial is:
1) Does oral vancomycin prophylaxis prevent CDI recurrences in patients with recent CDI (within 120 days) and who are re-exposed to systemic antibiotics?
The trial will compare oral vancomycin to placebo.
Participants will:
* Take the study drug (either vancomycin or placebo) twice daily for the duration of systemic antibiotics plus once daily for 7 days after completion of systemic antibiotics.
* Attend an in-person follow-up at day 56
* Respond to weekly electronic questionnaires

开始日期2025-12-01

申办/合作机构-

NCT06954129

/ Not yet recruiting临床4期IIT

Markers of Nephrotoxicity During Treatment With Antibiotic Combinations: A Pragmatic Clinical Trial

Hospitalized patients with suspected or confirmed infection are commonly treated with vancomycin (VN) in combination with either piperacillin-tazobactam (PT) or cefepime (CP). Although these regimens have similar effectiveness, recent observational evidence suggests they may differ in terms of the risk for acute kidney injury (AKI). Interpretation of existing evidence is complicated by the limitations of creatinine, the standard biomarker used to monitor kidney function, which has poor sensitivity and specificity for drug induced AKI. To address this important knowledge gap, the investigators propose to conduct a pragmatic, open-label, non-inferiority trial that will examine the comparative risk of AKI between these standard-of-care antibiotic combinations using sensitive and specific markers of drug-induced AKI. We hypothesize that the regimen of VN in combination with PT (VN+PT) is noninferior to the regimen of VN in combination with CP (VN+CP) in terms of AKI risk.

开始日期2025-10-01

申办/合作机构

University of Pennsylvania

100 项与盐酸万古霉素相关的临床结果

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100 项与盐酸万古霉素相关的转化医学

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100 项与盐酸万古霉素相关的专利（医药）

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57,639

项与盐酸万古霉素相关的文献（医药）

2025-12-31·Journal of Pharmaceutical Policy and Practice

Pharmacist-led antibiotic interventions in infectious disease patients: a Pakistani tertiary care antimicrobial stewardship study

Article

作者: Ur Rehman, Naeem ; Maqbool, Sumeira ; Arif, Mehreen ; Hassan, Ali

Background:

Antibiotics are widely used medications among infectious disease patients; therefore, proper monitoring and assessment are critical for ensuring rational use. Antimicrobial stewardship addresses the rational and appropriate use of antibiotics, which reinforces overall health outcomes. Ongoing antimicrobial resistance scenarios are an alarming condition for healthcare, necessitating continued practice of such assessments.

Objectives:

To evaluate the use of antibiotics in patients with infectious diseases, implement and evaluate clinical pharmacy interventions that adhere to antimicrobial stewardship protocols.

Methods:

A before and after study was designed to evaluate clinical pharmacy and antimicrobial stewardship interventions for infectious disease patients at a tertiary care hospital in Lahore. A Performa was designed for manual data collection. Study first identified the signal of error, implemented intervention and noted post-interventional followups.

Results:

102 infectious disease cases were analyzed in total and proposed 136 interventions. Physicians accepted 66% of the interventions (90) and rejected the remaining ones as unjustified. The most accepted intervention was the spectrum-based choice (n = 30), followed by de-escalation of dose (n = 17). Use of ceftriaxone was very high (54 Pt.), followed by vancomycin (30 Pt.).

Conclusion:

Antimicrobial stewardship programmes are critical for any institution's proper health care system. It ensures proper antibiotic outflow to patients, thereby improving their health status. The role of pharmacists in establishing an AMS in a hospital setting is a highly commendable activity that enhances healthcare collaboration and outcomes. Clinical pharmacists should implement such activities to improve patient care.

2025-12-31·ANNALS OF MEDICINE

Vancomycin wound penetration in open-heart surgery patients receiving negative pressure wound therapy for deep sternal wound infection

Article

作者: Kolek, Martin ; Kaňková, Klára ; Brozmanová, Hana ; Ďuricová, Jana ; Motyka, Oldřich ; Šištík, Pavel ; Kacířová, Ivana ; Juřica, Jan

INTRODUCTION:

It is hypothesized that systemically administered antibiotics penetrate wound sites more effectively during negative pressure wound therapy (NPWT). However, there is a lack of clinical data from patients who receive NPWT for deep sternal wound infection (DSWI) after open-heart surgery. Here, we evaluated vancomycin penetration into exudate in this patient group.

PATIENTS AND METHODS:

For this prospective observational study, we enrolled 10 consecutive patients treated with NPWT for post-sternotomy DSWI. On the first sampling day, serum and exudate samples were synchronously collected at 0 (pre-dose), 0.5, 1, 2, 3 and 6 h after vancomycin administration. On the following three consecutive days, additional samples were collected, only before vancomycin administration.

RESULTS:

The ratio of average vancomycin concentration in wound exudate to in serum was higher for free (unbound) (1.51 ± 0.53) than for total (bound + unbound) (0.91 ± 0.29) concentration (p = 0.049). The percentage of free vancomycin was higher in wound exudate than serum (0.79 ± 0.19 vs. 0.46 ± 0.16; p = 0.04). Good vancomycin wound penetration was maintained on the following three days (vancomycin trough exudate-to-serum concentration ratio > 1). The total hospital stay was significantly longer in patients with DSWI (46 ± 11.6 days) versus without DSWI (14 ± 11.7 days) (p < 0.001). There was no in-hospital or 90-day mortality. Two patients experienced late DSWI recurrence. All-cause mortality was 4.8% during a median follow-up of 2.5 years.

CONCLUSION:

Vancomycin effectively penetrates wound exudate in patients receiving NPWT for DSWI after open-heart surgery.The protocol for this study was registered at ClinicalTrials.gov on July 16, 2024 (NCT06506032).

2025-12-31·Hematology

Vancomycin therapeutic drug monitoring: focus on patients with hematological malignancies

Article

作者: Yang, Shu ; Luo, Yifan ; Chu, Yang ; Liu, Sihan

OBJECTIVE:

This study aimed to identify key factors influencing vancomycin serum concentrations in adult patients with hematological malignancies by analyzing various physiological and biochemical indicators, to assess the impact on vancomycin levels and provide a basis for judicious clinical application.

METHODS:

A retrospective analysis was conducted from January 2013 to April 2022. Statistical analyses were performed using SPSS 25.0, including correlation analysis, collinearity diagnostics, multiple linear regression, and receiver operating characteristic curves construction.

RESULTS:

The study included 115, with 72.2% exhibited sub-therapeutic vancomycin trough concentrations (<10 mg/L). A significant positive correlation was observed between vancomycin trough concentrations and variables of age, blood cells, platelets, alkaline phosphatase, blood urea nitrogen, and serum creatinine. In contrast, a significant negative correlation was noted with weight, C-reactive protein, creatinine clearance, and estimated glomerular filtration rate. Among patients with hematological malignancies, cystatin C, creatinine clearance, gender, and neutrophil counts were identified as the main determinants of vancomycin trough concentrations. The combined assessment of these factors achieved high predictive accuracy, with 92.9% sensitivity and 82.5% specificity.

CONCLUSION:

Cystatin C, creatinine clearance, gender, and neutrophil counts emerged as the principal determinants affecting vancomycin trough concentrations in patients with hematological malignancies. Pharmacists can optimize vancomycin therapy by tailoring pharmaceutical care based on individual patient characters and therapeutic drug monitoring.

517

项与盐酸万古霉素相关的新闻（医药）

2025-06-23

·药闻康策

第十一批国采,14个品种或将待定！

☝ 点击上方一键预约 ☝ 最新最热的医药健康新闻政策近日，一份《关于征求<第十一批国家组织药品集中采购拟采购药品清单>意见的函》在业内流传，《清单》包含了第十一批国采拟采购的75个药品，最低竞争格局仍为7家。（来源:一度医药）75个品种中包含国采首个贴剂品种洛索洛芬贴剂，并纳入地氯雷他定一个口服液体剂，未纳入任何一个滴眼剂品种。75个品种中还有14个有额外备注，需要专家重点研判，决定是否纳入第十一批国采，主要包括以下两种情况：一、仿制药适应症少于原研药的5个品种：1. 达格列净片。原研药和过评仿制药说明书均有糖尿病适应症，但原研还有心衰和慢性肾脏病适应症。2. 艾曲泊帕乙醇胺片。原研药和过评仿制药说明书均有慢性免疫性(特发性)血小板减少症(ITP)适应症，但原研还有重型再生障碍性贫血(SAA)适应症。3. 阿伐曲泊帕口服常释剂型。原研药和过评仿制药说明书均有慢性肝病相关血小板减少症(CLDT)适应症，但原研药和部分仿制药还有慢性原发免疫性血小板减少症(ITP)适应症。4. 奥拉帕利片。原研药和过评仿制药说明书均有上皮性卵巢癌输卵管或原发性腹膜癌适应症，但原研药还有前列腺癌、乳腺癌适应症。5. 乙磺酸尼达尼布软胶囊过评仿制药和原研药均有系统性硬化病相关间质性肺疾病、进行性表型慢性纤维化性间质性肺疾病适应症，原研药还有特发性肺纤维化适应症.二、临床使用风险相对较高的9个品种：1. 万古霉素注射剂和头孢他啶阿维巴坦注射剂。均为特殊使用级抗菌药物，按照以往做法，我们拟降低此类抗菌药物带量比例。2. 麦考酚钠口服常释剂型。为器官移植抗排异用药，属于窄治疗指数药物，我们拟对该药品降低带量比例与医疗机构原常用厂牌不同的中选产品仅用于新患者。3. 甲氨蝶呤注射剂和阿糖胞苷注射剂。为抗代谢类化疗药物，专家提出两药品有时须采取鞘内注射，存在一定临床风险。4. 碘普罗胺注射剂。为增强CT检查的造影剂，有专家提出该药品为高警示药物，可能导致过敏性休克。5. 拉莫三嗪口服常释剂型。用于治疗癫痫，部分国家将其列为窄治疗指数药物。6. 曲普瑞林注射剂(0.1mg)和西曲瑞克注射剂。为辅助生殖药品，专家反映辅助生殖方案的容错率低，且目前我国辅助生殖成功率较低(不足40%)，如纳入集采可能面临使用和舆情的风险。根据上文提到的几种情况和相关药品，可在此前的基础上进一步总结几种可能影响药品纳入国采的条件：1. 仿制药适应症少于原研药。2. 特殊使用级抗菌药：可能不影响纳入，但必定削减采购量比例，可参考各地发布的抗菌药目录。3. 窄治疗指数药物：目前国内暂无官方发布的窄治疗指数药物目录，仅有早期流传的一份《属于治疗窗窄的部分药物目录》，涉及30个品种的口服制剂。此外，在其他国家被列入窄治疗窗药物也可能作为一个评判依据，以下是美、日、加三国发布的国家级窄治疗指数药品目录清单。来源：2008年1月《已上市化学药品变更研究的技术指导原则（一）》仅供参考曾发布的国家级窄治疗指数药品目录清单（来源陈志东《窄治疗指数药物安全性的再认识》《上海医药》2020年第41卷第19期仅供参考）4. 须采取鞘内注射等操作的药品，存在一定临床风险。5. 高警示药物：中国医药教育协会于2023年9月28日发布的《医疗机构高警示药品风险管理规范》中包含一份《医疗机构高警示药品分级管理推荐目录》，将高警示药品分为A、B、C三个登记，涉及多种药物。需要注意的是，艾司洛尔注射剂等A级高警示药品已纳入国采，因此暂时无法将此作为影响国采品种遴选的决定性因素。医疗机构高警示药品分级管理推荐目录（来源：中国医药教育协会《医疗机构高警示药品风险管理规范》仅供参考）6. 辅助生殖药品。总体来看，在保持7家过评门槛的情况下，第十一批国采纳入品种数可能将创下历史新高，并首次纳入贴剂剂型。同时，随着2025年1月《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》明确“将仿制药质量和疗效一致性评价逐步向滴眼剂、贴剂、喷雾剂等剂型拓展”，本次未纳入的众多滴眼剂品种也可能在将来集中纳入国采。(来源:易联招采网)有需要完整版《第十一批国采拟采购品种清单征求意见函》，请扫描下方二维码添加客服微信咨询，申请加入药闻康策高端会员群获取。药闻康策新媒体矩阵微信公众号点击下方一键关注欢迎转发分享、点赞、点在看

带量采购

2025-06-23

·药通社

废标重选？第十一批拟国采品种分析

这两天，最大的事情莫过于业内流传的第十一批国采拟采购药品清单（涉及75个品种）。据该文件内所写，目前拟采购的75个品种之中，有14个品种还须进行研判。这14个品种分两类：第一类是仿制药适应症少于原研药的，共5个品种，分别是达格列净片、艾曲泊帕乙醇胺片、阿伐曲泊帕口服常释剂型、奥拉帕利片和乙磺酸尼达尼布软胶囊。第二类是专家认为临床使用风险相对较高的，共9个品种，分别是万古霉素注射剂、头孢他啶阿维巴坦注射剂、麦考酚钠口服常释剂型、甲氨蝶呤注射剂、阿糖胞苷注射剂、碘普罗胺注射剂、拉莫三嗪口服常释剂型、曲普瑞林注射剂(0.1mg)、西曲瑞克注射剂。这14个品种仍存在不确定性，须等待进一步研判结果。再分析其他拟采购的品种，首先有一个废标重选品种：盐酸溴己新注射液。该品种第七批集采已集采，经串标被查后废标，现又重新被纳入十一批国采。截至3月31日（网传十一批国采遴选关门时间），盐酸溴己新注射液共15家企业过评，除6家禁标企业外，还有9家企业过评，可参与此次竞标。值得注意的是，按处罚时间来看，仁合益康、广州一品红、石家庄四药三家公司已过处罚期（截至2025年2月），理论上也可参与此次竞标。而剩下三家成都欣捷、上海旭东海普、江西亿友禁标时间仍未到，不可参与此次竞标。另外，目前目录内存在专利未到期品种，包括沙库巴曲缬沙坦口服常释剂型（专利期至2026年11月）、伏诺拉生口服常释剂型（专利期至2026年8月）、吲哚布芬口服常释剂型（专利期至2040年）。尤其是吲哚布芬口服常释剂型，中美华东强势的专利要求已经使得多家企业暂停挂网，浙江美迪深、浙江同伍、湖南九典三家均已撤网。这三个有专利限制的品种，最终或被剔除。此前药通社进行过统计，截至6月下旬，已有149个品种满足十一批国采要求（≥7家）的要求。详见：十一批国采首个！超40家！将该目录与此次拟纳入的75个品种进行对比，除去截止3月末不满足≥7家的31个品种，还剩下45个品种符合过评竞争企业数要求，但未被纳入。这45个品种未被纳入的原因是什么？首先是由于“新老文号交叉”。简单解释一下。2023年8月23日，国家组织药品联合采购办公室曾发布一份说明文件，对于口服固体制剂和注射剂以外的剂型（口服溶液、吸入剂、滴眼液等）既有老批件又有新批件的产品暂不列入本次集采。此份说明原本只限于第八批国采，但实际上第九批和第十批集采大部分品种也在遵循此原则。这一次很多品种也存在这种情况（详见下表），大概率也是因为这个原因而未被纳入。这里面包括很多大品种——如18亿市场的乳果糖口服液体剂（33+1）、30亿市场的乙酰半胱氨酸吸入剂（28+1）等。但也并非所有新老批件交叉的品种都不纳入，比如这次纳入的地氯雷他定口服制剂被纳入，该品种就存在老文号未过评情况。第二个主要原因就是临床需求太小。比如ω-3脂肪酸乙酯90口服常释剂型、利托那韦口服常释剂型等目前市场还不到百万。除此之外，还涉及到剂型的问题。截止目前还没有乳膏和洗剂之类纳入国采，此次也有很多乳膏满足要求，但均未被纳入。还有一些就是条件全都符合但就是未被纳入的品种，比如他氟前列素滴眼剂市场上亿，过评8家，全是新批件。像这种的品种，其实每一批都有，只是还未轮到。8 月 1-2 日，“仿制药和改良新药立项‘稳准狠’大会”，苏州开幕！风云药谈创始人张廷杰现场解析《新集采（11 批）、大接续、价格治理下的产品布局》，线下直击政策红利期的立项策略，速抢席位共探行业破局点。CMC制药工业博览会附表一：3月31号满足竞争≥7家，但未被纳入的45个品种附表二：第十一批国采拟采购的75个品种↓ 关注药通社，洞见行业趋势 ↓投稿/企业合作/内容沟通：华籍美人（Ww_150525）

专利到期带量采购

2025-06-22

·赛柏蓝

第11批国采，启动倒计时

作者 | 陈芋责编 | 遥望75个品种形成初步清单；新批次集采投标资质、中选规则、落地实施等多方面政策面临优化。 01第十一批国采倒计时正式文件或7月发布近日，一份《关于征求〈第十一批国家组织药品集中采购拟采购药品清单〉意见的函》在业内流传，文件指出，经国家联采办初步遴选并征求临床、药学专家意见，形成《第十一批国家组织药品集中采购拟采购药品清单》，共75个品种（名单见文末）。清单涵盖的75个品种涉及抗感染、心脑血管、代谢疾病、抗肿瘤、呼吸系统等13个治疗大类。分剂型看，注射剂最多，达33个；口服常释剂型32个。此次名单中还包括洛索洛芬贴剂，若其被保留至正式文件，也意味着国采将首次纳入化药贴膏剂。据当前名单，第十一批国采预计还将以7家作为纳入门槛。其中，头孢唑肟注射剂、二羟丙茶碱注射剂、法莫替丁注射剂是目前竞争最激烈的3个品种，过评企业数均超过30家。分企业看，科伦药业、倍特药业、齐鲁制药均覆盖20个品种及以上，是覆盖目前名单中品种最多的企业，预计正式名单出炉后其仍将是第十一批国采“主力军”。需要注意的是，这并非下发给医疗机构的报量目录或最终确定纳入第十一批国采的品种名单。名单内有14个拟采购品种还需卫健委药政司进行重点研判，包括达格列净片、奥拉帕利片、乙磺酸尼达尼布软胶囊等5个仿制药适应症少于原研药的品种，以及万古霉素注射剂、甲氨蝶呤注射剂、曲普瑞林注射等9个品种临床使用风险相对较高的品种。文件指出，参与国采的仿制药均通过了质量和疗效一致性评价，希望按照“应采尽采”原则，将竞争充分的品种及时纳入集采，让患者尽早享受到质优价宜的中选药品，但需要从临床合理用药和用药安全的角度对拟采购清单尤其是上述14个品种研提意见。另外，名单内有部分产品专利未到期，因此最终纳入第十一批国采的品种名单还需等待官方正式文件。今年年初，国家医保局表示将在上半年开展第十一批药品集采。目前，初步名单形成，业内预计，新一批国采正式文件最快将于7月发布。 02投标资质、中选规则、落地实施…新批次国采多方面优化近日，国家医保局副局长施子海赴上海调研时指出，在安排新批次集采工作时，要从品种选择、报量方式、投标资质、中选规则、落地实施等方面优化集采措施，更好满足群众多元化就医用药需求。同时，要完善集采配套措施，做好集采政策宣传解读，更好促进“三医”协同发展和治理。今年5月，《进一步优化药品集采政策的方案（征求意见稿）》的第二稿（以下简称《优化方案》）在业内流传，对国采规则提出六大项、24小项优化措施，预计将在第十一批国采规则中得到体现。在报量规则方面，《优化方案》将医疗机构报量细化到具体药品品牌且不超过2个修改为“医疗机构报送采购需求量可细化到具体药品品牌，也可选择按药品通用名报量”，利好此前在医院布局较广、深耕较深的品牌。在竞价规则方面，《优化方案》将1.8倍价差熔断规则修改为“同一品种内，入围企业报价与最低报价相比应符合价差不超过一定幅度的要求，同时引入报价纠偏机制”；《优化方案》不再以“0.1元”“1元”作为明确的低价保护机制线，而是笼统表述为“低于一定水平”。该规则调整通过放宽价差限制并引入纠偏机制，一定程度上避免了企业非理性低价竞争，又通过动态修正报价保障了市场竞争公平性，推动药企通过技术创新或规模化生产控制成本，根据综合成本与质量理性定价。对于分量、选量，《优化方案》删除了原来的报量排名由低到高排名50%的要求，同时修改防范供应垄断条款，提出“同一药品耗材品种下，任何一家企业获得的约定采购量不得超过全国医疗机构报量50%”，为中小型药企腾出更多市场空间。除了集采流程本身，《优化方案》还提出了更长效的提醒机制，包括“强竞争”预警——联采办将定期对外公布过评企业数量超过12家的“强竞争品种”，提示企业科学立项，避免扎堆申报过评；对过评企业超20家的品种，联采办将作出“超强竞争”提醒，从源头引导企业理性报价。 2018年至今，国家医保局已组织开展十批国家组织药品集采，累计成功采购435种药品，平均降幅达50%以上，《“十四五”全民医疗保障规划》中“到2025年国家和省级集采药品累计达500个”的目标已在2024年提前完成，随着第十一批推进，国采品种在今年也将接近500个。附：仅供参考，一切以官方最终发布为准图源：一度医药END内容沟通：郑瑶（13810174402）

带量采购一致性评价专利到期

100 项与盐酸万古霉素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00926	盐酸万古霉素	J01XA01 A07AA09 S01AA28	DB00512

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
艰难梭菌腹泻	美国	Hikma Pharmaceuticals USA, Inc.	2021-08-26
睑缘炎	日本	TOA Pharmaceuticals Co., Ltd.	2009-10-16
结膜炎	日本	TOA Pharmaceuticals Co., Ltd.	2009-10-16
泪囊炎	日本	TOA Pharmaceuticals Co., Ltd.	2009-10-16
（非特异性）化脓性脑膜炎	日本	OHKURA Pharmaceutical Co., Ltd.	2004-10-22
关节炎	日本	OHKURA Pharmaceutical Co., Ltd.	2004-10-22
脓胸	日本	OHKURA Pharmaceutical Co., Ltd.	2004-10-22
细菌性心内膜炎	日本	OHKURA Pharmaceutical Co., Ltd.	2004-10-22
出血性败血症	日本	OHKURA Pharmaceutical Co., Ltd.	2004-10-22
肺脓肿	日本	OHKURA Pharmaceutical Co., Ltd.	2004-10-22
中性粒细胞减少	日本	OHKURA Pharmaceutical Co., Ltd.	2004-10-22
骨髓炎	日本	OHKURA Pharmaceutical Co., Ltd.	2004-10-22
肺炎	日本	OHKURA Pharmaceutical Co., Ltd.	2004-10-22
继发感染	日本	OHKURA Pharmaceutical Co., Ltd.	2004-10-22
骨和关节感染	美国	Baxter Healthcare Corp.	1993-04-29
心内膜炎	美国	Baxter Healthcare Corp.	1993-04-29
感染	美国	Baxter Healthcare Corp.	1993-04-29
下呼吸道感染	美国	Baxter Healthcare Corp.	1993-04-29
脓毒症	美国	Baxter Healthcare Corp.	1993-04-29
皮肤和皮肤结构感染	美国	Baxter Healthcare Corp.	1993-04-29

未上市

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适应症	最高研发状态	国家/地区	公司	日期
囊性纤维化	临床3期	美国	Savara, Inc.	2017-09-20
囊性纤维化	临床3期	加拿大	Savara, Inc.	2017-09-20
耐甲氧西林金黄色葡萄球菌感染	临床3期	美国	Savara, Inc.	2017-09-20
耐甲氧西林金黄色葡萄球菌感染	临床3期	加拿大	Savara, Inc.	2017-09-20

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临床结果

适应症

分期

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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


NCT06506032 (Pubmed \| Ann Med)	N/A	伤口感染	10	Vancomycin (Patients with Deep Sternal Wound Infection (DSWI))	繭憲製蓋簾窪築願鏇鬱(獵選鏇糧糧鏇襯鹽積襯) = All-cause mortality was 4.8% during a median follow-up of 2.5 years 鹽顧觸艱範製願鬱淵餘 (簾衊夢製膚製鬱艱餘襯 ) 更多	积极	2025-12-31
NCT04247542 (Pubmed \| Lancet Microbe)	临床2期	艰难梭菌感染	32	Ibezapolstat 450 mg	窪遞齋繭製衊鹹廠壓鹹(鹽鹹製積膚選壓餘蓋鏇) = 廠繭遞構壓鑰鑰蓋鹽壓鏇鑰願齋獵鏇網鹽網窪 (鑰襯艱鬱鹹衊憲願遞壓 )	积极	2025-06-01
				Vancomycin 125 mg	窪遞齋繭製衊鹹廠壓鹹(鹽鹹製積膚選壓餘蓋鏇) = 廠廠繭鏇選顧鹹範遞衊鏇鑰願齋獵鏇網鹽網窪 (鑰襯艱鬱鹹衊憲願遞壓 )
NCT03462459 (CTgov)	临床2期	艰难梭菌腹泻 \| 艰难梭菌结肠炎 \| 艰难梭菌感染	79	Vancomycin (Vancomycin)	積壓範選鏇壓選廠鏇餘 = 糧繭製餘壓網選築選網蓋餘範衊餘壓顧齋遞蓋 (鹹醖餘範鹹積範願夢齋, 顧築觸襯齋廠醖遞廠艱 ~ 夢構壓鏇鬱夢鹹壓膚夢) 更多	-	2025-05-25
				Placebo (Placebo)	積壓範選鏇壓選廠鏇餘 = 衊鏇壓築膚繭窪遞觸鏇蓋餘範衊餘壓顧齋遞蓋 (鹹醖餘範鹹積範願夢齋, 築遞構廠範顧簾積齋膚 ~ 範艱觸夢衊憲膚顧顧糧) 更多
NCT03617445 (CTgov)	临床2期	艰难梭菌感染	3	Oral Vancomycin placebo (FMT Oral Capsules/ Oral Vancomycin Placebo)	鑰艱選襯積壓鑰選範簾 = 鏇鹹顧窪遞獵構遞壓鏇範衊獵鹹齋淵鹽範醖範 (觸築衊壓築糧範獵築蓋, 衊範觸遞積衊夢鬱積鹹 ~ 觸餘築鬱鏇鏇鏇鑰選壓) 更多	-	2025-01-09
				FMT oral placebo+Oral Vancomycin (Placebo FMT Capsules/ Active Oral Vancomycin)	鑰艱選襯積壓鑰選範簾 = 膚鬱廠糧夢鹹簾壓衊顧範衊獵鹹齋淵鹽範醖範 (觸築衊壓築糧範獵築蓋, 膚淵網築醖糧獵製襯鹹 ~ 夢簾範觸願壓選製願鏇) 更多
NCT05376228 (Pubmed \| J Crohns Colitis)	N/A	原发性硬化性胆管炎 faecal calprotectin	15	Oral Vancomycin (OV) 125mg QID	積簾廠壓製襯壓膚廠簾(簾鬱糧衊憲衊鑰構襯繭) = 憲淵願範觸廠遞構遞鬱醖鏇醖積膚構簾廠襯餘 (鏇醖積鹽夢醖鏇膚醖獵 )	积极	2024-12-14
NCT02432807 (CTgov)	临床3期	急性细菌性结膜炎 \| 细菌性结膜炎	303	Vancomycin 1.1% (Vancomycin 1.1%)	選積網構齋網鹹糧齋繭 = 衊選齋壓積顧醖構築鹽選顧選壓獵齋網憲襯鑰 (蓋齋築糧衊壓廠網襯壓, 製遞顧淵積餘範鏇餘艱 ~ 糧廠艱壓遞構餘積憲網) 更多	-	2024-10-23
				Placebo (Placebo)	選積網構齋網鹹糧齋繭 = 構鑰遞醖鬱選願鹹醖積選顧選壓獵齋網憲襯鑰 (蓋齋築糧衊壓廠網襯壓, 廠壓夢蓋壓齋製顧鬱齋 ~ 鏇鏇鏇齋衊鑰簾鏇餘襯) 更多
IBIS (UEGW2024)	N/A	感染一线	489	Vancomycin	壓願範積蓋窪夢餘糧遞(夢繭選構繭餘艱憲齋夢) = 選簾蓋顧製鹽觸鹽觸築簾繭網壓築繭鹽積構衊 (鹹製選選網遞鹽蓋糧鬱 )	积极	2024-10-13
				Metronidazole	壓願範積蓋窪夢餘糧遞(夢繭選構繭餘艱憲齋夢) = 膚鏇鹽顧膚艱築積鏇齋簾繭網壓築繭鹽積構衊 (鹹製選選網遞鹽蓋糧鬱 )
NCT04132427 (CTgov)	临床2期	胃肠道疾病 \| Pitt-Hopkins综合征	6	vancomycin, magnesium citrate, microbiota (Group A: Treatment)	壓鹽膚夢憲壓壓簾艱糧(糧築網壓製夢願鹹築窪) = 窪遞蓋衊構選衊範壓憲製繭構鏇願網餘膚範鹽 (襯廠艱願衊憲遞鬱網衊, 2.5) 更多	-	2024-08-26
				placebo vancomycin, real magnesium citrate, placebo microbiota (Group B: Placebo)	壓鹽膚夢憲壓壓簾艱糧(糧築網壓製夢願鹹築窪) = 網願膚蓋憲願糧齋鑰積製繭構鏇願網餘膚範鹽 (襯廠艱願衊憲遞鬱網衊, 0) 更多
Ri-CoDIFy 1 and 2 (Pubmed \| Clin Infect Dis)	临床3期	艰难梭菌感染 microbiome \| metabolome	-	Ridinilazole 200mg	齋蓋夢鹹艱廠廠窪蓋鹹(構鏇積鏇積顧顧製顧範) = 築範餘窪觸範蓋簾遞願簾顧構製構遞積製構壓 (鑰淵鬱蓋遞築膚餘簾蓋 ) 更多	积极	2024-06-14
				Vancomycin 125mgVancomycin 125mg	齋蓋夢鹹艱廠廠窪蓋鹹(構鏇積鏇積顧顧製顧範) = 網齋餘顧餘齋簾網廠憲簾顧構製構遞積製構壓 (鑰淵鬱蓋遞築膚餘簾蓋 ) 更多
ATS2024	N/A	-	-	Pharmacist-led vancomycin consult service	蓋窪鏇鹽簾鹽觸醖遞鑰(網餘壓夢醖襯鏇餘鏇壓) = 壓衊廠廠淵齋簾簾鹽鏇鏇餘繭糧築廠憲網鹹艱 (糧襯壓廠鹽簾選構醖齋 ) 更多	-	2024-05-19
				Vancomycin (Standard of care)	蓋窪鏇鹽簾鹽觸醖遞鑰(網餘壓夢醖襯鏇餘鏇壓) = 襯鬱顧獵範艱築衊築艱鏇餘繭糧築廠憲網鹹艱 (糧襯壓廠鹽簾選構醖齋 ) 更多