更新于：2024-12-17

Amoxicillin Trihydrate

阿莫西林

更新于：2024-12-17

概要

概要

基本信息

简介阿莫西林三水合物是一种小分子药物，属于细胞壁抑制剂类，用作抗生素治疗细菌感染，如支气管炎、肺炎、尿路感染和链球菌性咽喉炎。阿莫西林通过阻止细菌细胞壁的形成来抑制细菌的生长。该药物有多种形式，包括片剂、胶囊和口服混悬液，自 1974 年获得 FDA 批准以来一直以不同的品牌销售。虽然通常是安全的，但有些人可能会出现腹泻、恶心和皮肤病等副作用皮疹。对青霉素过敏的人也可能对阿莫西林产生过敏反应。与任何药物一样，患者应遵循规定的剂量，如果症状持续或恶化，请咨询他们的医疗保健提供者。

药物类型

小分子化药

别名

(2S,5R,6R)-6-{[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid、6-(p-hydroxy-α-aminophenylacetamido)penicillanic acid、AmoxiciIIin

+ [57]

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

在研适应症

非在研适应症

原研机构

在研机构

Sandoz Pty Ltd.山德士有限公司

西安利君制药有限责任公司

+ [3]

非在研机构

GSK Plc

Pragma Pharmaceuticals LLC

最高研发阶段批准上市

首次获批日期

美国 (1974-01-18),

扁桃体炎

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C16H25N3O8S

InChIKeyMQXQVCLAUDMCEF-CWLIKTDRSA-N

CAS号61336-70-7

关联

461

项与阿莫西林相关的临床试验

NCT06406114 / Not yet recruiting临床2期IIT

Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.

开始日期2025-02-01

申办/合作机构

The General Hospital Corp.

[+1]

NCT06461429 / Not yet recruitingN/AIIT

Platform for Adaptive Trials in Perinatal Units (Core Protocol)

PLATIPUS is an adaptive platform trial aimed at improving the health of infants born preterm (before 37 weeks' gestation). PLATIPUS will compare how different treatments and care provided to pregnant women and people at risk of preterm birth and infants born preterm affect infant health.
The main questions PLATIPUS aims to answer are:
1. What effect/s do different treatments/care provided to pregnant women and people at risk of preterm birth have on the health of their infants? (Pregnancy domains)
2. What effect/s do different treatments/care given to infants born preterm have on their health ? (Neonatal domains).
This registration record relates to the PLATIPUS Core (or 'master') protocol which provides guidance for the overall running of the trial. Additional appendices will outline the aims, questions, treatments, and activities for each separate research question (domain). Each Domain-Specific Appendix will be registered separately on ClinicalTrials.gov and will link to this record.

开始日期2025-02-01

申办/合作机构

University of Melbourne

[+10]

NCT06731023 / Not yet recruitingN/AIIT

Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients With Extremely Refractory Helicobacter Pylori Infection: An Exploratory Study

Helicobacter pylori (H. pylori) infection, a prevalent global infectious disease, is a significant contributor to gastric cancer and other morbidities, imposing a substantial disease burden. With the rise in antibiotic resistance, the eradication of H. pylori is encountering formidable challenges. A subset of individuals, despite undergoing multiple treatment regimens, remain unable to successfully eradicate the infection. The persistence of infection in these cases could be attributed to either the limitations of detection methods leading to false positives or to the infection by superbugs that are highly resistant to antibiotics. This study is designed to ascertain whether these patients are infected with superbugs by employing various diagnostic techniques. Additionally, it aims to assess the antibiotic resistance profiles of strains associated with extremely refractory H. pylori infections through drug susceptibility testing. Based on the identified sensitivities, the study seeks to tailor treatment protocols with bismuth-containing quadruple therapy (Containing two kinds of antibiotics: sensitive antibiotic, rifabutin or high-dose metronidazole), to explore novel therapeutic strategies for patients with highly resistant H. pylori infections.

开始日期2025-01-01

申办/合作机构

山东大学

100 项与阿莫西林相关的临床结果

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100 项与阿莫西林相关的转化医学

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100 项与阿莫西林相关的专利（医药）

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21,815

项与阿莫西林相关的文献（医药）

2025-02-01·Infectious Diseases Now

Proposed macroscopic quality indicators of antimicrobial stewardship in primary care: An observational study

Article

作者: Bertrand, X ; Pouly, E ; Malinowski, L ; Slekovec, C

OBJECTIVE:

The objective of this study was to evaluate the ability of two macroscopic quality indicators to guide antibiotic stewardship strategies.

METHODS:

Setting: Bourgogne-Franche-Comté region (eight departments). Antibiotic reimbursement data, expressed in defined daily doses, were used to calculate two macroscopic quality indicators from 2015 to 2020. Urinary tract infection indicator: (fosfomycin + nitrofurantoin + pivmecillinam) / (ciprofloxacin + ofloxacin + norfloxacin) calculated in women aged 15 to 64. Indicator for ear, nose, throat and respiratory tract infections: (amoxicillin/ (amoxicillin-clavulanate + oral 3GC) calculated in children under 15 years of age.

RESULTS:

In 2020, global antibiotic consumption varied from 22.2 to 26.6 defined daily doses per 1000 inhabitants per day, depending on the department. The macroscopic quality indicators were lowest in the departments of Nièvre and Yonne. The scores for the urinary tract infection indicator were 0.55 and 0.74, respectively, while those for the ear, nose and throat and respiratory tract infection indicators were 1.85 and 2.12, respectively. Both scores continuously increased in all departments of the region during the survey, except in 2020 for the urinary tract infection indicator, due to a nitrofurantoin shortage.

CONCLUSION:

Even in departments with low antibiotic consumption, our macroscopic quality indicators help to identify antibiotic stewardship targets for the most common community-based infections,. They are easy to calculate from quantitative data without requiring any information on diagnosis. Complementarily to other indicators, they provide messages specifically addressed to general practitioners regarding population, molecules and diagnostic elements.

2025-02-01·PREVENTIVE VETERINARY MEDICINE

Quantification of antibiotic usage against Streptococcus suis in weaner pigs in the Netherlands between 2017 and 2021

Article

作者: Vrieling, Manouk ; Fabà, Lluís ; Gielen, Chretien ; Bouwknegt, Martijn ; Dame-Korevaar, Anita ; van Hout, Jobke

Streptococcus suis is an important pig pathogen that can cause severe disease in the post-weaning period. As there are no commercial vaccines available in the Netherlands, antibiotic treatment is often necessary to control disease. S. suis is regarded as one of the major causes of antibiotic prescription in weaned pigs, but scientific studies supporting this claim with quantitative data are lacking. The aim of this study was to obtain insight in, and to quantify usage of, antibiotics against S. suis in weaner pigs at sow farms in the Netherlands. Three sources of data were used, including 1) total antibiotic usage in weaner pigs in the Netherlands, as yearly reported by the Netherlands Veterinary Medicines Institute (SDa), and estimates from 2) pig veterinarians and 3) pig farmers on the relative amount of antibiotics prescribed against S. suis, via questionnaires. Information from the SDa on the total amount of antibiotic usage was combined with the estimates of the veterinarians to estimate the antibiotic usage against S. suis in weaner pigs. Our study shows that ∼90 % of the total amount of amoxicillin (AMOX) and ampicillin (AMPI) prescribed in weaner pigs is used for treatment of disease caused by S. suis (S. suis disease). Of all orally prescribed antibiotics against S. suis, AMOX comprises 85 % of the total absolute usage expressed by the mean defined daily dosage per animal farm (3.2 - 5.4 mean DDDA_F). Furthermore, veterinarians reported that at farms with structural S. suis disease problems second choice antibiotics (AMOX, AMPI) are more often prescribed than at farms with incidental S. suis disease. All together, we estimated that S. suis disease accounts for about 1/3rd of the total antibiotic usage in weaner pigs. This study is the first to quantify antibiotic usage against S. suis in weaner pigs and shows that S. suis is a hotspot of antibiotic usage. This underlines the severity and relevance of S. suis disease and the need for alternative control measures.

2025-01-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Ceftriaxone versus cefepime or carbapenems for definitive treatment of low-risk AmpC-Harboring Enterobacterales bloodstream infections in hospitalized adults: A retrospective cohort study

Article

作者: Mulbah, Jessica L. ; Veve, Michael P. ; Kenney, Rachel M ; Shallal, Anita B. ; Veve, Michael P ; Tibbetts, Robert J ; Shallal, Anita B ; Mulbah, Jessica L ; Tibbetts, Robert J. ; Kenney, Rachel M.

OBJECTIVE:

To compare outcomes of ceftriaxone to AmpC-stable therapies in patients with bacteremia caused by low-risk AmpC harboring Enterobacterales.

METHODS:

IRB-approved, retrospective cohort of hospitalized patients ≥18 years old with Serratia marcescens, Morganella morganii, or Providencia spp. bacteremia from 1/1/2017-2/28/2024. Patients were compared by definitive therapy with ceftriaxone vs AmpC-stable therapy (cefepime, carbapenem). The primary endpoint was 30-day all-cause mortality; secondary endpoints were clinical failure and development of ceftriaxone resistance.

RESULTS:

163 patients were included; 33.1 % received ceftriaxone, 66.9 % AmpC-stable therapies. 30-day all-cause mortality was 9.3 % ceftriaxone vs 10.1 % AmpC stable patients (P = 0.87); ceftriaxone definitive therapy was not associated with 30-day all-cause mortality (adjOR, 0.79; 95 %CI, 0.23-2.3). There were no differences in clinical failure (9.3 % vs 21.1 %, P = 0.059) or relapsing infection (5.6 % vs 9.3 %, P = 0.55) between ceftriaxone and AmpC-stable treated patients.

CONCLUSIONS:

Patients treated with definitive ceftriaxone for low-risk AmpC Enterobacterales bacteremia had similar outcomes to AmpC stable therapies.

429

项与阿莫西林相关的新闻（医药）

2024-12-10

·创药网

近一个月药物审批进展概览

本文梳理了近一个月（2024年10月16日～2024年11月15日）在研药物的审批情况，同时，对部分药物的研究情况进行简述和分析，供研发人员参考。据统计，在2024年10月16日～2024年11月15日期间，共有5个药物获批（表1）。这些药物涉及的适应症包括白血病、淋巴瘤、非小细胞肺癌、泌尿系统感染、慢性乙肝。以下对重点药物进行介绍和分析。表1：近一个月（2024年10月16日～2024年11月15日）的药物批准情况 01 Revumenib 2024年11月15日，美国食品药品监督管理局（FDA）批准Revumenib（商品名：Revuforj，图1），用于治疗携带赖氨酸甲基转移酶2A（KMT2A）易位的复发或难治性急性白血病成人患者和1岁及以上的儿童患者。 Revumenib是由美国Syndax Pharmaceuticals生产的首款获批Menin抑制剂。Revumenib是一种针对Menin-KMT2A相互作用的强效、选择性小分子抑制剂，正在开发用于治疗KMT2A重排急性白血病和NPM1突变型（mNPM1）急性髓系白血病（AML）。Revumenib用于治疗KMT2A重排急性白血病的新药申请曾获FDA的优先审评资格以及突破性疗法认定。 KMT2A是一种在人类中编码蛋白质的基因，位于第11号染色体上，主要涉及基因表达的调控，其突变与多种疾病相关。Menin抑制剂是一种能够破坏Menin-KMT2A蛋白与蛋白相互作用的小分子药物，主要用于治疗由KMT2A重排或NPM1突变引起的急性白血病。图1：Revumenib的化学结构式 KMT2A基因重排（KMT2Ar）可能会导致侵袭性急性白血病，其预后极差且复发率高。据估计，超过95%的KMT2Ar急性白血病患者携带KMT2A易位，这是一种染色体的一部分断裂后与另一染色体融合的重排类型。超过一半的KMT2Ar急性白血病患者在接受传统一线治疗后会复发，其中位总生存期（OS）不到一年。在接受三线或后续治疗时，仅5%的患者可达到完全缓解，其中位OS不足三个月。 Revuforj的批准主要基于FDA对104名携带KMT2A易位的复发/难治性（R/R）急性白血病患者在Ⅰ/Ⅱ期AUGMENT-101试验中接受Revuforj治疗的分析。在疗效评估人群中，完全缓解（CR）加部分血液学恢复的完全缓解（CRh）的比例为21%（22/104名患者；95%CI：13.8-30.3）。CR/CRh患者的中位缓解持续时间为6.4个月（95%CI：2.7-无法估计），达到CR或CRh的中位时间为1.9个月（范围：0.9至5.6个月）。23%（24/104名患者）在接受Revuforj治疗后接受了造血干细胞移植（HSCT）。这104名患者疗效分析的结果与此前在Journal of Clinical Oncology上发表的针对R/R KMT2Ar急性白血病患者（n=57）的Ⅱ期中期分析结果一致。 Revuforj的安全性评估基于FDA对135名携带KMT2A易位的R/R急性白血病患者的数据分析。最常见的不良反应（≥20%）包括实验室检测异常，包括出血、恶心、磷酸盐升高、肌肉骨骼疼痛、感染、天冬氨酸氨基转移酶升高、发热性中性粒细胞减少症、丙氨酸氨基转移酶升高、甲状旁腺激素完整升高、细菌感染、腹泻、分化综合征、心电图QT间期延长、磷酸盐降低、甘油三酯升高、钾降低、食欲下降、便秘、水肿、病毒感染、疲劳和碱性磷酸酶升高。导致剂量减少或永久停药的不良反应分别较低，为10%和12%的患者。 02 欧贝妥基奥仑赛 2024年11月8日，Autolus Therapeutics公司的CAR-T细胞疗法欧贝妥基奥仑赛（商品名：Aucatzyl，通用名为Obecabtagene autoleucel或Obe-cel）已获得FDA批准，用于治疗R/R B细胞前体急性淋巴细胞白血病（B-ALL）成人患者。Aucatzyl是获FDA批准的首个无需风险评估缓解策略计划（REMS）的CAR-T疗法，同时也是FDA批准的第五款CD19 CAR-T疗法。此次FDA的批准主要是基于Aucatzyl在R/R B-ALL成人患者中所进行的FELIX临床试验的结果。在94名至少接受过一次Aucatzyl输注的患者中，其中65名患者符合疗效可评估的标准。其中，63%的患者获得了总完全缓解（OCR），其中包括51%的患者在任何时间达成CR，12%患者在任何时间达成CR伴不完全的血液学恢复（CRi）。此外，主要疗效终点是在3个月内达成完全缓解，共有42%的患者达成，中位缓解持续时间（DOR）为14.1个月。安全性方面，Aucatzyl表现出低水平的细胞因子释放综合征（CRS），3级事件发生率为3%，无4级或5级事件。7%的患者出现≥3级免疫效应细胞相关神经毒性综合征（ICANS）。 Aucatzyl是一款靶向CD19抗原的自体CAR-T细胞疗法。它旨在克服当前CAR-T细胞疗法在临床活性和安全性方面的局限性。它的独特之处在于，设计的嵌合抗原受体在与CD19结合后具有较快的解离速度（Fast off-rate），从而能够尽量减少T细胞的过度激活，在降低毒副作用的同时，不易发生T细胞耗竭，提高CAR-T疗法的持久性。此前，该疗法已被FDA和欧洲药品管理局（EMA）授予孤儿药资格，还获得FDA授予的再生医学先进疗法（RMAT）认定以及EMA授予治疗成人R/R B细胞急性淋巴细胞性白血病的PRIME认定。 03 硫培南/丙磺舒 2024年10月25日，Iterum Therapeutics宣布，FDA已批准Iterum的新药申请，批准Orlynvah（硫培南酯/丙磺舒）用于治疗由指定微生物大肠杆菌、肺炎克雷伯菌或变形杆菌引起的女性成人无并发症的尿路感染（uUTIs），这些患者的口服抗菌治疗选择有限或无可选方案。这是Orlynvah首次获得批准的适应症，也是Iterum首个获得FDA批准的产品。 FDA批准Orlynvah是基于一个临床开发计划，该计划得到了强有力的数据支持，包括两个关键的Ⅲ期临床试验（称为SURE 1和REASSURE），这些试验评估了Orlynvah与环丙沙星（SURE 1）和阿莫西林/克拉维酸（Augmentin，REASSURE）在治疗成人女性uUTI方面的安全性和有效性。SURE 1显示在氟喹诺酮耐药感染中，Orlynvah优于环丙沙星，而REASSURE则在对阿莫西林/克拉维酸敏感的人群中显示出非劣效和统计学上的优越性。Orlynvah在SURE 1和REASSURE临床试验中总体耐受性良好。硫培南（Sulopenem etzadroxil，研发代码：PF-03709270，图2）是一种有口服活性的酯类活性分子，对大多数革兰氏阳性菌和革兰氏阴性菌具有广泛的抗菌活性。硫培南的化学结构具有青霉素、头孢菌素和碳青霉烯类药物的特性。硫培南以口服前药形式存在，该前药通过肠道酯酶水解，形成活性硫培南。图2：硫培南的化学结构式丙磺舒（Probenecid，图3）主要用在抗痛风药，通过抑制尿酸盐在近曲肾小管的主动再吸收，增加尿酸盐的排泄而降低血中尿酸盐的浓度，可缓解或防止尿酸盐结节的生成，减少关节的损伤，亦可促进已形成的尿酸盐溶解，无抗炎、镇痛作用。丙磺舒可以竞争性抑制弱有机酸（如青霉素、头孢菌素）在肾小管的分泌，故可以增加这些抗生素的血药浓度和延长它们的作用时间。图3：丙磺舒的化学结构式【参考资料】 1. Informa数据库, 检索日期: 2024年11月19日. 2. 药渡数据库, 检索日期: 2024年11月30日. 3. 药明康德、医药魔方、学术经纬、医药观澜、医麦客等网络公开资源. 本文其它内容请见《全球药物创新快讯》2024年第10期（总第146期）。

突破性疗法优先审批临床2期临床结果

2024-12-04

·梅斯医学

十个中国人中就有至少五人感染这种细菌！系列研究：11年随访发现幽门螺杆菌感染与胃癌发生密切相关，而多吃这几种食物容易增加感染风险

你是否曾有这样的经历：吃一顿普通的饭，肚子却胀得像个气球，甚至嗳气不止？是否感到上腹部经常性隐痛，总是挥之不去？又或者被口臭困扰，无论怎么刷牙都毫无改善？如果你符合以上一种或多种情况，别忽视，这可能是幽门螺杆菌（H. pylori）敲响的警钟。作为一种常见的胃部细菌，幽门螺杆菌在我国的感染率高达50%，它不仅与胃炎、消化性溃疡、胃麦芽糖淋巴瘤等胃部疾病密切相关，还可能导致胃癌、不明原因的缺铁性贫血等更严重的健康问题。好消息是，科学家们正不断揭开幽门螺杆菌的神秘面纱，为防治这种“餐桌杀手”提供了新的解决方案。根除H. pylori有效预防胃癌胃癌是极为常见的恶性肿瘤，也是全球癌症死亡的主要原因之一，而幽门螺杆菌是目前唯一确定的与胃癌发生密切相关的细菌性病原体。今年7月，一项发表在《Nature Medicine》杂志的题为“Gastric cancer prevention by community eradication of Helicobacter pylori: a cluster-randomized controlled trial”的研究，探讨了通过社区根除幽门螺杆菌来预防胃癌的有效性。研究采用了群集随机对照试验的方法，在山东省临朐县进行，涉及980个村庄的180,284名符合条件的参与者，随访时间长达11.8年。研究人员使用13C-尿素呼气试验（13C-urea breath test, CUBT）来检测H. pylori感染情况，并将检测结果为阳性的个体随机分配到接受为期10天的四联抗H. pylori治疗方案（包括奥美拉唑、四环素、甲硝唑和铋剂）或单一的日常剂量奥美拉唑和铋剂的症状缓解治疗组。研究的主要结果是胃癌的发病率。结果显示，接受抗H. pylori治疗的个体在意向治疗分析中胃癌发病率有所降低（风险比0.86，即降低了14%风险），并且在成功根除H. pylori的个体中观察到更强的效果（风险比0.81，即降低了19%风险）。此外，研究还观察到H. pylori阴性个体的胃癌发病率比接受症状缓解治疗的个体更低（风险比0.46，即降低了54%风险）。抗H. pylori治疗降低胃癌患病率（图片来源：Nature Medicine 2024）中国是胃癌的高疾病负担国家，胃癌发病率位列所有恶性肿瘤中的第4位、病死率的第3位。尽管本研究观察到的胃癌风险降低幅度适中，但考虑到中国胃癌的高发病率，即使基于保守的效果估计，通过H. pylori治疗每年可以预防超过85,000例胃癌新发病例。研究还指出，H. pylori根除对总体死亡率或其他个体癌症的风险没有影响，缓解了关于H. pylori根除可能引起其他长期系统效应的担忧。研究结果支持从成年早期开始实施大规模H. pylori筛查和治疗，作为高风险社区胃癌预防的公共卫生政策和临床实践。超加工食品：幽门螺杆菌的“助攻者” 除了医疗干预外，我们也需要关注日常生活中可能增加感染幽门螺杆菌风险的行为和习惯。近年来，研究发现，饮食结构对感染率有重要影响，其中，超加工食品（Ultra-Processed Foods, UPFs）成为一大隐藏风险。相关研究于今年3月，发表在《Food Science & Nutrition》杂志上，论文题目为“Ultra-Processed food intake and risk of Helicobacter pylori infection: A case–control study”。所谓的“超加工食品”是指在已经加工过的食品基础上再加工的食品，这类食品通常添加了多种食品添加剂，是典型的高糖、高脂、高热量的食品。那些我们习以为常的休闲小食，如薯片、汉堡、比萨，或是一杯看似无害的奶茶，可能正在悄悄给我们的胃带来隐患。它们共同的特点是高盐、高糖、高脂肪，而这些正是幽门螺杆菌喜欢的‘温床’。研究采用了病例对照研究设计，共纳入了150名幽门螺杆菌感染患者和302名健康对照个体。研究团队通过问卷调查了参与者的饮食习惯，评估他们食用超加工食品的频率，并使用NOVA系统对其摄入量进行分类和分析。研究发现，UPFs的摄入与H. pylori感染风险增加有关（1.71倍）。在调整了年龄、体重指数（BMI）、性别、能量摄入、体力活动、吸烟和饮酒状态后，这种关联仍然存在（感染风险增加2.17倍）。超加工食品的摄入增加H. pylori感染风险（图片来源：Food Science & Nutrition 2024）这项研究警示我们，现代生活中司空见惯的饮食习惯，可能正在为幽门螺杆菌的侵入大开方便之门。减少超加工食品的摄入，或许是保护我们胃部健康的第一步。新疗法助力青霉素过敏患者治疗如果我们感染了幽门螺杆菌，可以采用传统的标准三联疗法（阿莫西林、克拉霉素和兰索拉唑）进行治疗。但是对于青霉素过敏的患者，往往需要采用更复杂的铋剂四联疗法。那么，除此之外，是否还有其他有效疗法呢？今年8月，一项发表在《Gut》杂志上题为“Simplified Helicobacter pylori therapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy”的研究，评估了对于青霉素过敏患者，使用vonoprazan（一种新型钾竞争性酸阻断剂）和四环素（VT）双联疗法作为幽门螺杆菌感染的一线治疗的疗效和安全性。研究采用了随机对照试验的方法，共纳入了300名治疗未经验成年人，他们均感染了H. pylori并有青霉素过敏史。这些患者被随机1:1分配，接受为期14天的开放式标签VT双联疗法（vonoprazan 20 mg每天两次 + 四环素500 mg每天三次）或铋剂四联疗法（BQT：兰索拉唑30 mg每天两次 + 胶体铋150 mg每天三次 + 四环素500 mg每天三次 + 甲硝唑400 mg每天三次）。研究的主要结果是VT双联组与BQT组相比在根除率上的非劣性。次要结果包括评估不良反应。研究发现，在意向治疗分析（ITT）中，VT组和BQT组的根除率分别为92.0%和89.3%，差异为2.7%；在修正意向治疗分析（mITT）中，根除率分别为94.5%和93.1%，差异为1.5%，；在方案分析（PP）中，根除率分别为95.1%和97.7%，差异为2.6%。VT组的治疗相关不良事件（TEAEs）显著低于BQT组（14.0%对比48.0%），因TEAEs中断治疗的比例也更低（2.0%对比8.7%）。 VT双联疗法与BQT疗法具有相当的疗效（图片来源：Gut 2024）研究结果令人振奋：对于青霉素过敏患者，VT双联疗法不仅效果与传统方案旗鼓相当，还因为用药更简单、不良反应更少，成为治疗幽门螺杆菌的理想新选择！这无疑为许多患者提供了更便捷、更安全的治疗方案。小结幽门螺杆菌虽然隐藏在我们日常的饮食和生活中，但并非“不可防治”。从健康的饮食习惯到科学的医疗干预，我们有足够的手段来对抗这一“隐形杀手”： ● 从饮食开始：少吃超加工食品，多选择新鲜、天然食材；聚餐时分餐制、公筷公勺是有效的预防手段。 ● 重视早期筛查：定期进行幽门螺杆菌检测，尤其是有胃部不适症状的人群，便于早发现、早治疗。 ● 选择合适疗法：青霉素过敏患者可以咨询医生，采用如VT双联疗法的创新治疗方案。只有坚持科学防治和健康生活方式，幽门螺杆菌才不会成为威胁我们健康的“餐桌杀手”。现在就从你的下一顿饭开始，为健康投资，让胃部远离风险，共建更健康的未来！参考文献： [1] Pan KF, Li WQ, Zhang L, et al. Gastric cancer prevention by community eradication of Helicobacter pylori: a cluster-randomized controlled trial. Nat Med. 2024;30(11):3250-3260. [2] Ebrahimi Z, Shateri Z, Nouri M, et al. Ultra-Processed food intake and risk of Helicobacter pylori infection: A case-control study. Food Sci Nutr. 2024;12(7):5019-5026. [3] Gao W, Liu J, Wang X, et al. Simplified Helicobacter pylori therapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy. Gut. 2024;73(9):1414-1420. 撰文 | Shawn 编辑 | 阿拉斯加宝 ●女性更容易得“长新冠”！高福院士团队发布中国最大规模“长新冠”调查报告，高达30%人群存在长新冠 ●震撼！科室只剩主任、副主任等3名医生，6年时间招不到一个医生！科主任收入拿大头，别人1千5，自己分8千，我们需要怎样的科主任？ ●熬夜伤身，阿司匹林能逆转！哈佛最新：“百年神药”再添新用，减轻睡眠不足导致的炎症版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

临床结果临床研究

2024-12-03

·echemi

Zhejiang Anglikang Invests 79.91 Million for 4,105 Tons of Key Antibiotic Raw Material Production

Recently, Zhejiang Anglikang Pharmaceutical Co., Ltd. has completed the filing and public announcement for a project to produce 4,105 tons of D(-)-Hydroxyphenylglycine Methyl Ester and 1,230 tons of D(-)-Phenylglycine Hydrochloride. The planned investment for this project is 79.91 million yuan, aimed at utilizing the company's existing land resources to build new production facilities, production lines, and supporting ancillary facilities, with a total construction area expected to be 2,900 square meters. The project will employ advanced synthetic process technology and acquire key production equipment such as reactors and condensers. Upon completion, the project is expected to achieve an annual production capacity of 4,015 tons (dry weight) of D(-)-Hydroxyphenylglycine Methyl Ester and 1,230 tons (dry weight) of D(-)-Phenylglycine Hydrochloride, with an anticipated annual output value of 300 million yuan and tax contributions of 20 million yuan. By-products will include 20% hydrochloric acid (5,686.92 tons/year), ammonium sulfate (4,114.2 tons/year), and ammonium chloride (1,191.8 tons/year). D-Hydroxyphenylglycine Methyl Ester is an important raw material used in the enzymatic production of β-lactam antibiotics such as amoxicillin, cefuroxime axetil, cefaclor, and cefepime. According to previous environmental impact assessment reports, Zhejiang Anglikang Pharmaceutical Co., Ltd.'s project to produce 8,000 tons of amoxicillin and 2,000 tons of ampicillin plans to invest 300 million yuan and is expected to have an annual production capacity of 8,000 tons of amoxicillin and 2,000 tons of ampicillin upon completion, with a by-product of ammonium chloride at 3,164.68 tons/year. The current project can be seen as a further extension of the industrial chain. Zhejiang Anglikang Pharmaceutical Co., Ltd. is a modern pharmaceutical enterprise integrating the research, development, production, and sales of pharmaceutical intermediates, active pharmaceutical ingredients, and drug formulations, focusing on cardiovascular, oral cephalosporin, nephrology, and anesthetics. According to the company's latest financial report, in the first three quarters of the year, it achieved operating revenue of 1.122 billion yuan, a year-on-year decrease of 5.51%; the net profit attributable to the parent company was 49.93 million yuan, a year-on-year decrease of 54.52%; and the net profit after deducting non-recurring gains and losses was 39.91 million yuan, a year-on-year decrease of 54.33%.

财报

100 项与阿莫西林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00229	阿莫西林	J01CA04	DB01060

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
细菌性心内膜炎	澳大利亚	Sandoz Pty Ltd.	2008-05-22
泌尿系统感染	澳大利亚	Sandoz Pty Ltd.	2008-05-22
淋病	澳大利亚	Sandoz Pty Ltd.	2008-05-22
呼吸道感染	澳大利亚	Sandoz Pty Ltd.	2008-05-22
皮肤和皮肤结构感染	澳大利亚	Sandoz Pty Ltd.	2008-05-22
咽炎	美国	Pragma Pharmaceuticals LLC	2008-01-23
细菌感染	美国	USAntibiotics	1980-10-21
感染	日本	LTL Pharma Co., Ltd.	1974-09-06
感染	日本	山德士有限公司	1974-09-06
扁桃体炎	美国	GSK Plc	1974-01-18

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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


UEGW	N/A	感染一线	439	EA (esomeprazole-amoxicillin)	廠艱鹽襯選窪遞積顧廠(築繭糧範淵壓憲觸觸鹹) = 積窪遞願餘顧壓範獵鹹顧簾製蓋窪範蓋糧構糧 (艱製獵繭壓獵鹹築窪構 )	积极	2024-10-13
				B-quadruple (esomeprazole-amoxicillin-clarithromycin-bismuth)	廠艱鹽襯選窪遞積顧廠(築繭糧範淵壓憲觸觸鹹) = 觸鬱願蓋齋鬱艱觸築壓顧簾製蓋窪範蓋糧構糧 (艱製獵繭壓獵鹹築窪構 )
EURETINA2024	N/A	近视 \| 肺炎	-	Amoxicillin	範願蓋鬱鑰製觸遞襯齋(廠鹹築繭觸獵遞鏇廠願) = This clinical case suggests a potential episode of secondary uveal effusion with amoxicillin as the most probable etiology, based on the temporal sequence of events. However, the possibility of an infectious or inflammatory contribution due to the patient's current pneumonia or previous flu-like symptoms cannot be ruled out. Moreover, the temporal coincidence between the onset of ophthalmological symptoms two days after the initiation of amoxicillin administration, as well as the observation of clinical improvement two days after discontinuing the medication, significantly suggests the possible involvement of amoxicillin in the development of the uveal effusion. 繭製夢衊餘窪範鹹築衊 (蓋衊鬱膚構鹹襯願膚築 )	-	2024-09-19
				Azithromycin
NCT05901051 (Pubmed \| Helicobacter)	临床4期	幽门螺杆菌感染	327	Vonoprazan 20 mg + Amoxicillin 1000 mg BM-TID	鹹淵獵鬱鏇廠餘襯憲憲(鹽夢繭窪鬱獵製網醖餘) = 醖製鹽製廠願獵遞製簾糧範獵鬱獵範選簾鑰壓 (願齋鏇鑰遞獵網廠範網 )	积极	2024-07-01
				Vonoprazan 20 mg + Amoxicillin 1000 mg AM-TID	鹹淵獵鬱鏇廠餘襯憲憲(鹽夢繭窪鬱獵製網醖餘) = 膚繭顧襯憲鏇積積願簾糧範獵鬱獵範選簾鑰壓 (願齋鏇鑰遞獵網廠範網 )
NCT03060473 (TREAT, CTgov)	临床3期	未足月胎膜早破	21	Amoxicillin+Azithromycin+Ampicillin (Azithromycin)	窪簾廠壓蓋網顧艱積遞(廠壓觸範憲窪顧廠淵鹽) = 築顧構鹽觸願壓襯構窪膚鹹壓選齋鏇鹽遞艱醖 (鹽糧鬱膚艱壓鹹夢鹹製, 顧鹹簾製襯夢衊衊膚壓 ~ 顧鹽選艱遞餘積廠獵襯) 更多	-	2024-06-25
				Amoxicillin+Ampicillin+Erythromycin (Erythromycin)	窪簾廠壓蓋網顧艱積遞(廠壓觸範憲窪顧廠淵鹽) = 膚鹹構窪鬱鑰選鏇襯網膚鹹壓選齋鏇鹽遞艱醖 (鹽糧鬱膚艱壓鹹夢鹹製, 繭獵淵衊鑰構遞鏇範艱 ~ 鑰繭範襯築選鑰鬱糧齋) 更多
NCT05719831 (Pubmed \| Clin Gastroenterol Hepatol)	临床3期	幽门螺杆菌感染	623	H-VA-10 (vonoprazan 20 mg b.i.d. + amoxicillin 750 mg 4 times a day, 10 days)	餘夢簾遞鏇鹹膚顧願構(夢構遞簾觸窪壓觸壓製) = 積觸網襯鏇觸蓋鏇廠餘積淵鑰鹽構襯範製餘網 (糧範醖淵窪壓糧淵顧廠 )	积极	2024-06-01
				L-VA-10 (vonoprazan 20 mg b.i.d. + amoxicillin 1000 mg b.i.d, 10 days)	餘夢簾遞鏇鹹膚顧願構(夢構遞簾觸窪壓觸壓製) = 鹹餘範鬱糧艱醖衊憲鏇積淵鑰鹽構襯範製餘網 (糧範醖淵窪壓糧淵顧廠 )
NCT05870683 (SHARE2301, Pubmed)	N/A	幽门螺杆菌感染	368	Tegoprazan-amoxicillin (TA)	襯憲艱積網遞夢膚積憲(壓鹹鏇簾壓鏇鬱淵簾製) = 糧願獵製夢淵夢積廠構夢範獵築構網築鹽齋積 (齋願鹹膚鏇壓襯廠鑰構 )	积极	2024-05-01
				Esomeprazole-amoxicillin (EA)	襯憲艱積網遞夢膚積憲(壓鹹鏇簾壓鏇鬱淵簾製) = 積艱積獵窪壓憲遞鏇獵夢範獵築構網築鹽齋積 (齋願鹹膚鏇壓襯廠鑰構 )
AAAAI2024	N/A	超敏反应 LPS	-	Amoxicillin + Lipopolysaccharide	齋餘積鹽醖糧廠憲糧餘(餘衊選艱鹽製遞艱膚憲) = 願觸鹹簾齋網獵窪選獵鹹鏇艱鬱遞襯繭顧顧蓋 (窪鑰鹹醖餘憲製築顧範 ) 更多	积极	2024-02-23
				Amoxicillin	齋餘積鹽醖糧廠憲糧餘(餘衊選艱鹽製遞艱膚憲) = 醖夢繭襯鏇蓋網窪夢蓋鹹鏇艱鬱遞襯繭顧顧蓋 (窪鑰鹹醖餘憲製築顧範 ) 更多
DDW2023	N/A	幽门螺杆菌感染	-	14-OAC (omeprazole 20 mg bid ac, amoxicillin 1,000 mg bid pc, and clarithromycin 500 mg bid pc for 14 days)	壓範繭襯選選夢網積築(選構網壓襯艱築網蓋衊) = 74.8% vs 43.9% vs 52.2% 蓋鑰鹽夢窪壓鑰鹹觸淵 (齋襯壓構構鑰鑰築夢淵 )	-	2023-05-06
				7-VAB (vonoprazan 20 mg bid pc, amoxicillin 1,000 mg bid pc, and bismuth subsalicylate 1,048 mg bid pc for 7 days)
AAAAI2023	N/A	超敏反应	84	Amoxicillin challenge	鬱鹽夢壓網憲鬱夢選夢(積壓廠遞鹹製襯願餘壓) = 齋製繭願糧繭廠醖鹹糧鏇築觸願鬱淵淵憲醖獵 (鬱鏇構獵壓獵網醖網窪 ) 更多	积极	2023-02-01
AFRINEST study, SATT Bangladesh study, SATT Pakistan study (Pubmed \| J Glob Health)	N/A	细菌感染	7,617	Procaine-penicillin plus gentamicin	壓淵簾窪製觸餘餘鹽選(齋廠淵淵膚醖衊餘蓋繭): risk difference = -2.1 (95% CI, -3.8 ~ -0.4), P-Value = 0.016	积极	2022-11-21
				Amoxicillin plus gentamicin