主要研究目的研究空腹和餐后状态下单次口服受试制剂头孢地尼干混悬剂（规格：250mg/5ml，广东金城金素制药有限公司提供）与参比制剂头孢地尼干混悬剂（规格：250mg/5ml，持证商：Aurobindo Pharma Limited），在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂头孢地尼干混悬剂和参比制剂头孢地尼干混悬剂后的安全性。

开始日期2024-05-06

申办/合作机构

广东金城金素制药有限公司

NCT04016051 / Completed临床3期

Comparison of Treatment Satisfaction and Treatment Adherence of a Novel Application Form "Dose Sipping Technology" (DST) of Oral Clarithromycin vs. Clarithromycin Syrup in Children Suffering From Acute Otitis Media, Tonsillitis, Pharyngitis, or Acute Bacterial Bronchitis (DoSe iT)

This study was performed in children with upper respiratory tract infections (acute ear infection, infection of the tonsils or throat, or bacterial inflammation of the bronchi) who needed treatment with an antibiotic (clarithromycin). The study investigated a new technology which delivers the antibiotic in a straw (dose sipping technology, DST) in comparison to a marketed syrup.

开始日期2004-09-22

申办/合作机构

Grünenthal GmbH

100 项与急性细菌性支气管炎相关的临床结果

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100 项与急性细菌性支气管炎相关的转化医学

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0 项与急性细菌性支气管炎相关的专利（医药）

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项与急性细菌性支气管炎相关的文献（医药）

2023-01-01·Frontiers in pediatrics

Clinical features and pathogen distributions of microbiological-based protracted bacterial bronchitis in children of different ages in Northeast China.

Article

作者: Chen, Ning ; Zhang, Han ; Feng, Yong

BackgroundProtracted bacterial bronchitis (PBB) is often diagnosed clinically according to chronic wet cough, which can be resolved by appropriate antibiotics. Though rarely performed in PBB diagnosis, bacterial cultures by sputum or bronchoalveolar lavage (BAL) fluid can provide etiological features, which may be different in western countries and different areas of China. This study aimed to investigate the clinical and etiological features and outcomes in children of different ages with PBB in northeast China.MethodsWe retrospectively analyzed children diagnosed with PBB by positive BAL fluid or sputum bacterial cultures between 2017 and 2021. Children were divided into three age groups: <1 year (infants), 1-5 years (younger children), and ≥6 years (older children). Clinical characteristics, chest radiographic findings, bronchoscopy findings, microbiological findings, treatment strategies, and outcomes were reviewed and compared among the age groups. Factors associated with remission during follow-up were examined using logistic regression.ResultsA total of 45 children with PBB were included, consisting of 24 (53.3%) infants. The infants were often boys and had a shorter cough duration, a lower proportion of expectoration, a greater proportion of wheezing, and less bronchial wall thickening on high-resolution computed tomography compared to older children (P < 0.05). No significant differences were found among the age groups regarding macroscopic findings, except for a higher proportion of tracheobronchial malacia in infants than in older children (P = 0.013). The most commonly cultured bacteria were Haemophilus influenzae (42.2%), followed by Streptococcus pneumoniae (22.2%) and Klebsiella pneumoniae (20.0%). Compared to older children, infants had a higher remission (P = 0.009) and relatively lower relapse rates (P = 0.059). Short duration of cough (OR = 0.58, 95% CI: 0.34-0.99, P = 0.046) and absence of recurrent cephalosporins before diagnosis (OR = 0.05, 95% CI: 0.00-0.73, P = 0.028) were associated with remission.ConclusionsInfants are more prone to PBB, with increased wheezing. Gram-negative bacilli infections are common in infants in northeast China. Older children with PBB should be carefully assessed, treated and followed up, particularly those with long duration of cough and poor response to antibiotic treatments.

2022-11-01·BMJ Paediatrics Open

Protocol for CLASSIC PBB: comparison of lower airway sampling strategies in children with protracted bacterial bronchitis

Article

作者: Bowler, Robert ; Harris, Caroline ; Sinha, Ian ; Brodlie, Malcolm ; Kulkarni, Hemant ; Gilchrist, Francis J ; Aspey, Mathew ; Carroll, William D ; Hinton, Emily ; Desai, Seema ; Stock, Joanne ; Solis-Trapala, Ivonne ; Ogbolosingha, Aviva

BackgroundProtracted bacterial bronchitis (PBB) is an endobronchial infection and a the most common cause of chronic wet cough in young children. It is treated with antibiotics, which can only be targeted if the causative organism is known. As most affected children do not expectorate sputum, lower airway samples can only be obtained by bronchoalveolar lavage (BAL) samples taken during flexible bronchoscopy (FB-BAL). This is invasive and is therefore reserved for children with severe or relapsing cases. Most children with PBB are treated empirically with broad spectrum antibiotics. CLASSIC PBB will compare the pathogen yield from two less invasive strategies with that from FB-BAL to see if they are comparable.Methods131 children with PBB from four UK centres referred FB-BAL will be recruited. When attending for FB-BAL, they will have a cough swab and an induced sputum sample obtained. The primary outcome will be the discordance of the pathogen yield from the cough swab and the induced sputum when compared with FB-BAL. Secondary outcomes will be the sensitivity of each sampling strategy, the success rate of the induced sputum in producing a usable sample and the tolerability of each of the three sampling strategies.DiscussionIf either or both of the two less invasive airway sampling strategies are shown to be a useful alternative to FB-BAL, this will lead to more children with PBB having lower airway samples enabling targeted antibiotic prescribing. It would also reduce the need for FB, which is known to be burdensome for children and their families.Trial registration numberISRCTN79883982.

2022-07-01·American Journal of Physiology-Lung Cellular and Molecular Physiology

Recombinant human β-defensin 2 delivery improves smoking-induced lung neutrophilia and bacterial exacerbation

Article

作者: Bouffard, Gabrielle ; Maranda-Robitaille, Michaël ; Beaulieu, Marie-Josée ; Morissette, Mathieu C. ; Lechasseur, Ariane ; Milad, Nadia ; Pineault, Marie ; Aubin, Sophie ; Jensen, Benjamin A. H.

Treatment of the cigarette smoke-associated lung diseases, such as chronic obstructive pulmonary disease (COPD), has largely focused on broad-spectrum anti-inflammatory therapies. However, these therapies, such as high-dose inhaled corticosteroids, enhance patient susceptibility to lung infection and exacerbation. Our objective was to assess whether the cationic host defense peptide, human β-defensin 2 (hBD-2), can simultaneously reduce pulmonary inflammation in cigarette smoke-exposed mice while maintaining immune competence during bacterial exacerbation. Mice were exposed to cigarette smoke acutely (4 days) or chronically (5 days/wk for 7 wk) and administered hBD-2 intranasally or by gavage. In a separate model of acute exacerbation, chronically exposed mice treated with hBD-2 were infected with nontypeable Haemophilus influenzae before euthanasia. In the acute exposure model, cigarette smoke-associated pulmonary neutrophilia was significantly blunted by both local and systemic hBD-2 administration. Similarly, chronically exposed mice administered hBD-2 therapeutically exhibited reduced pulmonary neutrophil infiltration and downregulated proinflammatory signaling in the lungs compared with vehicle-treated mice. Finally, in a model of acute bacterial exacerbation, hBD-2 administration effectively limited neutrophil infiltration in the lungs while markedly reducing pulmonary bacterial load. This study shows that hBD-2 treatment can significantly attenuate lung neutrophilia induced by cigarette smoke exposure while preserving immune competence and promoting an appropriate host-defense response to bacterial stimuli.

项与急性细菌性支气管炎相关的新闻（医药）

2022-11-02

·药智网

56个品种过评，9个首家过评，注射剂过半！科伦、科睿、山东二叶...

看点 10月CDE新增受理号62个（41个品种、48家企业）10月有74个批文（含视同通过）涉及56个品种过评根据药智数据一致性评价分析系统统计，2022年10月份新增一致性评价受理号有62个；74个批文（含视同通过批文59个）过评（文末附10月申报与过评一致性评价详情表）。图1 2022年1月-2022年10月申报/通过趋势数据来源：药智数据，药智咨询整理过评详情10月累计有74个批文通过/视同通过一致性评价，涉及53家企业的56个品种，其中9个品种首家过评，其中扬子江药业集团北京海燕药业有限公司的注射用尼可地尔和远大生命科学（武汉）有限公司的盐酸戊乙奎醚注射液都以2个规格首家视同通过一致性评价（详情见附表1）。从过评企业而言，10月四川科伦药业有限公司和江西科睿药业有限公司各以3个品种通过或视同通过一致性评价占据了10月企业通过品种数榜首。详情见下图：图2 2022年10月企业通过品种数TOP10数据来源：药智数据，药智咨询整理科伦药业创立于1996年拥有省内外32家子(分)公司，生产基地分布于四川、湖南、黑龙江和云南等九个省区。目前公司有332个批文，31个品种通过一致性评价，3个品种处于补充申请一致性评价申报过程中，还有33个品种视同通过一致性评价，7个品种正处于视同一致性评价申报过程中。10月视同通过的奥硝唑注射液是继甲硝唑、替硝唑之后上市的第三代硝基咪唑类药物，与同类相比具有疗效确切、适用人群更广、不良反应更小等优势，目前已在临床广泛用于普外科、妇产科、儿科等科室。奥硝唑注射剂为2021年国家医保乙类品种，2021年中国公立医院销售18.5亿元。从品种看，10月头孢克肟片有3家企业过评位居榜首。详情见下图：图3 2022年10月品种通过受理号数TOP10数据来源：药智数据，药智咨询整理头孢克肟片目前有19家企业正在生产，共有32个批文和3个规格。可用于急性细菌性支气管炎、慢性支气管炎急性细菌感染性加重、支气管扩张症伴细菌感染、肺炎；肾盂肾炎、膀胱炎；急性胆道系统细菌性感染。目前已有6家企业通过一致性评价，山东鲁抗医药正处于一致性评价申报过程中，万邦德制药集团有限公司正视同一致性评价申报上市。 41个品种申报，注射剂过半2022年10月份CDE新增一致性评价受理号62个，涉及48家企业的41个品种，其中注射剂仍旧占据大壁江山。图4 2022年10月申报剂型详情数据来源：药智数据，药智咨询整理申报品种而言，2022年10月，注射用哌拉西林钠、注射用哌拉西林钠他唑巴坦钠、注射用头孢噻肟钠、注射用氨苄西林钠、盐酸利多卡因注射液、羟乙基淀粉130/0.4氯化钠注射液各有3个受理号被承办并列第一。详情见下图：图5 2022年10月品种申报受理号数TOP10数据来源：药智数据，药智咨询整理注射用哌拉西林钠，是半合成青霉素类抗生素，不耐酶，具广谱抗菌作用。目前生产该产品的有29家企业，69个批准文号和5个规格，暂无通过或视同通过一致性评价，但有7家企业正申报一致性，还有5家企业正以视同通过一致性评价申报上市。10月申报的3个受理号均为山东安信制药有限公司申报。注射用哌拉西林钠他唑巴坦钠为β-内酰胺类抗菌药，可用于缓解由细菌感染引起的不适症状。目前生产该产品的有25家企业，72个批准文号和9个规格，5个企业通过一致性评价，1家企业视同通过一致性评价，同时有8家企业正申报一致性，还有4家企业正以视同通过一致性评价申报上市。10月申报的3个受理号分别为山东鲁抗医药股份有限公司（2个受理号）和瀚晖制药有限公司（1个受理号）申报。从企业角度，10月山东二叶制药有限公司和山东安信制药有限公司各申报3个一致性评价受理号位列第一。详情见下图：图6 2022年10月企业申报受理号数TOP10数据来源：药智数据，药智咨询整理山东二叶制药有限公司于2017年07月18日成立。经营范围包括：生产制剂、原料药、医药中间体，销售公司自产产品。目前山东二叶制药有限公司持有4个品种13个批文，其中3个品种在一致性评价申请阶段。山东安信制药有限公司于2019年09月02日成立。公司经营范围包括：药品生产、销售（不含中药饮品及中成药）（凭许可证经营）；化工原料（不含危险品）的销售；医药辅料及中间体的生产、销售；技术转让、技术咨询服务；普通货运、专用运输（冷藏）等。目前山东安信制药有限公司持有4个品种13个批文，仅10月申报的注射用哌拉西林钠处于一致性评价申报阶段。附表1：2022年10月首家通过（含视同通过）一致性评价详情表附表2：2022年10月通过（含视同通过）一致性评价详情表附表3：2022年10月申报一致性评价详情表注：统计日期：截止2022年10月31日数据来源：药智数据-仿制药一致性评价分析系统PS：药智网公众号【ID:yaozh008】后台回复【10月一致性评价】，即可获取本文图表excel格式文档声明：如需转载，请务必注明文章作者和来源。如涉及作品内容、版权和其它问题，请您留言，我们将在第一时间删除。责任编辑 | 提特转载开白 | 马老师 18323856316（同微信）药智网原创作品 | 尽情分享朋友圈 | 转载请联系授权— Tips —如果您有医药行业相关的线索或对医药政策、研发创新、资本市场、产业发展有深度观察欢迎投稿给我们马老师 18323856316（同微信）邮箱：maxuelian@yaozh.com 阅读原文，是昨天最受欢迎的文章哦

一致性评价仿制药