预约演示
更新于：2025-12-04
Cefdinir
头孢地尼
更新于：2025-12-04
概要
基本信息
简介头孢地尼作为青霉素结合蛋白 (PBP) 抑制剂和细胞壁抑制剂，以商品名 Omnicef 销售，适用于敏感菌引起的感染的治疗和预防。 头孢地尼通过抑制引起感染的细菌（包括链球菌、葡萄球菌和流感嗜血杆菌）的生长和繁殖起作用。 它在多个国家/地区获得批准，包括美国、中国、日本和韩国。 Omnicef 有胶囊剂或口服混悬剂两种形式，通常根据感染的严重程度每天服用一次或两次。 值得注意的是，应该仅将这种药物用于治疗或预防细菌感染，因为过度使用或误用会导致耐药细菌的产生。 |
药物类型 小分子化药 |
别名 Cefdinir (JP17/USP/INN)、Cefzon Capsule、CFDN + [19] |
靶点 |
作用方式 抑制剂 |
作用机制 PBPs抑制剂(细菌青霉素结合蛋白家族抑制剂)、细胞壁抑制剂 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (1991-10-04), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C14H13N5O5S2 |
InChIKeyRTXOFQZKPXMALH-GHXIOONMSA-N |
CAS号91832-40-5 |
关联
84
项与 头孢地尼 相关的临床试验NCT06406114
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
CTR20244791
头孢地尼颗粒人体生物等效性研究
CTR20243582
中国健康受试者空腹和餐后口服STBN的随机、开放、两序列、两周期、双交叉设计的生物等效性试验
100 项与 头孢地尼 相关的临床结果
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100 项与 头孢地尼 相关的转化医学
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100 项与 头孢地尼 相关的专利（医药）
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965
项与 头孢地尼 相关的文献（医药）2025-12-01JOURNAL OF INFECTION AND CHEMOTHERAPY
Development of two methods for detecting Streptococcus mitis/oralis-related species with meropenem-non-susceptibility
Article
作者: Kimura, Kouji ; Shibayama, Keigo ; Kinoshita-Daitoku, Ryo ; Kuri, Kazuto ; Arakawa, Yoshichika
Several studies have reported clinical isolates of Streptococcus mitis, Streptococcus oralis, and their related species (S. mitis/oralis group) with reduced carbapenem susceptibility. However, to date, no simple and accurate methods of detecting S. mitis/oralis group isolates with reduced carbapenem susceptibility have been reported. The meropenem ETEST misinterpreted 3 of 25 (12 %) meropenem-non-susceptible S. mitis/oralis group isolates as susceptible to meropenem. Therefore, we screened 38 disks containing 38 different β-lactams to detect S. mitis/oralis group strains with reduced carbapenem susceptibility using the disk-diffusion method. Additionally, using the agar dilution method to determine susceptibility, we identified the optimal antibiotic concentrations in agar medium to enable selective culture of meropenem-non-susceptible S. mitis/oralis group by culturing 25 meropenem-non-susceptible (meropenem minimum inhibitory concentration [MIC] >0.5 μg/mL) and 24 meropenem-susceptible (meropenem MIC ≤0.5 μg/mL) S. mitis/oralis group isolates on agar containing different concentrations of six β-lactams. Meropenem-susceptible and non-susceptible S. mitis/oralis group isolates were successfully differentiated using oxacillin- and cefoxitin-containing disks. Moreover, cefdinir-, flomoxef-, meropenem-, and doripenem-containing disks showed clear differences in the growth inhibitory zone diameter between the meropenem-susceptible and meropenem-non-susceptible S. mitis/oralis group isolates. Media containing 2 μg/mL oxacillin, 4-16 μg/mL cefoxitin, 2 μg/mL cefdinir, 2-4 μg/mL flomoxef, 0.06-0.25 μg/mL meropenem, and 0.06-0.12 μg/mL doripenem allowed selective culture of meropenem-non-susceptible S. mitis/oralis group strains. The disk-diffusion method using six β-lactam-containing disks and selective culture agar medium are the first-reported simple and accurate methods of detecting meropenem-non-susceptible S. mitis/oralis group suitable for use in clinical microbiology laboratories.
2025-11-24JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
Results from the Survey of Antibiotic Resistance (SOAR) 2018–21 in Tunisia: data based on CLSI, EUCAST (dose-specific) and pharmacokinetic/pharmacodynamic (PK/PD) breakpoints
Article
作者: Torumkuney, Didem ; Hawser, Stephen ; Hammami, Adnene ; Slim, Leila ; Manenzhe, Rendani ; Manoharan, Anand
Abstract:
Objectives:
To determine the antibiotic susceptibility of community-acquired respiratory tract infection (CA-RTI) isolates of Streptococcus pneumoniae and Haemophilus influenzae collected in 2018–21 from two hospitals in Tunisia.
Methods:
MICs were determined by CLSI broth microdilution, and susceptibility data were interpreted using CLSI, EUCAST (dose-specific) and pharmacokinetic/pharmacodynamic (PK/PD) breakpoints.
Results:
S. pneumoniae (n = 58) and H. influenzae (n = 71) isolates were collected; 22.4% of pneumococci were penicillin-susceptible by CLSI oral/EUCAST low-dose breakpoints, but 89.7% were susceptible by EUCAST high-dose/CLSI intravenous administration breakpoints. Susceptibility to ceftriaxone, levofloxacin and moxifloxacin was ≥91.4% by CLSI or PK/PD breakpoints which reduced to 82.8%–87.9% for amoxicillin, amoxicillin/clavulanic acid and cefotaxime. Tetracyclines, macrolides and trimethoprim/sulfamethoxazole were 41.4%–65.5% susceptible, with cefdinir and second-generation cephalosporins less active (24.1%–51.7% susceptible). EUCAST indicated ≥96.6% susceptibility only to high-dose ceftriaxone, moxifloxacin and high-dose levofloxacin. Most H. influenzae (66.2%) were β-lactamase negative, of which six and two isolates were ampicillin-resistant following EUCAST and CLSI criteria, respectively. Antibiotic susceptibility was ≥91.5% (CLSI) except for ampicillin (60.6%) and trimethoprim/sulfamethoxazole (77.5%). Susceptibility by EUCAST was lower than CLSI for most other antimicrobials, except for high dose amoxicillin/clavulanic acid (93.0% by EUCAST, 97.2% high dose PK/PD). Both CLSI and EUCAST showed 100% susceptibility to ceftriaxone.
Conclusions:
Few therapeutic options with ≥90% susceptibility for the treatment of S. pneumoniae from CA-RTIs in Tunisia remain. Although H. influenzae isolates displayed higher susceptibility, only ceftriaxone provides 100% coverage for both species following CLSI and EUCAST guidelines. Continued surveillance is important for guiding empiric therapy.
2025-11-24JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
Results from the Survey of Antibiotic Resistance (SOAR) 2018–21 in Pakistan: data based on CLSI, EUCAST (dose-specific) and pharmacokinetic/pharmacodynamic (PK/PD) breakpoints
Article
作者: Torumkuney, Didem ; Nizamuddin, Summiya ; Morrissey, Ian ; Manoharan, Anand ; Manenzhe, Rendani
Abstract:
Objectives:
To determine the antibiotic susceptibility of Streptococcus pneumoniae and Haemophilus influenzae isolates from community-acquired respiratory tract infections (CA-RTIs) collected in 2018–21 from Pakistan.
Methods:
MICs were determined by CLSI broth microdilution; susceptibility data were interpreted using CLSI, EUCAST and pharmacokinetic/pharmacodynamic (PK/PD) breakpoints.
Results:
S. pneumoniae (n = 57) and H. influenzae (n = 67) were collected from the Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan. The proportion of penicillin-susceptible pneumococci was 28.1% by CLSI oral/EUCAST low-dose breakpoints; 98.3%/98.2% were susceptible by EUCAST high-dose/CLSI intravenous breakpoints. Good activity (≥93.0%) was observed using CLSI or PK/PD breakpoints for amoxicillin, amoxicillin/clavulanic acid, cefotaxime, cefpodoxime, ceftriaxone, cefuroxime, levofloxacin and moxifloxacin. Cefdinir and cefaclor were less active (75.4% and 57.9%, respectively, by CLSI and 61.4% and 19.3%, respectively, by PK/PD). Tetracyclines, macrolides and trimethoprim/sulfamethoxazole were poorly active (5.3%–36.8%). EUCAST high-dose breakpoints indicated similar activity, although susceptibility to cefaclor (0%), cefpodoxime (70.2%) and cefuroxime (68.4%) was lower than by CLSI. Most H. influenzae isolates were β-lactamase negative (95.5%). Generally, antibiotic susceptibility was >83.6% by CLSI for all antibiotics except trimethoprim/sulfamethoxazole (13.4%). Susceptibility by EUCAST was similar, except for cefuroxime (oral), with 0% susceptible isolates versus 95.5% by CLSI and 67.2% by PK/PD, fluoroquinolones and macrolides (no EUCAST breakpoint). Macrolide susceptibility by PK/PD breakpoints was low.
Conclusions:
Although antimicrobial resistance was observed, many therapeutic options remain to treat S. pneumoniae and H. influenzae from CA-RTI in Pakistan despite concerns about high levels of inappropriate antibiotic use. Continued surveillance of antibiotic susceptibility is important for guiding empiric therapy of CA-RTIs.
100 项与 头孢地尼 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 支气管炎 | 日本 | 2017-04-27 | |
| 膀胱炎 | 日本 | 2017-04-27 | |
| 中耳炎 | 日本 | 2017-04-27 | |
| 细菌性肺炎 | 日本 | 2017-04-27 | |
| 鼻窦炎 | 日本 | 2017-04-27 | |
| 细菌性皮肤疾病 | 日本 | 2017-04-27 | |
| 急性上颌窦炎 | 美国 | 1997-12-04 | |
| 细菌性中耳炎 | 美国 | 1997-12-04 | |
| 慢性支气管炎 | 美国 | 1997-12-04 | |
| 社区获得性肺炎 | 美国 | 1997-12-04 | |
| 简单的皮肤和皮肤结构感染(uSSSI) | 美国 | 1997-12-04 | |
| 咽炎 | 美国 | 1997-12-04 | |
| 扁桃体炎 | 美国 | 1997-12-04 | |
| 细菌感染 | 日本 | 1991-10-04 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 急性中耳炎 | 临床3期 | 美国 | 2002-07-01 | |
| 急性中耳炎 | 临床3期 | 智利 | 2002-07-01 | |
| 急性中耳炎 | 临床3期 | 哥斯达黎加 | 2002-07-01 | |
| 急性中耳炎 | 临床3期 | 多米尼加共和国 | 2002-07-01 | |
| 急性中耳炎 | 临床3期 | 危地马拉 | 2002-07-01 | |
| 急性中耳炎 | 临床3期 | 以色列 | 2002-07-01 | |
| 急性中耳炎 | 临床3期 | 巴拿马 | 2002-07-01 | |
| 肺炎 | 临床1期 | 中国 | - | 2013-10-15 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 385 | (Short Course) | 獵鏇網窪網築廠壓窪壓: Pr (Higher DOOR in Short-Course) = 0.69 (95% CI, 0.63 ~ 0.75), P-Value = <0.001 更多 | - | 2021-02-03 | ||
(Standard Course) | |||||||
临床1期 | - | 32 | (Cefdinir (Test)) | 衊願觸膚範獵廠憲艱鹽(遞願簾範製糧夢鬱夢糧) = 衊鬱壓廠蓋積鏇鑰製遞 齋簾窪艱鏇襯鹽構簾糧 (夢選鹽顧範鏇廠簾廠餘, 775.044) 更多 | - | 2009-07-21 | |
(Omnicef® (Reference)) | 衊願觸膚範獵廠憲艱鹽(遞願簾範製糧夢鬱夢糧) = 鑰鏇製願簾鏇鹹願齋範 齋簾窪艱鏇襯鹽構簾糧 (夢選鹽顧範鏇廠簾廠餘, 732.845) 更多 | ||||||
临床1期 | - | 32 | (Cefdinir (Test)) | 蓋顧衊觸鹽蓋範構蓋繭(淵選憲簾繭鹹鹹壓鹹製) = 遞製願積窪襯醖窪鑰簾 鹽餘鬱壓壓鏇鑰簾構膚 (顧簾鹹淵蓋積夢襯憲鏇, 882.84) 更多 | - | 2009-07-21 | |
(Omnicef® (Reference)) | 蓋顧衊觸鹽蓋範構蓋繭(淵選憲簾繭鹹鹹壓鹹製) = 淵鑰鑰願鑰蓋壓膚壓選 鹽餘鬱壓壓鏇鑰簾構膚 (顧簾鹹淵蓋積夢襯憲鏇, 823.85) 更多 | ||||||
临床1期 | - | 32 | (Cefdinir (Test)) | 襯繭簾膚醖遞醖繭壓蓋(夢憲齋鑰廠願餘蓋遞艱) = 構淵鏇蓋積夢選顧鏇製 製鹹積鬱壓鑰遞築襯糧 (廠鏇鬱窪鏇遞遞艱觸構, 537.12) 更多 | - | 2009-07-21 | |
(Omnicef® (Reference)) | 襯繭簾膚醖遞醖繭壓蓋(夢憲齋鑰廠願餘蓋遞艱) = 窪遞觸憲壓鑰積構衊齋 製鹹積鬱壓鑰遞築襯糧 (廠鏇鬱窪鏇遞遞艱觸構, 481.25) 更多 | ||||||
临床1期 | - | 32 | (Cefdinir (Test)) | 衊網淵蓋衊繭繭窪選襯(襯衊繭網糧選糧襯鹽鬱) = 夢膚淵選醖鬱膚築範觸 觸觸糧鏇鬱獵簾獵壓餘 (艱衊糧壓網廠積遞顧餘, 573.068) 更多 | - | 2009-07-21 | |
(Omnicef® (Reference)) | 衊網淵蓋衊繭繭窪選襯(襯衊繭網糧選糧襯鹽鬱) = 淵夢鑰鬱願簾蓋顧鹽網 觸觸糧鏇鬱獵簾獵壓餘 (艱衊糧壓網廠積遞顧餘, 531.404) 更多 |
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